510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD May 2023
DEVICE: ELEC Master, ELEC Master Dual
Mgnewton Ltd. 510(k) NO: K202963(Traditional)
ATTN: Byoung-Wook Ahn PHONE NO : 82 53 2146287
472, Hanjanggun-ro, Jain-myeon SE DECISION MADE: 05-MAY-23
Gyeongsan-si KR 38552 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H)
MMJ Labs, LLC 510(k) NO: K202993(Traditional)
ATTN: Amy Baxter PHONE NO : 877 8052899
195 Arizona Avenue, LW08 SE DECISION MADE: 15-MAY-23
Atlanta GA 30307 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C
Nucleix Ltd. 510(k) NO: K203245(Traditional)
ATTN: Shmulik Adler PHONE NO : 972 8 9161616
3 Pekeris St. SE DECISION MADE: 04-MAY-23
Rehovot IL 7660203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System
Immuno Concepts N.A., Ltd. 510(k) NO: K203599(Traditional)
ATTN: Eric S. Hoy PHONE NO : 214 4610784
9825 Goethe Road, Suite #350 SE DECISION MADE: 26-MAY-23
Sacramento CA 95827 510(k) STATEMENT
DEVICE: Oxus Sieve Beds
Oxus, Inc. 510(k) NO: K211056(Traditional)
ATTN: Ryan Lenarcic PHONE NO : 248 4750925
2046 Brown Rd. SE DECISION MADE: 31-MAY-23
Auburn Hills MI 48326 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FortiShield (Biosynthetic Wound Matrix)
Organogenesis Inc. 510(k) NO: K212579(Traditional)
ATTN: Christina Nichols PHONE NO : 858 5255942
150 Dan Rd SE DECISION MADE: 02-MAY-23
Canton MA 02021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System
MedSchenker, Inc. 510(k) NO: K212743(Traditional)
ATTN: Joseph Kim PHONE NO : 201 4589835
10 Industrial Ave, Suite 4 SE DECISION MADE: 03-MAY-23
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Autoplaque
Cedars-Sinai Medical Center: AIM 510(k) NO: K212758(Traditional)
ATTN: Damini Dey PHONE NO : 310 4231517
8700 Beverly Blvd SE DECISION MADE: 19-MAY-23
Los Angeles CA 90048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use
Jiangsu Zhiyu Medical Instrument C510(k) NO: K212857(Traditional)
ATTN: Lianhua Cao PHONE NO : 086 523 82565715
No 88, Nanyuan Road, Industrial PaSE DECISION MADE: 09-MAY-23
Taixing CN 225400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FEELject LDV (Low dead volume) syringe
Feeltech Co., Ltd. 510(k) NO: K213010(Traditional)
ATTN: Kim Geun Sik PHONE NO :
3, 4 Floor, Standard Factory 2-donSE DECISION MADE: 31-MAY-23
Gunsan KR 54001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ThermoTK
Zimmer MedizinSysteme GmbH 510(k) NO: K213256(Traditional)
ATTN: Ute Hauss PHONE NO : 49 731 9761216
Junkersstrasse 9 SE DECISION MADE: 25-MAY-23
Neu-Ulm DE 89231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App
BD Kiestra B.V. 510(k) NO: K213280(Traditional)
ATTN: Karin Brands PHONE NO : 31 646804924
Marconilaan 6 SE DECISION MADE: 04-MAY-23
Drachten NL 9207 JC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs
Ansell Healthcare Products, LLC 510(k) NO: K213289(Traditional)
ATTN: Tammy McGriff PHONE NO : 1 334 7969361
2301 Robb Drive SE DECISION MADE: 26-MAY-23
Reno NV 89523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CombiSet Hemodialysis Blood Tubing Set
Fresenius Medical Care Renal Thera510(k) NO: K213992(Traditional)
ATTN: Denise Oppermann PHONE NO : 781 9669103
920 Winter Street SE DECISION MADE: 31-MAY-23
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Revitalair 430+
US Hyperbaric Network 510(k) NO: K220290(Traditional)
ATTN: Jorge Millan PHONE NO : 786 4165587
7600 NW 69th Ave SE DECISION MADE: 04-MAY-23
Medley FL 33166 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pollogen STOP U Model UXV Device
Pollogen Ltd. 510(k) NO: K220322(Traditional)
ATTN: Elissa Burg PHONE NO : 972 52 6633572
6 Kaufman St. SE DECISION MADE: 04-MAY-23
Tel Aviv IL 6801298 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VirtuOst
O.N. Diagnostics 510(k) NO: K220402(Traditional)
ATTN: David Kopperdahl PHONE NO : 510 2040688
2150 Shattuck Ave. Ste. 610 SE DECISION MADE: 19-MAY-23
Berkeley CA 94704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neurophet AQUA
NEUROPHET, Inc. 510(k) NO: K220437(Traditional)
ATTN: Boreum Yoo PHONE NO : 82 2 69547971
12F, 124, Teheran-ro, Gangnam-gu SE DECISION MADE: 10-MAY-23
Seoul KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HD+12, HD+15
Cardioline S.P.A 510(k) NO: K220526(Traditional)
ATTN: Antonella Bornacin PHONE NO : 39 342 9026856
Via Linz 151 SE DECISION MADE: 15-MAY-23
Trento IT 38121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MyPAO Guides
Medacta International S.A. 510(k) NO: K220706(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 30-MAY-23
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sol-Guard Auto-disable Syringe
Sol-Millennium Medical Inc. 510(k) NO: K220713(Traditional)
ATTN: Ying Zhao PHONE NO : 919___ 3242268
315 Shawnee North Dr. Suite 100 SE DECISION MADE: 04-MAY-23
Suwanee GA 30024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000
Fresenius Medical Care Renal Thera510(k) NO: K220721(Traditional)
ATTN: Denise Oppermann PHONE NO : 781 9969103
920 Winter Street SE DECISION MADE: 11-MAY-23
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PVC Hydrophilic Urethral Catheter
Well Lead Medical Co., Ltd. 510(k) NO: K220722(Traditional)
ATTN: Jenny Zhu PHONE NO : 86 20 84758878 8092
No. 47 Guomao Avenue South, HualonSE DECISION MADE: 22-MAY-23
Guangzhou CN 511434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Armis VeriCyn Wound Wash
Armis Biopharma, Inc. 510(k) NO: K220759(Traditional)
ATTN: Angela Mallery PHONE NO : 651 2104766
2950 E. Harmony Road Ste. 252 SE DECISION MADE: 25-MAY-23
Fort Collins CO 80528 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter
Allwin Medical Devices, Inc 510(k) NO: K220781(Traditional)
ATTN: Digish Mehta PHONE NO : 714 5721709
3305 E. Miraloma Avenue, Suite 176SE DECISION MADE: 05-MAY-23
Anaheim CA 92806 510(k) STATEMENT
DEVICE: Endo Motor
Foshan COXO Medical Instrument Co.510(k) NO: K220829(Traditional)
ATTN: Yongjian Zheng PHONE NO : 86 137 02544788
BLDG 4, District A, Guangdong New SE DECISION MADE: 18-MAY-23
Foshan CN 528226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
Qura S.r.l. 510(k) NO: K220842(Traditional)
ATTN: Raffaella Tommasini PHONE NO : 39 0535 1803050
Via di Mezzo, 23 SE DECISION MADE: 19-MAY-23
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iLet® Dosing Decision Software
Beta Bionics, Inc. 510(k) NO: K220916(Traditional)
ATTN: Vikram Verma PHONE NO : 978 6026239
300 Baker Ave Ste 301 SE DECISION MADE: 19-MAY-23
Concord MA 01742-2131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERSAJET Hydrosurgery System (III)
Smith & Nephew Medical Limited 510(k) NO: K220964(Traditional)
ATTN: Zoe Smith PHONE NO : 44 774 0531714
101 Hessle Road SE DECISION MADE: 16-MAY-23
Hull GB HU3 2BN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter
Surgical Instrument Service and Sa510(k) NO: K221067(Traditional)
ATTN: Stephanie Boyle Mays PHONE NO : 541 5164205
(dba Medline ReNewal) 1500 NE HemlSE DECISION MADE: 31-MAY-23
Redmond OR 97756 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sientra, inc. Portfinder
Sientra, Inc. 510(k) NO: K221127(Traditional)
ATTN: Denise Dajles PHONE NO : 805 8796171
420 South Fairview Avenue Suite 20SE DECISION MADE: 10-MAY-23
Santa Barbara CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exactech® Alteon® Short Tapered Wedge
Exactech, Inc 510(k) NO: K221323(Traditional)
ATTN: Valdimir Talley PHONE NO : 352 3274824
2320 NW 66th Court SE DECISION MADE: 19-MAY-23
Gainesville FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oxymag - Transport and Emergency Ventilator
Magnamed Tecnologia Medica S/A 510(k) NO: K221634(Traditional)
ATTN: Toru Kinjo PHONE NO : 551 1461 58500
801/831, Rua Santa Monica SE DECISION MADE: 24-MAY-23
Cotia BR 06715-865 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses
Paragon Vision Sciences, Inc. 510(k) NO: K221768(Traditional)
ATTN: Vimala Punsammy PHONE NO : 480 5077660
2120 W. Guadalupe Rd. SE DECISION MADE: 05-MAY-23
Gilbert AZ 52233 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASEPT Peritoneal Drainage System
PFM Medical, Inc. 510(k) NO: K221779(Traditional)
ATTN: Jessica Jho PHONE NO : 801 4559267
1916 Palomar Oaks Way, Suite 150 SE DECISION MADE: 02-MAY-23
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Finger Pulse Oximeter, Model: X1906P
Shenzhen Changkun Technology Co., 510(k) NO: K221798(Traditional)
ATTN: Wang Qingpeng PHONE NO : 0755 2910 0487
Room 501, Changkun Technology BuilSE DECISION MADE: 04-MAY-23
Shenzhen CN 518118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CarnaLife Holo
MedApp S.A. 510(k) NO: K221870(Traditional)
ATTN: Andrzej Skalski PHONE NO : 48 662 444769
Armii Krajowej 25 SE DECISION MADE: 01-MAY-23
Krakow PL 30-150 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hydrozid Precise
BIBAWO Medical A/S 510(k) NO: K221897(Traditional)
ATTN: Sandra Larsen PHONE NO : 45 8140 1843
Klintehøj Vænge 6 SE DECISION MADE: 30-MAY-23
Birkerød DK 3460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IU Implant System Abutment
Warantec Co., Ltd, 510(k) NO: K221969(Traditional)
ATTN: Younggwang Choi PHONE NO : 82 2 62419001
411~412, 474, Dunchon-dearo, JungwSE DECISION MADE: 12-MAY-23
Seongnam-si KR 13229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Evita V800, Evita V600
Draegerwerk AG & Co. KGaA 510(k) NO: K222024(Traditional)
ATTN: Holger Nadler PHONE NO : 494 451 8826856
53/55 Moislinger Allee SE DECISION MADE: 16-MAY-23
Luebeck DE 23542 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avatar Medical Software V1
Avatar Medical 510(k) NO: K222035(Traditional)
ATTN: Elodie Brient-Litzler PHONE NO : 33 6 84496108__
11 rue de Lourmel SE DECISION MADE: 24-MAY-23
Paris FR 75015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPIC Deformity Band System
Astura Medical 510(k) NO: K222097(Traditional)
ATTN: Parker Kelch PHONE NO : 469 5015530 503
4949 W Royal Ln. SE DECISION MADE: 04-MAY-23
Irving TX 75063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Waypoint GPS
Waypoint Orthopedics, Inc. 510(k) NO: K222106(Traditional)
ATTN: Tiffini Wittwer PHONE NO : 707 7996732
300 Applebrooke Drive SE DECISION MADE: 12-MAY-23
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Babylog VN800, Babylog VN600
Draegerwerk AG & CO KGaA 510(k) NO: K222207(Traditional)
ATTN: Nataliia Semenova PHONE NO : 49 451 8828225
53/55 Moislinger Allee SE DECISION MADE: 16-MAY-23
Luebeck DE 23542 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advanced LumFix Spinal Fixation System
CG Bio Co., Ltd. 510(k) NO: K222229(Traditional)
ATTN: Iris Kim PHONE NO : 82 10 32229149
B1, 1F, 2F, C-dong, 29, JeyakdanjiSE DECISION MADE: 25-MAY-23
Hwaseong-Si KR 18608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gunther Tulip Vena Cava Filter Retrieval Set
Cook Incorporated 510(k) NO: K222254(Traditional)
ATTN: Daniel Corbin PHONE NO : 812 3254172
750 Daniels Way SE DECISION MADE: 16-MAY-23
BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System
CIRCA Scientific, Inc. 510(k) NO: K222311(Traditional)
ATTN: Fred Piazza PHONE NO : 303 9518767
14 Inverness Drive East, Suite H-1SE DECISION MADE: 25-MAY-23
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Claritag Advanced
DGI Technologies 510(k) NO: K222356(Traditional)
ATTN: Jeremy Josephson PHONE NO : 732 8875087
400 Candlewood Commons SE DECISION MADE: 18-MAY-23
Howell NJ 07731 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quicktome Software Suite
Omniscient Neurotechnology Pty Ltd510(k) NO: K222359(Traditional)
ATTN: Jennifer Dixon PHONE NO : 1647 6776248
Level 10, 580 George Street SE DECISION MADE: 30-MAY-23
Sydney AU 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: swiftPro System
Emblation Ltd. 510(k) NO: K222388(Traditional)
ATTN: Mairi MacFayden PHONE NO : 44 1259 236132
Forrester Lodge, Inglewood SE DECISION MADE: 04-MAY-23
Alloa GB FK10 2HU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIA Safeguard
RIA Tech Co., Ltd. 510(k) NO: K222416(Traditional)
ATTN: David Chao PHONE NO : 886 2 25211220
5F., NO. 25-2, SEC. 4, REN-AI RD.,SE DECISION MADE: 01-MAY-23
Taipei City TW 106073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sphincterotome
Hangzhou AGS MedTech Co., Ltd. 510(k) NO: K222421(Traditional)
ATTN: Jiayuan Zhang PHONE NO : 86 571 87671223
Building 5, Building 6, No. 597 KaSE DECISION MADE: 03-MAY-23
Hangzhou CN 311106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Latitud™ Hip Replacement System
Meril Healthcare Pvt. Ltd. 510(k) NO: K222436(Traditional)
ATTN: Yamini Patel PHONE NO : 91 971 4408139
Survey No. 135/2/B & 174/2, H1-H3 SE DECISION MADE: 09-MAY-23
Vapi IN 396191 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intraoperative Ultrasound Probe Cover
Exact Medical Manufacturing 510(k) NO: K222460(Traditional)
ATTN: Ryan Power PHONE NO : 716 6810076
21# Qingjjiang Rd XinBei District SE DECISION MADE: 12-MAY-23
Changzhou Jiangsu CN 213022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Retitrack
C. Light Technologies, Inc. 510(k) NO: K222484(Traditional)
ATTN: Christy K Sheehy-Bensinger PHONE NO : 518 3392895
84 High Street, Suite 303 SE DECISION MADE: 09-MAY-23
Medford MA 02155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anika Tissue Tack Fixation System
Anika Therapeutics, Inc. 510(k) NO: K222487(Traditional)
ATTN: Shajunath Nirupama PHONE NO : 781 4579520
32 Wiggins Avenue SE DECISION MADE: 08-MAY-23
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Harvest Printable Resin
Harvest Dental Products, LLC 510(k) NO: K222489(Traditional)
ATTN: Colleen Boswell PHONE NO : 714 5853431___
905 Columbia Street SE DECISION MADE: 12-MAY-23
Brea CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Regeneten Bioinductive Implant
Smith and Nephew Inc 510(k) NO: K222501(Traditional)
ATTN: Jenna Horsley PHONE NO : 617 2187921
150 Minuteman Road SE DECISION MADE: 11-MAY-23
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Mask
Guangzhou Fuzelong Hygiene Materia510(k) NO: K222545(Traditional)
ATTN: Haiyan Zeng PHONE NO : 86 020 87993188
12, Guancun Road, Jiangpu Street, SE DECISION MADE: 19-MAY-23
Guangzhou CN 510900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OpenTex
Purgo Biologics Inc. 510(k) NO: K222549(Traditional)
ATTN: Byungsun Kim PHONE NO : 82 70 48270451
#812, 27 Dunchon-daero 457beon-gilSE DECISION MADE: 11-MAY-23
Seongnam-si KR 13219 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BTL-785X
BTL Industries Inc. 510(k) NO: K222556(Traditional)
ATTN: David Chmel PHONE NO : 1 866 2851656
362 Elm Street SE DECISION MADE: 31-MAY-23
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BlueCheck™ Caries Detection & Monitoring
Incisive Technologies Pty Ltd 510(k) NO: K222560(Traditional)
ATTN: Kerry A Hegarty PHONE NO : 61 39653 3777
Level 4, 71 Collins Street SE DECISION MADE: 16-MAY-23
Melbourne AU 3000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
3M Company 510(k) NO: K222578(Traditional)
ATTN: Hilary Hovde PHONE NO : 651 7360364
2510 Conway Ave. Building 275-5W-0SE DECISION MADE: 18-MAY-23
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-HYADASE
VITROMED GmbH 510(k) NO: K222606(Traditional)
ATTN: Greg Holland PHONE NO : 949 2620411
Raiffeisenstr. 15a SE DECISION MADE: 26-MAY-23
Langenfeld DE 40764 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLS Martin LINOS Wrist System
KLS-Martin L.P. 510(k) NO: K222624(Traditional)
ATTN: Melissa Bachorski PHONE NO : 800 6251557
11201 Saint Johns Industrial ParkwSE DECISION MADE: 25-MAY-23
Jacksonville FL 32246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sweden & Martina Surgical Trays
Sweden & Martina S.p.A. 510(k) NO: K222640(Traditional)
ATTN: Alessia Pezzato PHONE NO : 39 049 9124300
Via Veneto, 10 SE DECISION MADE: 26-MAY-23
Due Carrare IT 35020 510(k) STATEMENT
DEVICE: Nihon Kohden NKV-440 Ventilator System
Nihon Kohden OrangeMed, Inc. 510(k) NO: K222644(Traditional)
ATTN: Sheryl Higgins PHONE NO : 949 5026448 7012
1800 E. Wilshire Avenue SE DECISION MADE: 31-MAY-23
Santa Ana CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility Scooter (ATTO SPORT MAX)
Moving Life Ltd 510(k) NO: K222703(Traditional)
ATTN: Igor Naroditsky PHONE NO : 972 54 4384386
Havat Alenby SE DECISION MADE: 19-MAY-23
Netzer Sereni IL 7039500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Introducer Needle
YouCare Technology Co., Ltd. (Wuha510(k) NO: K222705(Traditional)
ATTN: Bing Hu PHONE NO : 027 8792 6396830
Great Wall Science and Technology SE DECISION MADE: 22-MAY-23
Wuhan CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MX50N
WIDE Corporation 510(k) NO: K222716(Traditional)
ATTN: YeoJin Yun PHONE NO : 82 31 2181675
15F, The First Tower III, 602, DonSE DECISION MADE: 08-MAY-23
Hwaseong-Si KR 18469 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CX50N
WIDE Corporation 510(k) NO: K222719(Traditional)
ATTN: YeoJin Yun PHONE NO : 82 31 2181675
15F, The First Tower III, 602, DonSE DECISION MADE: 09-MAY-23
Hwaseong-Si KR 18469 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Radiation Planning Assistant (RPA)
University of Texas, MD Anderson C510(k) NO: K222728(Traditional)
ATTN: Stella Tsai PHONE NO : 713 5635464
1515 Holcombe Blvd. SE DECISION MADE: 17-MAY-23
Houston TX 77030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
Hologic, Inc. 510(k) NO: K222736(Traditional)
ATTN: Vlada Rudenko PHONE NO : 858 4107967
10210 Genetic Center Drive SE DECISION MADE: 16-MAY-23
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Insufflator
Scivita Medical Technology Co., Lt510(k) NO: K222812(Traditional)
ATTN: Ruqin Wu PHONE NO : 86 512 81877788
No.8, Zhong Tian Xiang, Suzhou IndSE DECISION MADE: 16-MAY-23
Suzhou CN 215000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ventana™ C Spinal System
Spinal Elements, Inc. 510(k) NO: K222833(Traditional)
ATTN: Julie Lamothe PHONE NO : 760 6071816
3115 Melrose Dr., Suite 200 SE DECISION MADE: 19-MAY-23
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
Institut Straumann AG 510(k) NO: K222836(Traditional)
ATTN: Dr. Renate Reiss PHONE NO : 41 61 9651259
Peter Merian Weg 12 SE DECISION MADE: 15-MAY-23
Basel CH 4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ceramic Brackets Orthometric
Orthometric - Industria e Comercio510(k) NO: K222847(Traditional)
ATTN: Silvio Zilio PHONE NO : 55 14 33112727
E Odontologicos Irineu Martins, 28SE DECISION MADE: 04-MAY-23
Marilia BR 17539-059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle
Nipro Medical Corporation 510(k) NO: K222852(Traditional)
ATTN: Jessica Oswald-McLeod PHONE NO : 305 4326699
3150 NW 107th Ave. SE DECISION MADE: 25-MAY-23
Doral FL 33172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iTFlow
Cardio Flow Design Inc. 510(k) NO: K222854(Traditional)
ATTN: Teruyasu Nishino PHONE NO : 81 09 42153347
22-3 Ichibancho, Chiyoda-ku SE DECISION MADE: 12-MAY-23
Tokyo JP 1020082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039
Shenzhen Kentro Medical Electronic510(k) NO: K222870(Traditional)
ATTN: Zewu Zhang PHONE NO : 86 0755 33825998
2nd Floor No 11, Shanzhuang Road, SE DECISION MADE: 10-MAY-23
Shenzhen CN 518100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
Pegavision Corporation 510(k) NO: K222885(Traditional)
ATTN: Estela Lin PHONE NO : 886 3 3298808
2F-1, No. 5, Shing Yeh St. SE DECISION MADE: 31-MAY-23
Taoyuan City TW 33341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Desensitizer
Guangzhou Beogene Biotech Co., Ltd510(k) NO: K222891(Traditional)
ATTN: Duan Qiangqiang PHONE NO : 86 166 26708885
Second floor, Building C, Self-comSE DECISION MADE: 25-MAY-23
Guangzhou CN 510540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: c1Trac
Zimmer MedizinSysteme GmbH 510(k) NO: K222912(Traditional)
ATTN: Ute Hauss PHONE NO : 49 731 9761216
Junkersstrasse 9 SE DECISION MADE: 16-MAY-23
Neu-Ulm DE 89231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683
Shenzhen Yuezhongxing Technology C510(k) NO: K222926(Traditional)
ATTN: Yuchao Chen PHONE NO : 86 135 10394198
No.2, Zhenye Road, Liulian CommuniSE DECISION MADE: 05-MAY-23
Shenzhen CN 518015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W
Microlife Intellectual Property Gm510(k) NO: K222979(Traditional)
ATTN: Ariel Wang PHONE NO : 886 2 87971288 366
Espenstrasse 139 SE DECISION MADE: 19-MAY-23
Widnau CH 9443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Akunah REFLECT
Akunah PTY LTD 510(k) NO: K222987(Traditional)
ATTN: Shanthan Pather PHONE NO : 61 488 109916
131 Warriewood St SE DECISION MADE: 10-MAY-23
Queensland AU 4151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette
Plasmapp Co., Ltd. 510(k) NO: K223015(Traditional)
ATTN: Byeong Geon Song PHONE NO : 82 042 7162115
BVC-111, 125 Gwahak-ro, Yuseong-guSE DECISION MADE: 09-MAY-23
Daejeon KR 34141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
Plasmapp Co,.Ltd. 510(k) NO: K223023(Traditional)
ATTN: Byeong Geon Song PHONE NO : 820 42 7162115
BVC-111, 125, Gwahak-ro, Yuseong-gSE DECISION MADE: 09-MAY-23
Daejeon KR 34141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tyvek Roll with CI for STERLINK Sterilizer
Plasmapp Co., Ltd. 510(k) NO: K223025(Traditional)
ATTN: Byeong Geon Song PHONE NO : 820 42 7162115
BVC-111, 125, Gwahak-ro, Yuseong-gSE DECISION MADE: 09-MAY-23
Daejeon KR 34141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Thermometer (Model QT001)
Shen Zhen Rong Feng Technology Co.510(k) NO: K223044(Traditional)
ATTN: Hong Xiao Lan PHONE NO : 86 1371 5151187
3/F R Building ShaSi Industrial PaSE DECISION MADE: 10-MAY-23
Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dark Star Deformity Pedicle Screw System
Republic Spine, LLC 510(k) NO: K223096(Traditional)
ATTN: James Doulgeris PHONE NO : 561 3628094
2424 N Federal HW, Suite 257 SE DECISION MADE: 26-MAY-23
Boca Raton FL 33431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Secondary Infusion Set
CareFusion 510(k) NO: K223101(Traditional)
ATTN: Paulina Davis PHONE NO : 714 3306037
10020 Pacific Mesa Blvd SE DECISION MADE: 12-MAY-23
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: myLEDmask
myBlend 510(k) NO: K223147(Traditional)
ATTN: Clédia Hettinger PHONE NO : 33____ 6 89081179
9 Rue du Commandant Pilot SE DECISION MADE: 14-MAY-23
Neuilly-sur-Seine FR 92200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy
WorldWork S.R.L 510(k) NO: K223182(Abbreviated)
ATTN: Daniela Baldissera PHONE NO : 39 0444 574297
Via Del Progresso, 47 SE DECISION MADE: 01-MAY-23
Montebello IT 36054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: coactiv+™ Antimicrobial Wound Gel
Kane Biotech, Inc. 510(k) NO: K223259(Traditional)
ATTN: Lori Christofalos PHONE NO : 1 204 7825028
290-100 Innovation Drive SE DECISION MADE: 24-MAY-23
Winnipeg CA R3T6G2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CryoX Vitrification Freeze Kit / Thaw Kit
Zhejiang Horizon Medical Technolog510(k) NO: K223265(Traditional)
ATTN: Wu Tang PHONE NO : 86 1662 1730534___
Rom 219, 2nd floor, Building 9, 13SE DECISION MADE: 11-MAY-23
Jiaxing CN 314006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spencer Probe Depth Electrodes
Ad-Tech Medical Instrument Corpora510(k) NO: K223269(Traditional)
ATTN: Brendan McCrea PHONE NO : 262 6341555 1100
400 W Oakview Pkwy SE DECISION MADE: 18-MAY-23
Oak Creek WI 53154-7213 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anchor Bolts as Accessories to Depth Electrodes
Ad-Tech Medical Instrument Corpora510(k) NO: K223276(Traditional)
ATTN: Brendan McCrea PHONE NO : 262 6341555 1100
400 West Oakview Parkway SE DECISION MADE: 18-MAY-23
Oak Creek WI 53154-7213 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposible Nitrile Gloves
HOLIK ASIA GROUP CO., LTD 510(k) NO: K223280(Traditional)
ATTN: Monica Zhou PHONE NO : 86 135 85161180
NO.18 Nanyi Road, Xuanzhou EconomiSE DECISION MADE: 08-MAY-23
Xuancheng CN 242000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEATING TENS/EMS, FT-810R
Hivox Biotek Inc. 510(k) NO: K223308(Traditional)
ATTN: Shaun Hsu PHONE NO : 886 2 85112668 322
5F., No. 123, Xingde Rd. Sanchong SE DECISION MADE: 13-MAY-23
New Taipei City TW 24158 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Internal Joint Stabilizer - Elbow
Skeletal Dynamics, Inc. 510(k) NO: K223318(Traditional)
ATTN: Alexandra Rodriguez Rojas PHONE NO : 305 5967585 ______
7300 N Kendall Drive, Suite 400 SE DECISION MADE: 10-MAY-23
Miami FL 33156 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201)
Guangzhou Yongyi Industrial Co., L510(k) NO: K223329(Traditional)
ATTN: Wei Hu PHONE NO :
No. 4, Majun Rd., Dongchong Town, SE DECISION MADE: 26-MAY-23
Guangzhou CN 523000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIRION Lateral Lumbar Interbody System
Astura Medical 510(k) NO: K223335(Traditional)
ATTN: Parker Kelch PHONE NO : 469 5015530 503
4949 W Royal Ln. SE DECISION MADE: 09-MAY-23
Irving TX 75063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)
Shenzhen Leqing Medical Instrument510(k) NO: K223428(Traditional)
ATTN: Shaodong Wang PHONE NO : 86 755 28392373
2-3/F, Building D, No.31 Fangkeng SE DECISION MADE: 08-MAY-23
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProLift Micro Expandable Spacer System
Life Spine, Inc. 510(k) NO: K223430(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S. Quality Drive SE DECISION MADE: 04-MAY-23
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)
Hartalega NGC SDN. BHD. 510(k) NO: K223437(Traditional)
ATTN: Kuan Mun Leong PHONE NO : 603 62771733
No. 1, Persiaran Tanjung Kawasan PSE DECISION MADE: 17-MAY-23
Sepang MY 43900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SafeBreak® Vascular
Lineus Medical 510(k) NO: K223486(Traditional)
ATTN: Vance Clement PHONE NO :
179 North Church Ave, Suite 202 SE DECISION MADE: 19-MAY-23
Fayetteville AZ 72701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
GE Medical Systems, LLC 510(k) NO: K223491(Traditional)
ATTN: Chris Paulik PHONE NO : 262 8945415
3000 N. Grandview Blvd SE DECISION MADE: 25-MAY-23
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zeolite Hemostatic Cotton
Hangzhou Zeo-Innov Life Technology510(k) NO: K223495(Traditional)
ATTN: Zhao Lijuan PHONE NO : 86 571___ 86651470
101, Building 2, No.291 Fucheng RoSE DECISION MADE: 02-MAY-23
Hangzhou CN 310018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ceribell Status Epilepticus Monitor
Ceribell, Inc. 510(k) NO: K223504(Traditional)
ATTN: Raymond Woo PHONE NO : 650 5564349
360 N Pastoria Ave SE DECISION MADE: 23-MAY-23
Sunnyvale CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Excella Navigation Instruments
Innovasis, Inc. 510(k) NO: K223511(Traditional)
ATTN: Michael Thomas PHONE NO : 801 2612236
614 E 3900 S SE DECISION MADE: 02-MAY-23
Salt Lake City UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonic DL
GE Medical Systems,LLC (GE Healthc510(k) NO: K223523(Traditional)
ATTN: Glen Sabin PHONE NO : 262 8944968
3200 N Grandview Blvd SE DECISION MADE: 30-MAY-23
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PressON Spinal Fixation System
Nexus Spine, LLC 510(k) NO: K223529(Traditional)
ATTN: Jared Crocker PHONE NO : 801 7028592
2825 East Cottonwood Parkway SuiteSE DECISION MADE: 02-MAY-23
Salt Lake City UT 84121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: vPATCH
Virility Medical, Ltd. 510(k) NO: K223595(Traditional)
ATTN: Tal Golan PHONE NO : 972 97 447780
24 Hanagar St., Suite 106 SE DECISION MADE: 01-MAY-23
Hod-Hasharon IL 4527713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprieve by RegenesisTM
Regenesis Biomedical Inc. 510(k) NO: K223620(Traditional)
ATTN: Randy Chavez PHONE NO : 480 2975800
5301 N Pima Road, Ste 150 SE DECISION MADE: 24-MAY-23
Scottsdale AZ 85250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SubtleMR (2.3.x)
Subtle Medical Inc. 510(k) NO: K223623(Traditional)
ATTN: Ajit Shankaranarayanan PHONE NO : 650 3978709___
883 Santa Cruz Ave Suite 205 SE DECISION MADE: 11-MAY-23
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Emerald Herbst
Island Dental Lab, Inc dba Emerald510(k) NO: K223624(Traditional)
ATTN: Israel Wettenstein PHONE NO : 347 5229800
76 S. Central Avenue #1D SE DECISION MADE: 10-MAY-23
Valley Stream NY 11580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Niti-S Biliary Speed D Stent
Taewoong Medical Co., Ltd 510(k) NO: K223626(Traditional)
ATTN: Jangsoo Lee PHONE NO : 82 70 46491515
14 Gojeong-ro, Wolgot-myeon SE DECISION MADE: 26-MAY-23
Gimpo-si KR 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I.V. Administration Set, I.V. Extension Set
BQ PLUS Medical Co., Ltd 510(k) NO: K223645(Traditional)
ATTN: Jin Zhang PHONE NO : 86 21 57609106
No. 18, Cheye Road, Chedum Town, SSE DECISION MADE: 18-MAY-23
Shanghai CN 201611 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cerebral Adaptive Index (CAI) Algorithm
Edwards Lifesciences, LLC 510(k) NO: K223651(Traditional)
ATTN: Sara Pesian PHONE NO : 949 2502232
One Edwards Way SE DECISION MADE: 26-MAY-23
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Catalyst R1 Reverse Shoulder System
Catalyst OrthoScience, Inc. 510(k) NO: K223655(Traditional)
ATTN: Dale Davison PHONE NO : 239 3259976 102
14710 Tamiami Trail North SE DECISION MADE: 09-MAY-23
Naples FL 34110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMDA Abutment
SIMDA Co., Ltd. 510(k) NO: K223663(Traditional)
ATTN: Young Woo Cha PHONE NO : 82 70 42562855
156-4, Gamjeon-dong SE DECISION MADE: 24-MAY-23
Busan KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F&P Solo Mask Range
Fisher & Paykel Healthcare Ltd 510(k) NO: K223696(Traditional)
ATTN: Reena Daken PHONE NO : 64 57 40100
15 Maurice Paykel Place, East TamaSE DECISION MADE: 17-MAY-23
Auckland NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PMMA BLOCK
Huliang(shanghai) Bio-Tech Co., Lt510(k) NO: K223706(Traditional)
ATTN: Quansheng Wang PHONE NO : 0086 021 20952966
Room 303, Building 5, Lane2388, XiSE DECISION MADE: 12-MAY-23
Shanghai CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Restrata® MiniMatrix
Acera Surgical, Inc. 510(k) NO: K223725(Traditional)
ATTN: Tamas Kovacs PHONE NO : 844 8792237
1650 Des Peres Rd., Suite 120 SE DECISION MADE: 18-MAY-23
St. Louis MO 63131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SimPro™ Now, GentleCath™ Hydrophilic
Dentsply Sirona 510(k) NO: K223756(Traditional)
ATTN: Laura Sobrin PHONE NO : 717 8494434
221 West Philadelphia Street, SuitSE DECISION MADE: 04-MAY-23
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Epione
Quantum Surgical SAS 510(k) NO: K223758(Traditional)
ATTN: Elise Lagacherie PHONE NO : 33 448 194050
ZAC Eureka 1000 Rue du Mas de VercSE DECISION MADE: 03-MAY-23
Montpellier FR 34000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smith & Nephew ACCORD™ Cable System
Smith & Nephew 510(k) NO: K223762(Traditional)
ATTN: Allison Francis PHONE NO : 901 5725959
7135 Goodlett Farns Parkway SE DECISION MADE: 30-MAY-23
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lumify Diagnostic Ultrasound System
Philips Ultrasound 510(k) NO: K223771(Traditional)
ATTN: Sudipta Chakrabarti PHONE NO : 203 2136862
22100 Bothell Everett Hwy SE DECISION MADE: 04-MAY-23
Bothell WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Agnes
Agnes Medical Co., Ltd 510(k) NO: K223805(Traditional)
ATTN: Jiwon Kim PHONE NO : 82 10 72925675
(Seohyeon-Dong, 5f Cocoplaza), 20,SE DECISION MADE: 04-MAY-23
Seongnam-Si KR 13591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PrecisionTAVI (v1.1)
DASI Simulations 510(k) NO: K223809(Traditional)
ATTN: Ana Minyayev PHONE NO : 614 5866760
5115 Parkcenter Ave Suite 205 SE DECISION MADE: 30-MAY-23
Dublin OH 43017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Genesis ACTIVE Implant System
Keystone Dental Inc. 510(k) NO: K223814(Traditional)
ATTN: Nancy DeAngelo PHONE NO : 1 781 3283490
154 Middlesex Turnpike SE DECISION MADE: 25-MAY-23
Burlington MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Model 9160 VitaloQUB
Vitalograph Ireland Ltd. 510(k) NO: K223818(Traditional)
ATTN: Tony O'Hanlon PHONE NO : 353 65 6864100
Gort Road Business Park SE DECISION MADE: 25-MAY-23
Ennis Co Clare IE V95 HFT4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tens & Ems Device
Shenzhen Jian Feng Electronic Tech510(k) NO: K223825(Traditional)
ATTN: Feng Wen PHONE NO : 86 755 33858361
#902, 903 Jialingyu Industrial BuiSE DECISION MADE: 09-MAY-23
Shenzhen CN 518104 510(k) STATEMENT
DEVICE: Vathin® Video Bronchoscope System
Hunan Vathin Medical Instrument Co510(k) NO: K223836(Traditional)
ATTN: Du Jing PHONE NO : 86 1891 5069265
1/F, Building 12, Innovation and ESE DECISION MADE: 15-MAY-23
Xiangtan CN 411100 510(k) STATEMENT
DEVICE: TrueBeam, TrueBeam STx, Edge, VitalBeam
Varian Medical Systems, Inc. 510(k) NO: K223839(Traditional)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
911 Hansen Way SE DECISION MADE: 22-MAY-23
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KBA3D
S.M.A.I.O. 510(k) NO: K223841(Traditional)
ATTN: Jean-Charles Roussouly PHONE NO : 33 6 70165171
2 place Berthe Morisot SE DECISION MADE: 30-MAY-23
Saint Priest FR 69800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FloPatch FP120
Flosonics Medical 510(k) NO: K223843(Traditional)
ATTN: Caleb Chin PHONE NO : 1 289 9982982
325 Front St W, Floor 4 SE DECISION MADE: 03-MAY-23
Toronto CA M5V 2Y1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iLet® ACE Pump
Beta Bionics, Inc 510(k) NO: K223846(Traditional)
ATTN: Vikram Verma PHONE NO : 978 6026239
300 Baker Avenue, Suite 301 SE DECISION MADE: 19-MAY-23
Concord MA 01742 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lexa MINI (RIS-303, RIS-305)
W&H Sterilization S.r.l. 510(k) NO: K223858(Traditional)
ATTN: Paola Zampino PHONE NO : 0039 035 6663000___
Via Bolgara, 2 SE DECISION MADE: 05-MAY-23
Brusaporto IT 24060 510(k) STATEMENT
DEVICE: Integrity™ Bone Staple Fixation System
Anika Therapeutics Inc. 510(k) NO: K223860(Traditional)
ATTN: Shajunath Nirupama PHONE NO : 978 3931081
32 Wiggins Avenue SE DECISION MADE: 22-MAY-23
Beford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Heat (Model: E0221)
Light Tree Ventures Europe B.V. 510(k) NO: K223893(Traditional)
ATTN: Alain Dijkstra PHONE NO : 86 135 103787481
Laan van Ypenburg 108, 2497 GC, ThSE DECISION MADE: 16-MAY-23
Hague NL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuEra Tight RF Model APMD145.M70-US
BIOS s.r.l. 510(k) NO: K223907(Special)
ATTN: Martina De Iturbe PHONE NO : 39 391 7461002
Via Guido Rossa 10/12 SE DECISION MADE: 02-MAY-23
Vimodrone IT 20055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Excipio SV Aspiration Catheter and Tubing
Contego Medical, Inc. 510(k) NO: K230030(Traditional)
ATTN: James Clossic PHONE NO : 1 305 6071708
3801 Lake Boone Trail SE DECISION MADE: 30-MAY-23
Raleigh NC 27607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pre-Sure
Lazarus 3D 510(k) NO: K230044(Traditional)
ATTN: Smriti Zaneveld PHONE NO : 541 7601805
421 Water Ave. NE, Ste 1100 SE DECISION MADE: 26-MAY-23
Albany OR 97321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System
Fiagon GmbH 510(k) NO: K230065(Traditional)
ATTN: Dirk Mucha PHONE NO : 49 3302 2012124
Neuendorfst. 23b SE DECISION MADE: 26-MAY-23
Hennigsdorf DE 16761 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Auto Segmentation
GE Medical Systems, LLC 510(k) NO: K230082(Traditional)
ATTN: Niki Mavrodieva PHONE NO : 1 905 302 3913
3000 N. Grandview Blvd. SE DECISION MADE: 04-MAY-23
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Genius AI Detection 2.0 with CC-MLO Correlation
Hologic, Inc. 510(k) NO: K230096(Traditional)
ATTN: Deborah Thomas PHONE NO : 508 2106107
250 Campus Drive SE DECISION MADE: 23-MAY-23
Marlborough MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: General Cutting Straight
Nakanishi Inc. 510(k) NO: K230106(Traditional)
ATTN: Masaaki Kikuchi PHONE NO : 81 289 647277
700 Shimohinata SE DECISION MADE: 24-MAY-23
Kanuma JP 322-8666 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORE 500 Digital Stethoscope
Eko Devices, Inc. 510(k) NO: K230111(Traditional)
ATTN: Sam Huang, Ph.D. PHONE NO : 1 844 3563384
1212 Broadway, Suite 100 SE DECISION MADE: 26-MAY-23
Oakland CA 94612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3D Anatomic Model
Ricoh USA, Inc. 510(k) NO: K230119(Traditional)
ATTN: Gary Turner PHONE NO : 1 954 6485680
5575 Venture Drive, Unit A SE DECISION MADE: 02-MAY-23
Parma OH 44130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
Careglove Global SDN. BHD. 510(k) NO: K230121(Traditional)
ATTN: Lim Kwee Shyan PHONE NO : 606 6782377
Lot 17479, Lrg Senawang 3/2, Off JSE DECISION MADE: 15-MAY-23
Seremban MY 70450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apollo Knotless Suture Anchor
Maruho Medical 510(k) NO: K230123(Traditional)
ATTN: Yannick Spenninck PHONE NO : 678 9002345
3005 Chastain Meadows Pkwy, suite SE DECISION MADE: 03-MAY-23
Marietta GA 30066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002
Hubei YJT Technology Co.,Ltd 510(k) NO: K230134(Traditional)
ATTN: Hua Xinag PHONE NO : 86 173 64042492
Room 1-8,8F, Building 7, Guannan FSE DECISION MADE: 23-MAY-23
Wuhan CN 43000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uMR Omega
Shanghai United Imaging Healthcare510(k) NO: K230152(Traditional)
ATTN: Xin Gao PHONE NO : 86 021 67076888 5386
No.2258 Chengbei Road, Jiading DisSE DECISION MADE: 23-MAY-23
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-Use Flexible Ureteroscope
Hunan Vathin Medical Instrument Co510(k) NO: K230200(Traditional)
ATTN: Du Jing PHONE NO : 86 189 15069265
1/F, Building 12, Innovation EntreSE DECISION MADE: 18-MAY-23
Xiangtan CN 411100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dentis I-FIX Abutment
Dentis Co., Ltd. 510(k) NO: K230203(Traditional)
ATTN: EunJin Shin PHONE NO : 82 53 5893646
99, Seongseoseo-ro, Dalseo-gu SE DECISION MADE: 03-MAY-23
Daegu KR 42718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs
Grand Work Plastic Products Co., L510(k) NO: K230217(Traditional)
ATTN: Wu Yuli PHONE NO : 86 311 66766067
Donggao Industrial Zone, Zanhuang SE DECISION MADE: 13-MAY-23
Shijiazhuang CN 050000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eminent Spine 3D Lumbar Interbody Fusion Systems
Eminent Spine, LLC 510(k) NO: K230219(Traditional)
ATTN: Stephen Courtney PHONE NO : 214 4155243
2004 Ventura Drive, Suite #100 SE DECISION MADE: 16-MAY-23
Plano TX 75093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dentis s-Clean SQ-SL Narrow Implant System
Dentis Co., Ltd. 510(k) NO: K230246(Traditional)
ATTN: EunJin Shin PHONE NO : 82 53 5893646
99, Seongseoseo-ro, Dalseo-gu SE DECISION MADE: 25-MAY-23
Daegu KR 42718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BB 8 Sinus Dilation Kit
Excelent Inc. 510(k) NO: K230258(Traditional)
ATTN: Kashif Mazhar PHONE NO : 626 2287222
68 TW Alexander Drive PO Box 13628SE DECISION MADE: 25-MAY-23
Durham NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Soreal Press, Soreal CAD
Shenzhen UP3d Technology Co., Ltd.510(k) NO: K230259(Traditional)
ATTN: Judy Zhang PHONE NO : 086 137 13634397__
401, Block B, Nanshan Yungu NanfenSE DECISION MADE: 25-MAY-23
Shenzhen CN 518055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BruxZir™ Incisal Coloring Liquid
Prismatik Dentalcraft, Inc. 510(k) NO: K230262(Traditional)
ATTN: So Hyun Park PHONE NO : 949 8635479
2144 Michelson Drive SE DECISION MADE: 16-MAY-23
Irvine CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Finesse™ Injectable PTA Balloon Dilatation Catheter
Summa Therapeutics, LLC 510(k) NO: K230263(Traditional)
ATTN: Timothy Murphy PHONE NO : 401 5246404
225 Dyer Street, 2nd Floor SE DECISION MADE: 26-MAY-23
Providence RI 02903 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Orchid Safety Release Valve
Linear Health Sciences, LLC 510(k) NO: K230266(Traditional)
ATTN: Daniel Clark PHONE NO : 310 7216222
5333 Wisteria Drive SE DECISION MADE: 04-MAY-23
Oklahoma City OK 73142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Saranas Early Bird Bleed Monitoring System
Saranas Inc. 510(k) NO: K230273(Traditional)
ATTN: Odell Roberts PHONE NO : 281 7014416___
2450 Holcombe Blvd. Suite X SE DECISION MADE: 25-MAY-23
Houston TX 77021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Babyroo TN300
Draeger Medical Systems, Inc. 510(k) NO: K230278(Traditional)
ATTN: Karl Nittinger PHONE NO : 267 2721913
3135 Quarry Road SE DECISION MADE: 30-MAY-23
Telford PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANDORATE® Suction Valve and ANDORATE® Biopsy Valve
GA Health Company Limited 510(k) NO: K230280(Traditional)
ATTN: Cindy Ye PHONE NO : 852 2833 9010
Unit 18, 21/F, Metropole Square, 2SE DECISION MADE: 11-MAY-23
Hong Kong HK 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Assert-IQ™ Insertable Cardiac Monitor
Abbott Medical 510(k) NO: K230286(Traditional)
ATTN: Laura Sparks PHONE NO : 818 4932364
15900 Valley View Ct. SE DECISION MADE: 17-MAY-23
Sylmar CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Samsung ECG Monitor Application with Irregular Heart Rhythm Notification
Samsung Electronics Co., Ltd 510(k) NO: K230292(Traditional)
ATTN: Hon Pak PHONE NO : 82 10 50814700
129 Samsung-ro, Yeoungton-gu SE DECISION MADE: 02-MAY-23
Suwon-si KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlexBand; FlexPatch; FlexBand Plus
International Life Sciences 510(k) NO: K230316(Traditional)
ATTN: Tiffini Wittwer PHONE NO : 707 7996732
2150 Northwest Parkway SE Suite G SE DECISION MADE: 26-MAY-23
Marietta GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lucas Plus
AMT Engineering Co., Ltd 510(k) NO: K230340(Traditional)
ATTN: SeoungSoo Choi PHONE NO : 82 311 6618066
811-812 Byoksan Technopia 560, DucSE DECISION MADE: 04-MAY-23
Gyeonggi do KR 13230 510(k) STATEMENT
DEVICE: LED Facial Mask
Shenzhen SUNGPO HI-TECH Electronic510(k) NO: K230351(Traditional)
ATTN: Ava Hu PHONE NO : 86 755 23337750
806 Chuangke Building, No.72-6 HuaSE DECISION MADE: 05-MAY-23
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAVI Dual (TM) Migraine Therapy
eNeura, Inc. 510(k) NO: K230358(Special)
ATTN: David Rosen PHONE NO : 239 3076062
101 West Dickman St. Suite 900 SE DECISION MADE: 16-MAY-23
Baltimore MD 21230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HELIOS 785 Pico
Laseroptek Co., Ltd. 510(k) NO: K230373(Traditional)
ATTN: Hong Chu PHONE NO : 82 318 0235150
#203 & #204 Hyundai I valley, 31, SE DECISION MADE: 22-MAY-23
Seongnam-si KR 13212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMONITOR IV
BIOTRONIK, Inc. 510(k) NO: K230375(Traditional)
ATTN: Jon Brumbaugh PHONE NO : 888 3450374
6024 Jean Road SE DECISION MADE: 19-MAY-23
Lake Oswego OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUROSCREW NG; EUROSCREW TCP NG
Teknimed 510(k) NO: K230394(Traditional)
ATTN: Fabian Marcq PHONE NO : 33 534 251060
11 rue Apollo SE DECISION MADE: 12-MAY-23
L'Union FR 31240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClariVy™ Cervical IBF System
Vy Spine, LLC 510(k) NO: K230414(Special)
ATTN: Jordan Hendrickson PHONE NO : 866 4897746
2236 Capital Circle NE, Suite 103-SE DECISION MADE: 12-MAY-23
Tallahassee FL 32308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®
Stryker 510(k) NO: K230416(Traditional)
ATTN: Allison Byrne PHONE NO : 201 8315969
325 Corporate Drive SE DECISION MADE: 19-MAY-23
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Bipolar Forceps
HG Innovations Ltd 510(k) NO: K230432(Traditional)
ATTN: Dr.M Umran Rafiq PHONE NO : 44 770 2195623
5 Elder Court, Lions Drive ShadswoSE DECISION MADE: 18-MAY-23
Lancashire GB BB1 2EQ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
Jiangxi Royall Smart Technology Co510(k) NO: K230443(Traditional)
ATTN: Shunzhou Yang PHONE NO : 86 134 21375258
Workshop 3#, Shangyou Lefeng TechnSE DECISION MADE: 22-MAY-23
Ganzhou CN 341200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DeepX DermoSight Dermatoscope
DeepX Health LLC 510(k) NO: K230448(Traditional)
ATTN: Laurens Kraal PHONE NO : 415 6905323
2101 L Street, NW - Suite 300 SE DECISION MADE: 17-MAY-23
Washington DC 20037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter
Boston Scientific Corporation 510(k) NO: K230453(Special)
ATTN: Cassie Clark PHONE NO : 763 4941425
1 Scimed Place SE DECISION MADE: 18-MAY-23
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Laser Thermal Therapy Kit
Elesta SPA 510(k) NO: K230460(Traditional)
ATTN: Fabio Andreola PHONE NO : 39 055 8826807
Via Baldanzese 17 SE DECISION MADE: 22-MAY-23
Calenzano IT 50041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MixJect® Transfer Device
West Pharma Services IL, Ltd. 510(k) NO: K230464(Traditional)
ATTN: Llanit Goldgraber PHONE NO : 972 09 777866
4 Hasheizaf St SE DECISION MADE: 22-MAY-23
Ra'anana IL 4366411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hi-Bond Universal
Mediclus Co., LTD. 510(k) NO: K230465(Traditional)
ATTN: Hyeon-A Jo PHONE NO : 82 43 2112877
No. 1210, 134 Gongdan-ro, HeungdeoSE DECISION MADE: 22-MAY-23
Cheongju-si KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ComASP Cefiderocol 0.008-128
Liofilchem s.r.l. 510(k) NO: K230479(Traditional)
ATTN: Fabio Brocco PHONE NO : 781 9020312
Via Scozia zona ind le SE DECISION MADE: 18-MAY-23
Roseto degli Abruzzi IT 64026 510(k) STATEMENT
DEVICE: HandX™ Monopolar Scissors
Human Xtensions Ltd. 510(k) NO: K230491(Traditional)
ATTN: Hani Rauch PHONE NO : 97 254 4503857
Meir Ariel 4 SE DECISION MADE: 10-MAY-23
Netanya IL 4250574 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: s-Clean Link Abutment Narrow
Dentis Co., Ltd. 510(k) NO: K230523(Traditional)
ATTN: Gyu Ri Kim PHONE NO : 82 535 893541
99, Seongseoseo-ro, Dalseo-gu SE DECISION MADE: 24-MAY-23
Daegu KR 42718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOZO Pro
ImpediMed Limited 510(k) NO: K230530(Special)
ATTN: Dennis Schlaht PHONE NO : 61 738 603700
Unit 1, 50 Parker Court SE DECISION MADE: 04-MAY-23
Pinkenba AU 4008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOZO Pro
ImpediMed Limited 510(k) NO: K230531(Special)
ATTN: Dennis Schlaht PHONE NO : 61 738 603700
Unit 1, 50 Parker Court SE DECISION MADE: 04-MAY-23
Pinkenba AU 4008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Klassic Knee Revision System
Total Joint Othopedics, Inc. 510(k) NO: K230537(Traditional)
ATTN: Chris Weaber PHONE NO : 650 9227326 ______
1567 E. Stratford Avenue SE DECISION MADE: 19-MAY-23
Salt Lake City UT 84106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Gloves (ABC-DG01)
Huizhou Anboson Technology Co., Lt510(k) NO: K230542(Traditional)
ATTN: Xuanli Weng PHONE NO : 86 752 2607756
2F, No.7, Hechang East Fourth RoadSE DECISION MADE: 31-MAY-23
Huizhou CN 516001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JAWS Nitinol Staple System
Paragon 28 Inc 510(k) NO: K230550(Traditional)
ATTN: Haylie Hertz PHONE NO : 303 7200017
14445 Grasslands Drive SE DECISION MADE: 11-MAY-23
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eclipse Treatment Planning System (v18.0)
Varian Medical Systems, Inc. 510(k) NO: K230557(Traditional)
ATTN: Peter J. Coronado PHONE NO : 650 4245728
3100 Hansen Way SE DECISION MADE: 26-MAY-23
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Green Non Sterile Powder Free Nitrile Examination Gloves
Central Medicare Sdn Bhd 510(k) NO: K230564(Traditional)
ATTN: Ang Shiao Ping PHONE NO : 605 629 0039 203
PT 2609-2620, Batu 8, Jalan ChangkSE DECISION MADE: 23-MAY-23
Teluk Intan MY 36000 510(k) STATEMENT
DEVICE: RFP-100A Connector Cable (Single Use)
Baylis Medical Technologies Inc. 510(k) NO: K230571(Traditional)
ATTN: Gallone Stephanie PHONE NO : 905___ 9485800
2645 Matheson Blvd. East SE DECISION MADE: 30-MAY-23
Mississauga CA L4W 5S4 510(k) STATEMENT
DEVICE: Diode Laser System
Smedtrum Medical Technology Co., L510(k) NO: K230580(Traditional)
ATTN: Crimson Wu PHONE NO : 886 2 22989578 301
1F., No. 8, Ln. 97, Wugong Rd., SE DECISION MADE: 26-MAY-23
New Taipei City TW 248016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Victan
Jiangsu Haize Medical Scientific D510(k) NO: K230593(Traditional)
ATTN: Vincy Gao PHONE NO : 08 605 1082833301
No.99, Furongzhongsan Road, XishanSE DECISION MADE: 30-MAY-23
Wuxi CN 214000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Nitrile Examination Gloves Powder Free
Latrile Gloves Private Limited 510(k) NO: K230601(Abbreviated)
ATTN: M Ragu PHONE NO : 8754 672072
Plot No : B5 - Sipcot Induatrial CSE DECISION MADE: 28-MAY-23
Dindigul IN 624201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcQMap® High Resolution Imaging and Mapping System
Acutus Medical, Inc. 510(k) NO: K230606(Traditional)
ATTN: Subhadra Elango PHONE NO : 1 442 2326086
2210 Faraday Ave, Suite 100 SE DECISION MADE: 02-MAY-23
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cortium™
ulrich medical USA 510(k) NO: K230614(Traditional)
ATTN: Hans Stover PHONE NO : 636 5190268
18221 Edison Avenue SE DECISION MADE: 02-MAY-23
Chesterfield MO 63005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electric Scooter (Model: S3312)
Guangdong Prestige Technology Co.,510(k) NO: K230615(Traditional)
ATTN: Zhang Zhao PHONE NO : 86 137 63128800
No.8,Road. 1,3rd Ind. District, QiSE DECISION MADE: 05-MAY-23
Dongguan CN 523950 510(k) STATEMENT
DEVICE: Polyguard and Polyshield Safety IV Catheters
Poly Medicure Limited 510(k) NO: K230616(Traditional)
ATTN: Ramdas Sharma PHONE NO : 91 987 3380144
Plot No. 115-116, Sector-59, HSIIDSE DECISION MADE: 05-MAY-23
Faridabad IN 121004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hubly Electric Drill (H100)
Hubly Inc. 510(k) NO: K230619(Traditional)
ATTN: Casey Grage PHONE NO : 703 7986332
750 Warrenville Rd Suite 303 SE DECISION MADE: 04-MAY-23
Lisle IL 60532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kodiak™ Dual Port Coaxial Introducer Kit
Argon Medical Devices 510(k) NO: K230631(Traditional)
ATTN: Pratusha Kudumula PHONE NO : 309 7069488
1445 Flat Creek Road SE DECISION MADE: 22-MAY-23
Athens TX 75751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wattson temporary pacing guidewire (2250)
Vascular Solutions LLC 510(k) NO: K230637(Traditional)
ATTN: Vite Beka PHONE NO : 763 2292388
6464 Sycamore Court North SE DECISION MADE: 05-MAY-23
Maple Grove MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CP620G LCD monitor, CP620 LCD monitor
Nanjing Jusha Display Technology C510(k) NO: K230643(Traditional)
ATTN: Donny Lee PHONE NO : 86 025 83305050
8A, Block 1. No. 301, Hanzhongmen SE DECISION MADE: 01-MAY-23
Nanjing CN 210036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates
Smith & Nephew, Inc. 510(k) NO: K230653(Traditional)
ATTN: Tyler Kulcsar PHONE NO : 732 6783967
1450 East Brooks Rd. SE DECISION MADE: 04-MAY-23
Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw
Signature Orthopaedics Pty Ltd 510(k) NO: K230655(Traditional)
ATTN: Declan Brazil PHONE NO : 61 294 285181
7 Sirius Road SE DECISION MADE: 03-MAY-23
Lane Cove AU 2066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pitch PaSoft Tissue Reinforcement Device
Xiros Ltd 510(k) NO: K230671(Traditional)
ATTN: Steve Curran PHONE NO : 44 113 2387200
Springfield House Lane, WhitehouseSE DECISION MADE: 31-MAY-23
Leeds GB LS17 7UE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114
CC Wellness LLC 510(k) NO: K230674(Traditional)
ATTN: Marlent Perez PHONE NO : 661 2951700
29000 N. Hancock Pkwy. SE DECISION MADE: 08-MAY-23
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WellsForm Tricuspid Annuloplasty Band (WF)
Genesee Biomedical Inc 510(k) NO: K230679(Traditional)
ATTN: Woodrow Mathison PHONE NO : 303 7773000
700 W. Mississippi Ave Unit D-5 SE DECISION MADE: 26-MAY-23
Denver CO 80223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RadiForce MX217
EIZO Corporation 510(k) NO: K230684(Abbreviated)
ATTN: Hiroaki Hashimoto PHONE NO : 81 762 742468
153 Shimokashiwano SE DECISION MADE: 12-MAY-23
Hakusan JP 924-8566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)
GBS Commonwealth Co., Ltd. 510(k) NO: K230708(Traditional)
ATTN: Jimmy Kim PHONE NO : 82 269 254469
C-309, Woolim Lion's Valley, 168, SE DECISION MADE: 22-MAY-23
Geumcheon-gu KR 08507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATEC Lateral Plate System
Alphatec Spine, Inc. 510(k) NO: K230721(Traditional)
ATTN: Aditya Aiyer PHONE NO : 1 760 4946671
1950 Camino Vida Roble SE DECISION MADE: 09-MAY-23
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor
Nanjing Jusha Display Technology C510(k) NO: K230723(Traditional)
ATTN: Donny Lee PHONE NO : 86 25 83305050
8A, Block 1. Nanjing InternationalSE DECISION MADE: 18-MAY-23
Nanjing CN 210036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200
Shenzhen IONKA Medical Technology 510(k) NO: K230739(Traditional)
ATTN: Chen Dongfa PHONE NO : 86 755 23406031
Room 601, No. 3, Jiazitang Second SE DECISION MADE: 26-MAY-23
Shenzhen CN 518132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uMR 570
Shanghai United Imaging Healthcare510(k) NO: K230758(Traditional)
ATTN: Xin Gao PHONE NO :
NO.2258 Chengbei Road, Jiading DisSE DECISION MADE: 18-MAY-23
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PrevisEA Device
Entac Medical Inc. 510(k) NO: K230769(Traditional)
ATTN: Buddy Lyons PHONE NO : 901 2923420
680 Oalkleaf Office Lance, Suite 2SE DECISION MADE: 19-MAY-23
Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
Abbott Laboratories 510(k) NO: K230790(Traditional)
ATTN: Melissa Vaughan PHONE NO : 972 5186895
1915 Hurd Drive SE DECISION MADE: 19-MAY-23
Irving TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADAS 3D
Adas3D Medical S.L 510(k) NO: K230803(Special)
ATTN: Antoni Riu PHONE NO : 0034 93 3283964
Rambla Catalunya 53, 4H SE DECISION MADE: 23-MAY-23
Barcelona ES 08007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kodiak Lumbar Spacer System
Met One Technologies, LLC 510(k) NO: K230851(Traditional)
ATTN: Adrian Carbonell PHONE NO : 915 3733855
513 W. San Antonio Ave, Suite C SE DECISION MADE: 26-MAY-23
El Paso TX 79901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath
Suzhou Endophix Co., Ltd. 510(k) NO: K230874(Traditional)
ATTN: Juan Wu PHONE NO : 86 17521 559984
NO. 151, Fengli Road SE DECISION MADE: 23-MAY-23
Suzhou CN 215000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoreLink Navigation Instruments
CoreLink, LLC 510(k) NO: K230880(Special)
ATTN: Steven Mounts PHONE NO : 888 3497808
2072 Fenton Logistics Park SE DECISION MADE: 02-MAY-23
St. Louis MO 63026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
Cook Ireland Ltd. 510(k) NO: K230909(Traditional)
ATTN: Laura O'Reilly PHONE NO : 35 361 334440
O'Halloran Road National TechnologSE DECISION MADE: 30-MAY-23
Limerick IE V94 N8X2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Artix BG
Inari Medical 510(k) NO: K230912(Special)
ATTN: Ellen Nguyen PHONE NO : 949 4184127
6001 Oak Canyon Suite 100 SE DECISION MADE: 02-MAY-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ViewFlex™ Eco Reprocessed ICE Catheter
Abbott Medical 510(k) NO: K230934(Special)
ATTN: Quynh Phuong Le PHONE NO : 949 4699779
14901 Deveau Place SE DECISION MADE: 03-MAY-23
Minnetonka MN 55345 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIX Humerus System
Jeil Medical Corporation 510(k) NO: K230938(Special)
ATTN: Bora Kim PHONE NO : 82 2 8503533
702, 703, 704, 705, 706, 804, 805,SE DECISION MADE: 03-MAY-23
Seoul KR 08378 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BFlex™ 2 Slim 3.8 Single-Use Bronchoscope
Verathon Medical (Canada) ULC 510(k) NO: K230948(Special)
ATTN: Chauneen L Wood PHONE NO : 425 4094114
2227 Douglas Road SE DECISION MADE: 03-MAY-23
Burnaby CA V5C 5A9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TriSalus TriNav® LV Infusion System
TriSalus Life Sciences 510(k) NO: K230957(Third Party - Traditional)
ATTN: Michael Aymami PHONE NO : 303 2434969
6272 W. 91st Avenue SE DECISION MADE: 02-MAY-23
Westminster CO 80031 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: First Glove Blue Nitrile Examination Gloves Powder Free
First Glove Sdn. Bhd. 510(k) NO: K230958(Abbreviated)
ATTN: Dean Segal PHONE NO : 60 123 891644
Unit 23-2, Level 23, Binjai 8, No.SE DECISION MADE: 30-MAY-23
Kuala Lumpur MY 50450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DLP™ Silicone Coronary Artery Ostial Cannulae
Medtronic, Inc. 510(k) NO: K230960(Special)
ATTN: Stephen Beier PHONE NO : 763 5266751
7611 Northland Drive SE DECISION MADE: 04-MAY-23
Minneapolis MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ahmed® Glaucoma Valve Model FP7
New World Medical, Inc. 510(k) NO: K230975(Special)
ATTN: Victor Arellano PHONE NO : 909 4664303 1118
19763 Edison Court SE DECISION MADE: 12-MAY-23
Rancho Cucamonga CA 91730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIS System
Surgical Information Sciences, Inc510(k) NO: K230977(Special)
ATTN: Ann Quinlan-Smith PHONE NO : 612 3250187
5201 Eden Avenue, Suite 300 SE DECISION MADE: 02-MAY-23
Edina MN 55436 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rod Registration Frame
NuVasive, Incorporated 510(k) NO: K230989(Special)
ATTN: Leah Andre PHONE NO : 865 7249780
7475 Lusk Blvd SE DECISION MADE: 05-MAY-23
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alinity i STAT High Sensitivity Troponin-I
Abbott Laboratories Diagnostics Di510(k) NO: K230994(Special)
ATTN: Judi Wallach PHONE NO : 1 224 6671132
100 Abbott Park Rd. Dept. 09AA, BuSE DECISION MADE: 04-MAY-23
Abbott Park IL 60064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Panther Fusion AdV/hMPV/RV Assay
Hologic, Inc. 510(k) NO: K231017(Special)
ATTN: Jon Kukowski PHONE NO : 218 7911313
10210 Genetic Center Dr SE DECISION MADE: 05-MAY-23
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMP by Method Mobility, AMP Plus (or +) by Method Mobility
Method Mobility 510(k) NO: K231032(Third Party - Traditional)
ATTN: Paul Dickie PHONE NO : 559 5772896
2562 N. Fordham SE DECISION MADE: 10-MAY-23
Fresno CA 93727 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: Ahmed® Glaucoma Valve Model FP8
New World Medical, Inc. 510(k) NO: K231051(Special)
ATTN: Victor Arellano PHONE NO : 909 4664303 1118
19763 Edison Court SE DECISION MADE: 12-MAY-23
Rancho Cucamonga CA 91730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ExacTrac Dynamic 1.1.2
Brainlab AG 510(k) NO: K231052(Special)
ATTN: Sadwini Suresh PHONE NO : 49 899 915681259
Olof-Palme-Str.9 SE DECISION MADE: 11-MAY-23
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMAVAC® 100 Sustained Vacuum System
SOMAVAC Medical Solutions, Inc. 510(k) NO: K231063(Special)
ATTN: Phil Ryan PHONE NO : 901___ 2122198
3144 Stage Post Rd Unit 101 SE DECISION MADE: 12-MAY-23
Bartlett TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dexcom G7 Continuous Glucose Monitoring (CGM) System
Dexcom, Inc. 510(k) NO: K231081(Special)
ATTN: Bob Shen PHONE NO : 858 5294459
6340 Sequence Dr SE DECISION MADE: 15-MAY-23
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Symbia Pro.specta VA20A Family
Siemens Medical Solutions USA, Inc510(k) NO: K231102(Special)
ATTN: Tabitha Estes PHONE NO : 865 8044553
810 Innovation Drive SE DECISION MADE: 17-MAY-23
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex FiberTak Suture Anchor
Arthrex Inc. 510(k) NO: K231113(Special)
ATTN: Kristi Frisch PHONE NO : 239 5984302 73849
1370 Creekside Boulevard SE DECISION MADE: 18-MAY-23
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JuggerKnot Soft Anchor
Riverpoint Medical LLC 510(k) NO: K231128(Special)
ATTN: Rebecca DeFrancia PHONE NO : 503 5178001
825 NE 25th Ave. SE DECISION MADE: 17-MAY-23
Portland OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
Xenta Biomedical Science Co., Ltd.510(k) NO: K231137(Traditional)
ATTN: Huang Ling PHONE NO : 86 20 31707187
Building C5, 9th Floor, Rm 901, NoSE DECISION MADE: 19-MAY-23
Guangzhou CN 510535 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: aprevo® transforaminal lumbar interbody fusion device
Carlsmed, Inc. 510(k) NO: K231140(Special)
ATTN: Karen Liu PHONE NO : 760 7661926
1800 Aston Ave., Ste. 100 SE DECISION MADE: 19-MAY-23
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GI Genius System 100 and GI Genius System 200
Cosmo Artificial Intelligence - AI510(k) NO: K231143(Special)
ATTN: Nhan Ngo Dinh PHONE NO : 39 06 90287198__
Riverside II, Sir John Rogerson’s SE DECISION MADE: 19-MAY-23
Dublin IE D02 KV60 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROSA Hip System
Orthosoft, Inc (d/b/a Zimmer CAS) 510(k) NO: K231162(Special)
ATTN: Victorien Thiaux PHONE NO : 1 819 5800189
75 Queen St., Suite 3300 SE DECISION MADE: 23-MAY-23
Montreal CA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support
Imperative Care Inc. 510(k) NO: K231168(Special)
ATTN: Shivani Patel PHONE NO : 510 4688862
1359 Dell Avenue SE DECISION MADE: 22-MAY-23
Campbell CA 95008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
Plasmapp Co., Ltd. 510(k) NO: K231169(Special)
ATTN: Seung Hun Lee PHONE NO : 82 42 7162115
BVC-111, 125, Gwahak-ro, Yuseong-gSE DECISION MADE: 25-MAY-23
Daejeon KR 34141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stingray LP Catheter
Boston Scientific 510(k) NO: K231176(Special)
ATTN: Gabrielle Reynolds PHONE NO :
Two Scimed Place SE DECISION MADE: 25-MAY-23
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTERA™ hip system
Conformis Inc 510(k) NO: K231178(Special)
ATTN: Mary Kruitwagen PHONE NO : 781 3459038
600 Technology Park Dr Fourth FlooSE DECISION MADE: 23-MAY-23
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD Horizon™ Spinal System
Medtronic Sofamor Danek, USA Inc. 510(k) NO: K231184(Special)
ATTN: Justin O’Connor PHONE NO : 901 3963133
1800 Pyramid Place SE DECISION MADE: 26-MAY-23
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPIQ Series Diagnostic Ultrasound System
Philips Ultrasound LLC 510(k) NO: K231190(Third Party - Traditional)
ATTN: Courtney Nix PHONE NO : 1 570 9162958
22100 Bothell Everett Hwy SE DECISION MADE: 12-MAY-23
Bothell WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
Intuitive Surgical, Inc. 510(k) NO: K231224(Special)
ATTN: Michael Prutton PHONE NO : 408 3178653 ______
1266 Kifer Road SE DECISION MADE: 12-MAY-23
Suunyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S-COMP Reform® POCT Navigation Instruments
Precision Spine, Inc. 510(k) NO: K231229(Special)
ATTN: Michael Dawson PHONE NO : 601 4204244
2050 Executive Drive SE DECISION MADE: 25-MAY-23
Pearl MS 39208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS
Conformis, Inc. 510(k) NO: K231233(Special)
ATTN: Nivedita Namjoshi PHONE NO : 781 3745604
600 Technology Park Drive SE DECISION MADE: 26-MAY-23
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iRoot SP Plus
Innovative BioCeramix, Inc. 510(k) NO: K231259(Special)
ATTN: Quanzu Yang PHONE NO : 604 2216800
8218 North Fraser Way RM 101 SE DECISION MADE: 31-MAY-23
Burnaby CA V3N0E9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)
Osteonic Co., Ltd. 510(k) NO: K231326(Special)
ATTN: Da Kyung Ham PHONE NO : 82 2 69028456
1206Ho, 38, Digital-ro, 29-gil, GuSE DECISION MADE: 31-MAY-23
Seoul KR 08381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment
3M ESPE Dental Products 510(k) NO: K231338(Third Party - Traditional)
ATTN: Chandrapaul Parsram PHONE NO : 651 4673014
2510 Conway Avenue SE DECISION MADE: 10-MAY-23
Saint Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Combi Touch
Mectron S.p.A. 510(k) NO: K231391(Third Party - Traditional)
ATTN: Edoardo Tronchet PHONE NO : 39 0185 35361_____
Via Loreto 15/A SE DECISION MADE: 15-MAY-23
Carasco IT 16042 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)
3M Company, Unitek Orthodontic Pro510(k) NO: K231464(Third Party - Traditional)
ATTN: Brittany Randolph PHONE NO : 651 2423464 ______
2510 Conway Avenue SE DECISION MADE: 22-MAY-23
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 264
TOTAL WITH SUMMARIES 252
TOTAL WITH STATEMENTS 12
