| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K220780 |
03/31/2023 |
ROVO Mechanical Thrombectomy Device |
2MG, Inc |
Ted Karmon |
| K222456 |
03/12/2023 |
High Protection Surgical Gown |
3A Medical Products Co., Ltd |
Amy Ma |
| K222859 |
03/23/2023 |
3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG) |
3M |
Melanie Avila |
| K221585 |
03/23/2023 |
3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit |
3M Health Care Business Group |
Margaret Marsh |
| K230141 |
03/17/2023 |
LOQTEQ« VA Elbow Plates 2.7/3.5 System |
aap Implantate AG |
Agnieszka Mierzejewska |
| K222447 |
03/03/2023 |
FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System |
Abbott Diabetes Care Inc. |
Catherine Yang |
| K223602 |
03/02/2023 |
Traumatic brain injury (TBI) test |
Abbott Laboratories |
Lisa Kelly |
| K230283 |
03/01/2023 |
Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 4 |
Abbott Medical |
Chidalu Mozie |
| K222379 |
03/03/2023 |
Alinity m STI Assay |
Abbott Molecular Inc. |
Paul Matushek |
| K223666 |
03/17/2023 |
AblacathÖ Mapping Catheter |
Ablacon, Inc. |
Frank Rodriguez |
| K223352 |
03/02/2023 |
Tenderfoot |
Accriva Diagnostics, Inc. |
Wenni Haley |
| K222975 |
03/01/2023 |
Advantis Platform |
Advantis Medical Imaging Single Member P.C. |
Paris Ziogkas |
| K223878 |
03/17/2023 |
Aevumed RAPID Suture Anchors |
Aevumed, Inc. |
Saif Khalil |
| K223742 |
03/08/2023 |
Dental Ceramic Blocks |
Aidite (Qinhuangdao) Technology Co., Ltd |
Chen Yingying |
| K230115 |
03/17/2023 |
Denture Base Resin |
Aidite (Qinhuangdao) Technology Co., Ltd |
Chen Yingying |
| K222423 |
03/23/2023 |
Fixone All Suture Anchor |
AJU Pharm Co., Ltd. |
Gun Tak Lee |
| K230383 |
03/06/2023 |
Savvy Surgical Mask - Level 3 |
ALG Health LLC |
Doug Soper |
| K223073 |
03/17/2023 |
Alio |
Alio, Inc. |
Kimberly Snyder |
| K213906 |
03/08/2023 |
extriCARE 1000 Negative Pressure Wound Therapy System |
Alleva Medical Ltd |
Max Choi |
| K230308 |
03/01/2023 |
Alma Harmony |
Alma Lasers, Inc. |
Jessica Rivera Montejo |
| K223765 |
03/23/2023 |
ATEC Lateral Navigation Instruments |
Alphatec Spine, Inc. |
Sandy Gill |
| K223611 |
03/29/2023 |
Calibrate LTX Interbody System |
Alphatec Spine, Inc. |
Neha Mohindroo |
| K221883 |
03/07/2023 |
Solero Microwave Tissue Ablation (MTA) System and Accessories |
AngioDynamics, Inc. |
Kasey E Newcomb |
| K223581 |
03/27/2023 |
Solero Microwave Tissue Ablation (MTA) System and Accessories |
AngioDynamics, Inc. |
Kasey E Newcomb |
| K223323 |
03/24/2023 |
Blood Collection Needle (with/without Needle Holder) |
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. |
Bingyi Xiang |
| K223915 |
03/29/2023 |
Tactoset |
Anika Therapeutics. Inc. |
Wei Zhao |
| K222268 |
03/28/2023 |
Annalise Enterprise CXR Triage Trauma |
Annalise-AI Pty Ltd |
Minta Chen |
| K222179 |
03/28/2023 |
Annalise Enterprise CXR Triage Trauma |
Annalise-AI Pty Ltd |
Minta Chen |
| K221841 |
03/18/2023 |
EOlife« |
ARCHEON |
Valentine OQDA |
| K230590 |
03/30/2023 |
ARDO Bellis |
ARDO Medical AG |
Thomas Schlieper |
| K230303 |
03/02/2023 |
AccuFFRangio Plus |
ArteryFlow Technology Co., Ltd. |
Jianping Xiang |
| K230433 |
03/10/2023 |
Arthrex Knotless FiberTak Suture Anchor |
Arthrex Inc. |
Kelsey Roberts |
| K222007 |
03/08/2023 |
Arthrex Virtual Implant Positioning (VIP) System |
Arthrex Inc. |
Ivette Galmez |
| K230435 |
03/17/2023 |
Arthrex 3.9 mm SwiveLock Anchor |
Arthrex, Inc. |
Stacy Valdez |
| K223095 |
03/16/2023 |
Senhance Surgical System |
Asensus Surgical, Inc. |
Casey Hinckley |
| K220966 |
03/08/2023 |
SINEFIX |
BAAT Medical Products B.V. |
Jasper Springer |
| K230520 |
03/21/2023 |
Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) |
Barco NV |
Julie Vandecandelaere |
| K220613 |
03/08/2023 |
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia |
Bausch & Lomb Incorporated |
Barbara Klube-Falso |
| K230022 |
03/31/2023 |
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library |
Baxter Healthcare Corporation |
Meaghan Bonn |
| K223175 |
03/10/2023 |
lntravascular Administration Sets with Stopcock and Manifold |
Baxter Healthcare Corporation |
Meaghan Bonn |
| K230041 |
03/31/2023 |
Spectrum IQ Infusion System with Dose IQ Safety Software |
Baxter Healthcare Corporation |
Meaghan Bonn |
| K213898 |
03/01/2023 |
ProTrack Pigtail Wire |
Baylis Medical Company Inc. |
May Tsai |
| K222478 |
03/10/2023 |
BD Vacutainer« Luer-LokÖ Access Device, BD Vacutainer« Blood Transfer Device |
Becton Dickinson and Company |
Katherine Kenner Lemus |
| K222559 |
03/24/2023 |
BD BACTECÖ Myco/F Lytic Culture Vials |
Becton, Dickinson and Company |
Kamisha Gray |
| K220212 |
03/24/2023 |
BD Vacutainer« Push Button Blood Collection Set, BD Vacutainer« Push Button Blood Collection Set with Pre-Attached Holder |
Becton, Dickinson and Company |
Kelly Hilliger |
| K222591 |
03/24/2023 |
BD BACTECÖ Plus Aerobic/F Culture Vials |
Becton, Dickinson and Company |
Susan Kircher |
| K223653 |
03/06/2023 |
BD Vaginal Panel |
Becton, Dickinson and Company |
Joseph Basore |
| K220101 |
03/08/2023 |
Pulse Oximeter |
Beijing Choice Electronic Technology Co., Ltd. |
Haiying Zhao |
| K223365 |
03/27/2023 |
RODIN Palette Naturalizing Kit |
Belport Company, Inc., Gingi-Pak |
Jingtian Peng |
| K212423 |
03/29/2023 |
EndoDrill« Model X |
Bibbinstruments AB |
Marie Grey |
| K222280 |
03/01/2023 |
Bigfoot Unity« Diabetes Management System |
Bigfoot Biomedical, Inc. |
Kate Lee |
| K213362 |
03/22/2023 |
BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel |
BioFire Defense, LLC |
Cynthia Phillips |
| K230404 |
03/16/2023 |
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel |
BioFire Diagnostics, LLC |
Kevin Bourzac |
| K230142 |
03/22/2023 |
Epi-Stop Nasal Gel/epistaxis pack |
BioMed ENT, Inc. |
Antonius Voermans |
| K222430 |
03/09/2023 |
VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 ╡g/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 ╡g/mL), VITEK 2 AST-GN Fosfomycin |
bioMerieux SA, Inc. |
Craig Buehler |
| K214001 |
03/15/2023 |
Comprehensive« Shoulder System, Comprehensive« Reverse Shoulder System |
Biomet Manufacturing Corp. |
Aishwarya Pandey |
| DEN220030 |
03/29/2023 |
RemeOsÖ Screw LAG Solid |
Bioretec Ltd. |
Mari Ruotsalainen |
| K230253 |
03/02/2023 |
OPTRELLÖ Mapping Catheter with TRUErefÖ Technology |
Biosense Webster, Inc. |
John Jimenez |
| K221340 |
03/02/2023 |
iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) |
Boston Scientific Corporation |
Inderdeep Tiwana |
| K223824 |
03/22/2023 |
POLARSHEATHÖ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAPÖ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAPÖ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZEÖ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZEÖ Esophageal Temperature S |
Boston Scientific Corporation |
Derek Charchuk |
| K223279 |
03/14/2023 |
RT Elements (4.0) |
Brainlab AG |
Sadwini Suresh |
| K220068 |
03/31/2023 |
Butterfly iQ/iQ+ Ultrasound System |
Butterfly Network, Inc. |
Brian Sawin |
| K230356 |
03/31/2023 |
AspirexÖ Thrombectomy System |
C.R. Bard, Inc. |
Aaron Conovaloff |
| K221324 |
03/30/2023 |
ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) |
Camber Spine Technologies |
Noel Hetrick |
| K223837 |
03/22/2023 |
SPIRA«-C Integrated Fixation System |
Camber Spine Technologies |
Brooks McAdam |
| K223803 |
03/24/2023 |
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System |
Canary Medical USA LLC |
Kevin Leung |
| K223017 |
03/31/2023 |
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 |
Canon Medical Systems Corporation |
Paul Biggins |
| K223726 |
03/07/2023 |
Aquilion Precision (TSX-304A/4) V10.14 with AiCE |
Canon Medical Systems Corporation |
Paul Biggins |
| K222819 |
03/03/2023 |
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i |
Canon Medical Systems Corporation |
Paul Biggins |
| K222260 |
03/28/2023 |
Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 |
Capenergy Medical S.L. |
Pilar Sanchez |
| K223076 |
03/24/2023 |
BD TexiumÖ Closed Male Luer |
CareFusion |
Elgin Oktay |
| K230363 |
03/09/2023 |
CPS Locator 3D Delivery Catheter |
CenterPoint Systems LLC |
Marybeth Gamber |
| K221930 |
03/09/2023 |
CEREGLIDE 71 Intermediate Catheter |
Cerenovus, Inc. |
Ariell Joner |
| K221934 |
03/09/2023 |
CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set |
Cerenovus, Inc. |
Ariell Joner |
| K223086 |
03/22/2023 |
Ceribell Instant EEG Headcap |
Ceribell, Inc. |
Raymond Woo |
| K230174 |
03/20/2023 |
TENS and EMS Stimulation (OTC) |
Changsha Yuwen Medical Equipment Co., Ltd |
Chen Dahui |
| K230163 |
03/20/2023 |
TENS and EMS Stimulation (OTC) |
Changsha Yuwen Medical Equipment Co., Ltd |
Chen Dahui |
| K223776 |
03/03/2023 |
PEEK Spinal Infusion Cage |
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd |
Jing Huang |
| K223570 |
03/31/2023 |
SonoAir Series Digital Color Doppler Ultrasound System |
CHISON Medical Technologies Co., Ltd. |
Yingying Chen |
| K222709 |
03/21/2023 |
Retraction, CWM-910T, APOLEX Tite |
Chungwoo CO., LTD. |
Il Kwon Lee |
| K223916 |
03/29/2023 |
PUMA-G System |
CoapTech Inc. |
Jack Kent |
| K223672 |
03/21/2023 |
Instrument Case P1340904 |
Cochlear |
Denis DiMartino |
| K213247 |
03/14/2023 |
JETT PLASMA Medical II |
Compex, Spol. s.r.o |
Eva Hamplova |
| K221661 |
03/03/2023 |
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) |
Compression Works Inc |
John Croushorn |
| K223245 |
03/20/2023 |
Colibrφ |
Copan WASP Srl |
Giovanna Catalano |
| K223708 |
03/21/2023 |
Entasis 3D Dual-Lead Sacroiliac Implant System |
CoreLink, LLC |
Steven Mounts |
| K223828 |
03/16/2023 |
BENCOX Delta Option Heads |
Corentec Co., Ltd. |
Yoorim Bae |
| K230191 |
03/22/2023 |
AriseÖ UHP Dilatation Catheter |
Creagh Medical Ltd |
Peter Bather |
| K223342 |
03/30/2023 |
MotoBANDÖ CP Implant System: DynaBunionÖ 4D Minimal-incision Bunion System, DynaMETÖ Lesser TMT Fusion System |
CrossRoads Extremity Systems, LLC |
Kim Strohkirch |
| K230533 |
03/22/2023 |
MotiveÖ Electrode |
CyMedica Orthopedics, Inc. |
Kereshmeh Shahriari |
| K230382 |
03/24/2023 |
3 Series NeoLux |
Daavlin Distributing Co. |
Michele Thiel |
| K213867 |
03/28/2023 |
Carestation 750/750c |
Datex-Ohmeda, Inc. |
Kimberly Mangum |
| K223418 |
03/17/2023 |
DeGen Impulse AMÖ System |
DeGen Medical |
Craig Black |
| K222367 |
03/23/2023 |
SAVE GBR |
Dentis Co., Ltd. |
Gyu Ri Kim |
| K221402 |
03/22/2023 |
CEREC Tessera Abutment Block, CEREC Tessera Abutment System |
Dentsply Sirona Inc. |
Courtney Clark |
| K230295 |
03/10/2023 |
ATTUNE« Revision Cones |
DePuy Ireland UC |
Kathy Boggs |
| K220963 |
03/17/2023 |
Simplexa COVID-19 & Flu A/B Direct |
DiaSorin Molecular LLC |
Sharon Young |
| K221587 |
03/03/2023 |
DHX-70H, XTG-70H |
DIGIMED Co., Ltd. |
Youngbae Kwon |
| K223790 |
03/09/2023 |
Huvex Interspinous Fusion System |
Dio Medical Corp. |
Milan George |
| K222663 |
03/09/2023 |
MultiStage Balloon Dilatation Catheter |
Dongguan TT Medical, Inc. |
Yuying Bi |
| K222187 |
03/01/2023 |
Multistage Balloon Dilatation Catheter |
Dongguan TT Medical, Inc. |
Yuying Bi |
| K223753 |
03/14/2023 |
Cervical Plate System |
Double Medical Technology Inc. |
Yan Zuo |
| K230054 |
03/21/2023 |
DSM Biomedical Calcium Phosphate Cement |
DSM Biomedical |
Diana Osgood |
| K223902 |
03/02/2023 |
FibroScan« device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) |
Echosens |
Fanny Patoureaux |
| K222813 |
03/16/2023 |
Nitrile Examination Gloves |
Ecoglove Medical Manufacturing Company Limited |
Nguyen Anh Tu |
| K223823 |
03/27/2023 |
Disposable Surgical Face Mask |
Efofex, Inc. |
Siddhant Doshi |
| K213744 |
03/10/2023 |
Avoset Infusion Pump System |
Eitan Medical Ltd. |
Guy Mlechkovich |
| K230441 |
03/17/2023 |
EMPOWR Stem Extender, 50mm |
Encore Medical, L.P DBA Enovis |
Thorsen Trey |
| K222880 |
03/03/2023 |
Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) |
Endolumik Inc. |
Mara McFadden |
| K222619 |
03/16/2023 |
Ensmile |
Ensmile Pvt Ltd |
Mirza Gohar Rehman |
| K223760 |
03/15/2023 |
ECHELON LINEARÖ 60 mm Cutter (GLC60);ECHELON LINEARÖ 80mm Cutter (GLC80);ECHELON LINEARÖ 100 mm Cutter (GLC100);ECHELON LINEARÖ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEARÖ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEARÖ Cutters 80mm Blue Reloa |
Ethicon Endo-Surgery |
Alicia Butler |
| K220725 |
03/20/2023 |
HPR45i |
F Care Systems USA LLC |
Patrick Danciu |
| K221053 |
03/01/2023 |
Magnes-C Anterior Cervical Plate System |
Fellowship of Orthopaedic Researchers, Inc. |
Stephen D. Cook |
| K221965 |
03/17/2023 |
FemDx FalloView |
FemDx Medsystems, Inc. |
PeiJie Cao |
| K223432 |
03/09/2023 |
Vassallo GT 018 Hybrid |
Filmecc CO., LTD |
Toshiya Osawa |
| K213272 |
03/31/2023 |
Formus Hip |
Formus Labs, Ltd |
Richie Christian |
| K222096 |
03/23/2023 |
Endo Ultrasonic Activator |
Foshan COXO Medical Instrument Co.,Ltd. |
Yongjian Zheng |
| K223350 |
03/13/2023 |
Remi Robotic Navigation System |
Fusion Robotics, LLC |
Sarah Braun |
| K223441 |
03/23/2023 |
SpaceFlex Acetabular Cup |
G21, S.r.l. |
Filippo Foroni |
| K221680 |
03/01/2023 |
Xeleris V Processing and Review System |
GE Healthcare |
George Mashour |
| K230145 |
03/14/2023 |
ONE-CUF |
GE Medical Systems Information Technologies, Inc. |
Jennifer Strauther |
| K223490 |
03/21/2023 |
FlightPlan for Embolization |
GE Medical Systems SCS |
Ning Wen |
| K223514 |
03/09/2023 |
Spectral Bone Marrow |
GE Medical Systems, LLC |
Katelyn Rowley |
| K220026 |
03/21/2023 |
Genomadix Cube CYP2C19 System |
Genomadix Inc. |
Amanda Dwyer |
| K222176 |
03/02/2023 |
BoneView |
Gleamer |
Antoine Tournier |
| K221623 |
03/10/2023 |
FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm |
GME German Medical Engineering GmbH |
Dietmar Fischer |
| K221924 |
03/15/2023 |
Digital Routines |
GNC Holdings, LLC |
YongKai Wong |
| K230206 |
03/24/2023 |
Entarik Feeding Tube System; Entarik Feeding Tube |
Gravitas Medical, Inc. |
Saheel Sutaria |
| K222101 |
03/17/2023 |
Prism |
GrayMatters Health Ltd. |
Adar Shani |
| K230046 |
03/25/2023 |
Vinyl examination gloves |
Guangdong Kingfa Sci.& Tech.Co., Ltd. |
Xiaoge Yu |
| K221158 |
03/06/2023 |
Single-Use Video Flexible Ureterorenoscope System |
Guangzhou Red Pine Medical Instrument Co., Ltd. |
Lifang Zhang |
| K223930 |
03/06/2023 |
A1417MCW/A1717MCW/F1417MCW |
H&abyz Co., Ltd. |
Jimin Han |
| K221713 |
03/03/2023 |
Polypectomy Snare |
Hangzhou AGS MedTech Co., Ltd. |
Jiayuan Zhang |
| K222718 |
03/10/2023 |
Vial Adapter |
Hangzhou Qiantang Longyue Biotechnology Co., LTD |
Zhengxu Xiang |
| K220549 |
03/07/2023 |
MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 |
Hans Biomed Corporation |
Lucy Choi |
| K222672 |
03/06/2023 |
Disposable Insulin Syringe |
Hantech Medical Device Co., Ltd. |
Rachel Jin |
| DEN210039 |
03/30/2023 |
SNOO Smart Sleeper |
Happiest Baby, Inc. |
Harvey Karp |
| K223162 |
03/17/2023 |
Healgen« Accurate Oral Fluid Drug Test, Healgen« Accurate Oral Fluid Drug Test COT |
Healgen Scientific LLC |
Jianqiu Fang |
| K223889 |
03/22/2023 |
Stativ« Knotted UHMWPE Suture Anchor |
Healthium Medtech Limited |
Pankaj Dawar |
| K212906 |
03/14/2023 |
HeartBuds Electronic Stethoscope |
Heartbuds LLC |
Seth Ellis |
| K223137 |
03/14/2023 |
Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application |
hearX SA (Pty) Ltd. |
Seline Van Der Wat |
| K223895 |
03/23/2023 |
Disposable Medical Nitrile Examination Gloves |
Hebei Titans Hongsen Medical Technology Co., Ltd. |
Xiaojing Shao |
| K221919 |
03/09/2023 |
DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets |
Hemodia SAS |
Anne-Lyse Miard |
| K230461 |
03/24/2023 |
Quantra Hemostasis Analyzer |
HemoSonics, LLC |
Debbie Winegar |
| K221805 |
03/23/2023 |
AccurSound Electronic Stethoscope AS-101 |
Heroic Faith International Ltd. |
Yuan-Ren Cheng |
| K223049 |
03/22/2023 |
CardioSTAT« ECG Test Solution |
Icentia Inc. |
DaniΦle Grondines |
| K222485 |
03/29/2023 |
SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser |
IDS, Limited |
K.Y. Ahn |
| K213660 |
03/31/2023 |
RadAlly |
Imaging Wave, LLC |
Edward Kantor |
| K222573 |
03/03/2023 |
imani i2Plus Breast Pump |
imani Co. |
Hyo-Soon Hwang |
| K222838 |
03/16/2023 |
iSyncBrain⌐-C |
iMediSync Inc. |
Young-Geun Kim |
| K230026 |
03/28/2023 |
SQUALE |
Implanet, S.A. |
RΘgis Le Couδdic |
| K212394 |
03/23/2023 |
Implant-One Multi-Unit Abutment |
Implant Logistics, Inc. |
Thomas Arendt |
| K223436 |
03/02/2023 |
Artix AX |
Inari Medical |
Ellen Nguyen |
| K223419 |
03/23/2023 |
Triever16 Curve |
Inari Medical |
Ellen Nguyen |
| K223613 |
03/17/2023 |
InThrill Thrombectomy System |
Inari Medical, Inc |
Ellen Nguyen |
| K230331 |
03/07/2023 |
Protrieve Sheath |
Inari Medical, Inc. |
Kaitlyn Weinkauf |
| K223609 |
03/14/2023 |
RevCoreÖ Thrombectomy Catheter. |
Inari Medical, Inc. |
Suzanne Moreno |
| K221084 |
03/03/2023 |
Dyna Locking Trochanteric NailÖ |
Innosys |
Yu-jin Kang |
| K222954 |
03/13/2023 |
Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens |
Innova Vision Inc. |
Kari Huang |
| K223043 |
03/20/2023 |
The Integrity Spine Core System |
Integrity Spine |
Timothy Leak |
| K222839 |
03/16/2023 |
EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System |
Intuitive Surgical Inc |
Amrit Jaggi |
| K222884 |
03/02/2023 |
Rapid NCCT Stroke |
iSchemaView, Inc. |
James Rosa |
| K222146 |
03/28/2023 |
Disposable Endoscopic Hemoclip |
Jiangsu Vedkang Medical Science and Technology Co., Ltd. |
Lin Feng |
| K221893 |
03/17/2023 |
KARL STORZ Bipolar Resectoscopes with HF Cable |
KARL STORZ Endoscopy America, Inc |
Leigh Spotten |
| K223923 |
03/30/2023 |
HOPKINS Telescopes |
KARL STORZ Endoscopy-America, Inc |
Alita McElroy |
| K222151 |
03/23/2023 |
Sterilization Wrap |
Kenpax International Limited |
Jerome Ren |
| K221938 |
03/28/2023 |
KLS Martin Pure Pectus System |
KLS Martin L.P. |
Melissa Bachorski |
| K222397 |
03/29/2023 |
KLS Martin Level One Rib Fixation System |
KLS-Martin L.P. |
Melissa Bachorski |
| K223375 |
03/15/2023 |
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. |
Kossan International Sdn Bhd3 |
Cho Sow Fong |
| K223423 |
03/01/2023 |
32HQ713D |
LG Electronics Inc. |
Jinhwan Jun |
| K223642 |
03/09/2023 |
LED Lip Perfector, model: ZC-05 |
Light Tree Ventures Europe B.V. |
Alain Dijkstra |
| K230124 |
03/15/2023 |
LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) |
Light Tree Ventures Europe B.V. |
Alain Dijkstra |
| K221758 |
03/17/2023 |
SMR Stemless Anatomic |
LimaCorporate S.p.A |
Roberto Gabetta |
| K221373 |
03/09/2023 |
Essenz HLM |
LivaNova Deutschland GmbH |
Julia E. Leslie |
| K223102 |
03/15/2023 |
Tegamen Nitrile Examination Gloves |
M/S Tegamen Safety Products Private Limited |
Manmohan Gulati |
| K200452 |
03/27/2023 |
Meril-Bonewax |
M/s. Meril Endo Surgery Private Limited |
Umesh Sharma |
| K223154 |
03/16/2023 |
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ |
Magstim Company Ltd. |
Tom Campbell |
| K230002 |
03/24/2023 |
Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs |
Mah Sing Healthcare Sdn Bhd |
Ivan Tan Chee Wei |
| K222098 |
03/08/2023 |
ManaSport+ |
ManaMed, Inc. |
Trevor Theriot |
| K221706 |
03/09/2023 |
AccuContour |
Manteia Technologies Co., Ltd. |
Dandan Chen |
| DEN200011 |
03/31/2023 |
Masimo SafetyNet |
Masimo Corporation |
Linus Park |
| K212161 |
03/06/2023 |
Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories |
Masimo Corporation |
Katelynn Kirby |
| K230315 |
03/06/2023 |
Materialise Shoulder SystemÖ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner |
Materialise NV |
Giulia Girola |
| K223853 |
03/30/2023 |
Medartis APTUS« Ulna Plates |
Medartis AG |
Claudia De Santis |
| K223024 |
03/07/2023 |
MedCAD AccuPlan System |
MedCAD |
Brian Buss |
| K222112 |
03/30/2023 |
Comfort Marker 2.0 |
Medical Precision BV |
Blerta Kukaj |
| K222036 |
03/22/2023 |
MPXA-2000 |
Medipixel, Inc. |
Hye-ri Choi |
| K221984 |
03/29/2023 |
InterView XP; InterView FUSION |
Mediso Medical Imaging Systems, LTtd. |
Daniel Cser |
| K223040 |
03/01/2023 |
Endo SmartCap |
Medivators Inc |
Disha Kabrawala |
| K223236 |
03/24/2023 |
Medline Surgical Face Mask and Medline Procedural Face Mask |
Medline Industries, LP |
Kelsey Closen |
| K223688 |
03/08/2023 |
CONDUITÖ Lateral Lumbar Intervertebral Fusion Cage, CONDUITÖ Instruments |
Medos International S└RL |
Delano Martins |
| K223488 |
03/23/2023 |
ClosureFastÖ Endovenous Radiofrequency Ablation Catheter |
Medtronic, Inc. |
Aditi Dave |
| K230301 |
03/07/2023 |
Athena III Cervical Plate System |
Medyssey USA, Inc. |
Youngsu Jang |
| K222332 |
03/23/2023 |
MeMed BV |
MeMed Diagnostics Ltd. |
Efrat Hartog-David |
| K221782 |
03/17/2023 |
Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes |
Merit Medical Pte. Ltd. |
Pauline Liow |
| K230636 |
03/30/2023 |
Maestro Microcatheter |
Merit Medical System, Inc. |
Garry Courtney |
| K212696 |
03/03/2023 |
Aspira Pleural Drainage System |
Merit Medical Systems, Inc. |
Jennifer Webb |
| K230009 |
03/03/2023 |
EZ Bond Universal |
Meta Biomed Co., LTD. |
Suk Song Oh |
| K223084 |
03/16/2023 |
MilkMate Breast Pump |
MilkMate Products, Inc. |
Patrice Meagher |
| K222983 |
03/15/2023 |
NeuroBlate Fusion-S Software V3.17 |
Monteris Medical, |
David H Mueller |
| K230256 |
03/03/2023 |
Rebellion, Phantom Multi-Bite Kerrison Rongeur |
Morpheus AG |
Dimitri Krutsch |
| K222875 |
03/09/2023 |
Powered Muscle Stimulator (Model name:MagGraver F200) |
Nanjing Vishee Medical Technology Co., Ltd. |
Kai QIU |
| K223628 |
03/02/2023 |
NEBA« Compact EEG2R Mobile Headset |
Neba Health, LLC |
Howard Merry |
| DEN210033 |
03/06/2023 |
Lenire Tinnitus Treatment Device |
Neuromod Devices Limited |
Fran Coogan |
| K221772 |
03/17/2023 |
NeuroRPM |
New Touch Digital Inc. |
Chan Lee |
| K221320 |
03/30/2023 |
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX |
Nidek Co., LTD. |
Tsutomu Sunada |
| K223144 |
03/01/2023 |
Galaxy System |
Noah Medical Corp. |
Sam Mostafavi |
| K221921 |
03/28/2023 |
DTX Studio Clinic 3.0 |
Nobel Biocare AB |
Wim Vrydag |
| K221872 |
03/30/2023 |
ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System |
Nova Eye Inc. (Business name Nova Eye Medical) |
Don Watton |
| K220234 |
03/15/2023 |
Precice Intramedullary Limb Lengthening System |
NuVasive Specialized Orthopedics, Inc. |
Madison Heffron |
| K223321 |
03/13/2023 |
Omnia Medical Coupler-C Anterior Cervical Plate |
Omnia Medical, LLC |
Troy Schifano |
| K222105 |
03/23/2023 |
RESPONSE 5.5/6.0 Cannulated Screw System |
OrthoPediatrics Corp. |
Jennifer Gregory |
| K230243 |
03/29/2023 |
ROSA« Knee System |
Orthosoft d/b/a Zimmer CAS |
Aura Helena Corredor |
| K222746 |
03/27/2023 |
Overjet Caries Assist |
Overjet, Inc. |
Adam Odeh |
| K221292 |
03/10/2023 |
Uni Knee Resurfacing System |
Overture Resurfacing Inc. |
Riley Williams |
| K221996 |
03/20/2023 |
P-Cure Proton Beam Therapy System |
P-Cure Ltd. |
Ori Lubin |
| K221209 |
03/08/2023 |
PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops |
PADM Medical Inc. |
Xiomara Perdomo |
| K230474 |
03/24/2023 |
EVA5 Insufflator |
Palliare Ltd. |
John O'Dea |
| K223589 |
03/03/2023 |
Grappler Suture Anchor R3FLEX IOL System |
Paragon 28, Inc. |
Haylie Hertz |
| K223452 |
03/05/2023 |
Nitronox Scavenger Plus |
Parker Hannifin Corporation |
Dylan Alu |
| K222355 |
03/08/2023 |
PathKeeper System |
PathKeeper Surgical LTD |
Erez Lampert |
| K230294 |
03/03/2023 |
CoverScan (CoverScan v1.1) |
Perspectum |
Ioan Wigley |
| K223440 |
03/02/2023 |
Plasma Pen (Plasma MD); Plasma Pen (Plasma +) |
Plasma Concepts |
Brendan Aarons |
| K223625 |
03/28/2023 |
CapnoSpotÖ Pneumothorax Decompression Indicator |
Pneumeric, Inc. |
Johnathon M.E. Aho |
| K220088 |
03/30/2023 |
Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Professional Latex Sdn Bhd |
Kok Yoon Lim |
| K223453 |
03/02/2023 |
Insulin Syringe |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K230076 |
03/08/2023 |
Enhanced AURORAÖ Medical Diode System, and related accessories |
Psoria-Shield, Inc. |
John Yorke |
| K230312 |
03/31/2023 |
Iris AirShuttleÖ |
Qfix |
McKenzie Banasik |
| K220673 |
03/16/2023 |
Sterile Silver Alginate Wound Dressing |
Qingdao Bright Moon Biomedical Materials Co., Ltd. |
Deng Yunlong |
| K222394 |
03/03/2023 |
Electronic Sphygmomanometers |
Qingdao Yasee Medical Device Co., Ltd. |
Shaoju Tian |
| K230236 |
03/03/2023 |
Lyra Influenza A+B Assay |
Quidel Corporation |
Selena Liu |
| K230349 |
03/10/2023 |
Lyra RSV+hMPV Assay |
Quidel Corporation |
Selena Liu |
| DEN220039 |
03/08/2023 |
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set |
Quidel Corporation |
Xiaoxi Wang |
| K220226 |
03/28/2023 |
X-Y Lubricating Jelly |
R&R Medical Corporation Ltd |
Wilson Chang |
| K222312 |
03/29/2023 |
RayStation 12A |
RaySearch Laboratories AB (publ) |
David Hedfors |
| K213892 |
03/07/2023 |
Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine |
RB Health (US) LLC |
Joseph Macfarlane |
| K221652 |
03/03/2023 |
NIKKICART |
Renal Care Dialysis Solutions, S.A. DE C.V. |
Jose Enrique Aguirre Valades |
| K223681 |
03/08/2023 |
Respiree Cardio-Respiratory Monitor |
Respiree PTE Ltd. |
Gurpreet Singh |
| K223326 |
03/30/2023 |
Axiom PSR System |
Restor3d |
Brianna Prindle |
| K221696 |
03/02/2023 |
ReWalk P6.0 |
ReWalk Robotics Ltd. |
Miri Pariente |
| K220122 |
03/15/2023 |
APEX 6 |
RF Innovations, Inc |
William Rittman |
| K230194 |
03/22/2023 |
HF Surgery Generator 400KHZ |
Richard Wolf Medical Instruments Corporation |
Mike McAndrew |
| K223377 |
03/30/2023 |
BIASURGE Advanced Surgical Solution |
Rochal Technologies LLC |
William Coulston |
| K230161 |
03/30/2023 |
ONLINE TDM Phenytoin - Free Phenytoin application |
Roche Diagnostics |
Dr. Leslie Patterson |
| K222445 |
03/06/2023 |
LC ChromeFlow |
S&C Polymer Silicon- und Composite Spezialitaten GmbH |
Christian Boettcher |
| K220398 |
03/10/2023 |
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire |
Scientia Vascular, LLC |
Thomas Lippert |
| K212207 |
03/23/2023 |
Sterile Hypodermic Syringe for Single Use |
Shandong Weigao Group Medical Polymer Co., Ltd. |
Lina Liu |
| K223393 |
03/16/2023 |
Electric Wheelchair |
Shanghai BangBang Robotics Co., Ltd. |
Canfeng Liu |
| K223778 |
03/31/2023 |
Diode Laser Hair Removal System (RD-SLD600) |
Shanghai Omni Laser Skinology Co., Ltd. |
Avril Ouyang |
| K223325 |
03/10/2023 |
uMI Panorama |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin GAO |
| K230238 |
03/31/2023 |
BIOEASYÖ U-Catch MAX Multi-Drug Test Cup, BIOEASYÖ U-Catch MAX Multi-Drug Test Cup Rx |
Shenzhen Bioeasy Biotechnology Co.,Ltd. |
Yoyo Lin |
| K223928 |
03/28/2023 |
Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K |
Shenzhen Fansizhe Science And Technology Co., Ltd |
Endang Cheng |
| K230060 |
03/03/2023 |
Light Based Hair Removal Device GP592 |
Shenzhen GSD Tech Co., Ltd. |
Huifang Yao |
| K223882 |
03/27/2023 |
Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) |
Shenzhen Honpal Optoelectronic Technology Co., Ltd. |
Wang Tianming |
| K223693 |
03/09/2023 |
Electric breast pump (model: M5) |
Shenzhen Lutejiacheng Technology Co., Ltd. |
Athena Pan |
| K223203 |
03/02/2023 |
1.5T 24E Posterior Array |
Shenzhen RF Tech Co., Ltd. |
Gary Wang |
| K223192 |
03/27/2023 |
XT Stain/Glaze |
Shenzhen Xiangtong Co.,Ltd. |
Xue Gong |
| K221589 |
03/24/2023 |
Starly pad |
Shenzhen Xingyuanli Technology Co., Ltd. |
Tse Adrian |
| K230021 |
03/31/2023 |
IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32 |
Shenzhen Yangyi Technology ., Ltd |
Wang Jie |
| K222417 |
03/20/2023 |
Shina Safety Needle |
Shina Corporation |
Seunggi Jeon |
| K222104 |
03/20/2023 |
Atellica« CH Diazo Total Bilirubin (D_TBil) |
Siemens Healthcare Diagnostics Inc. |
Anthony Calabro |
| K221119 |
03/17/2023 |
RCRP Flex reagent cartridge |
Siemens Healthcare Diagnostics Inc. |
Ian Thompson |
| K230561 |
03/21/2023 |
Syngo Carbon Space VA30A |
Siemens Healthcare GmBH |
Vijay Ramadas |
| K223343 |
03/28/2023 |
MAGNETOM Amira; MAGNETOM Sempra |
Siemens Medical Solutions USA Inc. |
Alina Goodman |
| K221808 |
03/18/2023 |
InterOss Collagen |
SigmaGraft Inc. |
Elcin Chang |
| K223875 |
03/20/2023 |
MOBINEURO Alita Intraoperative MRI System |
Sino Canada Health Engineering Research Institute (Hefei) |
Gong Zhang |
| K221697 |
03/03/2023 |
INJECTION PIN (KIP(02031-02061) (03031-03061)) |
SLK Ortho Llc |
Lawrence Kluge |
| K230555 |
03/30/2023 |
Cemented Tibia Baseplate no Taper with JRNY Lock |
Smith & Nephew, Inc. |
Madison Padgett |
| K230093 |
03/02/2023 |
Disposable 4 Layers Surgical Face Mask |
Social Medical Supply LLC |
Shahzil Amin |
| K230019 |
03/14/2023 |
SofWave System |
Sofwave Medical Ltd. |
Ruthie Amir |
| K222457 |
03/06/2023 |
Provata Implant System |
Southern Implants (pty) Ltd |
Leith C Cumming |
| K222871 |
03/29/2023 |
Stethophone v1 |
Sparrow Acoustics Inc. |
Nadezda Ivanova |
| K230482 |
03/23/2023 |
SwedgeÖ Pedicle Screw Fixation System |
Spinal Resources, Inc. |
Bernie Bedor |
| K230583 |
03/22/2023 |
Tryptik Ti |
Spineart SA |
Franck Pennesi |
| K230797 |
03/24/2023 |
SmartMTA Capsule |
Sprig Oral Health Technologies, Inc. |
Ricky Quintana |
| K222617 |
03/21/2023 |
EasyTouch Lancing Device |
STAT Medical Devices |
Hemel Mariano |
| K230582 |
03/28/2023 |
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 |
STERIS Corporation |
Jennifer Nalepka |
| K230605 |
03/31/2023 |
1788 4K Camera System with Advanced Imaging Modality |
Stryker |
April Malmborg |
| K223305 |
03/29/2023 |
Trevo NXT ProVue Retriever |
Stryker Neurovascular |
Heli Chambi |
| K230255 |
03/28/2023 |
Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 |
Stryker Sustainability Solutions |
Scott English |
| K230251 |
03/28/2023 |
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) |
Stryker Sustainability Solutions |
Scott English |
| K221995 |
03/28/2023 |
Gas Insufflator |
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. |
Guofang Ma |
| K222620 |
03/23/2023 |
Sterilized Latex Surgical Gloves |
Suzhou Colour-way New Material Co., Ltd. |
Yongping Xu |
| K222136 |
03/08/2023 |
Cryo-Thermo Compression Device (FGK002) |
Suzhou MicroPort RehabTech (Group) Co., Ltd. |
Liang Hong |
| K220014 |
03/01/2023 |
RSHOCK |
SWIMS America Corp |
Matthieu Commeau |
| K222174 |
03/28/2023 |
RadioLens v1.0 |
Synapsica |
Meenakshi Singh |
| K223422 |
03/30/2023 |
Emory Cardiac Toolbox 4.3 |
Syntermed |
Kenneth Van Train |
| K223593 |
03/22/2023 |
Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar |
Taiwan Surgical Corporation |
Ken Chen |
| K214070 |
03/21/2023 |
OviTex PRS (Long Term Resorbable) |
TELA Bio |
John Urtz |
| K221129 |
03/10/2023 |
CloudTMS for OCD |
TeleEMG, LLC |
Joe F Jabre |
| K221301 |
03/09/2023 |
DESS Dental Smart Solutions |
Terrats Medical SL |
Roger Terrats |
| K223844 |
03/21/2023 |
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae) |
Thermo Fisher Scientific |
Cynthia Knapp |
| K221198 |
03/10/2023 |
Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| K220464 |
03/22/2023 |
Tigon Medical Gryphon Anchor Line |
Tigon Medical |
Jeremy Clark |
| K222897 |
03/07/2023 |
Enlight 2100 |
Timpel S.A. |
Rafael Holtzhacker |
| K221544 |
03/17/2023 |
MagVenture TMS Atlas Neuro Navigation System |
Tonica Elektronik A/S |
Jan Kjoller |
| K230003 |
03/31/2023 |
Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank |
Topzir Biotech Co., Ltd |
Hui Liu |
| K211059 |
03/31/2023 |
CereFlow V1.2 |
Translational MRI, LLC |
Zhihai Ricky Xiang |
| K222465 |
03/07/2023 |
Tyber Medical Anatomical Plating System |
Tyber Medical, LLC |
Lisa Boyle |
| K212121 |
03/23/2023 |
VHT-200 Wound Treatment System |
Vaporox, Inc. |
Alan Sage |
| K222775 |
03/13/2023 |
Aarhus Applicator Set |
Varian Medical Systems, Inc |
Peter J. Coronado |
| K230271 |
03/28/2023 |
ISOLIS Cryoprobe |
Varian Medical Systems, Inc. |
Peter J Coronado |
| K213815 |
03/29/2023 |
SiJoin«T3 |
VGI Medical, Inc. |
Tov Vestgaarden |
| K220407 |
03/07/2023 |
Visby Medical Sexual Health Test |
Visby Medical |
Beth Lingenfelter |
| K223443 |
03/17/2023 |
Viz AAA |
Viz. ai, Inc. |
Pooja Shah |
| K230471 |
03/21/2023 |
LinkSymphoKnee û Fixed Bearing Ultracongruent (FB UC) Articulating Surface |
Waldemar Link GmbH & Co. KG |
Pia Muller |
| K222603 |
03/02/2023 |
6F Wallaby Long Sheath |
Wallaby Medical Inc |
Nathaniel Knock |
| K223381 |
03/15/2023 |
iExaminer System with Panoptic Plus |
Welch Allyn, Inc. |
Jeffrey E. Thompson |
| K221816 |
03/09/2023 |
Wesper Lab |
Wesper Inc. |
Amir Reuveny |
| K222828 |
03/20/2023 |
Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A |
WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. |
Mac Lai |
| K223232 |
03/06/2023 |
Procedure mask/Surgical mask/Face mask |
Winner Medical Co., Ltd. |
Mingni Liu |
| K230527 |
03/29/2023 |
WishBone Medical Plate and Screw System |
WishBone Medical, Inc. |
Kayla Johnston |
| K222729 |
03/28/2023 |
Electrical Scooter, WT-T4QP2 |
WuÆs Tech Co., Ltd. |
Dr.Jen Ke-Min |
| K221352 |
03/13/2023 |
Surgical Face Mask |
Wuhan Huashida Protective Products Co., Ltd. |
Chen Mei |
| K230274 |
03/31/2023 |
Medical Diode Laser (M2) |
Wuhan Pioon Technology Co.,Ltd. |
Feng Zhang |
| K221621 |
03/06/2023 |
Pro-X1Ö Trochanteric Nailing System |
X-Bolt Orthopedics |
Brian Thornes |
| K222991 |
03/15/2023 |
Air Compression Leg Massager (model: EMK-701) |
Xiamen Emoka Health Science & Technology Co., Ltd. |
Iris Fung |
| K223401 |
03/07/2023 |
Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) |
Xiamen Probtain Medical Techology Co., Ltd |
Jianli Kang |
| K220644 |
03/25/2023 |
Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy« Nitrile Examination Glove, Tested for use with Chemotherapy Drugs |
YTY Industry (Manjung) Sdn Bhd |
Punitha Samy |
| K223464 |
03/14/2023 |
Leg and Foot Air Wave Pressure Therapy Device |
Zhangzhou Easepal Innovation Co Ltd. |
Xu Zibing |
| K230321 |
03/08/2023 |
PersonaÖ Personalized Knee System |
Zimmer, Inc. |
Gregory Foster |
| K221700 |
03/09/2023 |
AutoPulse NXT Resuscitation System |
ZOLL Circulation, Inc. |
Brian Robey |
