510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD October 2022
DEVICE: Velano Vascular Blood Collection Adapter
Velano Vascular 510(k) NO: K201237(Traditional)
ATTN: Tiffini Wittwer PHONE NO : 844 8352668
221 Pine Street #200 SE DECISION MADE: 03-OCT-22
San Francisco CA 94104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mico One Orthodontic Screw
Ze Fang Technology Co., Ltd. 510(k) NO: K202163(Traditional)
ATTN: Anita Chen PHONE NO : 8860 939 855759
No.17, Aly. 81, Ln. 2, Sec. 1, ZhoSE DECISION MADE: 07-OCT-22
Taichung TW 412 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aurolase Therapy, Laser Delivery Device (LDD)
Nanospectra Biosciences, Inc. 510(k) NO: K202953(Traditional)
ATTN: David Jorden PHONE NO : 713 8422720
8285 El Rio Street, #150 SE DECISION MADE: 03-OCT-22
Houston TX 77054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nova Primary Glucose Analyzer System
Nova Biomedical Corporation 510(k) NO: K203549(Traditional)
ATTN: Rachel Gilbert PHONE NO : 781 6473700 1724
200 Prospect Street SE DECISION MADE: 18-OCT-22
Waltham ME 02454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AT-Patch ECG Analysis System
ATsens Co., Ltd 510(k) NO: K203638(Traditional)
ATTN: KeonHoon Lee PHONE NO : 82 70 52200220
Point Town 806, 11, Gumi-ro, BundaSE DECISION MADE: 12-OCT-22
Seongnam-si KR 13637 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown, Model number: IL-4036YKTP-L4, CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown, Model number: IL-4063WKTP-L4, CoverU Disposable Gown with Tape Chemo Gown, Model number: IL-4036YKTP-CM, CoverU Disposable Gown with Tape Chemo Gown, Model number: IL-4063WKTP-CM
Medtecs (Taiwan) Corp. 510(k) NO: K210414(Traditional)
ATTN: William Yang PHONE NO : 886 2 27392222
11F., No. 9, Songgao Road, Xinyi DSE DECISION MADE: 21-OCT-22
Taipei City TW 11073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Gown Rk-3011C
Xiantao Rhycom Non-woven Products 510(k) NO: K211060(Traditional)
ATTN: Liu Yang PHONE NO : 86 152 71157850
Chuangye Road, Longhuashan Sub-disSE DECISION MADE: 28-OCT-22
Xiantao CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)
Guangzhou Sonostar Technologies Co510(k) NO: K211321(Abbreviated)
ATTN: Weizhong Cai PHONE NO : 86 20 32382095
504#, C Building,#27 Yayingshi RoaSE DECISION MADE: 13-OCT-22
Guangzhou CN 510665 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Proximerge 2 Dental Implant System
Quadric BioMed, LLC 510(k) NO: K211409(Traditional)
ATTN: Aaron Bass PHONE NO : 719 2700755
640 Southpointe Court #150 SE DECISION MADE: 19-OCT-22
Colorado Springs CO 80906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CREOKORREKT Aligners
CreoDent Prosthetics LTD 510(k) NO: K211427(Traditional)
ATTN: Calvin Shim PHONE NO : 212 3023860
515 West 45th Street 11FL SE DECISION MADE: 13-OCT-22
New York NY 10036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CASSATT™ SIJ Fixation System
CTL Medical Corporation 510(k) NO: K211785(Traditional)
ATTN: Sean Suh PHONE NO : 214 5455820
4550 Excel Parkway SE DECISION MADE: 17-OCT-22
Addison TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PiezoImplant System
Rex Implants, Inc. 510(k) NO: K211872(Traditional)
ATTN: Giuseppe Vercellotti PHONE NO : 614 4594922
850 Michigan Avenue SE DECISION MADE: 12-OCT-22
Columbus OH 43215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)
ARFTX Medical LLC 510(k) NO: K211892(Traditional)
ATTN: Ozgen Ozfidan PHONE NO : 917 4452085
50 Laura Street #2524 SE DECISION MADE: 06-OCT-22
Jacksonville FL 32202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A&D Medical UM-212BLE Blood Pressure Monitor
A&D Company, Ltd 510(k) NO: K212168(Traditional)
ATTN: Chanda Melville PHONE NO : 678 2308565
1756 Automation Parkway SE DECISION MADE: 06-OCT-22
San Jose CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PCA Syringe Sets
Baxter Healthcare Corporation 510(k) NO: K212262(Traditional)
ATTN: Jeffrey E. Thompson PHONE NO : 224 2703806
25212 West Illinois Route 120 SE DECISION MADE: 03-OCT-22
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MCI-Neuro Fixation System
MCI Medical Concept Innovation Inc510(k) NO: K212391(Traditional)
ATTN: Carlos Lacerda PHONE NO : 01 954 3062521
4592 North Hiatus Road SE DECISION MADE: 21-OCT-22
Sunrise FL 33351 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Welch Allyn Connex Central Station
Welch Allyn, Inc. 510(k) NO: K212473(Traditional)
ATTN: Megan Pellenz PHONE NO : 315 5694257
4341 State Street Road SE DECISION MADE: 28-OCT-22
Skaneateles Falls NY 13153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KODEX – EPD™ System 1.5.0
Philips Medical Systems Nederland,510(k) NO: K212493(Traditional)
ATTN: Betina Schepers PHONE NO : 31 611 710116
Veenpluis 4-6 SE DECISION MADE: 24-OCT-22
Best NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Face Mask
Lyncmed Medical Technology (Beijin510(k) NO: K212649(Traditional)
ATTN: Naomi Zhou PHONE NO : 86 10 86468058
Room 1601, Building No. 2, ZhubangSE DECISION MADE: 25-OCT-22
Beijing CN 100022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IM/ST Fixture System
Guilin FiTeeth Medical Instrument 510(k) NO: K212702(Traditional)
ATTN: Jun Zhou PHONE NO : 86 773 2350558
Southeast Side of Renmin Road ExteSE DECISION MADE: 13-OCT-22
Guilin CN 541199 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORAcollect®•Dx
DNA Genotek Inc 510(k) NO: K212745(Traditional)
ATTN: Austin Udocor PHONE NO : 613 3153476
3000 - 500 Palladium Drive SE DECISION MADE: 27-OCT-22
Ottawa CA K2V 1C2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATTUNE Revision Cones
Depuy Ireland UC 510(k) NO: K212746(Traditional)
ATTN: Erin Combs PHONE NO : 574 4048348
Loughbeg SE DECISION MADE: 17-OCT-22
Ringaskiddy IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
CoaguSense, Inc. 510(k) NO: K212779(Special)
ATTN: Michael Acosta PHONE NO : 510 8922379
48377 Fremont Blvd. Suite 113 SE DECISION MADE: 05-OCT-22
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Varixis Elbow System
Auxein Medical Private Limited 510(k) NO: K213014(Traditional)
ATTN: Rahul Luthra PHONE NO : 91 971 7586969
Plot No.168,169,170 Phase-IV, SectSE DECISION MADE: 03-OCT-22
Sonipat IN 131028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STIMPOD NMS450 Nerve Stimulator
Xavant Technology (Pty) Ltd 510(k) NO: K213049(Traditional)
ATTN: Roche Janse van Rensburg PHONE NO : 27 12 7435959
Unit 102 Tannery Industrial Park, SE DECISION MADE: 16-OCT-22
Pretoria ZA 0184 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SuperCheck Pro Blood Glucose Monitoring System
OK BioTech Co., Ltd. 510(k) NO: K213061(Traditional)
ATTN: Laurie Liu PHONE NO : 886 3 5160258___
No. 91, Sec. 2, Gongdao 5th Rd. SE DECISION MADE: 07-OCT-22
Hsinchu City TW 30070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BTI Interna Dental Implant System UnicCa - Prosthetic Components
B.T.I. Biotechnology Institute, SL510(k) NO: K213106(Traditional)
ATTN: Jose Ramon Rivero PHONE NO : 0034 945 297030
Leonardo Da Vinci 14, Parque TechnSE DECISION MADE: 20-OCT-22
Minano ES 01510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OW100S (model OW100S-US)
Tissue Regeneration Technologies, 510(k) NO: K213120(Traditional)
ATTN: John Warlick PHONE NO :
251 Heritage Walk SE DECISION MADE: 12-OCT-22
Woodstock GA 30188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOS Wrist Spanning Plate
Smith & Nephew, Inc. 510(k) NO: K213123(Traditional)
ATTN: Jyothsna Baravatula PHONE NO : 901 4565171
1450 E Brooks Rd SE DECISION MADE: 18-OCT-22
Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: System, Image Processing, Radiological
Xironetic, LLC 510(k) NO: K213128(Traditional)
ATTN: Christian El Amm PHONE NO : 405 4123574
712 N Broadway Ave SE DECISION MADE: 21-OCT-22
Oklahoma City OK 73102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Safety Insulin Pen Needles
Zhejiang Kindly Medical Devices Co510(k) NO: K213183(Traditional)
ATTN: Yong Zhang PHONE NO : 86 138 06556169
No.758, 5th Binhai Road, Binhai InSE DECISION MADE: 14-OCT-22
Wenzhou CN 325025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIFE A1AT kit
Helena Laboratories, Corp. 510(k) NO: K213396(Traditional)
ATTN: Rachel Easley PHONE NO : 409 8423714
1530 Lindbergh Drive SE DECISION MADE: 13-OCT-22
Beaumont TX 77707 510(k) STATEMENT
DEVICE: AccuSert Needle Inserter
Emed Technologies Corporation 510(k) NO: K213429(Traditional)
ATTN: Peter Kollings PHONE NO : 916 9320071
1262 Hawks Flight Ct, Ste. 200 SE DECISION MADE: 20-OCT-22
El Dorado Hills CA 95762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HemosIL Liquid Anti-Xa
Instrumentation Laboratory Co. 510(k) NO: K213464(Special)
ATTN: Carol Marble PHONE NO : 781 8614467
180 Hartwell Road SE DECISION MADE: 04-OCT-22
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Houdini Cross Support Catheter
Cruzar Medsystems Inc 510(k) NO: K213466(Traditional)
ATTN: Dave Tornatore PHONE NO : 412 9656673
50 Braintree Hill Office Park SuitSE DECISION MADE: 20-OCT-22
Braintree MA 02184 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps
Katalyst Surgical, LLC 510(k) NO: K213610(Traditional)
ATTN: Liz Morgan PHONE NO : 636 5365950
754 Goddard Ave SE DECISION MADE: 07-OCT-22
Chesterfield MO 63005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuCath Wedge Pressure Catheter
PFM Medical, Inc. 510(k) NO: K213666(Traditional)
ATTN: Jessica Jho PHONE NO : 760 7588749
1916 Palomar Oaks Way Suite 150 SE DECISION MADE: 06-OCT-22
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eclipse Blood Collection Set
Eclipse Medcorp LLC 510(k) NO: K213690(Traditional)
ATTN: Julie Summerville PHONE NO : 972 3802911
5916 Stone Creek Drive Suite #120 SE DECISION MADE: 26-OCT-22
The Colony TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORiGO System
Bien-Air Surgery SA 510(k) NO: K213697(Traditional)
ATTN: Sveva Crivelli PHONE NO : 41 32 3446440
Rue de l'Ouest 2b SE DECISION MADE: 31-OCT-22
Le Noirmont CH 2340 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infinity Pro, Logic, Quality, Sprint
Olsen Indústria e Comércio S.A. 510(k) NO: K213742(Traditional)
ATTN: Ana Cláudia Espíndola PHONE NO : 55 48 21066000
Av. Ivo Luchi, 68 SE DECISION MADE: 19-OCT-22
Palhoça BR 88133-510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoreLevee
Lutronic Corporation 510(k) NO: K213748(Traditional)
ATTN: Haewon Park PHONE NO : 978 4474763
Lutronic Center, 219, Sowon-Ro SE DECISION MADE: 14-OCT-22
Deogyang-Gu, Goyang-si KR 410220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
Roche Molecular Systems, Inc. 510(k) NO: K213804(Traditional)
ATTN: Rita Hoady PHONE NO : 925 4871055
4300 Hacienda Drive SE DECISION MADE: 22-OCT-22
Pleasanton CA 94588-2722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONVOY Acetabular System
Globus Medical Inc. 510(k) NO: K213842(Traditional)
ATTN: Jennifer Antonacci PHONE NO : 610 9301800 1861
2560 General Armistead Ave. SE DECISION MADE: 03-OCT-22
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HeartFlow Analysis
HeartFlow, Inc. 510(k) NO: K213857(Traditional)
ATTN: Windi Hary PHONE NO : 415 5313435
1400 Seaport Boulevard, Building BSE DECISION MADE: 14-OCT-22
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VisionAir Patient-Specific Airway Stent
New COS Inc. DBA VisionAir Solutio510(k) NO: K213969(Traditional)
ATTN: Keith Grafmeyer PHONE NO : 440 3134099
7100 Euclid Ave, Ste 180 SE DECISION MADE: 07-OCT-22
Cleveland OH 44103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TELIGEN System
Medos International, SARL 510(k) NO: K213978(Traditional)
ATTN: Daria Bochenek PHONE NO : 41 61 9656154
Chemin-Blanc 38 SE DECISION MADE: 18-OCT-22
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520
TP Orthodontics, Inc. 510(k) NO: K214054(Traditional)
ATTN: Cristiane Muller PHONE NO : 219 7852591
100 Center Plaza SE DECISION MADE: 14-OCT-22
La Porte IN 46350-9672 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: eWave Monitor
WearLinq, Inc. 510(k) NO: K214073(Traditional)
ATTN: Konrad Morzkowski PHONE NO : 650 7858742
1819 Polk St #148 SE DECISION MADE: 20-OCT-22
San Francisco CA 94109 510(k) STATEMENT
DEVICE: PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
Kontour(Xi’an) Medical Technology 510(k) NO: K214109(Traditional)
ATTN: Rongrong Cong PHONE NO : 086 29 63364685
No.6, Qinling Avenue, Caotang TechSE DECISION MADE: 28-OCT-22
Xi'an CN 710304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AAMI4 Isolation Gown
Hubei Xinxin Non-woven Co.,Ltd. 510(k) NO: K214116(Traditional)
ATTN: Nicole Jin PHONE NO : 86 728 2618155
Taizihu Industrial Park, PengchangSE DECISION MADE: 11-OCT-22
Xiantao CN 433018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization
Shinva Ande Healthcare Apparatus C510(k) NO: K220057(Traditional)
ATTN: Xiaolei Tian PHONE NO : 86 0533 3917821
No.77 Development Zone North Road,SE DECISION MADE: 07-OCT-22
Zibo CN 255086 510(k) STATEMENT
DEVICE: YADU Surgical Gowns
HeNan YADU Industrial Co., Ltd. 510(k) NO: K220092(Traditional)
ATTN: Charles Shen PHONE NO : 1 608 2179358
No. 234, West Jianpu Road SE DECISION MADE: 07-OCT-22
Changyuan CN 453400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: eClinic Stethopod
HomeDiagnostic LLC 510(k) NO: K220099(Third Party - Traditional)
ATTN: Jian Gong PHONE NO : 1 866 9764038
3160 De La Cruz Blvd Suite 100 SE DECISION MADE: 20-OCT-22
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MOST-T Autoclave
Shinva Medical Instrument Co., Ltd510(k) NO: K220102(Traditional)
ATTN: Liu Xiaolin PHONE NO : 86 0533 3587752
Xinhua Medical Scientific Zone, ZiSE DECISION MADE: 12-OCT-22
Zibo CN 255086 510(k) STATEMENT
DEVICE: RespiraSense
PMD Solutions 510(k) NO: K220111(Traditional)
ATTN: Sinead O'Sullivan PHONE NO : 353 0 212428760
Bishopstown House Model Farm Rd SE DECISION MADE: 07-OCT-22
Cork IE T12 T922 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIREFLY® Cervical Navigation Guide
Mighty Oak Medical Inc. 510(k) NO: K220132(Traditional)
ATTN: Mark A. Wylie PHONE NO : 720 3989703
750 W. Hampden Avenue, Suite 120 SE DECISION MADE: 26-OCT-22
Englewood CO 80110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP
LED SpA 510(k) NO: K220138(Traditional)
ATTN: Amalia Lamberti PHONE NO : 39 06 92870045
Via Selciatella, 40 SE DECISION MADE: 05-OCT-22
Aprilia IT 04011 510(k) STATEMENT
DEVICE: ClearCorrect System
ClearCorrect, LLC 510(k) NO: K220140(Traditional)
ATTN: Christopher Klaczyk PHONE NO : 512 8315128
21 Cypress Boulevard, Suite 1010 SE DECISION MADE: 05-OCT-22
Round Rock TX 78665 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electrically Powered Wheelchair, Joy Rider
Tung Keng Enterprise Co., Ltd. 510(k) NO: K220156(Traditional)
ATTN: Jen Ke-Min PHONE NO : 886 4 25351000
No. 1, Lane 160, Sec. 2, Tan-Fu RoSE DECISION MADE: 07-OCT-22
Taichung City CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Enteral Transition Adaptor
GBUK Group Ltd 510(k) NO: K220165(Traditional)
ATTN: Rachael Hume PHONE NO : 44 0 1757606992
Blackwood Hall Business Park, NortSE DECISION MADE: 21-OCT-22
Selby GB YO85DD 510(k) STATEMENT
DEVICE: SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)
Bionet Co., Ltd. 510(k) NO: K220169(Traditional)
ATTN: ChuelWon Lee PHONE NO : 82 102 0672442
5F, 61 Digital-ro 31-gil Guro-gu SE DECISION MADE: 11-OCT-22
Seoul KR 08375 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The GIRO Growth Modulation System
Pega Medical, Inc. 510(k) NO: K220190(Traditional)
ATTN: Ariel R. Dujovne PHONE NO : 450 6885144 241
1111 Autoroute Chomedey SE DECISION MADE: 24-OCT-22
Laval CA H7W 5J8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electronic Sphygmomanometer (Model: LT-P30)
Zhuhai Linte Medical Instrument Co510(k) NO: K220220(Traditional)
ATTN: Wallace Huang PHONE NO : 86 1382 3146691
4th Floor, Building 1, No.66, YongSE DECISION MADE: 03-OCT-22
Zhuhai CN 519090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Auto Folding Scooter, S21F
Heartway Medical Products Co., Ltd510(k) NO: K220227(Traditional)
ATTN: Ke-Min Jen PHONE NO : 886 4 23583232
No.18, Jingke Central 1st Rd., NanSE DECISION MADE: 12-OCT-22
Taichung City TW 40852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIM-Ablation
MIM Software Inc. 510(k) NO: K220256(Traditional)
ATTN: Daniel Darkow PHONE NO : 216 4550600
25800 Science Park Drive - Suite 1SE DECISION MADE: 07-OCT-22
Cleveland OH 44122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSafe NeuFlo Needleless Connector
Amsino International, Inc. 510(k) NO: K220267(Traditional)
ATTN: Jane Gao PHONE NO : 86 139 16147664
708 Corporate Center Drive SE DECISION MADE: 07-OCT-22
Pomona CA 91768 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Onetouch Non-paraben Lubricant Gel
Thai Nippon Rubber Industry Public510(k) NO: K220273(Traditional)
ATTN: Tossaporn Nilkhamhang PHONE NO : 66 38 317999
789/139 Pinthong Industrial EstateSE DECISION MADE: 21-OCT-22
Sriracha TH 20230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
Syntheon 510(k) NO: K220305(Traditional)
ATTN: Sean McBryer PHONE NO : 305 2663388
13755 SW 119 Avenue SE DECISION MADE: 28-OCT-22
Miami FL 33186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAL Infiltration System
MicroAire Surgical Instruments, LL510(k) NO: K220318(Traditional)
ATTN: Glenn Gerstenfeld PHONE NO : 434 9758013
3590 Grand Forks Blvd SE DECISION MADE: 14-OCT-22
Charlottesville VA 22911 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uMR Omega with uWS-MR-MRS
Shanghai United Imaging Healthcare510(k) NO: K220332(Traditional)
ATTN: Xin Gao PHONE NO :
NO.2258 Chengbei Road, Jiading DisSE DECISION MADE: 27-OCT-22
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gemini Sterilization Wrap
Medline Industries, LP 510(k) NO: K220365(Traditional)
ATTN: Jennifer Mason PHONE NO : 847 6433652
Three Lakes Drive SE DECISION MADE: 06-OCT-22
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PADnet Xpress
Collaborative Care Diagnostics LLC510(k) NO: K220527(Special)
ATTN: James Hartnett PHONE NO : 651 2805570
860 Blue Gentian Rd Suite 180 SE DECISION MADE: 20-OCT-22
Eagan MN 55121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Colibrí System
Copan WASP S.r.l. 510(k) NO: K220546(Traditional)
ATTN: Giovanna Catalano PHONE NO : 39 331 6746551
Via A. Grandi, 32 SE DECISION MADE: 05-OCT-22
Brescia IT 25125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hudson RCI Triflo II Incentive Deep Breathing Exerciser
Medline Industries, Inc. 510(k) NO: K220565(Traditional)
ATTN: Nicole Schaffer PHONE NO : 724 6409680
1 Three Lakes Drive SE DECISION MADE: 25-OCT-22
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
Penumbra, Inc. 510(k) NO: K220683(Traditional)
ATTN: Sindokht (Sisi) SoltanzadehPHONE NO : 269 3309520
One Penumbra Place SE DECISION MADE: 04-OCT-22
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BriefCase
Aidoc Medical, Ltd. 510(k) NO: K220709(Traditional)
ATTN: Nimrod Epstein PHONE NO : 972 73 7946870
3 Aminadav St., SE DECISION MADE: 07-OCT-22
Tel Aviv IL 6706703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: allFlex Ureteral Catheters, Krait Ureteral Catheters
Allwin Medical Devices, Inc 510(k) NO: K220730(Traditional)
ATTN: Digish Mehta PHONE NO : 714 5721709
3305 E. Miraloma Avenue, Suite 176SE DECISION MADE: 13-OCT-22
Anaheim CA 92806 510(k) STATEMENT
DEVICE: VITEK 2 AST-Gram Positive Cefoxitin Screen
bioMerieux, Inc 510(k) NO: K220805(Traditional)
ATTN: Debra Broyles PHONE NO : 314 7318805
595 Anglum Rd. SE DECISION MADE: 13-OCT-22
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Preat Abutments
Preat Corporation 510(k) NO: K220823(Traditional)
ATTN: Chris Bormes PHONE NO : 1 800 2327732
2625 Skyway Dr, Suite B SE DECISION MADE: 26-OCT-22
Santa Maria CA 93455 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iCare IC200
Icare Finland Oy 510(k) NO: K220852(Traditional)
ATTN: Hannes Hyvönen PHONE NO : 358 9 87751150
Ayritie 22 SE DECISION MADE: 06-OCT-22
Vantaa FI 01510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PicoWay Laser System
Candela Corporation 510(k) NO: K220853(Traditional)
ATTN: Danielle Gibboney PHONE NO : 617 9043820
251 Locke Drive SE DECISION MADE: 13-OCT-22
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-CUBE 50, X-CUBE 60
Alpinion Medical Systems Co., Ltd.510(k) NO: K220857(Traditional)
ATTN: Boyeon Cho PHONE NO : 82 70 74652104
5FL, I dong, 77, heungan-daero 81bSE DECISION MADE: 13-OCT-22
Anyang-si KR 14117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vapotherm Aerosol Adapter AAA-2
Vapotherm Inc. 510(k) NO: K220869(Traditional)
ATTN: Michael J. Webb PHONE NO : 978 3147212
100 Domain Drive SE DECISION MADE: 28-OCT-22
Exeter NH 03833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel
BioFire Defense, LLC 510(k) NO: K220870(Traditional)
ATTN: Cynthia Pillips PHONE NO : 801 2623592 1370
79 W 4500 S, Suite 14 SE DECISION MADE: 20-OCT-22
Salt Lake City UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex BioSuture
Arthrex Inc. 510(k) NO: K220880(Special)
ATTN: Stacy Valdez PHONE NO : 1 239 6435553 72010
1370 Creekside Boulevard SE DECISION MADE: 27-OCT-22
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IO Needle Safety Sheath
Actuated Medical, Inc 510(k) NO: K220890(Traditional)
ATTN: Douglas R. Dillon PHONE NO : 814 3550003
310 Rolling Ridge Drive SE DECISION MADE: 31-OCT-22
Bellefonte PA 16823 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys CMV IgG
Roche Diagnostics 510(k) NO: K220911(Traditional)
ATTN: Bin Sun PHONE NO : 317 2923781
9115 Hague Road SE DECISION MADE: 12-OCT-22
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tornier Perform Humeral System – Fracture
Tornier, Inc. 510(k) NO: K220914(Traditional)
ATTN: Renee Stoffel PHONE NO : 952 6837471
10801 Nesbitt Ave South SE DECISION MADE: 14-OCT-22
Bloomington MN 55437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys HSV-1 IgG (08948844160)
Roche Diagnostics 510(k) NO: K220923(Traditional)
ATTN: Cynthia Aker PHONE NO : 1 463 3362138
9115 Hague Road PO Box 50416 SE DECISION MADE: 12-OCT-22
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys HSV-2 IgG (08948887160)
Roche Diagnostics 510(k) NO: K220924(Traditional)
ATTN: Cynthia Aker PHONE NO : 1 463 3362138
9115 Hague Road PO Box 50416 SE DECISION MADE: 12-OCT-22
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Excelsior
Merit CRO, Inc. 510(k) NO: K220929(Traditional)
ATTN: Yijuan Huang PHONE NO : 608 8863386
6527 Normandy Lane, Suite 100 SE DECISION MADE: 31-OCT-22
Madison WI 53719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Architect CMV IgG
Abbott Laboratories 510(k) NO: K220949(Traditional)
ATTN: Shannon Reibling PHONE NO : 224 6683735
Dept 09AA, Bldg. AP8A, 100 Abbott SE DECISION MADE: 27-OCT-22
Abbott Park IL 60064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple
Ever Global (Vietnam) Enterprise C510(k) NO: K220992(Traditional)
ATTN: Jerry Lin PHONE NO : 84 61 3514022
Long Thanh Industrial Zone, Taman SE DECISION MADE: 19-OCT-22
Long Thanh VN 810000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shoulder PacemakerTM
NCS Lab Srl 510(k) NO: K220994(Traditional)
ATTN: Matteo Mantovani PHONE NO : 39 059 669813
Via Pola Esterna 4/12 SE DECISION MADE: 14-OCT-22
Carpi MO 41012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
Effortless Oxygen. LLC 510(k) NO: K221014(Traditional)
ATTN: Samir Ahmad PHONE NO :
251 E Sierra Dr. SE DECISION MADE: 17-OCT-22
Phoenix AZ 85012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NextDent Ortho Flex
Vertex-Dental BV 510(k) NO: K221022(Abbreviated)
ATTN: Connie Peterse-van der KoppPHONE NO : 31 88 6160412
Centurionbaan 190 SE DECISION MADE: 21-OCT-22
Soesterberg NL 3769AV 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch
Synovis Life Technologies, Inc. 510(k) NO: K221029(Traditional)
ATTN: Megan Sajjad PHONE NO : 414 2181464
(A Subsidiary of Baxter InternatioSE DECISION MADE: 19-OCT-22
St. Paul MN 55114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vascu-Guard Vascular Repair Patch
Synovis Life Technologies, Inc. 510(k) NO: K221032(Traditional)
ATTN: Sajjad Megan PHONE NO : 414 2181464
(A Subsidiary of Baxter InternatioSE DECISION MADE: 19-OCT-22
St. Paul MN 55114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILO TFX MIS Sacroiliac Joint Fixation System
Aurora Spine, Inc. 510(k) NO: K221047(Traditional)
ATTN: Laszlo Garamszegi PHONE NO : 760 4242004
1930 Palomar Point Way, Suite #103SE DECISION MADE: 03-OCT-22
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nuheara IQbuds 2 PRO Hearing Aid
Nuheara Limited 510(k) NO: K221064(Traditional)
ATTN: John Luna PHONE NO : 425 2091646
13555 S.E. 36th St., Suite 100 SE DECISION MADE: 30-OCT-22
Bellevue WA 98006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Hypodermic Needles for Single Use
Sichuan Prius Biotechnology Co., L510(k) NO: K221066(Traditional)
ATTN: Yan Liu PHONE NO : 86 831 3839889
No.2 Prius Road, Luo Long IndustriSE DECISION MADE: 04-OCT-22
Yibin CN 644104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Hypodermic Syringes for Single Use with Needles
Sichuan Prius Biotechnology Co., L510(k) NO: K221068(Traditional)
ATTN: Yan Liu PHONE NO : 86 831 3839889
No.2 Prius Road, Luo Long IndustriSE DECISION MADE: 04-OCT-22
Yibin CN 644104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUEdraw Lancing Device, Mini Lancing Device
Trividia Health 510(k) NO: K221072(Traditional)
ATTN: Jacqueline Davis PHONE NO : 800 3427226
2400 N.W. 55th Court SE DECISION MADE: 18-OCT-22
Fort Lauderdale FL 33309 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Hypodermic Syringes for Single Use with Safety Needles
Sichuan Prius Biotechnology Co., L510(k) NO: K221073(Traditional)
ATTN: Yan Liu PHONE NO : 86 831 3839889
No.2 Prius Road, Luo Long IndustriSE DECISION MADE: 04-OCT-22
Yibin CN 644104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Hypodermic Syringes for Single Use
Sichuan Prius Biotechnology Co., L510(k) NO: K221079(Traditional)
ATTN: Yan Liu PHONE NO : 86 831 3839889
No.2 Prius Road, Luo Long IndustriSE DECISION MADE: 04-OCT-22
Yibin CN 644104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Safety Hypodermic Needles for Single Use
Sichuan Prius Biotechnology Co., L510(k) NO: K221080(Traditional)
ATTN: Yan Liu PHONE NO : 86 831 3839889
No.2 Prius Road, Luo Long IndustriSE DECISION MADE: 04-OCT-22
Yibin CN 644104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-CUBE 70, X-CUBE 90
Alpinion Medical Systems Co., Ltd.510(k) NO: K221093(Traditional)
ATTN: Boyeon Cho PHONE NO : 82 70 74652104
5FL, I dong, 77, heungan-daero 81bSE DECISION MADE: 14-OCT-22
Anyang-si KR 14117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II
Arthrex Inc. 510(k) NO: K221128(Traditional)
ATTN: Lai Saeteurn PHONE NO : 1 239 5984302 71764
1370 Creekside Boulevard SE DECISION MADE: 05-OCT-22
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infant Heel WarmerTM; Heel Snuggler®
International Biomedical 510(k) NO: K221154(Traditional)
ATTN: Amy Pieper PHONE NO : 512 8730033
8206 Cross Park Drive SE DECISION MADE: 07-OCT-22
Austin TX 78754 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JR MEDIC Nitrile Examination Gloves Powder Free- Black
JR Engineering & Medical Technolog510(k) NO: K221169(Abbreviated)
ATTN: Ganesan Subramaniam PHONE NO : 603 605 72081
Lot 8 &10, Jalan Zurah 3 & Lot 1&3SE DECISION MADE: 25-OCT-22
Hulu Selangor MY 44200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107
Shenzhen AOJ Medical Technology Co510(k) NO: K221170(Traditional)
ATTN: Jack Wang PHONE NO : 86 755 27786026
Room 301&4F, Blk A, Building A, JiSE DECISION MADE: 07-OCT-22
Shenzhen CN 518126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOCUS Interbody System
OC Medical Devices 510(k) NO: K221172(Traditional)
ATTN: Jack Mathews PHONE NO : 888 4635803
15 East Montgomery Crossroads, SuiSE DECISION MADE: 14-OCT-22
Savannah GA 31406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Multi-Lancet Device 2, ReliOn Premier Lancing Device
Arkray, Inc. 510(k) NO: K221175(Traditional)
ATTN: Shinjiro Sekimoto PHONE NO : 81 50 58300922
Yousuien-nai, 59 Gansuin-cho, KamiSE DECISION MADE: 17-OCT-22
Kyoto JP 602-0008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Silverlon Wound Contact, Burn Contact Dressings
Argentum Medical, Inc. 510(k) NO: K221218(Traditional)
ATTN: Kathy Herzog PHONE NO : 612 7994562
2571 Kaneville Ct SE DECISION MADE: 26-OCT-22
Geneva IL 60134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aqua Naina Plus Sterile Saline Solution
Chemtex USA Inc. 510(k) NO: K221263(Special)
ATTN: Haribabu Talasila PHONE NO : 732 4474353
27-29 Dwight Place SE DECISION MADE: 12-OCT-22
Fairfield NJ 07004-3303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AI-Rad Companion Organs RT
Siemens Medical Solutions USA, Inc510(k) NO: K221305(Traditional)
ATTN: Kira Kuzmenchuk PHONE NO : 1 484 9019471
40 Liberty Blvd. Mail Code 65-3 SE DECISION MADE: 14-OCT-22
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle
Jiangxi Maidikang Medical Devices 510(k) NO: K221308(Traditional)
ATTN: Wu Huansheng PHONE NO : 86 136 17915949
Room 308, floor 3, building 1, JiaSE DECISION MADE: 17-OCT-22
Yichun CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing
Changzhou Endoclean Medical Device510(k) NO: K221310(Traditional)
ATTN: Wang Qi PHONE NO : 86 0519 68213060
West Side of 4th Floor, Building ESE DECISION MADE: 07-OCT-22
Changzhou CN 213149 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System
GE Medical Systems Information Tec510(k) NO: K221321(Traditional)
ATTN: Honghong Yang PHONE NO : 86 1391 5289019
9900 Innovation Drive SE DECISION MADE: 18-OCT-22
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUSTMBITE Snoring System
Dental Choice Holdings LLC 510(k) NO: K221322(Traditional)
ATTN: Danielle M Jackson PHONE NO : 502 7364647
10100 Linn Station Road SE DECISION MADE: 27-OCT-22
Louisville KY 40223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YUWELL Electronic Blood Pressure Monitor
Jiangsu Yuyue Medical Equipment & 510(k) NO: K221372(Traditional)
ATTN: Yinzhen Zhu PHONE NO : 86 188131 85546
No.1 Baisheng Road Development ZonSE DECISION MADE: 17-OCT-22
Danyang CN 212300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
Hebei Titans Hongsen Medical Techn510(k) NO: K221374(Traditional)
ATTN: Chai Wu PHONE NO : 86 177 69045117
Eastern Industrial Zone, Nangong CSE DECISION MADE: 26-OCT-22
Xingtai CN 051800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vented Vial Transfer Pin
Jiangsu Caina Medical Co., Ltd. 510(k) NO: K221406(Traditional)
ATTN: Jianwei Pan PHONE NO : 86 510 86205183
No.23, Huanxi Road, Zhutang Town SE DECISION MADE: 28-OCT-22
Jiangyin CN 214415 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AlphaID™ At Home Genetic Health Risk Service
Progenika Biopharma S.A., a Grifol510(k) NO: K221420(Traditional)
ATTN: Diego Tejedor PHONE NO : 34 944 064525
Ibaizabal bidea, Edificio 504, ParSE DECISION MADE: 27-OCT-22
Derio ES 48160 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPERTILT PLUS (STP)
Power Plus Mobility 510(k) NO: K221435(Traditional)
ATTN: Jason Mohan PHONE NO : 416 8091301
50 Malcom Rd SE DECISION MADE: 28-OCT-22
Guelph CA N1K1A9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PureLift Pro Plus
Xtreem Pulse LLC 510(k) NO: K221443(Special)
ATTN: Andrew Barile PHONE NO : 212 6439062
353 W. 29 St. Suite 3 SE DECISION MADE: 21-OCT-22
New York NY 10001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Southern Anterior Screw Fixated Cage (SASCA)
Southern Medical (Pty) Ltd 510(k) NO: K221447(Traditional)
ATTN: Dalene Styger PHONE NO : 27 12 66762434
55 Regency Drive, Route 21 CorporaSE DECISION MADE: 14-OCT-22
Irene ZA 0178 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Genius AI Detection 2.0
Hologic, Inc. 510(k) NO: K221449(Traditional)
ATTN: Deborah Thomas PHONE NO : 508 2106107
250 Campus Drive SE DECISION MADE: 06-OCT-22
Marlborough MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Reclaim Monobloc Revision Femoral Stem
DePuy Ireland UC 510(k) NO: K221462(Traditional)
ATTN: Jennifer Hill PHONE NO : 44 783 4974433
SE DECISION MADE: 21-OCT-22
Loughbeg IE P43 ED82 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Artemis Proximal Femoral Nail System
GLW, Inc. 510(k) NO: K221489(Traditional)
ATTN: Arundhati Radhakrishnan PHONE NO : 201 2683281
300 Sylvan Avenue SE DECISION MADE: 27-OCT-22
Englewood Cliffs NJ 07632 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SteriTite Container System with MediTray Parts
Case Medical, Inc. 510(k) NO: K221492(Traditional)
ATTN: Michael Polozani PHONE NO : 201 3131999 633
50 West Street SE DECISION MADE: 07-OCT-22
Bloomfield NJ 07003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Miha Bodytec II
Miha Bodytec GmbH 510(k) NO: K221498(Traditional)
ATTN: Felix Schweigert PHONE NO : 49 821 45549222
Siemensstr. 1 SE DECISION MADE: 07-OCT-22
Gersthofen DE 86368 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.via View&GO
Siemens Healthcare GmBH 510(k) NO: K221501(Traditional)
ATTN: Frederike Jakob PHONE NO : 49 0162 1092694
Siemensstraße 1, Forchheim SE DECISION MADE: 14-OCT-22
Erlangen DE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Surgiphor™ Antimicrobial Irrigation System
BD 510(k) NO: K221504(Traditional)
ATTN: Shelley Wilcox PHONE NO : 720 2766575
75 N Fairway Dr SE DECISION MADE: 14-OCT-22
Vernon Hills IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TrusFIL-Flow Flowable Composite Restorative
Rizhao HuGe Biomaterials Company, 510(k) NO: K221510(Traditional)
ATTN: Maggie Zheng PHONE NO : 86 633 2277268
No.2 North Zhaoyang Road, DistrictSE DECISION MADE: 12-OCT-22
Rizhao City CN 276800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens
Interojo Inc. 510(k) NO: K221517(Traditional)
ATTN: Si-Chul Rho PHONE NO : 82 2 7801225
28& 25 Sandan-Ro 15 Beon-Gil SE DECISION MADE: 04-OCT-22
Pyongtaek-City KR 459040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Safety Lancet
SteriLance Medical (Suzhou) Inc. 510(k) NO: K221521(Traditional)
ATTN: Susan Sun PHONE NO : 86 1341 8660174
No.168 PuTuoShan Road, New DistricSE DECISION MADE: 28-OCT-22
Suzhou CN 215153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MectaLIF Anterior Extension
Medacta International S.A. 510(k) NO: K221545(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 24-OCT-22
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neurosteer EEG Recorder
Neurosteer Inc. 510(k) NO: K221563(Traditional)
ATTN: Nathan Intrator PHONE NO : 844 4445601
375 South End Avenue Suite 26C SE DECISION MADE: 24-OCT-22
New York NY 10280 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUDWIG Electrosurgical Device
Aesthetics Biomedical 510(k) NO: K221574(Traditional)
ATTN: Lawrence A. Rheins PHONE NO : 760 8775385
4602 North 16th Street, Suite 300 SE DECISION MADE: 16-OCT-22
Phoenix AZ 85016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pre-Formed Blue
Lake Region Medical 510(k) NO: K221575(Traditional)
ATTN: Deko Hussein PHONE NO : 952 6428302
340 Lake Hazeltine Drive SE DECISION MADE: 07-OCT-22
Chaska MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ameda Pearl Electric Breast Pump
Ameda, Inc. 510(k) NO: K221576(Traditional)
ATTN: Sean Pettibone PHONE NO : 847 5302552
485 Half Day Road; Suite 320 SE DECISION MADE: 12-OCT-22
Buffalo Grove IL 60089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets
Owen Mumford Ltd 510(k) NO: K221613(Traditional)
ATTN: Darren Mansell PHONE NO : 01993 812021
Owen Mumford, Brook Hill, WoodstocSE DECISION MADE: 03-OCT-22
Woodstock GB OX20 ITU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spine CAMP™
Medical Metrics, Inc. 510(k) NO: K221632(Traditional)
ATTN: Kirk Johnson PHONE NO : 1 210 2188405
2121 Sage Road SE DECISION MADE: 18-OCT-22
Houston TX 77056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hair Removal Device (Model: IPL-D26, IPL-D19)
Shenzhen Desida Technology Co., Lt510(k) NO: K221643(Traditional)
ATTN: Gong Yong PHONE NO : 86 755 28227189
5F, Building A, Sanmin Industrial SE DECISION MADE: 21-OCT-22
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLH™ POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K221646(Traditional)
ATTN: Shana Foster PHONE NO :
1800 Pyramid Place SE DECISION MADE: 04-OCT-22
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InfaTherm Disposable Infant Warming Mattress
International Biomedical 510(k) NO: K221653(Traditional)
ATTN: Amy Pieper PHONE NO : 512 8730033
8206 Cross Park Drive SE DECISION MADE: 06-OCT-22
Austin TX 78754 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non Sterile Powder Free Latex Examination Glove
New Era Medicare Sdn. Bhd. 510(k) NO: K221667(Traditional)
ATTN: Fatin Nor Irdina binti AhmadPHONE NO : 60 14 9072860
Plot 2621-2624 SE DECISION MADE: 28-OCT-22
Teluk Intan MY 36000 510(k) STATEMENT
DEVICE: Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)
Fotona d.o.o. 510(k) NO: K221712(Traditional)
ATTN: Marko Berdajs PHONE NO : 386 1 5009119
Stegne 7 SE DECISION MADE: 12-OCT-22
Ljubljana SI 1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate
Stryker Corporation 510(k) NO: K221728(Traditional)
ATTN: Katie McNeil PHONE NO : 201 7498518
2 Pearl Court SE DECISION MADE: 19-OCT-22
Allendale NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448)
Smith and Nephew, Inc. 510(k) NO: K221740(Traditional)
ATTN: Renesha Srivastava PHONE NO :
150 Minuteman Road SE DECISION MADE: 20-OCT-22
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive Cohere ALIF System Intervertebral Body Fusion Device
NuVasive, Incorporated 510(k) NO: K221751(Traditional)
ATTN: Jessica LeBlanc PHONE NO : 951 8160973
7475 Lusk Boulevard SE DECISION MADE: 21-OCT-22
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cornisol
Aurolab 510(k) NO: K221759(Traditional)
ATTN: Krishna Kumar PHONE NO :
No.1, Sivagangai Main Road SE DECISION MADE: 05-OCT-22
Veerapanjan, Madurai IN 625020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InBody Blood pressure monitor, Model BPBIO480KV
InBody Co, Ltd. 510(k) NO: K221764(Traditional)
ATTN: Kichul Cha PHONE NO : 82 02 5013939
15, Heugam-Gil , Ipjang-Myueon, SeSE DECISION MADE: 07-OCT-22
Cheonan-Si KR 31025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fiber Laser Treatment System
Shanghai Apolo Medical Technology 510(k) NO: K221770(Traditional)
ATTN: Felix Li PHONE NO : 86 138 49190618
SE DECISION MADE: 13-OCT-22
Shanghai CN 200231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Safety Lancets
Suzhou Kyuan Medical Apparatus Co.510(k) NO: K221778(Traditional)
ATTN: Shi Ye PHONE NO : 86 512 65995113
Beiqiao Town, Suzhou City, P.R.ChiSE DECISION MADE: 03-OCT-22
Suzhou CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SafetiCET (SC-150);SafetiCET (SC-180);SafetiCET (SC-220);SafetiCET (SC-250);SafetiCET (SC-250B)
NSP Tech Pte Ltd 510(k) NO: K221783(Traditional)
ATTN: HC Tan PHONE NO : 65 981 80450
10 Admiralty Street, Northlink BuSE DECISION MADE: 24-OCT-22
Singapore SG 757695 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERN FIX Sternal Stabilization System
Neos Surgery SL 510(k) NO: K221795(Traditional)
ATTN: Eduard Garcia Puig PHONE NO :
Parc Technologic del Valles SE DECISION MADE: 19-OCT-22
Barcelona ES 08290 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device
Bonraybio Co., LTD. 510(k) NO: K221810(Traditional)
ATTN: Clare Huang PHONE NO : 886 4 24912385
4F., No. 118, Gongye 9th Rd., DaliSE DECISION MADE: 31-OCT-22
Taichung City TW 41280 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rebellion; Phantom Multi-Bite Kerrison Rongeur
Morpheus AG 510(k) NO: K221818(Special)
ATTN: Timo Rack PHONE NO : 49 746 1703820
Bahnhofstraße 18 SE DECISION MADE: 07-OCT-22
Spaichingen DE 78549 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apyx One Console
Apyx Medical Corporation 510(k) NO: K221830(Traditional)
ATTN: David Ceretti PHONE NO : 1 727 8038508
5115 Ulmerton Road SE DECISION MADE: 11-OCT-22
Clearwater FL 33760-4004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves
Integra LifeSciences Production Co510(k) NO: K221840(Traditional)
ATTN: Amanda Erwin PHONE NO : 609 62979053
11 Cabot Boulevard SE DECISION MADE: 14-OCT-22
Mansfield MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201
Zhejiang LuDe Technology Developme510(k) NO: K221857(Traditional)
ATTN: Iris Du PHONE NO : 86 513 80580127__
NO. 298 Jichang North Road, LongwaSE DECISION MADE: 13-OCT-22
Wenzhou CN 325024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZSFab Lumbar Interbody System
ZS Fab Inc. 510(k) NO: K221858(Traditional)
ATTN: Xuewei Ma PHONE NO : 617 4688665
96 Clematis Ave Suite 2F SE DECISION MADE: 14-OCT-22
Waltham MA 02453 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
23andMe, Inc. 510(k) NO: K221885(Traditional)
ATTN: Marianna Frendo PHONE NO : 650 6869288
349 Oyster Point Blvd SE DECISION MADE: 26-OCT-22
South San Francisco CA 94080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sublime Microcatheter
Surmodics Inc. 510(k) NO: K221886(Traditional)
ATTN: Holly Ramirez PHONE NO : 952 5007545
7905 Golden Triangle Drive Suite 1SE DECISION MADE: 14-OCT-22
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring
ProSomnus Sleep Technologies 510(k) NO: K221889(Abbreviated)
ATTN: Divya Mavalli PHONE NO : 925 3077069
5860 W Las Positas Blvd. Suite 25 SE DECISION MADE: 06-OCT-22
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISIONAIR
PacificMD Biotech Llc 510(k) NO: K221892(Traditional)
ATTN: Jetmir Palushi PHONE NO : 201 8198685
3195 Saint Rose Pkwy, Suite 210 SE DECISION MADE: 05-OCT-22
Henderson NV 89052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arm Blood Pressure Monitor
Alicn Medical Shenzhen,Inc 510(k) NO: K221913(Special)
ATTN: Fang Meisong PHONE NO : 86 755 26501548
Room 410, Building A, 3rd Sub-parkSE DECISION MADE: 12-OCT-22
Shenzhen CN 518118 510(k) STATEMENT
DEVICE: ROSA® Knee System
Orthosoft d/b/a Zimmer CAS 510(k) NO: K221928(Traditional)
ATTN: Kavina Veeren PHONE NO : 514 2458906
75 Queen Street, Suite 3300 SE DECISION MADE: 04-OCT-22
Montreal CA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Standalone ALIF Interbody Fusion System
Eminent Spine 510(k) NO: K221936(Traditional)
ATTN: Stephen Courtney PHONE NO : 214 4155243
2004 Ventura Drive Suite 100 SE DECISION MADE: 17-OCT-22
Plano TX 75093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tyber Medical Staple Fixation System (various)
Tyber Medical, LLC. 510(k) NO: K221947(Traditional)
ATTN: Lisa Boyle PHONE NO : 610 2957984
83 South Commerce Way Suite 310 SE DECISION MADE: 20-OCT-22
Bethlehem PA 18017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Branchor Balloon Guide Catheter
Asahi Intecc Co., Ltd 510(k) NO: K221951(Special)
ATTN: Katsuhiko Fujimura PHONE NO : 81 561 561859
3-100 Akatsuki-cho SE DECISION MADE: 11-OCT-22
Seto JP 489-0071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flex-MI
EMSI, Inc. 510(k) NO: K221958(Traditional)
ATTN: Chad Sagnip PHONE NO : 813 4710129
3504 Cragmont Sr., Suite 100 SE DECISION MADE: 21-OCT-22
Tampa FL 33619 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Gown (G4003)
Xiantao Topmed Nonwoven Protective510(k) NO: K221977(Traditional)
ATTN: Vivian Zhu PHONE NO : 86 2787 861070
North of the National Road 318, ToSE DECISION MADE: 20-OCT-22
Xiantao CN 433000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Oximeter (Model C101A2, C101B1, C101A3)
Shenzhen IMDK Medical Technology C510(k) NO: K221979(Special)
ATTN: Yuan Xia PHONE NO : 86 755 27155684
C Zone 10F, Building 16, Yuanshan SE DECISION MADE: 16-OCT-22
Shenzhen CN 518106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter
Transit Scientific, LLC 510(k) NO: K221986(Special)
ATTN: Jennifer Arnold PHONE NO : 412 4963609
2757 South 300 West, Suite E SE DECISION MADE: 18-OCT-22
Salt Lake City UT 84115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Oligio
WON TECH Co., Ltd. 510(k) NO: K221989(Traditional)
ATTN: Hyun Sik Yoon PHONE NO : 82 10 67505346
64 Techno 8-ro SE DECISION MADE: 13-OCT-22
Yuseong-gu KR 34028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electronic Pulse Stimulator
Beijing Choice Electronic Technolo510(k) NO: K221992(Traditional)
ATTN: Haiying Zhao PHONE NO : 86 10 88794631
No.9 Shuangyuan road, Badachu Hi-tSE DECISION MADE: 21-OCT-22
Beijing CN 100041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hailie Sensor NF0107 & NF0108
Adherium (NZ) Ltd 510(k) NO: K221994(Traditional)
ATTN: Tara Creaven-Capasso PHONE NO : 64 9 3072771
Level 11, 16 Kingston Street SE DECISION MADE: 04-OCT-22
Auckland NZ 1010 510(k) STATEMENT
DEVICE: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System
Alphatec Spine 510(k) NO: K222028(Traditional)
ATTN: Neha Mohindroo PHONE NO : 760 3566596
1950 Camino Vide Roble SE DECISION MADE: 07-OCT-22
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spinal Inner Fixation System
Changzhou Geasure Medical Apparatu510(k) NO: K222031(Traditional)
ATTN: Jing Huang PHONE NO : 86 136 56146897
No. 12, Jinfeng Road West Taihu ScSE DECISION MADE: 28-OCT-22
Changzhou CN 213149 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROMARK System
Neurent Medical 510(k) NO: K222032(Traditional)
ATTN: Karen E. Peterson PHONE NO : 651 3984341
1 Oran Point, Main Street, OranmorSE DECISION MADE: 26-OCT-22
Galway IE H91D7X2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)
Elekta Solutions AB 510(k) NO: K222047(Traditional)
ATTN: Helena Skar PHONE NO : 46 076 8543688
Kungstensgatan 18 Box 7593 SE DECISION MADE: 26-OCT-22
Stockholm SE SE-10393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
WRP Asia Pacific SDN. BHD. 510(k) NO: K222058(Traditional)
ATTN: Siti Iylia Zarith Bt Hasan PHONE NO : 60 3 87061486
Lot 1, Jalan 3, Kawasan PerusahaanSE DECISION MADE: 22-OCT-22
Sepang MY 43900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Alma Soprano Titanium
Alma Lasers Inc. 510(k) NO: K222064(Traditional)
ATTN: Jessica Rivera-Montejo PHONE NO : 224___ 3772000___
485 Half Day Rd Ste 100 SE DECISION MADE: 12-OCT-22
Buffalo Grove IL 60089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Durex Penck III Regular
RB Health (US) LLC 510(k) NO: K222068(Traditional)
ATTN: Kyle Prince PHONE NO : 862 3250012
399 Interpace Parkway SE DECISION MADE: 12-OCT-22
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoNaut
Therenva SAS 510(k) NO: K222070(Traditional)
ATTN: Audrey Gallois PHONE NO : 00 33 972522921
74F rue de Paris SE DECISION MADE: 25-OCT-22
Rennes FR 35000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves
Zibo Langu New Material Technology510(k) NO: K222074(Traditional)
ATTN: Wang Qidong PHONE NO : 0086 533 7856083
Room 1120-2, Entreperneurship IncuSE DECISION MADE: 17-OCT-22
Zibo CN 255400 510(k) STATEMENT
DEVICE: Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
Stryker Endoscopy 510(k) NO: K222079(Traditional)
ATTN: Divya Sekar PHONE NO : 669 2044851
5900 Optical Ct SE DECISION MADE: 11-OCT-22
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Garion Image-Intensified Fluoroscopic X-Ray System, Mobile
SG Healthcare CO LTD 510(k) NO: K222080(Traditional)
ATTN: Byung Ju Kang PHONE NO : 82 2 4496908
10, Yangnyeong-ro, Yangpyeong-ri, SE DECISION MADE: 06-OCT-22
Seoul KR 17408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ID-510 iRestore Elite
Freedom Laser Therapy, Inc. 510(k) NO: K222081(Traditional)
ATTN: Wei-Chih Chen PHONE NO : 714 6699888
16782 Von Karman Avenue, Unit 15 SE DECISION MADE: 13-OCT-22
Irvine CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Standard Tapered Bougie, 38 Fr.
Standard Bariatrics, Inc. 510(k) NO: K222085(Traditional)
ATTN: Michelle Schnell PHONE NO : 513 7026083
4362 Glendale Milford Road SE DECISION MADE: 31-OCT-22
Cincinnati OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCIg60 Infusion System
EMED Technologies Corporation 510(k) NO: K222087(Traditional)
ATTN: Olena Whalen PHONE NO : 916 9320071
1262 Hawks Flight Court Suite 200 SE DECISION MADE: 13-OCT-22
El Dorado Hills CA 95762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Abiomed 14Fr Low Profile Introducer Set
Abiomed Inc. 510(k) NO: K222113(Traditional)
ATTN: Ken Ryder PHONE NO :
22 Cherry Hill Drive SE DECISION MADE: 13-OCT-22
Danvers MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Soft Palate Elevator
The TMJ Clinic, PC. 510(k) NO: K222127(Abbreviated)
ATTN: John Summer PHONE NO : 503 2417353
833 SW 11th Ave. # 810 SE DECISION MADE: 24-OCT-22
Portland OR 97205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Safety Blood Collection Needle (Without Needle Holder)
Anhui Hongyu Wuzhou Medical Manufa510(k) NO: K222141(Traditional)
ATTN: Bingyi Xiang PHONE NO : 86 556 5129666
No. 2 Guanyin Road, Economic DevelSE DECISION MADE: 21-OCT-22
Anqing CN 246400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHO Photocoagulator
Norlase 510(k) NO: K222157(Traditional)
ATTN: Jan Forstberg PHONE NO : 45 40 109302
Brydehusvej 13 SE DECISION MADE: 11-OCT-22
Ballerup DK DK-2750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-Z Chek Chlorine Residual Test Strips (K100-0101B)
Reprocessing Products Corporation 510(k) NO: K222167(Traditional)
ATTN: Dave Cox PHONE NO : 520 8885551
1643 W. MODERN COURT SE DECISION MADE: 18-OCT-22
TUCSON AZ 85705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40
SuperSonic Imagine 510(k) NO: K222191(Traditional)
ATTN: Shalyna Bansropun PHONE NO : 33 4 13102428
Zac de l`enfant 135 rue Emilien GaSE DECISION MADE: 28-OCT-22
Aix en Provence FR 13290 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Collagen P.I.N. (Percutaneous Induction Needling)
Induction Therapies LLC 510(k) NO: K222199(Traditional)
ATTN: Amelia Aslam PHONE NO : 502 5943116
1920 Stanley Gault Parkway, Suite SE DECISION MADE: 21-OCT-22
Louisville KY 40223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biological Feedback and Stimulation System
Medlander Medical Technology Inc. 510(k) NO: K222201(Traditional)
ATTN: Wang Wang PHONE NO : 86 159 96375859
Building 5, Acceleration Zone, NanSE DECISION MADE: 21-OCT-22
Nanjing CN 211100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DualXSLIM(R) T/PLIF
Amplify Surgical, Inc. 510(k) NO: K222203(Traditional)
ATTN: Erickson Nathan PHONE NO : 435 2379524
9272 Jeronimo Rd Suite 107B SE DECISION MADE: 18-OCT-22
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cold Sore Device (Model: QPZ-01)
Light Tree Ventures Europe B.V. 510(k) NO: K222205(Traditional)
ATTN: Alain Dijkstra PHONE NO : 86 135 103787481
Laan van Ypenburg 108, 2497 GC, ThSE DECISION MADE: 07-OCT-22
Hague NL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcQMap High Resolution Imaging and Mapping System
Acutus Medical Inc. 510(k) NO: K222209(Traditional)
ATTN: Subhadra Elango PHONE NO : 1 442 2326086
2210 Faraday Ave, Suite 100 SE DECISION MADE: 17-OCT-22
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPD Dental Implant Abutments
Implant Protesis Dental 2004 S.L 510(k) NO: K222215(Traditional)
ATTN: Francesc Fumanal PHONE NO : 34 93 2788491
Cami del Mig. 71. SE DECISION MADE: 21-OCT-22
Mataro ES 08302 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S.I.N. Dental Implant System
S.I.N. - Sistema de Implante Nacio510(k) NO: K222231(Traditional)
ATTN: Denise Domiciano PHONE NO : 5511 2169 3000 3236
Avenida Vereador Abel Ferreira, 11SE DECISION MADE: 27-OCT-22
Sao Paulo BR 03340-000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex 2.4 mm Volar Distal Radius Plate System
Arthrex Inc. 510(k) NO: K222267(Traditional)
ATTN: Stacy Valdez PHONE NO : 1_____ 239 6435553 72010
1370 Creekside Boulevard SE DECISION MADE: 03-OCT-22
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DESS Dental Smart Solutions
Terrats Medical SL 510(k) NO: K222269(Traditional)
ATTN: Roger Terrats PHONE NO : 34 935 646006
Carrer Mogoda 75-99 SE DECISION MADE: 26-OCT-22
Barbera del Valles ES 08210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments
Globus Medical Inc. 510(k) NO: K222270(Traditional)
ATTN: Kelly Baker PHONE NO : 610 9301800 1670
2560 General Armistead Ave. SE DECISION MADE: 21-OCT-22
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONDUIT Cages; FIBERGRAFT BG Putty
DePuy Spine 510(k) NO: K222276(Traditional)
ATTN: Philip Desjardins PHONE NO : 202 5891005
325 Paramount Dr. SE DECISION MADE: 15-OCT-22
Raynham MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intracept Intraosseous Nerve Ablation System
Relievant Medsystems, Inc. 510(k) NO: K222281(Traditional)
ATTN: Thomas A. Slater PHONE NO : 1 650 3681000 135
1230 Midas Way, Suite 200 SE DECISION MADE: 26-OCT-22
Sunnyvale CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System
Hospital Equipment Manufacturing C510(k) NO: K222282(Traditional)
ATTN: Himanshu Sachdeva PHONE NO : 91 120 4088888
A19/A20, Sector 7 SE DECISION MADE: 27-OCT-22
Noida IN 201301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)
Applied Medical Resources Corporat510(k) NO: K222284(Special)
ATTN: Blake Stacy PHONE NO : 949 7138163
22872 Avenida Empresa SE DECISION MADE: 14-OCT-22
Rancho Santa Margarita CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DESS Dental Smart Solutions
Terrats Medical SL 510(k) NO: K222288(Traditional)
ATTN: Roger Terrats PHONE NO : 34 935 646006
Carrer Mogoda 75-99 SE DECISION MADE: 27-OCT-22
Barberà del Vallès ES 08210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid
Onetexx SDN BHD 510(k) NO: K222298(Traditional)
ATTN: Freddy Low PHONE NO : 605 8070666
No 73-86, JLN Logam 5, PerindustriSE DECISION MADE: 18-OCT-22
Kamunting MY 34600 510(k) STATEMENT
DEVICE: Unistik® Pro
Owen Mumford Ltd 510(k) NO: K222303(Traditional)
ATTN: Darren Mansell PHONE NO : 01 993___ 812021
Owen Mumford, Brook Hill, WoodstocSE DECISION MADE: 25-OCT-22
Woodstock GB OX20 ITU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fresenius Liberty Select Cycler
Fresenius Medical Care Renal Thera510(k) NO: K222318(Traditional)
ATTN: Denise Oppermann PHONE NO : 781 9969103
920 Winter Street SE DECISION MADE: 31-OCT-22
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask
Luoyang Sunmed Devices Co., Ltd. 510(k) NO: K222335(Traditional)
ATTN: Tian Qian PHONE NO : 86 18637 911566
No. 8 Huaxia Road, Hi-Tech Zone, LSE DECISION MADE: 11-OCT-22
Luoyang CN 471003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JR MEDIC
JR Engineering & Medical Technolog510(k) NO: K222348(Abbreviated)
ATTN: Ganesan Subramaniam PHONE NO : 603 60 572081
Lot 8 &10, Jalan Zurah 3 & Lot 1&3SE DECISION MADE: 27-OCT-22
Hulu Selangor MY 44200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)
JR Engineering & Medical Technolog510(k) NO: K222349(Abbreviated)
ATTN: Ganesan Subramaniam PHONE NO : 603 60 572081
Lot 8 &10, Jalan Zurah 3 & Lot 1&3SE DECISION MADE: 21-OCT-22
Hulu Selangor MY 44200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elastic Traction System
Micro-Tech (Nanjing) Co., Ltd. 510(k) NO: K222354(Traditional)
ATTN: Sally He PHONE NO : 86 25 58646395
No.10 Gaoke Third Road, Nanjing NaSE DECISION MADE: 03-OCT-22
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AI-Rad Companion (Musculoskeletal)
Siemens Medical Solutions USA, Inc510(k) NO: K222361(Traditional)
ATTN: Kira Kuzmenchuk PHONE NO : 1484 9019471
40 Liberty Blvd. SE DECISION MADE: 20-OCT-22
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Leltek Ultrasound Imaging System (Model: LU700 Series)
Leltek Inc 510(k) NO: K222365(Traditional)
ATTN: Paul Chang PHONE NO : 886 2 29137577
6F.-3, No. 293, Sec. 1, Beixin Rd.SE DECISION MADE: 25-OCT-22
New Taipei City TW 23147 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EsoCheck Cell Collection Device
Lucid Diagnostics, Inc. 510(k) NO: K222366(Traditional)
ATTN: Lishan Aklog PHONE NO : 212 9494319
One Grand Central Place, Suite 460SE DECISION MADE: 26-OCT-22
New York NY 10165 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PURE Laser
Endymed Medical, Ltd. 510(k) NO: K222369(Traditional)
ATTN: Ohad Fisher PHONE NO : 972 4 6309100
12 Leshem St. North Industrial ParSE DECISION MADE: 07-OCT-22
Caesarea IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)
Shandong Lianfa Medical Plastic Pr510(k) NO: K222376(Traditional)
ATTN: Charles Shen PHONE NO : 086___ 531 61328777
No. 1 Shuangshan Sanjian Road, ZhaSE DECISION MADE: 03-OCT-22
Jinan CN 250200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TriVerse Total Knee Replacement System
Signature Orthopaedics Pty Ltd. 510(k) NO: K222380(Traditional)
ATTN: Declan Brazil PHONE NO : 61 2 94285181
7 Sirius Road SE DECISION MADE: 04-OCT-22
Lane Cove West AU 2066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Evo® sEEG System
NeuroOne Medical Technologies Corp510(k) NO: K222404(Traditional)
ATTN: Debra Kridner PHONE NO : 763 4434476
7599 Anagram Drive SE DECISION MADE: 20-OCT-22
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil
NeoCoil, LLC 510(k) NO: K222407(Special)
ATTN: Katie Gonzalez PHONE NO : 262 5226124
N27 W23910A Paul Road SE DECISION MADE: 14-OCT-22
Pewaukee WI 53072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rexious Spinal Fixation System
Dio Medical Corporation 510(k) NO: K222415(Traditional)
ATTN: Milan George PHONE NO : 877 3945407 102
2100 Campus Lane, Suite 100 SE DECISION MADE: 25-OCT-22
East Norriton PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nuvola
Gruppo Europeo Ortodonzia srl 510(k) NO: K222418(Traditional)
ATTN: Massimiliano Bucceri PHONE NO : 39 06 72671754
via Cropani, 118 A/B SE DECISION MADE: 07-OCT-22
Rome IT 00173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Protect-It Custom Fit Dental Guard
DOC Brands, Inc. 510(k) NO: K222424(Traditional)
ATTN: Sean Stubbs PHONE NO : 865___ 6043525
407 E. Lancaster Avenue SE DECISION MADE: 07-OCT-22
Wayne PA 19087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMA TT Glenoid
LimaCorporate S.p.A. 510(k) NO: K222427(Traditional)
ATTN: Michela Zanotto PHONE NO : 39 043 2945511
Via Nazionale 52 SE DECISION MADE: 06-OCT-22
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: b-ONER MOBIO Total Knee System
b-ONE ORTHO, Corp. 510(k) NO: K222431(Traditional)
ATTN: Allison Gecik PHONE NO : 973 9658940
3 Wing Drive Suite #259 SE DECISION MADE: 06-OCT-22
Cedar Knolls NJ 07927 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439
Hunan Guangye Biotechnology Co., L510(k) NO: K222432(Traditional)
ATTN: Eileen Li PHONE NO : 86 0755 89373426
Room A701, Jinhong Park IncubationSE DECISION MADE: 11-OCT-22
Changsha City CN 410006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Renamel® Microhybrid ;Renamel® Flowable Microhybrid
Cosmedent, Inc 510(k) NO: K222435(Traditional)
ATTN: Gary Chuven PHONE NO : 312 644958617_
401 N Michigan Ave, Suite 2500 SE DECISION MADE: 11-OCT-22
Chicago IL 60611 510(k) STATEMENT
DEVICE: UNITY Sacroiliac Joint Fixation System
Dio Medical Corporation 510(k) NO: K222448(Traditional)
ATTN: Milan George PHONE NO : 716 4655551
2100 Campus Lane Suite 100 SE DECISION MADE: 13-OCT-22
East Norriton PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3Dicom MD
Singular Health Pty Ltd 510(k) NO: K222470(Traditional)
ATTN: James Hill PHONE NO : 61 81300 167795
3/26 Railway Road SE DECISION MADE: 25-OCT-22
Subiaco AU 6008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods
Medos-International, SARL 510(k) NO: K222473(Traditional)
ATTN: Denielle Smith PHONE NO : 978 5388842
Chemin Blanc 38 SE DECISION MADE: 13-OCT-22
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mobility Scooter, Model: W3331F
Zhejiang Innuovo Rehabilitation De510(k) NO: K222495(Traditional)
ATTN: Leo Zheng PHONE NO : 86 183 58936043
No.196 Industry Road, Hengdian MovSE DECISION MADE: 17-OCT-22
Dongyang CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)
Humanwell Healthcare Group Medical510(k) NO: K222498(Traditional)
ATTN: Aixue Yao PHONE NO : 186 2772 6855______
14th F, 1500# Century Avenue SE DECISION MADE: 26-OCT-22
Wuhan CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CurvaFix IM System
CurvaFix, Inc. 510(k) NO: K222505(Traditional)
ATTN: Steve Dimmer PHONE NO : 206 3274284___
1406 Place NE Suite 107 SE DECISION MADE: 27-OCT-22
Bellevue WA 98007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S.I.N. Instrument Kits
S.I.N. – Sistema de Implante Nacio510(k) NO: K222514(Traditional)
ATTN: Denise Domiciano PHONE NO : 55 11 21693000 3236
Avenida Vereador Abel Ferreira, 11SE DECISION MADE: 27-OCT-22
São Paulo BR 03340-000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FaSet Fixation System
Dio Medical Corporation 510(k) NO: K222515(Traditional)
ATTN: Milan George PHONE NO : 877 3945407 102
2100 Campus Lane, Suite 100 SE DECISION MADE: 05-OCT-22
East Norriton PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi
Shenzhen Ishine Technology Company510(k) NO: K222537(Traditional)
ATTN: Chaohui An PHONE NO : 86____ 138 23508753
Room 213 Building 4, No.45, Makan SE DECISION MADE: 14-OCT-22
Shenzhen CN 518055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electric nasal aspirator
Shenzhen XinLianFeng Technology CO510(k) NO: K222547(Traditional)
ATTN: Ma Qiang PHONE NO : 86____ 135 90244726
No.5, Tongxi Road, Pingdong CommunSE DECISION MADE: 20-OCT-22
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zimmer Persona Personalized Knee System
Zimmer, Inc. 510(k) NO: K222566(Traditional)
ATTN: Lauren Ricker PHONE NO : 574 3067578___
1800 W Center Street SE DECISION MADE: 17-OCT-22
Warsaw IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System
Dio Medical Corporation 510(k) NO: K222572(Traditional)
ATTN: Milan George PHONE NO : 877 3945407 102___
2100 Campus Lane, Suite 100 SE DECISION MADE: 18-OCT-22
East Norriton PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stela Automix System
SDI Limited 510(k) NO: K222581(Traditional)
ATTN: Quynh Jewell PHONE NO : 61 3 87277107
3-15 Brunsdon Street, Bayswater SE DECISION MADE: 28-OCT-22
Melbourne AU 3153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stela Capsule System
SDI Limited 510(k) NO: K222583(Traditional)
ATTN: Quynh Jewell PHONE NO : 61 3 87277107
3-15 Brunsdon Street, Bayswater SE DECISION MADE: 28-OCT-22
Melbourne AU 3153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FilmArray Pneumonia Panel plus
BioFire Diagnostics, LLC 510(k) NO: K222601(Special)
ATTN: Kevin Bourzac PHONE NO : 801 7366354 1358
515 Colorow Drive SE DECISION MADE: 27-OCT-22
Salt Lake City UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASSALLO GT EXT
Filmecc Co. Ltd. 510(k) NO: K222631(Traditional)
ATTN: Toshiya Osawa PHONE NO : 81 52 7681212
1703 Wakita-cho, Moriyama-ku SE DECISION MADE: 26-OCT-22
Nagoya-shi JP 463-0024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UHR Bipolar Implants, Restoration GAP II Implants
Howmedica Osteonics Corp., dba Str510(k) NO: K222632(Traditional)
ATTN: Margaret Klippel PHONE NO : 201 8315559
325 Corporate Drive SE DECISION MADE: 21-OCT-22
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
Sirius Medical Systems B.V. 510(k) NO: K222643(Special)
ATTN: Bram Schermers PHONE NO :
High Tech Campus 41 SE DECISION MADE: 19-OCT-22
Eindhoven NL 5656AE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System
Smith+Nephew, Inc 510(k) NO: K222653(Traditional)
ATTN: Lilian Hren PHONE NO : 901 5588200
1450 Brooks Rd SE DECISION MADE: 28-OCT-22
Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEBO Wound Dressing
MEBO Life Science Inc. 510(k) NO: K222657(Special)
ATTN: Sidney Hong PHONE NO : 626___ 3487978
325 North Puente Street # A SE DECISION MADE: 18-OCT-22
Brea CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vitrea CT Cardiac Analysis
Canon Medical Informatics, Inc. 510(k) NO: K222662(Special)
ATTN: Jay Vaishnav PHONE NO : 952___ 4879769
5850 Opus Parkway, Suite 300 SE DECISION MADE: 14-OCT-22
Minnetonka MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mobility+ Enteral Feeding System
Rockfield Medical 510(k) NO: K222678(Traditional)
ATTN: Orla Connaughton PHONE NO : 353 91 763000
iHub GMIT, Dublin Road SE DECISION MADE: 27-OCT-22
Galway IE H91 DCH9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Perfit FS Dental Zirconia Fully Sintered Block
Vatech Acucera, Inc. 510(k) NO: K222686(Special)
ATTN: Kwon Kyung Wook PHONE NO : 82 31 80051851
2544, Nambuk-daero, Idong-eup, CheSE DECISION MADE: 06-OCT-22
Yongin-si KR 17138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUVIS-spine
Curexo, Inc. 510(k) NO: K222698(Special)
ATTN: Jungeun Park PHONE NO : 82 31 7887935
577, Gangnam-Daero, Seocho-Gu SE DECISION MADE: 07-OCT-22
Seoul KR 06530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tibial baseplate, Tibial insert
United Orthopedic Corporation 510(k) NO: K222700(Special)
ATTN: Lois Ho PHONE NO : 886 3 5773351 2220
No 57, Park Ave 2, Science Park SE DECISION MADE: 06-OCT-22
Hsinchu TW 30075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs
Guang Dong Kingfa Sci. & Tech.Co.,510(k) NO: K222714(Special)
ATTN: Xiaoge Yu PHONE NO : 86 135 70952157
No. 28 Delong Ave., Shijiao Town, SE DECISION MADE: 07-OCT-22
Qingyuan CN 511545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CL24N
WIDE Corporation 510(k) NO: K222717(Traditional)
ATTN: YeoJin Yun PHONE NO : 82 31 2181675
15F, The First Tower III, 602, DonSE DECISION MADE: 31-OCT-22
Hwaseong-Si CN 18469 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
Safeskin Retailing (HK) Limited 510(k) NO: K222721(Traditional)
ATTN: Alvin Ho PHONE NO : 60 128 265625____
26th Floor, Beautiful Group Tower,SE DECISION MADE: 18-OCT-22
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CW60N
WIDE Corporation 510(k) NO: K222722(Traditional)
ATTN: YeoJin Yun PHONE NO : 82 31 2181675
15F, The First Tower III, 602, DonSE DECISION MADE: 31-OCT-22
Hwaseong-Si KR 18469 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)
Shanghai AnQing Medical Instrument510(k) NO: K222737(Special)
ATTN: Shuwen Fan PHONE NO : 86 021 61117375
3 & 4 Floor, No.2 Building, 366 HuSE DECISION MADE: 05-OCT-22
Shanghai CN 201201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Route 92 Medical Full Length 070 Access System
Route 92 Medical, Inc. 510(k) NO: K222743(Special)
ATTN: Kirsten Valley PHONE NO : 650 2798427
155 Bovet Road, Suite 100 SE DECISION MADE: 04-OCT-22
San Mateo CA 94402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sol-M Luer Lock Syringe
Sol-Millennium Medical Inc. 510(k) NO: K222744(Special)
ATTN: Ying Zhao PHONE NO : 919 3242268
315 Shawnee North Dr. Suite 100 SE DECISION MADE: 11-OCT-22
Suwanee GA 30024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors
Responsive Arthroscopy LLC 510(k) NO: K222763(Special)
ATTN: Garrett Ahlborg PHONE NO : 612 5326800___
701 N. 3rd Street, Suite 208 SE DECISION MADE: 13-OCT-22
Minneapolis MN 55401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SafeBreak Vascular
Lineus Medical, LLC 510(k) NO: K222791(Special)
ATTN: Vance Clement PHONE NO :
179 North Church Ave, Suite 202 SE DECISION MADE: 16-OCT-22
Fayetteville AZ 72701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WavelinQ™ Generator
C.R. Bard, Inc. 510(k) NO: K222793(Special)
ATTN: Jakob Wells PHONE NO : 602___ 8305382
1625 West 3rd Street SE DECISION MADE: 17-OCT-22
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-Pac Expandable Lumbar Cage System
Expanding Innovations, inc 510(k) NO: K222797(Special)
ATTN: Robert Jaramillo PHONE NO : 925___ 8192257
110 Pioneer Way, Ste 1 SE DECISION MADE: 14-OCT-22
Mountain View CA 94041-1519 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMA Elbow system - Line extension
LimaCorporate S.p.A. 510(k) NO: K222807(Traditional)
ATTN: Marco Tallerico PHONE NO : 390 432 945511
Via Nazionale 52 SE DECISION MADE: 26-OCT-22
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci Firefly Imaging System
Intuitive Surgical Inc. 510(k) NO: K222827(Special)
ATTN: Melissa Gonzalez PHONE NO : 408 5238684
1266 Kifer Road SE DECISION MADE: 20-OCT-22
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-Patch Cardiac Monitor
Shandong CoreCare Technology Limit510(k) NO: K222842(Traditional)
ATTN: Cao Cheng PHONE NO : 86____ 186 10294350
Suite 801-2, Incubator Phase I, InSE DECISION MADE: 20-OCT-22
Jinan CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Radiography CXDI-Pro, Digital Radiography D1
Canon, Inc. 510(k) NO: K222855(Special)
ATTN: Mr. Akira Hirai PHONE NO : 81 3 37582111
9-1 Imaikami-Cho, Nakahara-Ku SE DECISION MADE: 17-OCT-22
Kawasaki JP 211-8501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMAVAC 100 Sustained Vacuum System
SOMAVAC Medical Solutions, Inc. 510(k) NO: K222856(Special)
ATTN: Phil Ryan PHONE NO : 901 2122198
3144 Stage Post Rd Unit 101 SE DECISION MADE: 19-OCT-22
Bartlett TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mercu 1717V
iRay Technology Taicang Ltd. 510(k) NO: K222886(Special)
ATTN: Junjie Qian PHONE NO : 86 0512 53690872
No. 33 Xinggang Rd., Taicang Port SE DECISION MADE: 20-OCT-22
Taicang CN 215434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIANCE ULTRA 32" 4K ZEROWIRE DUO
NDS Surgical Imaging, LLC. 510(k) NO: K222890(Special)
ATTN: Jim Leng PHONE NO : 408 3100832
100 Paramount Drive, Suite 101 SE DECISION MADE: 19-OCT-22
Sarasota FL 34232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Examination Glove
Jiangsu Cureguard Glove Co., Ltd. 510(k) NO: K222937(Traditional)
ATTN: Guo Hua PHONE NO : 86 134 85097856
No. 65 Shenzhen Road, The EconomicSE DECISION MADE: 01-OCT-22
Suqian CN 223800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2008T BlueStar Hemodailysis Machine
Fresenius Medical Care Renal Thera510(k) NO: K222952(Traditional)
ATTN: Denise M Oppermann PHONE NO : 781 9969103
920 Winter Street SE DECISION MADE: 27-OCT-22
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cirq Arm System (2.0);Alignment System Spine
Brainlab AG 510(k) NO: K222966(Special)
ATTN: Sadwini Suresh PHONE NO : 49 899 915680
Olof-Palme-Str. 9 SE DECISION MADE: 27-OCT-22
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation 510(k) NO: K222968(Special)
ATTN: Janine F Reyes PHONE NO : 714 6697853
1385 Shimoishigami SE DECISION MADE: 25-OCT-22
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Vinyl Examination Gloves
Jiangxi Handspro Products Solution510(k) NO: K223008(Traditional)
ATTN: Jun Yin PHONE NO : 86 186 16636918
Chuangye Avenue, Fenglin IndustriaSE DECISION MADE: 08-OCT-22
Jiujiang City CN 330406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VS3-Iridium System (VS3-IR)
Visionsense Ltd. 510(k) NO: K223020(Special)
ATTN: Guy Wroclawski PHONE NO : 972 50 2049052
20 Hamagshimim St. SE DECISION MADE: 28-OCT-22
Petach Tikva, Hamerkaz IL 4934829510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Viz LVO ContaCT
Viz.ai, Inc. 510(k) NO: K223042(Special)
ATTN: Gregory Ramina PHONE NO : 239 8983105
201 Mission St 12th Floor SE DECISION MADE: 21-OCT-22
San Francisco CA 94105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EzRay Air 2 Wall (Model: VEX-S350W)
Vatech Co., Ltd 510(k) NO: K223058(Special)
ATTN: Daniel Kim PHONE NO : 82 31 3799492
13, Samsung 1-ro 2-gil SE DECISION MADE: 26-OCT-22
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DigiX FDX
Allengers Medical Systems Limited 510(k) NO: K223060(Special)
ATTN: Sanjeev K Marjara PHONE NO : 91 1762 282600
FDA Hall Unit-2, Bhankarpur, MubarSE DECISION MADE: 26-OCT-22
Derabassi, Distt. Mohali IN 14050510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLY II Uterine Positioning System™ (UPS)
CooperSurgical, Inc. 510(k) NO: K223064(Special)
ATTN: Yin Huang PHONE NO : 475 2399538
95 Corporate Drive SE DECISION MADE: 28-OCT-22
Trumbull CT 06611 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices
Adcura, Inc. 510(k) NO: K223065(Special)
ATTN: Andrew Rogers PHONE NO : 1_____ 952 4000407
11010 Prairie Lakes Dr Ste 375 SE DECISION MADE: 26-OCT-22
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Remi Robotic Navigation System
Fusion Robotics, LLC 510(k) NO: K223070(Special)
ATTN: Sarah Braun PHONE NO : 423 8384454
168 Centennial Parkway, Unit 170 SE DECISION MADE: 28-OCT-22
Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stage
SpinTech, Inc. 510(k) NO: K223079(Special)
ATTN: Rana El Hachem PHONE NO : 248 7126789
30200 Telegraph Road Suite 140 SE DECISION MADE: 28-OCT-22
Bingham Farms MI 48025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bakri Essential Postpartum Balloon
Cook Incorporated 510(k) NO: K223098(Special)
ATTN: Ian Herman PHONE NO : 812 3353575 104034
750 Daniels Way, P.O. Box 489 SE DECISION MADE: 28-OCT-22
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)
PT. Sintong Unigolden Glove 510(k) NO: K223235(Abbreviated)
ATTN: MP Vivekanandan PHONE NO : 62 62 3533339
Jl. Lintas Sumatera, Kel. Hessa PeSE DECISION MADE: 26-OCT-22
Kota Kisaran ID 21272 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 295
TOTAL WITH SUMMARIES 282
TOTAL WITH STATEMENTS 13
