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  1. 510(k) Clearances

May 2023 510(K) Clearances

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
                                      
 
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