510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD November 2022
DEVICE: Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
Procise Diagnostics 510(k) NO: K201256(Traditional)
ATTN: Dan Kiser PHONE NO : 858 9220592
9449 Carroll Park Drive SE DECISION MADE: 04-NOV-22
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Closed System Transfer Device
Shinva Ande Healthcare Apparatus C510(k) NO: K201460(Traditional)
ATTN: XiaoLei Tian PHONE NO : 086 533 3917816
No.77 Development Zone North Road,SE DECISION MADE: 23-NOV-22
Zibo CN 255086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
DiaSorin Molecular LLC 510(k) NO: K202755(Traditional)
ATTN: Sharon Young PHONE NO : 562 2406680
11331 Valley View Street SE DECISION MADE: 05-NOV-22
Cypress CA 90630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eonis SCID-SMA kit
PerkinElmer Inc 510(k) NO: K203035(Traditional)
ATTN: Eva Nalian PHONE NO : 1 647 6338435
940 Winter St SE DECISION MADE: 09-NOV-22
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KNH Surgical Face Mask
KNH Surgical Face Mask 510(k) NO: K203528(Traditional)
ATTN: Robert Y.L. Pan PHONE NO : 886 6 79415743 5800
1, 2, 4F, of No.66-1, Sanji, JiangSE DECISION MADE: 16-NOV-22
Tainan TW 72548 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oxyfit Pulse Oximeter
Shenzhen Viatom Technology Co., Lt510(k) NO: K203812(Traditional)
ATTN: Zhou Saixin PHONE NO : 86 0755 86638929
4E, Building 3, Tingwei IndustrialSE DECISION MADE: 08-NOV-22
Shenzhen CN 518101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sysmex XW-100 Automated Hematology Analyzer
Sysmex America, INC. 510(k) NO: K210346(Dual Track)
ATTN: Sharita Brooks PHONE NO : 224 5439618
577 Aptakisic Road SE DECISION MADE: 08-NOV-22
Lincolnshire IL 60069-4325 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
Sebia 510(k) NO: K210623(Traditional)
ATTN: Karen Anderson PHONE NO : 1 800 8356497 3704
1705 Corporate Drive Suite 400 SE DECISION MADE: 18-NOV-22
Norcross GA 30093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smith & Nephew Intramedullary Nail Systems
Smith & Nephew, Inc. 510(k) NO: K210980(Traditional)
ATTN: Leah Hawkins PHONE NO : 901 4638447
7135 Goodlett Farms Parkway SE DECISION MADE: 14-NOV-22
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304
JKH HEALTH CO., LTD. 510(k) NO: K211050(Traditional)
ATTN: Pu Jiang PHONE NO : 86 755 27926589
4-5F, Building 12, Hengmingzhu IndSE DECISION MADE: 28-NOV-22
Shenzhen CN 518104 510(k) STATEMENT
DEVICE: TFX-LT2000 Therapy Light
ToeFX, Inc. 510(k) NO: K211265(Traditional)
ATTN: Monika Yazdanian PHONE NO : 1 289 9338637
1280 Main Street West #039, Ste. BSE DECISION MADE: 17-NOV-22
Hamilton CA L8S 4M3 510(k) STATEMENT
DEVICE: Implanter incl. Accessories
Guilin Woodpecker Medical Instrume510(k) NO: K211358(Traditional)
ATTN: Yang Yunfeng PHONE NO : 86 773 2350532
Information Industrial Park, GuiliSE DECISION MADE: 21-NOV-22
Guilin City CN 541004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)
Beiang Air Tech LTD. 510(k) NO: K211507(Traditional)
ATTN: Yan Zhang PHONE NO : 86 199 51234257
175#, Songbei Road, Suzhou IndustrSE DECISION MADE: 22-NOV-22
Suzhou CN 215000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Brightway Holdings Sdn. Bhd. 510(k) NO: K211816(Traditional)
ATTN: G. Baskaran PHONE NO : 60 3 33431007
Lot 1559, Jalan Istimewa, Batu BelSE DECISION MADE: 02-NOV-22
Klang MY 42100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LifeSPARC System
CardiacAssist, Inc. 510(k) NO: K211830(Traditional)
ATTN: Megan Walsh PHONE NO : 412 2307324
620 Alpha Drive, Suite 2 SE DECISION MADE: 15-NOV-22
Pittsburgh PA 15238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg Sump Catheter System Kit, vanSonnenberg Sump Catheter System
Boston Scientific Corporation 510(k) NO: K211934(Traditional)
ATTN: Liz Johnston PHONE NO : 763 4941676
One Scimed Place SE DECISION MADE: 10-NOV-22
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid
Spes Medica SRL 510(k) NO: K211954(Traditional)
ATTN: Giorgio Facco PHONE NO : 0039 0828 614191
Via Europa -Zona Industriale SE DECISION MADE: 10-NOV-22
Battipaglia IT 84091 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mapping Suction Probe
inomed Medizintechnik GmbH 510(k) NO: K212164(Traditional)
ATTN: Alexander Maier PHONE NO : 49 7641 9414845
Im Hausgruen 29 SE DECISION MADE: 11-NOV-22
Emmendingen DE 79312 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eclipse MINI Model 98900
Spacelabs Healthcare Ltd. 510(k) NO: K212317(Traditional)
ATTN: Roger Moldon PHONE NO : 011 44 1992507730
Unit B, Foxholes Centre, John TateSE DECISION MADE: 07-NOV-22
Hertford GB SG13 7DT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omnia Medical TiBrid-SC
Omnia Medical, LLC 510(k) NO: K212612(Traditional)
ATTN: Morgan Hill PHONE NO : 440 2225414
6 Canyon Road, Suite 300 SE DECISION MADE: 15-NOV-22
Morgantown WV 26508 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dyflex-II
Taeyeon Medical Co., Ltd. 510(k) NO: K212700(Traditional)
ATTN: Sin-Ae Kang PHONE NO : 82 33 7427555
132-1 Donghwagongdan-Ro, Munmak-euSE DECISION MADE: 15-NOV-22
Wonju-Si KR 26365 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Paneffort AAMI Level 3 Isolation Gown
Paneffort, LLC 510(k) NO: K212717(Traditional)
ATTN: Harry Harry PHONE NO : 855 122 84810
SE DECISION MADE: 30-NOV-22
Rochester NY 14626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Canady Flex RoboWrist
US Medical Innovations, LLC 510(k) NO: K212736(Traditional)
ATTN: Jerome Canady PHONE NO : 412 5084831
6930 Carroll Avenue, Suite 1000 SE DECISION MADE: 22-NOV-22
Takoma Park MD 20912 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medwell Technology Ltd Syringes, various sizes
Medwell Technology Ltd 510(k) NO: K212764(Traditional)
ATTN: Andy Song PHONE NO : 86 1390 2646099
8th Building, Pujing, Fumin IndustSE DECISION MADE: 04-NOV-22
Dongguan City CN 523770 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Gown
Xianning Marveldas Protective Arti510(k) NO: K212812(Traditional)
ATTN: Zhuxiao Kang PHONE NO : 86 157 2066625
Guishan Road #30, Hi-New IndustriaSE DECISION MADE: 16-NOV-22
Xianning CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece
Shenzhen Carejoy Technology Co., L510(k) NO: K212910(Traditional)
ATTN: Wei Hui PHONE NO : 86 133 21110919
5 / F, Building E, No.10, East SnoSE DECISION MADE: 17-NOV-22
Shenzhen CN 518129 510(k) STATEMENT
DEVICE: Konig Mogen Clamp
Medline Industries, Inc 510(k) NO: K212911(Traditional)
ATTN: Jennifer Mason PHONE NO : 847 6433652
Three Lakes Drive SE DECISION MADE: 18-NOV-22
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vision Monitor- MonCvONE
Metrovision 510(k) NO: K212936(Traditional)
ATTN: Jacques Charlier PHONE NO : 33 320 171956
4 rue des Platanes SE DECISION MADE: 21-NOV-22
Perenchies FR 59840 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Auxilock GFS Mini, GFS II Large, and GFS Ultimate
Auxein Medical Private Limited 510(k) NO: K213018(Traditional)
ATTN: Rahul Luthra PHONE NO : 91 971 7586969
Plot No. 168, 169, 170 Phase-IV, SSE DECISION MADE: 18-NOV-22
Sonipat IN 131028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Supra Non-Stick Bipolar Forceps
Guenter Bissinger Medizintechnik G510(k) NO: K213042(Abbreviated)
ATTN: Matthias Bissinger PHONE NO : 49 7641 914330
Hans-Theisen-Str. 1 SE DECISION MADE: 17-NOV-22
Teningen DE 79331 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Humerus & Ulna System
Auxein Medical Private Limited 510(k) NO: K213108(Traditional)
ATTN: Rahul Luthra PHONE NO : 91 971 7586969
Plot No. 168, 169, 170 Phase-IV, SSE DECISION MADE: 04-NOV-22
Sonipat IN 131028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VSI HoloMedicine
ApoQlar GmbH 510(k) NO: K213215(Traditional)
ATTN: Liliana Duarte PHONE NO : 49 402 4192779
C/o The-Labs.Space,Raboisen 32 SE DECISION MADE: 25-NOV-22
Hamberg DE 20095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable hemoclip
Beijing ZKSK Technology Co.,Ltd 510(k) NO: K213217(Traditional)
ATTN: Ma Li PHONE NO : 86 138 11778090
Building 9, 6 & No.6 Yuan Hengye NSE DECISION MADE: 14-NOV-22
Beijing CN 101105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dermal Cooling System
R2 Technologies, Inc. 510(k) NO: K213294(Traditional)
ATTN: Ragan Reppond PHONE NO : 925 3784400
2603 Camino Ramon, Suite 200 SE DECISION MADE: 10-NOV-22
San Ramon CA 94583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C.C. LIFE 21
21 Equipment S.R.L. 510(k) NO: K213295(Traditional)
ATTN: Dolores Moretto PHONE NO : 39 011 883522
Piazza Bodoni 3 SE DECISION MADE: 17-NOV-22
Torino IT 10123 510(k) STATEMENT
DEVICE: PRIMED Pediatric Facemask
PRIMED Medical Products Inc. 510(k) NO: K213427(Traditional)
ATTN: Mitra Fard PHONE NO : 1 877 8774633
200, 2003-91 St, SW, Edmonton, SE DECISION MADE: 22-NOV-22
Edmonton CA T6X 0W8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Glenoid Reconstruction System
Medacta International S.A. 510(k) NO: K213459(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 23-NOV-22
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QStat Cartridge
HemoSonics, LLC 510(k) NO: K213917(Traditional)
ATTN: Iskra Mrakovic PHONE NO : 919 7656913 429
400 Preston Avenue, Suite 250 SE DECISION MADE: 29-NOV-22
Charlottesville VA 22903 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmartSurgN Visualization System
SmartSurgN Incorporated 510(k) NO: K213943(Traditional)
ATTN: Cathy Mantor PHONE NO : 510 4990253
3150 Almaden Expressway Suite 252 SE DECISION MADE: 29-NOV-22
San Jose CA 95118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Gloves
Emerald Glove Manufacturing Sdn Bh510(k) NO: K213981(Traditional)
ATTN: Amran A. Aziz PHONE NO : 60 133 951755
Lot 18912 & Lot 18911, Jalan PerusSE DECISION MADE: 12-NOV-22
Taiping MY 834600 510(k) STATEMENT
DEVICE: Back 3 COLOR
SWIMS America Corp 510(k) NO: K214090(Traditional)
ATTN: Matthieu Commeau PHONE NO : 917 3717388
1133 Westchester Avenue Suite N 22SE DECISION MADE: 01-NOV-22
White Plains NY 10604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dentca Base Premium, Dentca Base Hi-Impact
Dentca, Inc. 510(k) NO: K220042(Traditional)
ATTN: Jason Lee PHONE NO : 424 5588726
357 Van Ness Way, Ste 250 SE DECISION MADE: 17-NOV-22
Torrance CA 90501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSure Enteral Feeding Pump
Amsino International Inc. 510(k) NO: K220230(Traditional)
ATTN: Jane Gao PHONE NO : 86 139 16147664
708 Corporate Center Drive SE DECISION MADE: 10-NOV-22
Pomona CA 91768 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
Neurosoft Ltd. 510(k) NO: K220254(Traditional)
ATTN: Michael Durdin PHONE NO : 7 4932 240434
5, Voronin str. SE DECISION MADE: 30-NOV-22
Ivanovo RU 153032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers
Vortex Surgical Inc 510(k) NO: K220263(Traditional)
ATTN: Andrew Ritts PHONE NO : 636 7784350
680 Crown Industrial Ct Ste F SE DECISION MADE: 03-NOV-22
Chesterfield MO 63005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable surgical face mask
Shandong Aida Medical Products Co.510(k) NO: K220302(Abbreviated)
ATTN: Wang Bing PHONE NO : 0086 536 8131936
Wangjiazhuang, Wangliu Strret OffiSE DECISION MADE: 16-NOV-22
Weifang CN 261053 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PosiSep X BAM Hemostat Dressing/Intranasal Splint
Hemostasis LLC 510(k) NO: K220326(Traditional)
ATTN: Lakshmi Ganesh Bollina PHONE NO : 651 8551466 2026
5000 Township Pkwy SE DECISION MADE: 14-NOV-22
St Paul MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONET Anterior Cervical Plate System
CTL Medical Corporation 510(k) NO: K220334(Traditional)
ATTN: Sean Suh PHONE NO : 214 5455820
4550 Excel Pkwy Ste 300 SE DECISION MADE: 09-NOV-22
Addison TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lotus Prophy Angle
AJK Engineering, Inc. 510(k) NO: K220346(Traditional)
ATTN: Ajay Kumar PHONE NO : 888 9621652
1605 Ashley Court SE DECISION MADE: 07-NOV-22
Sommerville SC 29486 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polso Watch
Chronisense Medical, Ltd. 510(k) NO: K220351(Traditional)
ATTN: Bridget Ross PHONE NO : 972 4 8275095
2 Hacarmel St. P.O.B. 399 SE DECISION MADE: 18-NOV-22
Yokneam Illit IL 2066724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tandry CMF Plate System
Microware Precision Co., Ltd. 510(k) NO: K220360(Traditional)
ATTN: Harrison Du PHONE NO : 886 4 24636275 100
No. 12, Keyuan 2nd Rd., Situn DistSE DECISION MADE: 10-NOV-22
Taichung TW 40763 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
Summit Glove, Inc 510(k) NO: K220371(Traditional)
ATTN: James Hull PHONE NO : 1 330 8680066
310 South Grant Street SE DECISION MADE: 02-NOV-22
Minerva OH 44657 510(k) STATEMENT
DEVICE: AVIEW RT ACS
Coreline Soft Co.,Ltd 510(k) NO: K220408(Traditional)
ATTN: Hyeyi Park PHONE NO : 82 2 5717321
4,5F (Yeonnam-dong), 49, World CupSE DECISION MADE: 10-NOV-22
Seoul KR 03991 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System
Apex BioTechnology Corp. 510(k) NO: K220421(Special)
ATTN: Lisa Liu PHONE NO : 011 8863 5641952
No. 7, Li-Hsin Road V, Hsinchu SciSE DECISION MADE: 04-NOV-22
Hsinchu CN 30078 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10
PENTAX of America, Inc. 510(k) NO: K220465(Traditional)
ATTN: William Goeller PHONE NO : 201 5712300 2318
3 Paragon Drive SE DECISION MADE: 16-NOV-22
Montvale NJ 07645-1782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ibiomedi Electronic Stethoscope ES-2020
Sound Land Corp. 510(k) NO: K220466(Traditional)
ATTN: Chi-Hsun Hung PHONE NO : 886 3 3961958 120
No.32, Keji 1st Rd., Guishan Dist.SE DECISION MADE: 03-NOV-22
Taoyuan TW 33383 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Durex Patronus CloseFit, Durex Patronus Regular
RB Health (US) LLC 510(k) NO: K220489(Traditional)
ATTN: Kaitlyn Chan PHONE NO : 862 3250012
399 Interpace Pkwy SE DECISION MADE: 07-NOV-22
Parsippany NJ 07054-1133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endoscopy Oxygen Mask
Engineered Medical Systems Inc. 510(k) NO: K220533(Traditional)
ATTN: Tamara Lefevers PHONE NO : 37 2465500 113
2055 Executive Dr SE DECISION MADE: 16-NOV-22
Indianapolis IN 46241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cardio10
Bionet Co., Ltd. 510(k) NO: K220535(Traditional)
ATTN: Kyungeun Park PHONE NO : 82 10 88176451
5F, 61 Digital-ro 31 gil, Guro-gu SE DECISION MADE: 15-NOV-22
Seoul KR 08375 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Klarity SRS Baseplate, Klarity Promise Baseplate
Klarity Medical & Equipment (GZ) C510(k) NO: K220539(Traditional)
ATTN: Lucy Li PHONE NO : 86 20 82226380
No. 14 3rd St., Shawan GETDD SE DECISION MADE: 01-NOV-22
Guangzhou CN 510730 510(k) STATEMENT
DEVICE: Blood Administration Sets
Baxter Healthcare Corporation 510(k) NO: K220558(Traditional)
ATTN: James L. Vangeisen PHONE NO : 224 2703308
25212 West Illinois Route 120 SE DECISION MADE: 17-NOV-22
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment
MegaGen Implant Co., Ltd. 510(k) NO: K220562(Traditional)
ATTN: Hyo-Eun Lee PHONE NO : 82 53 2222828
45, Secheon-ro, 7-gil SE DECISION MADE: 10-NOV-22
Daegu KR 42921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TorchTM Software
Voximetry, Incorporated 510(k) NO: K220630(Traditional)
ATTN: Sue Wallace PHONE NO : 262 7516441
8517 Excelsior Drive Suite 207 SE DECISION MADE: 28-NOV-22
Madison WI 53717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Heater-Cooler System 3T
LivaNova Deutschland GmbH 510(k) NO: K220635(Traditional)
ATTN: Julia E. Leslie PHONE NO : 49 89 32301141
Lindbergh Strasse 25 SE DECISION MADE: 16-NOV-22
Munchen DE 80939 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COSY Cervicothoracic Occipital Rod-Screw System
SIGNUS Medizintechnik GmbH 510(k) NO: K220658(Traditional)
ATTN: Holger Noss PHONE NO : 0049 60239 166212
Industriestraße 2 SE DECISION MADE: 18-NOV-22
Alzenau DE 63755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AccuCTP
ArteryFlow Technology Co., Ltd. 510(k) NO: K220663(Traditional)
ATTN: Jianping Xiang PHONE NO : 86 571 86772567__
459 Qianmo Road, Suite C1-501, BinSE DECISION MADE: 22-NOV-22
Hangzhou CN 310051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Urine Collection Tube
Zhejiang Gongdong Medical Technolo510(k) NO: K220739(Traditional)
ATTN: Handson Wei PHONE NO : 86 0576 84115678
No. 10 Beiyuan Ave., Huangyan SE DECISION MADE: 17-NOV-22
Taizhou CN 318020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 10PL
Tentech Co. Ltd. 510(k) NO: K220794(Traditional)
ATTN: Lee Dong Gun PHONE NO : 82 02 69542203
3F Hyungkyung Building, 611, SeollSE DECISION MADE: 10-NOV-22
Gangnam-gu KR 06103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Parky App
H2O Bilisim Yazilim 510(k) NO: K220820(Traditional)
ATTN: Yagmur Selin Gulmus-Kolay PHONE NO : 90 312 2196219
Mustafa Kemal Mah. 2119. Sok. No 3SE DECISION MADE: 17-NOV-22
Cankaya TR 06510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL
Acuitive Technologies, Inc. 510(k) NO: K220833(Traditional)
ATTN: Matthew Poggie PHONE NO : 201 6612678
50 Commerce Drive SE DECISION MADE: 04-NOV-22
Allendale NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)
Dentsply Sirona 510(k) NO: K220841(Traditional)
ATTN: Courtney Clark PHONE NO : 248 8954379
221 West Philadelphia Street, SuitSE DECISION MADE: 16-NOV-22
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORE-SNARE
Incore Co., Ltd. 510(k) NO: K220846(Traditional)
ATTN: Jae-Hun Lee PHONE NO : 82 2 8663514
11, Hyeoksin-daero, 78-gil, Dong-gSE DECISION MADE: 21-NOV-22
Daegu KR 41072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smooth Drive contra angle and straight handpieces
Lares Research 510(k) NO: K220874(Traditional)
ATTN: Bruce Holderbein PHONE NO : 530 3451767 2862
295 Lockheed Ave SE DECISION MADE: 07-NOV-22
Chico CA 95973 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: xvision Spine System
Augmedics Ltd. 510(k) NO: K220905(Traditional)
ATTN: Contact Title PHONE NO : 972 4 3730111
1 Ha-Tsmikha St SE DECISION MADE: 17-NOV-22
Yokneam Illit IL 2069205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM Endoscope Model EB-710P
FUJIFILM Corporaton 510(k) NO: K220957(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 10-NOV-22
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System
ImSonic Medical China, INC. 510(k) NO: K220983(Traditional)
ATTN: Xiaohui Hao PHONE NO : 86 1371 8322801
No. 168 Yuanfeng Road SE DECISION MADE: 11-NOV-22
Kunshan CN 215300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cobas HCV
Roche Molecular Systems, Inc. 510(k) NO: K221007(Traditional)
ATTN: Ashley Malich PHONE NO : 925 3680881
4300 Hacienda Drive SE DECISION MADE: 04-NOV-22
Pleasanton CA 94588-2722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Insulin Syringes without needle
Berpu Medical Technology Co., Ltd 510(k) NO: K221045(Traditional)
ATTN: Buxin Yu PHONE NO : 300 4496829
No. 14 Xingji Road, Yongxing StreeSE DECISION MADE: 03-NOV-22
Wenzhou CN 325000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infusion Sets for Single Use with Needles
Sichuan Prius Biotechnology Co., L510(k) NO: K221069(Traditional)
ATTN: Yan Liu PHONE NO : 86 831 3839889
No.2 Prius Road, Luo Long IndustriSE DECISION MADE: 21-NOV-22
Yibin CN 644104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infusion Sets for Single Use
Sichuan Prius Biotechnology Co., L510(k) NO: K221075(Traditional)
ATTN: Yan Liu PHONE NO : 86 831 3839889
No.2 Prius Road, Luo Long IndustriSE DECISION MADE: 21-NOV-22
Yibin CN 644104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use
Sichuan Prius Biotechnology Co., L510(k) NO: K221078(Traditional)
ATTN: Yan Liu PHONE NO : 86 831 3839889
No.2 Prius Road, Luo Long IndustriSE DECISION MADE: 21-NOV-22
Yibin CN 644104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl
Rhino Health Inc. 510(k) NO: K221082(Traditional)
ATTN: Mark Lee PHONE NO : 1 833 8988989
309 A East, Route 66 SE DECISION MADE: 30-NOV-22
Church Rock NM 87311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CryoRobot Select System
TMRW Life Sciences, Inc. 510(k) NO: K221086(Traditional)
ATTN: Christina Miracle PHONE NO : 513 3144653
250 Hudson Street Floor 6 SE DECISION MADE: 04-NOV-22
New York NY 10013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OmniTaper EV Dental Implants, DS Implants abutments with EV connection
Dentsply Sirona 510(k) NO: K221094(Traditional)
ATTN: Courtney Clark PHONE NO : 248 8954379
221 West Philadelphia Street, SuitSE DECISION MADE: 16-NOV-22
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WISE Cortical Strip (WCS)
WISE S.r.l. 510(k) NO: K221123(Traditional)
ATTN: Luca Ravagnan PHONE NO : 0039 02 84962910
Via Michelangelo Buonarroti ,38 SE DECISION MADE: 22-NOV-22
Cologno Monzese IT 20093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bodygard SFS Surgical Gown Level 4
Feliks Plastik Laminasyon Ve Ambal510(k) NO: K221139(Traditional)
ATTN: Ali Serdar Serteser PHONE NO : 90 5332 097295
Sanayi ve Tic A. S. Eskisehir OrgaSE DECISION MADE: 10-NOV-22
Odunpazari TR 26110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CuringPen Dental Curing Light
Changzhou Sifary Medical Technolog510(k) NO: K221152(Traditional)
ATTN: Iris Cai PHONE NO : 86 0519 85962691
No. 99, Qingyang Road, Xuejia CounSE DECISION MADE: 23-NOV-22
Changzhou CN 213000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UniVy OsteoVy Cervical IBF System
Vy Spine, LLC 510(k) NO: K221162(Traditional)
ATTN: Jordan Hendrickson PHONE NO : 866 4897746
2236 Capital Circle NE, Suite 103-SE DECISION MADE: 04-NOV-22
Tallahassee FL 32308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl
Sri Trang Gloves (Thailand) Public510(k) NO: K221165(Abbreviated)
ATTN: Jordan Smith PHONE NO : 813 6064301
110 Kanjanavanit Road SE DECISION MADE: 20-NOV-22
Hat Yai TH 80230 510(k) STATEMENT
DEVICE: Disposable Insulin Pen Needle
Ningbo Medsun Medical Co., Ltd. 510(k) NO: K221178(Traditional)
ATTN: Liu Ping PHONE NO : 86 574 86301708
No.55 Jinxi Road, Zhenhai SE DECISION MADE: 17-NOV-22
Ningbo CN 315221 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEYE-DS
AEYE Health, Inc. 510(k) NO: K221183(Traditional)
ATTN: Zack Dvey-Aharon PHONE NO : 914 3364208
200 Park Avenue (17th Floor) SE DECISION MADE: 10-NOV-22
New York NY 10166 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORiGO System
Bien-Air Surgery SA 510(k) NO: K221184(Traditional)
ATTN: Jonas Guerdat PHONE NO : 41 32 3446440
Rue de l'Ouest 2b SE DECISION MADE: 02-NOV-22
Le Noirmont CH 2340 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PainShield MD PLUS
NanoVibronix, Inc. 510(k) NO: K221210(Special)
ATTN: Hrishikesh Gadagkar PHONE NO : 410 2450501
525 Executive Blvd. SE DECISION MADE: 23-NOV-22
Elmsford NY 10523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
Beckman Coulter, Inc. 510(k) NO: K221225(Traditional)
ATTN: Kuljeet Kaur PHONE NO : 1 952 4651914
1000 Lake Hazeltine Drive SE DECISION MADE: 10-NOV-22
Chaska MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle
Jiangsu Kangbao Medical Equipment 510(k) NO: K221247(Traditional)
ATTN: Rujun Tang PHONE NO : 86 514 88223540
78#, North Suzhong Road Baoying SE DECISION MADE: 01-NOV-22
Yangzhou CN 225800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EasyOne Filter
NDD Medizintechnik AG 510(k) NO: K221250(Traditional)
ATTN: Andreas Senn PHONE NO : 41 44 5126541
Technoparkstrasse 1 SE DECISION MADE: 22-NOV-22
Zurich CH 8005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SR-1 Skin Treatment System
AVAVA, Inc 510(k) NO: K221268(Traditional)
ATTN: Jay Bhawalkar PHONE NO : 617 3777945
275 Second Avenue, Floor 3 SE DECISION MADE: 21-NOV-22
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: pNOVUS 21 Microcatheter
phenox Ltd 510(k) NO: K221279(Third Party - Traditional)
ATTN: Sarah Cregg PHONE NO :
Kamrick Court, Ballybrit Business SE DECISION MADE: 28-NOV-22
Galway IE H91 XY38 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Multitom Rax
Siemens Medical Solutions 510(k) NO: K221281(Traditional)
ATTN: Denise Adams PHONE NO : 610 9442184
40 Liberty Boulevard SE DECISION MADE: 17-NOV-22
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Empatica Health Monitoring Platform
Empatica S.r.l. 510(k) NO: K221282(Traditional)
ATTN: Alberto Poli PHONE NO : 39 335 6316498
Via Stendhal, 36 SE DECISION MADE: 20-NOV-22
Milan IT 20144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BriefCase
Aidoc Medical, Ltd. 510(k) NO: K221330(Traditional)
ATTN: Nimrod Epstein PHONE NO : 972 73 7946870
3 Aminadav St., SE DECISION MADE: 18-NOV-22
Tel-Aviv IL 6706703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FBCC Night Guard
FBCC Inc 510(k) NO: K221369(Traditional)
ATTN: Pablo Osorio PHONE NO :
6711 S Sepulveda Blvd, Unit 602 SE DECISION MADE: 18-NOV-22
Los Angeles CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WOLF Thrombectomy™ SmartClaw Catheter
DeVoro Medical, Inc 510(k) NO: K221391(Traditional)
ATTN: Vanessa Fowler PHONE NO : 763 4942537
46724 Lakeview Blvd SE DECISION MADE: 10-NOV-22
Fremont CA 94358 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIX Rib System
Jeil Medical Corporation 510(k) NO: K221412(Traditional)
ATTN: Sejin Ryu PHONE NO : 82 2 8503583
702, 703, 704, 705, 706, 804, 805,SE DECISION MADE: 22-NOV-22
Seoul KR 08378 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E3 and Profile
Diagnosys LLC 510(k) NO: K221471(Traditional)
ATTN: Jeffrey Farmer PHONE NO : 978 4581600
55 Technology Drive, Suite 100 SE DECISION MADE: 22-NOV-22
Lowell MA 01851 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dolphin Blue Imaging
Patterson Dental Supply, Inc. 510(k) NO: K221478(Traditional)
ATTN: Erin Daly PHONE NO : 608 3454888
Dolphin Imaging & Management SolutSE DECISION MADE: 01-NOV-22
Chatsworth CA 91311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Persona Personalized Knee System
Zimmer, Inc. 510(k) NO: K221479(Traditional)
ATTN: Gregory Foster PHONE NO : 574 3710519
1800 W. Center Street SE DECISION MADE: 17-NOV-22
Warsaw IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Minimally Invasive Prostate Surgery Navigation System
Augment Intelligent Medical System510(k) NO: K221499(Traditional)
ATTN: Chen Lihong PHONE NO : 86 025 58600482
1801-1812,Floor18,Block B,KechuangSE DECISION MADE: 22-NOV-22
Nanjing CN 211808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NP Medical nCompass Extension Set with Stabilizing Base
NP Medical 510(k) NO: K221518(Traditional)
ATTN: Krishna Govindarajan PHONE NO : 484 3541755
101 Union Street SE DECISION MADE: 03-NOV-22
Clinton MA 01510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANNE Pediatric
Sibel Inc. 510(k) NO: K221530(Traditional)
ATTN: Sarah Coughlin PHONE NO : 224 2518859
6650 W. Touhy Ave. SE DECISION MADE: 22-NOV-22
Niles IL 60714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GammaTile
GT Medical Technologies 510(k) NO: K221539(Traditional)
ATTN: Jessica Newhard PHONE NO : 480 2768609
1809 S Holbrook Lane Suite 107 SE DECISION MADE: 09-NOV-22
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EFAI ChestSuite XR Pneumothorax Assessment System
Ever Fortune AI Co., Ltd. 510(k) NO: K221552(Traditional)
ATTN: Joseph Chang PHONE NO : 866 4 23226363
RM.D, 8F, NO. 573, SEC 2, Taiwan BSE DECISION MADE: 08-NOV-22
Taichung City TW 403020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T-Line Hernia Mesh
Deep Blue Medical Advances, Inc. 510(k) NO: K221556(Traditional)
ATTN: William Perry PHONE NO : 408 2429323
701 W Main Street, Suite 410 SE DECISION MADE: 28-NOV-22
Durham NC 27701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALPHALOK Plating System
Vilex LLC 510(k) NO: K221558(Traditional)
ATTN: Brock Johnson PHONE NO : 801 9164157
111 Moffitt Street SE DECISION MADE: 15-NOV-22
McMinnville TN 37110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hexanium ACIF
SpineVision, S.A.S. 510(k) NO: K221578(Special)
ATTN: Quang Tran PHONE NO : 33 1 53332553
10 Rue de la Renaissance SE DECISION MADE: 14-NOV-22
Antony FR 92160 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-Use Flexible Cystoscope
Hunan Vathin Medical Instrument Co510(k) NO: K221580(Traditional)
ATTN: Du Jing PHONE NO : 86 1891 5069265
1/F, Building 12, Innovation and ESE DECISION MADE: 18-NOV-22
Xiangtan CN 411100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-Use Flexible Rhinolaryngoscope
Hunan Vathin Medical Instrument Co510(k) NO: K221581(Traditional)
ATTN: Du Jing PHONE NO : 86 1891 5069265
1/F, Building 12, Innovation and ESE DECISION MADE: 18-NOV-22
Xiangtan CN 411100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus
ConvaTec, Inc. 510(k) NO: K221593(Traditional)
ATTN: Courtney Smith PHONE NO : 239 7762947
7815 National Service Road, Suite SE DECISION MADE: 17-NOV-22
Greensboro NC 27409 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether
AnX Robotica Corp 510(k) NO: K221608(Traditional)
ATTN: Tim Thomas PHONE NO : 770 4802911
6010 W. Spring Creek Parkway SE DECISION MADE: 22-NOV-22
Plano TX 75024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nextra CH Cannulated Hammertoe System
Nextremity Solutions, Inc. 510(k) NO: K221610(Traditional)
ATTN: Elise Fox PHONE NO : 574 3762062
1195 Polk Drive SE DECISION MADE: 04-NOV-22
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avenda Health AI Prostate Cancer Planning Software
Avenda Health, Inc. 510(k) NO: K221624(Traditional)
ATTN: Brittany Berry-Pusey PHONE NO : 435 6029160
4130 Overland Avenue SE DECISION MADE: 22-NOV-22
Culver City CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Multiflex Steerable Sheath
VizaraMed, Inc. 510(k) NO: K221655(Traditional)
ATTN: Jack P Douglas PHONE NO : 707 9934002
1914 O'Toole Way SE DECISION MADE: 14-NOV-22
San Jose CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Luminopia One
Luminopia, Inc. 510(k) NO: K221659(Traditional)
ATTN: Scott Xiao PHONE NO : 857 3656636
955 Massachusetts Ave #335 SE DECISION MADE: 04-NOV-22
Cambridge MA 02139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: United U2 femoral head, 22mm delta ceramic head
United Orthopedic Corporation 510(k) NO: K221675(Special)
ATTN: Lois Ho PHONE NO : 886 3 5773351 2220
No 57, Park Ave 2, Science Park SE DECISION MADE: 04-NOV-22
Hsinchu TW 30075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synapse 3D Base Tools v6.6
FUJIFILM Corporation 510(k) NO: K221677(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
26-30 Nishiazabu, 2-Chome SE DECISION MADE: 10-NOV-22
Minato-Ku JP 106-8620 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SprintRay High Impact Denture Base
SprintRay Inc. 510(k) NO: K221678(Traditional)
ATTN: Sara Moghtadernejad PHONE NO : 917 9123858
2705 Media Center Drive, Suite 100SE DECISION MADE: 10-NOV-22
Los Angeles CA 90065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)
Edwards Lifesciences, LLC 510(k) NO: K221704(Traditional)
ATTN: Michelle Ducca PHONE NO : 805 3686785
1 Edwards Way SE DECISION MADE: 22-NOV-22
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CINA
AVICENNA.AI 510(k) NO: K221716(Special)
ATTN: Stephane Berger PHONE NO : 33 6 12122813
Espace Mistral-Batiment A 297 AvenSE DECISION MADE: 22-NOV-22
La Ciotat FR 13600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABTross ALIF Expandable Cage System
Aegis Spine, Inc. 510(k) NO: K221719(Traditional)
ATTN: KiHyang Kim PHONE NO : 719 3377579
9781 S. Meridian Blvd, Ste 300 SE DECISION MADE: 03-NOV-22
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
Haemonetics Corporation 510(k) NO: K221722(Traditional)
ATTN: Ergang Alexis PHONE NO : 224 2442850
125 Summer Street SE DECISION MADE: 15-NOV-22
Boston MA 02110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device
Ethicon, Inc. 510(k) NO: K221744(Traditional)
ATTN: Jenny Wang PHONE NO : 646 8969786
1000 US-202 SE DECISION MADE: 15-NOV-22
Raritan NJ 08869-1425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BoneMRI v1.4
MRlguidance B.V. 510(k) NO: K221762(Traditional)
ATTN: Marijn van Stralen PHONE NO :
Gildstraat 91a SE DECISION MADE: 16-NOV-22
Utrecht NL 3572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EEA Circular Stapler with Tri-Staple Technology
Covidien 510(k) NO: K221771(Traditional)
ATTN: Leo Chan PHONE NO : 86 21 33230182
Rooms 501, 502, 601, 602, No. 3 buSE DECISION MADE: 30-NOV-22
Min Hang District, Shanghai CN 20510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vista BC Sealer
Inter-Med, Inc. 510(k) NO: K221811(Traditional)
ATTN: Alex Johnson PHONE NO : 262 6315306
2200 South St SE DECISION MADE: 21-NOV-22
Racine WI 53404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da)
Baisheng Medical Co., Ltd. 510(k) NO: K221815(Traditional)
ATTN: Xi Chen PHONE NO : 86 0750 6628113
No.11, Fusheng Road, Xinhui DistriSE DECISION MADE: 23-NOV-22
Jiangmen CN 529100 510(k) STATEMENT
DEVICE: BENCHMARK BMX81 Access System
Penumbra, Inc 510(k) NO: K221822(Traditional)
ATTN: Sindokht (Sisi) SoltanzadehPHONE NO : 510 9959799
One Penumbra Place SE DECISION MADE: 04-NOV-22
Alameda CA 95132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HemoSphere Advanced Monitor, HemoSphere ClearSight Module
Edwards Life Sciences LLC 510(k) NO: K221833(Traditional)
ATTN: Varad Raghuwanshi PHONE NO : 949 7564502
One Edwards Way SE DECISION MADE: 07-NOV-22
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Universal CMF System
Stryker Leibinger GmbH & Co. KG 510(k) NO: K221855(Traditional)
ATTN: Amelia Kesti PHONE NO : 269 3305919
Boetzinger Strasse 41 SE DECISION MADE: 09-NOV-22
Freiburg DE D-79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LED Light Therapy Mask (model: MK66R-B)
Light Tree Ventures Europe B.V. 510(k) NO: K221946(Traditional)
ATTN: Alain Dijkstra PHONE NO : 86 755 25024651
Laan van Ypenburg 108, 2497 GC SE DECISION MADE: 22-NOV-22
Hague NL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: aprevo® anterior lumbar interbody fusion device with interfixation
Carlsmed, Inc. 510(k) NO: K222009(Traditional)
ATTN: Karen Liu PHONE NO : 760 7661926
1800 Aston Ave. Ste. 100 SE DECISION MADE: 22-NOV-22
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elos Accurate Customized Abutment
Elos Medtech Pinol A/S 510(k) NO: K222044(Traditional)
ATTN: Lise Terkelsen PHONE NO : 45 216 11225
Engvej 33 SE DECISION MADE: 30-NOV-22
Goerloese DK 3330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Yomi Robotic System
Neocis Inc. 510(k) NO: K222049(Traditional)
ATTN: Olga Lewis PHONE NO : 858 3866456
2800 Biscayne Blvd Suite 600 SE DECISION MADE: 04-NOV-22
Miami FL 33137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VitroPRO
CIVCO Medical Instruments Co., Inc510(k) NO: K222052(Traditional)
ATTN: Jim Leong PHONE NO : 319 4002577
102 First Street South SE DECISION MADE: 22-NOV-22
Kalona IA 52247 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Denti.AI Auto-Chart
Denti.AI Technology Inc. 510(k) NO: K222054(Traditional)
ATTN: Lyudmila Tuzova PHONE NO : 647 467 9741
99 Yorkville Ave Suite 214 SE DECISION MADE: 22-NOV-22
Toronto CA M5R3K5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Sterile Lancet
Tianjin Rilifine Medical Device Co510(k) NO: K222055(Traditional)
ATTN: Qiusheng Jiang PHONE NO : 86 22 23233999
No 32, Jingguan Road, Yixingbu, BeSE DECISION MADE: 15-NOV-22
Tianjin CN 300402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental LT Clear V2 Resin
Formlabs Ohio, Inc. 510(k) NO: K222061(Traditional)
ATTN: Ritika Sharma PHONE NO :
27800 Lemoyne Rd SE DECISION MADE: 10-NOV-22
Millbury OH 43447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
Quanta Dialysis Technologies Ltd 510(k) NO: K222067(Traditional)
ATTN: Sam Drew PHONE NO : 017 89 400043
Tything Road SE DECISION MADE: 10-NOV-22
Alcester GB B49 6EU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie
Asahi Polyslider Co., Ltd. 510(k) NO: K222084(Traditional)
ATTN: Yoshitaka Akagi PHONE NO : 81 867 421171
860-2 Misaki SE DECISION MADE: 02-NOV-22
Maniwa JP 719-3226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Black Diamond™ POCT Spinal System
Osseus Fusion Systems 510(k) NO: K222107(Traditional)
ATTN: Jonathan Rosen PHONE NO : 888 3305960
1931 Greenville Ave Suite 200 SE DECISION MADE: 03-NOV-22
Dallas TX 75206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accure Laser
Accure Acne, Inc. 510(k) NO: K222109(Traditional)
ATTN: Karl Nicholls PHONE NO : 720 6153572
4699 Nautilus Ct. South, Suite 205SE DECISION MADE: 17-NOV-22
Boulder CO 80301-5307 510(k) STATEMENT
DEVICE: Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle
Anhui Hongyu Wuzhou Medical Manufa510(k) NO: K222124(Traditional)
ATTN: Bingyi Xiang PHONE NO : 86 556 5129666
No. 2 Guanyin Road, Economic DevelSE DECISION MADE: 04-NOV-22
Anqing City CN 246400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hisense LCD monitor HMD2G21S, HMD3G21S
Qingdao Hisense Medical Equipment 510(k) NO: K222132(Traditional)
ATTN: Lu Zhonghao PHONE NO : 86 532 83091111
No. 399 Songling Road, Laoshan DisSE DECISION MADE: 08-NOV-22
Qingdao CN 266100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUS610 Blood pressure monitor
Globalcare Medical Technology Co.,510(k) NO: K222160(Traditional)
ATTN: Chiara Cavagnolo PHONE NO :
No. 7 Factory, European IndustrialSE DECISION MADE: 22-NOV-22
Zhongshan City CN 528415 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
Shanghai AnQing Medical Instrument510(k) NO: K222162(Traditional)
ATTN: Shuwen Fan PHONE NO : 86 021 61117375
3 & 4 Floor, No.2 Building, 366 HuSE DECISION MADE: 09-NOV-22
Shanghai CN 201201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLIX
Optovue, Inc. 510(k) NO: K222166(Traditional)
ATTN: Robert Lundberg PHONE NO : 951 7412776
2800 Bayview Drive SE DECISION MADE: 09-NOV-22
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler
Owen Mumford Ltd 510(k) NO: K222168(Traditional)
ATTN: Darren Mansell PHONE NO : 44 0 1993812021
Brook Hill SE DECISION MADE: 03-NOV-22
Woodstock GB OX20 1TU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bloomi Delight Oil-Based Personal Lubricant
The Bloomi Inc.. 510(k) NO: K222175(Traditional)
ATTN: Rebecca Story PHONE NO : 1 510 4105570
SE DECISION MADE: 15-NOV-22
Alamo CA 94507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SiOxD Wound Matrix
SiOxMed, LLC. 510(k) NO: K222189(Traditional)
ATTN: Mitch Dellinger PHONE NO : 336 2424498
2011 Muddy Creek Road SE DECISION MADE: 18-NOV-22
Clemmons NC 27012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exo Iris (El2001)
Exo Imaging Inc. 510(k) NO: K222198(Traditional)
ATTN: Antoanela Gomard PHONE NO : 650 2830458
4201 Burton Drive SE DECISION MADE: 09-NOV-22
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D
Qingdao Hisense Medical Equipment 510(k) NO: K222208(Traditional)
ATTN: Lu Zhonghao PHONE NO : 86 532 83091111
No. 399 Songling Road, Laoshan DisSE DECISION MADE: 17-NOV-22
Qingdao CN 266100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)
Hartalega NGC Sdn. Bhd. 510(k) NO: K222225(Traditional)
ATTN: Kuan Mun Leong PHONE NO : 603 6277 1733
No. 1, Persiaran Tanjung Kawasan PSE DECISION MADE: 11-NOV-22
Sepang MY 43900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cala kIQ
Cala Health, Inc. 510(k) NO: K222237(Traditional)
ATTN: Danielle McDonnell Boyd PHONE NO : 1 415 8192935
1800 Gateway Dr, Suite 300 SE DECISION MADE: 22-NOV-22
San Mateo CA 94404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Sterile Lancet
Tianjin Rilifine Medical Device Co510(k) NO: K222246(Traditional)
ATTN: Qiusheng Jiang PHONE NO : 86 22 23233999
No 32, Jingguan Road, Yixingbu, BeSE DECISION MADE: 21-NOV-22
Tianjin CN 300402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Combined High Frequency X-ray Source
Suzhou Powersite Electric Co., Ltd510(k) NO: K222258(Traditional)
ATTN: Xinyue Lu PHONE NO : 86____ 13722 611742
Building 5, No.188 Fuchunjiang RoaSE DECISION MADE: 01-NOV-22
Suzhou CN 215151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Steripath Micro Blood Collection System
Magnolia Medical Technologies 510(k) NO: K222299(Traditional)
ATTN: Greg Bullington PHONE NO : 1 206 3691319
200 West Mercer Street, Suite 500 SE DECISION MADE: 30-NOV-22
Seattle WA 98119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonata Transcervical Fibroid Ablation System 2.2
Gynesonics, Inc. 510(k) NO: K222304(Traditional)
ATTN: Diane King PHONE NO : 650 2163883
600 Chesapeake Drive SE DECISION MADE: 08-NOV-22
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MissLan™ Digital Pregnancy Rapid Test
Guangzhou Decheng Biotechnology Co510(k) NO: K222305(Traditional)
ATTN: Weifang Liu PHONE NO : 86 020 82557192
Room 107/218/212/405, Building 2, SE DECISION MADE: 30-NOV-22
Guangzhou CN 510000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gamma4 System
Stryker GMBH 510(k) NO: K222309(Traditional)
ATTN: Cindy Leon PHONE NO : 201 8315374
325 Corporate Drive SE DECISION MADE: 15-NOV-22
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Catalyst EA Convertible Stemmed Shoulder
Catalyst OrthoScience, Inc. 510(k) NO: K222317(Traditional)
ATTN: Dale Davison PHONE NO : 239 3259976 102
14710 Tamiami Trail North SE DECISION MADE: 10-NOV-22
Naples FL 34110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aevumed PHANTOM™-LP Suture Anchors
Aevumed, Inc. 510(k) NO: K222363(Traditional)
ATTN: Saif Khalil PHONE NO : 610 7457284
109 Great Valley Parkway SE DECISION MADE: 28-NOV-22
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)
Xtrallux, LLC 510(k) NO: K222364(Traditional)
ATTN: Carlos Piña PHONE NO : 888 4250290
7260 NW 58th Street SE DECISION MADE: 16-NOV-22
Miami FL 33166 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kowa SL-19
Kowa Company, Ltd. 510(k) NO: K222372(Traditional)
ATTN: Nariaki Morita PHONE NO : 81 42 4407612
3-1, Chofugaoka 3-Chome SE DECISION MADE: 21-NOV-22
Chofu-shi JP 1820021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Led Mask Platinum Md
CellReturn Co., LTD. 510(k) NO: K222377(Traditional)
ATTN: Ilsoo Kim PHONE NO : 82 10 26460017
237, Namdongseo-ro. Namdong-gu SE DECISION MADE: 03-NOV-22
Incheon KR 21634 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flex-Thread™ Ulna Intramedullary Nail System
Flower Orthopedics Corporation DBA510(k) NO: K222390(Traditional)
ATTN: Christina Rovaldi PHONE NO : 215 3234029
100 Witmer Road Suite 280 SE DECISION MADE: 21-NOV-22
Horsham PA 19044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo
Ellex Medical Pty Ltd 510(k) NO: K222395(Traditional)
ATTN: Rashmi Pillay PHONE NO : 61 8 70748105
3-4 Second Avenue Mawson Lakes SE DECISION MADE: 02-NOV-22
Adelaide AU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Safety Lancet
Beijing Ruicheng Medical Supplies 510(k) NO: K222408(Traditional)
ATTN: Yuechao Li PHONE NO : 86 189 10106615
No.13 Yanqi Ave, Yanqi Economic DeSE DECISION MADE: 29-NOV-22
Beijing CN 101400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Blood Pressure Cuff
Wenzhou Xikang Medical Instruments510(k) NO: K222420(Traditional)
ATTN: Wang Tiance PHONE NO : 86____ 577 86876969
No. 1478 Haining Road, Haibin StreSE DECISION MADE: 21-NOV-22
Wenzhou CN 325024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Syngo Dynamics (Version VA40F)
Siemens Medical Solutions USA, Inc510(k) NO: K222428(Traditional)
ATTN: Jiayan Liu PHONE NO : 1 734 6047870
400 W. Morgan Road SE DECISION MADE: 14-NOV-22
Ann Arbor MI 48108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Automatically Retractable Safety Syringes (with detachable needle)
Shantou Wealy Medical Instrument C510(k) NO: K222452(Traditional)
ATTN: Yanjun Zhu PHONE NO : 0086 1341 1946936
North Jinhuan Road (near of QishanSE DECISION MADE: 23-NOV-22
Shantou CN 515064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Self-adhesive Electrode
Guangdong Comytens Medical Technol510(k) NO: K222453(Traditional)
ATTN: Mr. Deng Jiuzhen PHONE NO : 86 134 18878095
Building A-102, No. 24, JiangjunmaSE DECISION MADE: 04-NOV-22
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Calibrate LTX Interbody System
Alphatec Spine, Inc. 510(k) NO: K222455(Traditional)
ATTN: Cynthia Dorne PHONE NO : 760 4946740
1950 Camino Vida Roble SE DECISION MADE: 18-NOV-22
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EchoGo Heart Failure
Ultromics Limited 510(k) NO: K222463(Traditional)
ATTN: Jaco Jacobs PHONE NO : 447 786 565167
4630 Kingsgate Cascade Way, OxfordSE DECISION MADE: 23-NOV-22
Oxford GB OX4 2SU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lancing System, Sterile Lancet for Single Use, Lancing Device
Shandong Lianfa Medical Plastic Pr510(k) NO: K222472(Traditional)
ATTN: Charles Shen PHONE NO : 086 531 61328777
No. 1 Shuangshan Sanjian Road, ZhaSE DECISION MADE: 30-NOV-22
Jinan CN 250200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SNOR LOCK
Solbaro Co., Ltd 510(k) NO: K222475(Traditional)
ATTN: Donghoon Kim PHONE NO :
4th fl. 137, Janggam-ro SE DECISION MADE: 10-NOV-22
Gamgok-myeon, Eumseong-gun KR 276510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OmegaAI Image Viewer
RamSoft Inc. 510(k) NO: K222476(Traditional)
ATTN: Deeksha Shukla PHONE NO : 1 647 7972745
150 Wheeler Ave SE DECISION MADE: 17-NOV-22
Toronto CA M4L3V4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hair Growth Device
Dongguan Lescolton Medical Equipme510(k) NO: K222477(Traditional)
ATTN: Qixiang Liu PHONE NO : 86 769 81013189
402, Building 1, #3, Xinxing 3rd RSE DECISION MADE: 18-NOV-22
Dongguan CN 523443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)
Foshan Nanhai Plus Medical Co., Lt510(k) NO: K222480(Traditional)
ATTN: Eric Li PHONE NO : 086 757 8691419
Shatou Jiujiang Town Nanhai DistriSE DECISION MADE: 14-NOV-22
Foshan CN 5282000 510(k) STATEMENT
DEVICE: Everyway Analog OTC TENS
Everyway Medical Instruments Co., 510(k) NO: K222488(Traditional)
ATTN: Jimmy Cheng PHONE NO : 866 2 26620038
3FL., No.5, Lane 155, Section 3, PSE DECISION MADE: 15-NOV-22
Shenkeng District, New Taipei City510(k) STATEMENT
DEVICE: HBL Blade Assembly
Hand Biomechanics Lab, Inc 510(k) NO: K222490(Traditional)
ATTN: Dustin Dequine PHONE NO : 916 9235073
77 Scripps Drive, Suite 104 SE DECISION MADE: 14-NOV-22
Sacramento CA 95825 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CODA™ Anterior Cervical Plate System
Pioneer Surgical Technology, Inc.,510(k) NO: K222493(Traditional)
ATTN: Alicia Kaufman PHONE NO : 763 7726137
375 River Park Circle (DBA ResolveSE DECISION MADE: 18-NOV-22
Marquette MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electromed SmartVest Airway Clearance System
Electromed, Inc. 510(k) NO: K222496(Special)
ATTN: Gregory Spurlock PHONE NO : 952 2015088
500 Sixth Ave NW SE DECISION MADE: 18-NOV-22
New Prague MN 56071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zaga Zygomatic System
Southern Implants (Pty) Ltd 510(k) NO: K222497(Traditional)
ATTN: Leith C. Cumming PHONE NO : 27 12 6671046
1 Albert Road SE DECISION MADE: 09-NOV-22
Irene ZA 0062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: H1
Karl Storz Endoscopy America, Inc.510(k) NO: K222504(Traditional)
ATTN: Mario Trujillo PHONE NO : 424 2188184___
2151 E. Grand Avenue SE DECISION MADE: 10-NOV-22
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248
3M Company 510(k) NO: K222508(Traditional)
ATTN: Yumi Wackerfuss PHONE NO : 651 7373556
2510 Conway Avenue, Bldg. 275-5W-0SE DECISION MADE: 01-NOV-22
St. Paul MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FX Contra
Nakanishi INC. 510(k) NO: K222518(Traditional)
ATTN: Masaaki Kikuchi PHONE NO : 81 289 647277
700 Shimohinata SE DECISION MADE: 17-NOV-22
Kanuma JP 322-8666 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zirconia Block
Yilink (Tianjin) Biotechnology Co.510(k) NO: K222520(Traditional)
ATTN: Yaqiong Zhu PHONE NO : 086 022 88522665
No 9 Kaituo Road Balitai Town JinnSE DECISION MADE: 14-NOV-22
Tianjin CN 300350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Xiantao Rayxin Medical Products Co510(k) NO: K222529(Traditional)
ATTN: Maggie Dai PHONE NO : 86 728 2617597
No. 258 Pengchang Road, Middle StrSE DECISION MADE: 14-NOV-22
Xiantao CN 433018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Patient Examination Glove
Jiangxi Jiangxi Zhonghong Pulin Me510(k) NO: K222534(Traditional)
ATTN: Zhou Ziyu PHONE NO : 86____ 152 4713517
Yinshawan Park, High-tech IndustriSE DECISION MADE: 23-NOV-22
Jiujiang CN 332599 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OCS Lung Donor Flush Set
TransMedics, Inc. 510(k) NO: K222535(Traditional)
ATTN: Miriam Provost PHONE NO : 978 4947897___
200 Minuteman Road Suite 302 SE DECISION MADE: 18-NOV-22
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Facet Blood Lancets
Facet Technologies LLC 510(k) NO: K222539(Traditional)
ATTN: James Bonds PHONE NO : 770 5906462___
3900 N. Commerce Dr. SE DECISION MADE: 18-NOV-22
Atlanta GA 30344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uPMR 790
Shanghai United Imaging Healthcare510(k) NO: K222540(Traditional)
ATTN: Xin Gao PHONE NO :
NO. 2258 Chengbei Road, Jiading DiSE DECISION MADE: 14-NOV-22
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Current Health System
Current Health Ltd. 510(k) NO: K222550(Special)
ATTN: Shyama Ramjagsingh PHONE NO : 44 131 2858101
The Stamp Office, Level 3, 10 WateSE DECISION MADE: 01-NOV-22
Edinburgh GB EH1 3EG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Humask Pro Vision, Humask Pro Vision 3000
Entreprise Premont Inc. 510(k) NO: K222551(Abbreviated)
ATTN: Charlie Marchand PHONE NO : 1 819 5193255 215
731 boul. Saint-Laurent Est SE DECISION MADE: 10-NOV-22
Louiseville CA J5V 1J1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Treace Medical Concepts (TMC) Hammertoe Fixation System
Treace Medical Concepts, Inc. 510(k) NO: K222564(Traditional)
ATTN: Kristina Hall PHONE NO : 904 3735940
203 Fort Wade Rd. Suite 150 SE DECISION MADE: 15-NOV-22
Ponte Vedra FL 32081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ai Ray Dental X-Ray Device
Guilin Woodpecker Medical Instrume510(k) NO: K222569(Traditional)
ATTN: Xunxian Wu PHONE NO : 86 773 2269636
Information Industrial Park, GuiliSE DECISION MADE: 23-NOV-22
Guilin City CN 541004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal Device
Shenzhen Noble Smart Manufacturing510(k) NO: K222598(Traditional)
ATTN: Guo Yi PHONE NO : 86 755 29769796
3F, Building A, Zhengchangda TechnSE DECISION MADE: 17-NOV-22
Shenzhen CN 518103 510(k) STATEMENT
DEVICE: Male Latex Condoms
Suzhou Colour-way New Material Co.510(k) NO: K222611(Traditional)
ATTN: Yongping Xu PHONE NO : 86 512 65371017
No. 20, Anmin Road, Huangdai Town,SE DECISION MADE: 28-NOV-22
Suzhou CN 215152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder-Free Latex examination gloves
Guangdong Kingfa Sci.&Tech. Co., L510(k) NO: K222612(Traditional)
ATTN: Xiaoge Yu PHONE NO : 86 135 70952157
No.28, Delong Ave., Shijiao Town, SE DECISION MADE: 25-NOV-22
Qingyuan CN 511545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Life Spine ALIF Buttress Plate System
Life Spine, Inc. 510(k) NO: K222628(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S. Quality Drive SE DECISION MADE: 16-NOV-22
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VHA Radiotherapy Bolus
VHA DEAN 510(k) NO: K222639(Traditional)
ATTN: Beth Ripley PHONE NO : 858 2043375___
810 Vermont Ave NW SE DECISION MADE: 04-NOV-22
Washington DC 20420 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Signia™ Small Diameter Reloads Including Regular (Round) Tip Version
Covidien 510(k) NO: K222641(Traditional)
ATTN: Robert Zott PHONE NO : 917 4216878
60 Middletown Avenue SE DECISION MADE: 29-NOV-22
North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Treace Medical Concepts (TMC) Implant Fixation System
Treace Medical Concepts 510(k) NO: K222645(Traditional)
ATTN: Brittany Grochala PHONE NO : 515 8650494
203 Fort Wade Road, Suite 150 SE DECISION MADE: 21-NOV-22
Ponte Vedra FL 32081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer
Cardicare Company, Ltd. 510(k) NO: K222652(Traditional)
ATTN: Ying Hao PHONE NO : 86 571 28036398
9 Yan An Road, Wu Shan Plaza Town,SE DECISION MADE: 28-NOV-22
Hangzhou City CN 310002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LDE4 Lancing Device
i-SENS, Inc. 510(k) NO: K222656(Traditional)
ATTN: H.S. Yoo PHONE NO : 82 2 9100516
43, Banpo-Daero 28-Gil, Seocho-Gu,SE DECISION MADE: 23-NOV-22
Seoul KR 06646 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx
Vivachek Biotech (Hangzhou) Co., L510(k) NO: K222667(Traditional)
ATTN: Jessica Chen PHONE NO : 86 182 57349413
Level 2, Block 2, 146 East ChaofenSE DECISION MADE: 10-NOV-22
Hangzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alexandrite and Nd:YAG Laser models CANLASE and TORLASE
Canadian Pioneer Medical Technolog510(k) NO: K222673(Traditional)
ATTN: Rashid Reza Mir Sayah PHONE NO : 1 437 7727788
210 Drumlin Circle, Concord SE DECISION MADE: 17-NOV-22
Vaughan CA L4K 3E3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vericor Support Catheter
VascuPatent Medical (Shenzhen) Co.510(k) NO: K222679(Traditional)
ATTN: Heather Li PHONE NO : 86 189 22846103
Room 314&316, Building A, Branch 3SE DECISION MADE: 07-NOV-22
Shenzhen CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Face Mask (DF3-001)
Wellmed Dental Medical Supply Co.,510(k) NO: K222697(Traditional)
ATTN: Tang Renxian PHONE NO : 86 1360 3081892
301 Zhongxing Science and TechnoloSE DECISION MADE: 04-NOV-22
Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MANTA Laser
SQUALUS MED Ltd. 510(k) NO: K222701(Traditional)
ATTN: Gil Shapira PHONE NO : 972 4 677991
7 HaEshel Street SE DECISION MADE: 18-NOV-22
Caesarea IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WaveForm A Interbody System
SeaSpine Orthopedics Corporation 510(k) NO: K222732(Traditional)
ATTN: Jesse Albright PHONE NO : 760 2165176
5770 Armada Drive SE DECISION MADE: 07-NOV-22
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing
Diversatek Healthcare 510(k) NO: K222734(Traditional)
ATTN: Alyssa Roelli PHONE NO : 414 2657620 4814
102 E. Keefe Ave. SE DECISION MADE: 08-NOV-22
Milwaukee WI 53212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)
HDI, Inc. 510(k) NO: K222741(Traditional)
ATTN: Taekyou Kim PHONE NO : 82 31 7353510
A-1504, 14, Sagimakgol-ro, 45 BeonSE DECISION MADE: 07-NOV-22
Seongnam-si KR 13209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: High Fluid-Resistant Surgical and Procedure Mask
America’s Supply Chains 510(k) NO: K222749(Third Party - Traditional)
ATTN: Paul Park PHONE NO : 617 8003602
600 Harrold St., #370 SE DECISION MADE: 14-NOV-22
Fort Worth TX 76107 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ViewMate Multi Ultrasound System
Shenzhen Mindray Bio-Meidcal Elect510(k) NO: K222754(Traditional)
ATTN: Jin Jiahong PHONE NO : 86 755 81885695
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 09-NOV-22
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)
Sanhe Laserconn Tech Co., Ltd. 510(k) NO: K222800(Traditional)
ATTN: Xia Aijiang PHONE NO : 0086 157 26687295
X03-A Building, Baishijingu IndustSE DECISION MADE: 07-NOV-22
Langfang CN 065201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Opulent TiNbN Coated Knee
Meril Healthcare Pvt. Ltd. 510(k) NO: K222816(Traditional)
ATTN: Neelam Desai PHONE NO : 91 905 4623695
Survey No. 135/2/B & 174/2, H1-H3 SE DECISION MADE: 18-NOV-22
Vapi IN 396191 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system
Medtronic 510(k) NO: K222873(Traditional)
ATTN: Sarah Meyer PHONE NO : 763 5262350
8200 Coral Sea Street NE SE DECISION MADE: 07-NOV-22
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DynamicIQ
GE Medical Systems SCS 510(k) NO: K222895(Traditional)
ATTN: Tong Zhao PHONE NO : 86 151 42077290
283, rue de la Miniere SE DECISION MADE: 22-NOV-22
Buc FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
SafeSource Direct, LLC 510(k) NO: K222898(Third Party - Traditional)
ATTN: Justin Hollingsworth PHONE NO : 205 3330090
200 St Nazaire Rd. SE DECISION MADE: 07-NOV-22
Broussard LA 70518 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Tailored-H Cervical Stand Alone System
BeSpoke Technologies, LLC 510(k) NO: K222903(Traditional)
ATTN: Daniel Hoehn PHONE NO : 314 4940313
118 S. Cherry St, Suite E SE DECISION MADE: 18-NOV-22
Winston-Salemn NC 27101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS
Canadian Pioneer Medical Technolog510(k) NO: K222915(Traditional)
ATTN: Rashid Reza Mir Sayah PHONE NO : 437 7727788
210 Drumlin Circle #2, Concord SE DECISION MADE: 15-NOV-22
Vaugham CA L4K 3E3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DentCare Aligners
DentCare Dental Lab Pvt Ltd. 510(k) NO: K222918(Traditional)
ATTN: Abin Johns Raju PHONE NO : 91 9072 666345____
NAS Road, 130 Jn. Muvattupuzha SE DECISION MADE: 25-NOV-22
Ernakulam IN 686661 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Humeris® 135 Shoulder System
FX Shoulder USA, Inc. 510(k) NO: K222936(Traditional)
ATTN: Cory Trier PHONE NO : 800 2800775
13465 Midway Road Suite 101 SE DECISION MADE: 07-NOV-22
Dallas TX 75244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SM-V
SEDECAL SA 510(k) NO: K222951(Abbreviated)
ATTN: Mª Luisa Gómez de Agüero PHONE NO : 34 91 6280544
C/ Pelaya, 9-13 Pol. Ind. Rio De JSE DECISION MADE: 21-NOV-22
Algete ES 28110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioPoly Lesser Toe Hemiarthroplasty Implant
BioPoly, LLC 510(k) NO: K222964(Traditional)
ATTN: Herb Schwartz PHONE NO : 260 9996135
7136 Gettysburg Pike SE DECISION MADE: 22-NOV-22
Fort Wayne IN 46804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws
Avanti Orthopaedics, Inc. 510(k) NO: K222967(Traditional)
ATTN: J. Doug Patterson PHONE NO : 302 5306369
1814 Gilpin Avenue SE DECISION MADE: 23-NOV-22
Wilmington DE 19806 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem
Alphatec Spine Inc. 510(k) NO: K222973(Traditional)
ATTN: Andrew Zhang PHONE NO : 1 760 4946860
1950 Camino Vida Roble SE DECISION MADE: 17-NOV-22
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pentax Medical Valve Set
Yangzhou Fartley Medical Instrumen510(k) NO: K222980(Traditional)
ATTN: Tina Han PHONE NO : 0086 150 51101225
Beizhou Road, Lidian Town, GuangliSE DECISION MADE: 21-NOV-22
Yangzhou CN 225106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material
Innovative BioCeramix Inc. 510(k) NO: K222992(Traditional)
ATTN: Quanzu Yang PHONE NO : 604 2216800
101-8218 North Fraser Way SE DECISION MADE: 22-NOV-22
Burnaby CA V3N0E9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Banded Face Mask
Hubei Medlink Healthcare Co., Ltd 510(k) NO: K223003(Special)
ATTN: Niki Wang PHONE NO : 86 27 85827780
36F, Tower1, New World InternationSE DECISION MADE: 18-NOV-22
Wuhan CN 430000 510(k) STATEMENT
DEVICE: Wireless/Wired X-Ray Flat Panel Detectors
Allengers Medical Systems Limited 510(k) NO: K223009(Traditional)
ATTN: Sanjeev K. Marjara PHONE NO : 91 1762 282600
FDA Hall Unit-2, Bhankarpur, MubarSE DECISION MADE: 27-NOV-22
Derabassi, Distt. Mohali IN 14050510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIS System (Version 5.6.0)
Surgical Information Sciences, Inc510(k) NO: K223032(Traditional)
ATTN: Ann Quinlan-Smith PHONE NO : 612 3250187
4602 141st Ln NE SE DECISION MADE: 21-NOV-22
Ham Lake MN 55304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci E-200 Electrosurgical Generator
Intuitive Surgical 510(k) NO: K223039(Traditional)
ATTN: Shamsa Karimi PHONE NO : 408 8066720
1266 Kifer Road SE DECISION MADE: 28-NOV-22
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Renasys Edge (66803126)
Smith & Nephew Medical Limited 510(k) NO: K223041(Traditional)
ATTN: Zoe Smith PHONE NO : 44 77 40531714
101 Hessle Road SE DECISION MADE: 22-NOV-22
Hull GB HU3 2BN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: World Total Knee System
Signature Orthopaedics Pty Ltd. 510(k) NO: K223062(Special)
ATTN: Declan Brazil PHONE NO : 61 2 94285181
7 Sirius Road SE DECISION MADE: 04-NOV-22
Lane Cove AU 2113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)
Guangdong Golden Leaves Technology510(k) NO: K223068(Traditional)
ATTN: Wenhong Zhou PHONE NO : 86 134 16994806
5/F, Building 2, No. 8, QiaolongheSE DECISION MADE: 23-NOV-22
Dongguan CN 523730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)
Intuitive Surgical, Inc 510(k) NO: K223080(Traditional)
ATTN: Connor McCarty PHONE NO : 805 7984205
1266 Kifer Road SE DECISION MADE: 22-NOV-22
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Facet Manatee Reusable Lancing Base
Facet Technologies LLC 510(k) NO: K223099(Traditional)
ATTN: James Bonds PHONE NO : 770 5906462
3900 N. Commerce Dr. SE DECISION MADE: 28-NOV-22
Atlanta GA 30344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: truSculpt iD
Cutera Inc. 510(k) NO: K223110(Special)
ATTN: Julia Brown PHONE NO : 415 6721858
3240 Bayshore Blvd. SE DECISION MADE: 03-NOV-22
Brisbane CA 94005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
DRTECH Corporation 510(k) NO: K223124(Special)
ATTN: Ella An PHONE NO : 82 31 7797787
Suite No. 1, 2 Floor/Suite No. 2, SE DECISION MADE: 18-NOV-22
Jungwon-gu, Seongnam-si KR 13216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable
Edwards Lifeciences, LLC 510(k) NO: K223127(Special)
ATTN: Michelle Ducca PHONE NO : 805 3686785
1 Edwards Way SE DECISION MADE: 07-NOV-22
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)
Iridex Corporation 510(k) NO: K223132(Special)
ATTN: Bill Hyatt PHONE NO : 650 6058727
1212 Terra Bella Ave. SE DECISION MADE: 09-NOV-22
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vision 2, EVARVision, TrackVision 2, HeartVision 2
GE Medical Systems SCS 510(k) NO: K223152(Traditional)
ATTN: Ning Wen PHONE NO : 336 2042 4417
283 rue de la Miniere SE DECISION MADE: 22-NOV-22
Buc FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aquilo Sports CCT1500 System
Aquilo SPorts LLC 510(k) NO: K223164(Third Party - Traditional)
ATTN: JP Spence PHONE NO : 502 5230378___
1902 Campus Pl Ste 12 SE DECISION MADE: 04-NOV-22
Louisville KY 40299 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AquaPulse® Irrigation Tubing
GA Health Company Limited 510(k) NO: K223171(Special)
ATTN: Cindy Ye PHONE NO : 852 28339010
Unit 18, 21/F, Metropole Square, 2SE DECISION MADE: 10-NOV-22
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SelectSite C304 Deflectable Catheter System, C315 Delivery System
Medtronic 510(k) NO: K223178(Special)
ATTN: Sarah Meyer PHONE NO : 763 5262350
8200 Coral Sea Street NE SE DECISION MADE: 08-NOV-22
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BreathID® Smart System
Meridian Bioscience Israel Ltd. 510(k) NO: K223185(Special)
ATTN: Raffi Werner PHONE NO : 972 8 9737502
4 Ha'Maayan St SE DECISION MADE: 10-NOV-22
Modiin IL 7177872 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Intraosseous Vascular Access System EMS Powered Driver (D001003)
Bard Access Systems 510(k) NO: K223198(Special)
ATTN: Nasreen Al-Quaid PHONE NO : 484 5692865___
605 North 5600 West SE DECISION MADE: 10-NOV-22
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2.1 x 255mm Drill, 22mm Stop
Biomet Microfixation 510(k) NO: K223199(Special)
ATTN: Jay Sharma PHONE NO : 904 7414400___
1520 Tradeport Drive SE DECISION MADE: 15-NOV-22
Jacksonville FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAVEN™ Patient-Specific Instrumentation
Paragon 28, Inc 510(k) NO: K223227(Special)
ATTN: Greg Kowalczyk PHONE NO : 732 2333744
14445 Grasslands Drive SE DECISION MADE: 17-NOV-22
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense
Baxter Healthcare Corproration 510(k) NO: K223246(Special)
ATTN: Jigar Shah PHONE NO : 201 2841024
1069 State Route 46 East SE DECISION MADE: 18-NOV-22
Batesville IN 47006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Micro3D Wound Matrix
Reprise Biomedical 510(k) NO: K223257(Special)
ATTN: Carrie Powers PHONE NO : 612 2846780
17400 Medina Road SE DECISION MADE: 21-NOV-22
Plymouth MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKR 3000
Konica Minolta, INC. 510(k) NO: K223267(Special)
ATTN: Tsutomu Fukui PHONE NO : 81 42 5898429
1 Sakura-machi SE DECISION MADE: 17-NOV-22
Hino-shi JP 191-8511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POSE™ Health Care Surgical Mask
America's Supply Chains 510(k) NO: K223270(Third Party - Traditional)
ATTN: Paul Park PHONE NO : 617 8003602___
7555 Warren Pkwy, Unit 486 SE DECISION MADE: 01-NOV-22
Frisco TX 75034 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Momentum® MIS Posterior Spinal Fixation System
Ulrich Medical USA 510(k) NO: K223274(Special)
ATTN: Hans Stover PHONE NO : 636 5190268
18221 Edison Avenue SE DECISION MADE: 28-NOV-22
Chesterfield MO 63005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: easy Claire
Y&J BIO Co., Ltd. 510(k) NO: K223278(Special)
ATTN: Youngsam Chun PHONE NO : 82 031 51803490
B-916, 947, Hanam-daero SE DECISION MADE: 17-NOV-22
Hanam-si KR 12982 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TempSure System
Cynosure LLC 510(k) NO: K223292(Special)
ATTN: Michael King PHONE NO : 781 9932454
5 Carlisle Road SE DECISION MADE: 23-NOV-22
Westford MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTOUR® NEXT GEN Blood Glucose Monitoring System
Ascensia Diabetes Care US Inc. 510(k) NO: K223293(Special)
ATTN: Larnie James PHONE NO : 417 93530560__
100 Summit Lake Drive SE DECISION MADE: 18-NOV-22
Valhalla NY 10595 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Lingshi Hongruida Health Protectio510(k) NO: K223320(Traditional)
ATTN: Yin Hongmei PHONE NO : 86 311 66766067
Yangjiayuan, Liangdu Town, LingshiSE DECISION MADE: 02-NOV-22
Jinzhong CN 031300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Purgo
AeroClean Technologies, Inc. 510(k) NO: K223328(Special)
ATTN: Richard Foster PHONE NO : 773 7916198
10455 Riverside Drive, Ste. 100 SE DECISION MADE: 30-NOV-22
Palm Beach Gardens FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tera Harz Clear
Graphy Inc. 510(k) NO: K223355(Third Party - Traditional)
ATTN: Moon Soo Part PHONE NO : 82 33 7480433
603, #617, Ace Gasan Forhu, 225, GSE DECISION MADE: 03-NOV-22
Seoul KR 08503 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 271
TOTAL WITH SUMMARIES 257
TOTAL WITH STATEMENTS 14
