| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K214093 |
12/28/2021 |
VSP Bolus |
3D Systems |
Benjamin Johnson |
| K210347 |
02/08/2021 |
VSP System |
3D Systems |
Scott Brewer |
| K213779 |
12/03/2021 |
Customize |
3D-Side SA |
Laurent Paul |
| K213809 |
12/06/2021 |
3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader |
3M Company |
Hilary Hovde |
| K210277 |
02/01/2021 |
3M Attest Rapid Readout Biological Indicator, 1295 |
3M Company |
Mary Fretland |
| K210457 |
02/16/2021 |
7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key |
7D Surgical Inc. |
Daniel Zisind |
| K210555 |
02/25/2021 |
7D Surgical System - Drill Guide |
7D Surgical Inc. |
Daniel Zisind |
| K213932 |
12/16/2021 |
A-dec 300, A-dec 500 |
A-dec, Inc. |
Raquel Peregrino de Brito |
| K210392 |
02/10/2021 |
WorkMate Claris System |
Abbott |
Ed Sandberg |
| K213996 |
12/20/2021 |
FreeStyle Libre 3 Continuous Glucose Monitoring System |
Abbott Diabetes Care Inc. |
Rodney Huang |
| K214117 |
12/30/2021 |
AfinionÖ HbA1c, AfinionÖ 2 and Alere AfinionÖ AS100 Analyzer |
Abbott Diagnostics Technologies AS |
Danial Kirmani |
| K210452 |
02/16/2021 |
Creatinine2 |
Abbott Ireland Diagnostics Division |
Magdalena Suszko |
| K210458 |
02/16/2021 |
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System |
Abbott Medical |
Steve Vitale |
| K210480 |
02/19/2021 |
AcuPebble SA |
Acurable Limited |
Esther Rodriguez-Villegas |
| K210285 |
02/02/2021 |
Adaptable Ortho Innovations Intramedullary Nail System |
Adaptable Ortho Innovations, LLC |
Steve Palin |
| K213871 |
12/13/2021 |
Ennovate Cervical Spinal and Occiput System |
Aesculap Implant Systems, LLC. |
Paul Amudala |
| K214041 |
12/23/2021 |
Aesculap AICON Container |
Aesculap Inc. |
Omunique (Nikki) Luke |
| K214043 |
12/23/2021 |
BriefCase |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K213886 |
12/13/2021 |
BriefCase |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K210436 |
02/12/2021 |
Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere |
Alcon Laboratories Inc. |
Alicia Plesnarski |
| K210564 |
02/25/2021 |
Infrared Thermometer |
Alicn Medical Shenzhen, Inc |
Fang Meisong |
| K210563 |
02/25/2021 |
Arm Blood Pressure Monitor |
Alicn Medical Shenzhen,Inc |
Fang Meisong |
| K210565 |
02/25/2021 |
Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711 |
Alicn Medical Shenzhen,Inc |
Fang Meisong |
| K213924 |
12/15/2021 |
Gastric Alimetry System |
Alimetry Ltd. |
Yaara Yarmut |
| K213906 |
12/14/2021 |
extriCARE 1000 Negative Pressure Wound Therapy System |
Alleva Medical Ltd |
Max Choi |
| K210499 |
02/22/2021 |
Alpha Dent Implants Dental Implants System |
Alpha Dent Implants GmbH |
Simha Sibony |
| K214006 |
12/22/2021 |
Invictus« Spinal Fixation System |
Alphatec Spine, Inc. |
Sandy Gill |
| K213849 |
12/10/2021 |
SafeOp 2: Neural Informatix System |
Alphatec Spine, Inc. |
David Gramse |
| K214075 |
12/27/2021 |
Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) |
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. |
Bingyi Xiang |
| K210302 |
02/03/2021 |
Disposable Medical mask |
Anhui JBH Medical Apparatus Co., Ltd. |
Dandan Yang |
| K210464 |
02/16/2021 |
Auto Disable Syringe |
Anhui Tiankang Medical Technology Co.,Ltd. |
Bai Baodong |
| K213941 |
12/16/2021 |
Annalise Enterprise CXR Triage Pneumothorax |
Annalise-AI |
Eric Qin |
| K210401 |
02/10/2021 |
Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitril |
Ansell Healthcare Products LLC |
Donald Cronk |
| K213887 |
12/13/2021 |
GAL-1A Plus Blood Glucose Monitoring System |
Apex BioTechnology Corp. |
Lisa Liu |
| K210266 |
02/01/2021 |
OverStitch Sx Endoscopic Suturing System |
Apollo Endosurgery Inc. |
David Hooper |
| K213971 |
12/20/2021 |
Atrial Fibrillation History Feature |
Apple Inc. |
Luke Olson |
| K213916 |
12/15/2021 |
ArchForm Orthodontic Software System |
ArchForm, Inc |
Andrew S. Martz |
| K213855 |
12/10/2021 |
Arrow Pressure Injectable Midline Catheter |
Arrow International LLC Subsidiary of Teleflex Incorporated |
Kim Pennington |
| K213838 |
12/09/2021 |
AneuGuide |
ArteryFlow Technology Co., Ltd. |
Jianping Xiang |
| K213837 |
12/09/2021 |
Arthrx Fracture Plates |
Arthrex Inc. |
Stacy Valdez |
| K210423 |
02/11/2021 |
Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand |
Arthrocare Corporation |
Shruthi Bhat |
| K213800 |
12/06/2021 |
Artiglass NRFitTM Tip L.O.R. Glass Syringes |
Artiglass Srl |
Sabrina Baccarin |
| K213868 |
12/10/2021 |
ASAHI Gladius Mongo18 PV ES |
Asahi Intecc Co., LTD. |
Tomoya Eguchi |
| K213889 |
12/13/2021 |
PicoStar |
Asclepion Laser Technologies GmbH |
Carolin Kuehling |
| K214047 |
12/27/2021 |
EL CAPITAN Anterior Lumbar Interbody Fusion System |
Astura Medical |
Parker Kelch |
| K210477 |
02/19/2021 |
AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE |
AtriCure Inc. |
Melissa Smallwood |
| K210293 |
02/02/2021 |
AtriClip LAA Exclusion System |
AtriCure, Inc. |
Mary Galeano |
| K210325 |
02/04/2021 |
APOLLO Anterior Cervical Plate (ACP) System |
Aurora Spine, Inc. |
Laszlo Garamszegi |
| K210521 |
02/23/2021 |
DEXA-C Cervical Interbody System |
Aurora Spine, Inc. |
Laszlo Garamszegi |
| K213775 |
12/02/2021 |
GlovatexÖ White Latex Gloves, GlovanilÖ Blue Nitrile Gloves |
Avecena Gloves Sdn Bhd |
Mohd Aswad bin Ramli |
| K210350 |
02/08/2021 |
Gemini 2 810+980 Soft Tissue Laser |
Azena Medical, LLC |
Lindsay Tilton |
| K210268 |
02/01/2021 |
LTJ Screws and Washer |
AzurMeds Inc. |
Jean-Marie Berger |
| K210483 |
02/19/2021 |
MOBIO Total Knee System |
b-ONE ORTHO, Corp. |
Allison Gecik |
| K213778 |
12/03/2021 |
IV Administration Set |
B.Braun Medical Inc. |
Tracy Larish |
| K213957 |
12/17/2021 |
Demetra Dermatoscope BDEM-01 |
Barco NV |
Imke Storm |
| K210264 |
02/01/2021 |
BD PowerPiCC Catheter |
Bard Access Systems, Inc. |
Mary Strickland |
| K213896 |
12/14/2021 |
BD Trek Powered Bone Biopsy System |
Bard Peripheral Vascular |
Courtney Willson |
| K214016 |
12/22/2021 |
15L Cycler Drainage Bag |
Baxter Healthcare Corporation |
Maninee Patel |
| K210335 |
02/05/2021 |
Blood Administration Set |
Baxter Healthcare Corporation |
James L. Vangeisen |
| K210430 |
02/12/2021 |
Intravascular Extension Set |
Baxter Healthcare Corporation |
Meaghan Bonn |
| K213898 |
12/14/2021 |
ProTrack Pigtail Wire |
Baylis Medical Company Inc. |
May Tsai |
| K213844 |
12/09/2021 |
Surgical Gown |
Bayteks Teknik Tekstil San. ve Tic. A.S. |
Spero Hegbe |
| K210585 |
02/26/2021 |
BD CTGCTV2 |
Becton Dickinson and Company |
Sue Werner |
| K213953 |
12/17/2021 |
BD Vacutainer« Trace Element K2EDTA Tubes, BD Vacutainer« Trace Element Serum Tubes |
Becton Dickinson and Company |
Angela Mariani |
| K213955 |
12/17/2021 |
0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub |
Becton, Dickinson and Company |
Samhitha Mohan |
| K214122 |
12/30/2021 |
BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel |
Becton, Dickinson and Company |
Joseph Basore |
| K213811 |
12/07/2021 |
Sterile Hypodermic Syringes for Single Use |
Berpu Medical Technology Co., Ltd. |
Buxin Yu |
| K210417 |
02/11/2021 |
Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL |
Bio Compression Systems, Inc. |
Marc Somelofski |
| K213948 |
12/17/2021 |
OxyMinder |
Bio-Med Devices, Inc. |
Ken K Close |
| K213954 |
12/17/2021 |
BIOFIRE SPOTFIRE Respiratory (R) Panel |
BioFire Diagnostics |
Kevin Bourzac |
| K213863 |
12/10/2021 |
Everion+ System |
Biofourmis Singapore Pte. Ltd |
Milan Shah |
| K213987 |
12/20/2021 |
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls |
Biokit, S.A. |
Angels Roma |
| K214068 |
12/27/2021 |
Quantia IgE |
Biokit, S.A. |
Angels Roma |
| K210511 |
02/23/2021 |
InTray GC |
Biomed Diagnostics Incorporated |
John F Antiabong |
| K210287 |
02/02/2021 |
VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL) |
bioMerieux, Inc |
Cherece L Jones |
| K214023 |
12/22/2021 |
VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 ╡g/mL) |
bioMerieux, Inc |
Kyle J Olney |
| K213931 |
12/16/2021 |
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 ╡g/mL) |
bioMerieux, Inc. |
Debra Broyles |
| K213899 |
12/14/2021 |
VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 ╡g/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 ╡g/mL), VITEK 2 AST-YS Caspofungin |
bioMerieux, Inc. |
Esther Hernandez |
| K214001 |
12/21/2021 |
Comprehensive« Shoulder System, Comprehensive« Reverse Shoulder System |
Biomet Manufacturing Corp. |
Aishwarya Pandey |
| K213997 |
12/21/2021 |
Kontact Dental Implant System |
Biotech Dental, SAS |
Delphine Mercier |
| K210419 |
02/11/2021 |
BIOTEQ Drainage Catheter BT-PDS-series |
Bioteque Corporation |
Stella Hsu |
| K214038 |
12/23/2021 |
Oscar Peripheral Multifunctional Catheter system |
BIOTRONIK, Inc. |
Jon Brumbaugh |
| K210289 |
02/02/2021 |
Infant Phototherapy Equipment |
Bistos Co., Ltd. |
Dae Eun Kim |
| K213877 |
12/13/2021 |
ExactechGPS« System |
Blue Ortho |
Matthieu Coic |
| K210382 |
02/09/2021 |
Blustone Synergy Diamond SA Cervical System |
Blustone Synergy, LLC |
Tom Gentry |
| K213864 |
12/10/2021 |
Bonebridge Osteosynthesis Plating System |
Bonebridge AG |
Christof Gerber |
| K210353 |
02/08/2021 |
AutoCap RX |
Boston Scientific Corporation |
Kyra McNamara |
| K213879 |
12/13/2021 |
Self-adhesive Electrode |
Bozhou Rongjian Medical Appliance Co.,Ltd. |
Zhifang Wu |
| K213773 |
12/02/2021 |
Insufflation Retention Device |
Bpendo, LLC |
Robert Holbrook |
| K210381 |
02/09/2021 |
I.V. Administration Set |
BQ PLUS Medical Co., Ltd. |
Jin Zhang |
| K213930 |
12/16/2021 |
Brainlab Elements Guide XT, Guide 3.0 |
Brainlab AG |
Chiara Cunico |
| K213989 |
12/20/2021 |
Cranial EM System |
Brainlab AG |
Chiara Cunico |
| K210405 |
02/10/2021 |
ProTEC-USA EZDoff Gown |
Cadillac Products, Inc. |
Andrew Stone |
| DEN210055 |
12/03/2021 |
The N-SWEAT Patch |
Candesant Biomedical, Inc. |
Scott A. Wilson |
| K213780 |
12/02/2021 |
DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1 |
Canon Inc. |
Akira Hirai |
| K210340 |
02/05/2021 |
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR |
Canon Medical Systems Corporation |
Paul Biggins |
| K213834 |
12/09/2021 |
Cardio Flow Peripheral Guide Wire |
Cardio Flow, Inc. |
Michael J. Kallok |
| K213861 |
12/10/2021 |
CER-S |
CardioCalm Srl |
Fabio Badilini |
| K210586 |
02/26/2021 |
Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system |
Cardiovascular Systems Inc. |
Kris Miller |
| K210282 |
02/01/2021 |
WIRION Embolic Protection System |
Cardiovascular Systems Inc. |
Erika Huffman |
| K213907 |
12/14/2021 |
CareGUARD Sterilization Wrap |
Care Essentials Pty Ltd |
Abhay Sinha |
| K210324 |
02/04/2021 |
V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186 |
CareFusion 2200 Inc |
Jane Weber |
| K213993 |
12/21/2021 |
Powder Free Chloroprene Examination Glove Coloured (Blue, Green) |
Careglove Global SDN BHD |
Lim Kwee Shyan |
| K213933 |
12/16/2021 |
Percent Oxygen Sensors |
CareOx, LLC |
Young Kim |
| K214028 |
12/22/2021 |
MICOR Lens Fragmentation System |
Carl Zeiss Meditec Cataract Technology Inc. |
Gary Mocnik |
| K210542 |
02/24/2021 |
aprevo Transforaminal IBF |
Carlsmed, Inc. |
Karen Liu |
| K214004 |
12/21/2021 |
CCBIO ASCPO Needle |
CC Biotechnology Corporation |
Edgar Yeh |
| K214084 |
12/27/2021 |
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS |
CEFLA S.C. |
Lorenzo Bortolotti |
| K210548 |
02/25/2021 |
Medline Integrated Arterial Catheter |
Centurion Medical Products |
Amy Ganton |
| K213947 |
12/17/2021 |
Ultrasonic Endo Activation Device (Model:Actor I pro) |
ChangZhou BoMedent Medical Technology Co.,Ltd |
Yang Chunyuan |
| K210445 |
02/16/2021 |
Nordiwell Surprotect Face Mask |
Changzhou Combat Protective Equipment Co., Ltd. |
Yanmei Song |
| K210524 |
02/23/2021 |
Surgical Mask |
Changzhou Holymed Products Co., Ltd. |
Shan Shang |
| K213910 |
12/15/2021 |
Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs |
Changzhou Universal Medical Equipment Co. Ltd |
Cai Jin Fu |
| K210490 |
02/19/2021 |
ChM 4.5mm Cortical screws |
ChM sp. z o.o. |
Andrzej Sobolewski |
| K213768 |
12/01/2021 |
Bolt Navigation System |
Circinus Medical Technology, LLC |
Patrick West |
| K213998 |
12/21/2021 |
cvi42 Auto Imaging Software Application |
Circle Cardiovascular Imaging Inc |
Sydney Toutant |
| K210320 |
02/04/2021 |
ClearCorrect System |
ClearCorrect LLC |
Christopher Klaczyk |
| K214040 |
12/23/2021 |
ClearPoint Array System (version 1.1) |
ClearPoint Neuro, Inc. |
Pete Piferi |
| K214125 |
12/30/2021 |
TRANBERG Thermoguide Therapy System |
Clinical Laserthermia Systems AB |
Dan Mogren |
| K213808 |
12/06/2021 |
Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream |
Co-Innovation Biotech Co.,Ltd. |
Hong Feng |
| K210306 |
02/03/2021 |
GII Spinal Fixation System |
Coligne AG |
Robert B Lange |
| K214058 |
12/27/2021 |
Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer |
ConMed Corporation |
Kavita Amin |
| K213946 |
12/17/2021 |
Compass BDS Biliary Stent |
Cook Ireland LTD |
Kieran Casey |
| K210476 |
02/19/2021 |
EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle |
Cook Ireland Ltd. |
Fay Dalton |
| K214036 |
12/23/2021 |
AVIEW |
Coreline Soft Co.,Ltd. |
Hyeyi Park |
| K210539 |
02/24/2021 |
CoreLink Midline Fixation System |
CoreLink, LLC |
Steven Mounts |
| K214059 |
12/27/2021 |
CoreLink Navigation Instruments |
CoreLink, LLC |
Steven Mounts |
| K213818 |
12/07/2021 |
VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula |
Covidien |
Michael Mach |
| K210338 |
02/05/2021 |
Edge Insulated Blade Electrode |
Covidien LLC |
Miranda Miles |
| K213911 |
12/15/2021 |
Microstream CO2 NanoPod |
Covidien LLC |
Andrew Berkeland |
| K210402 |
02/10/2021 |
Curiteva Sacroiliac Joint Fusion System |
Curiteva, Inc. |
Eric Linder |
| K214123 |
12/30/2021 |
T-FIX« 3DSI Joint Fusion System |
Cutting Edge Spine, LLC |
Kyle Kuntz |
| K213970 |
12/20/2021 |
D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply |
Danameco Medical Joint Stock Corporation |
Huynh Thi Li Li |
| K210569 |
02/26/2021 |
Disposable Monopolar Laparoscopic Shafts and Reusable Handles |
Dannik LLC |
Olga Haberland |
| K210384 |
02/09/2021 |
CARESCAPE R860 |
Datex-Ohmeda, Inc. |
Trishia Mercier |
| K213867 |
12/10/2021 |
Carestation 750/750c |
Datex-Ohmeda, Inc. |
Kimberly Mangum |
| K213901 |
12/14/2021 |
CyclopsÖ Anterior Cervical Plate System |
DeGen Medical |
Craig Black |
| K213918 |
12/15/2021 |
DeGen Navigated Instrumentation |
DeGen Medical |
Craig Black |
| K210523 |
02/23/2021 |
Implanova |
Dental Evolutions Inc. |
Matthew Mineros |
| K210362 |
02/08/2021 |
s-Clean Pre-Milled Abutment |
Dentis Co., Ltd. |
Gyu Ri Kim |
| K210410 |
02/11/2021 |
s-Clean Pre-Milled Abutment Mini |
Dentis Co., Ltd. |
Gyu Ri Kim |
| K210581 |
02/26/2021 |
Actis DuoFix Hip Prosthesis- Collarless |
DePuy Ireland UC |
Elaine Pears |
| K213781 |
12/03/2021 |
ATTUNE« Porous Fixed Bearing Tibial Base with AFFIXIUMÖ 3DP |
DePuy Ireland UC |
Erin Combs |
| K213839 |
12/09/2021 |
DePuy Corail AMT Hip Prosthesis |
DePuy Orthopaedics Inc. |
Erin Combs |
| K210530 |
02/24/2021 |
WOLF Thrombectomy System, 6F |
DeVoro Medical, Inc. |
Michael Wallace |
| K213919 |
12/15/2021 |
Dexcom G7 Continuous Glucose Monitoring System |
Dexcom, Inc. |
Neeta Sharma |
| K210421 |
02/11/2021 |
Diafil & Diafil Capsule |
Diadent Group International |
Kab Sun Lee |
| K210333 |
02/05/2021 |
DiaPaste |
Diadent Group International |
Kab Sun Lee |
| K210272 |
02/01/2021 |
LIAISON Anti-HAV |
DiaSorin Inc. |
John C. Walker |
| K213858 |
12/10/2021 |
LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus |
DiaSorin Inc. |
Christa Blaisdell |
| K213936 |
12/16/2021 |
LIAISON MeMed BV, LIAISON MeMed BV Control Set |
DiaSorin Inc. |
John C. Walter |
| K213843 |
12/09/2021 |
Nitrile Examination Gloves |
Dong Tai City Huayi Gloves Co.,Ltd. |
Huamei Wang |
| K213788 |
12/06/2021 |
TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) |
Dongguan Bohuikang Technology Co.,Ltd |
Rihua Meng |
| K210305 |
02/03/2021 |
Pulse Oximeter |
Dongguan Lingxin Technologies Co., LTD |
Cony Tang |
| K210372 |
02/08/2021 |
Disposable Surgical Mask |
Dongguan Shin Yi Healthcare Products Factory |
Zhao Shuge |
| K210394 |
02/10/2021 |
Electrosurgical accessory |
Dornier MedTech America Inc. |
John Hoffer |
| K210561 |
02/25/2021 |
Advisor Pro Platform |
DreaMed Diabetes Ltd. |
Inbal Beinglass Peled |
| K210321 |
02/04/2021 |
Dukal Corporation Level 1 Pediatric Face Mask |
Dukal Corporation |
Megan Quevedo |
| K214101 |
12/29/2021 |
Project E Beauty LED Light Therapy Mask (Model: PE730) |
Duplex International Trading Limited |
Patrick Lee |
| K210375 |
02/08/2021 |
Powder Free Blue Nitrile Examination Glove |
Duramitt sdn Bhd |
Terence Lim |
| K213894 |
12/14/2021 |
DWFritz ASM2000 |
DWFritz Automation, Inc. |
Curtis Smith |
| K213882 |
12/13/2021 |
EarliPoint System |
EarliTec Diagnostics, Inc. |
Thomas Ressemann |
| K213791 |
12/06/2021 |
Unispace SA Cervical Cage |
Edisoninno Co., Ltd. |
So-yeon Jang |
| K213794 |
12/06/2021 |
Eko Murmur Analysis Software (EMAS) |
Eko Devices, Inc. |
Sam Huang |
| K210500 |
02/22/2021 |
Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD |
Elekta Limited |
Lorenzo Muratori |
| K213787 |
12/06/2021 |
Monaco RTP System |
Elekta Solutions AB |
Anju Kurian |
| K213958 |
12/17/2021 |
Bioabsorbable Anchor |
Embody, Inc. |
Brianna Schehr |
| K213981 |
12/20/2021 |
Nitrile Examination Gloves |
Emerald Glove Manufacturing Sdn Bhd |
Amran A. Aziz |
| K210279 |
02/01/2021 |
Enbio S |
Enbio Group AG |
Lukasz Rogowski |
| K213991 |
12/21/2021 |
Enbio S |
Enbio Group AG |
Lukasz Rogowski |
| K210308 |
02/03/2021 |
EMPOWR Porous Femur with HAnano SurfaceTM |
Encore Medical, L.P. |
Christine Chesnutt |
| K213793 |
12/06/2021 |
EMPOWR Revision Knee |
Encore Medical, L.P. |
Michael Siano |
| K213767 |
12/01/2021 |
Endure ETCO2/02 Nasal Cannula |
Endure Industries Inc |
Manoj Kumar |
| K214037 |
12/23/2021 |
Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac |
Ergo-Flex Technologies, LLC |
Linda Anderson |
| K213783 |
12/03/2021 |
Apyx |
Escala Medical |
Edit Goldberg |
| K210468 |
02/16/2021 |
SC1 Handheld Ultrasound Imaging System (Model: SC1) |
FCU Co., Ltd. |
Lee Hee Yeon |
| K214066 |
12/27/2021 |
FEops HEARTguide |
FEops nv |
Peter Mortier |
| K213949 |
12/17/2021 |
VASSALLO GT 018 Floppy |
Filmecc Co., Ltd. |
Toshiya Osawa |
| K210281 |
02/01/2021 |
Fist Assist Devices Model FA-1 |
Fist Assist Devices, LLC |
Tej Singh |
| K213992 |
12/21/2021 |
CombiSet Hemodialysis Blood Tubing Set |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K210276 |
02/01/2021 |
Disposable Nitrile Gloves |
Fujian Ercon Medical Management Co., Ltd. |
Lin Ruijin |
| K214089 |
12/28/2021 |
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 |
Fujifilm Corporation |
Randy Vader |
| K213829 |
12/08/2021 |
SCENARIA View |
FUJIFILM Healthcare Corporation |
Randy Vader |
| K213763 |
12/01/2021 |
Sonosite PX Ultrasound System |
FUJIFILM Sonosite, Inc. |
Anoush Frankian |
| K213980 |
12/20/2021 |
Peridot Spinal Interbody System |
GBS Commonwealth Co., Ltd. |
Jimmy Kim |
| K213972 |
12/20/2021 |
Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX |
GE Healthcare Information Technologies, Inc. |
James T Turner |
| K213938 |
12/16/2021 |
Revolution Ascend |
GE Healthcare Japan Corporation |
He Haibo |
| K214039 |
12/23/2021 |
LOGIQ P10, LOGIQ P9, LOGIQ P8 |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Bryan Behn |
| K210438 |
02/12/2021 |
Versana Premier |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K213999 |
12/21/2021 |
Deep Learning Image Reconstruction |
GE Medical Systems, LLC. |
Amy Yang |
| K210280 |
02/01/2021 |
Geistlich Mucograft«, Geistlich Mucograft« Seal |
Geistlich Pharma AG |
Marco Steiner |
| K210556 |
02/25/2021 |
Preview Shoulder |
Genesis Software Innovations |
Matt Miller |
| K214086 |
12/27/2021 |
Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty |
Genoss Co., Ltd. |
Woojung Park |
| K213802 |
12/06/2021 |
StimOnTM Pain Relief System (GM2439) |
Gimer Medical Co., Ltd. |
Rex Chang |
| K213842 |
12/09/2021 |
ONVOY Acetabular System |
Globus Medical Inc. |
Jennifer Antonacci |
| K210534 |
02/24/2021 |
GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System |
Gramercy Extremity Orthopedics, LLC |
Michael P. Simpson |
| K210352 |
02/08/2021 |
GGM Breathing Circuit Bacterial Filter |
Great Group Medical Co., Ltd. |
Kiki Hung |
| K213848 |
12/10/2021 |
Medical nitrile examination gloves (Model: JL001) |
Guangdong Jiali Pharmaceutical Co.,Ltd |
Jiali Chen |
| K213851 |
12/10/2021 |
Disposable Medical Nitrile gloves |
Guangdong Xingcan Brothers Medical Technology Co.,Ltd |
Suhai Yin |
| K214077 |
12/27/2021 |
Digital Thermometer, Model: DT007, DT008 |
Guangzhou Berrcom Medical Device Co., Ltd. |
Zhigang Du |
| K210376 |
02/09/2021 |
Superior Hair Remover |
Guangzhou Haoxingwan Technology Co., Ltd. |
Chun Tao |
| K214063 |
12/27/2021 |
Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle |
Guangzhou Shengwei Medical Devices Co., Ltd |
Xiaojun Cai |
| K210367 |
02/08/2021 |
D-Laser Blue, D-Laser 16 |
Guilin Woodpecker Medical Instrument Co., Ltd. |
Yang Yunfeng |
| K213831 |
12/08/2021 |
Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle |
Gyrus ACMI, Inc. |
Dolan Mills |
| K213883 |
12/13/2021 |
NanoZoomer S360MD Slide scanner system |
Hamamatsu Photonics K.K. |
Shinichi Fujisaka |
| K210406 |
02/10/2021 |
Bipolar Coagulation Foreceps |
Hangzhou AGS MedTech Co., Ltd. |
Yanping Fu |
| K214103 |
12/29/2021 |
Shani Darden LED light therapy mask |
Harpar Grace International |
Alana Marie Chalmers |
| K214074 |
12/27/2021 |
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs |
Hartalega NGC SDN. BHD. |
Kuan Mun Leong |
| K213857 |
12/10/2021 |
HeartFlow Analysis |
HeartFlow, Inc. |
Windi Hary |
| K213760 |
12/01/2021 |
ABMD Software |
HeartLung Corporation |
Morteza Naghavi |
| K214015 |
12/22/2021 |
Palm NRG cellulite body device (model: Palm NRG body device) |
Heat In A Click LLC. |
Guy Levi |
| K214091 |
12/28/2021 |
Dental Image Plate Scanner, Model DFC-4T-SMART |
Hefei DentaFilm Medical Equipment Co., Ltd |
Ming Chang Qiu |
| K210331 |
02/05/2021 |
CardiaMend Pericardial and Epicardial Reconstruction Matrix |
Helios Cardio Inc. |
Yiannis Monovoukas |
| K213917 |
12/15/2021 |
QStat Cartridge |
HemoSonics, LLC |
Iskra Mrakovic |
| K210411 |
02/11/2021 |
PosiSep EAR Fragmentable Ear Dressing |
Hemostasis LLC |
Lakshmi Ganesh Bollina |
| K213812 |
12/07/2021 |
PALACOS MV pro |
Heraeus Medical GmbH |
Ljuba Jaeckel |
| K213801 |
12/06/2021 |
Veuron-Brain-pAb2 |
Heuron Co., Ltd. |
Dong Hoon Shin |
| K210383 |
02/09/2021 |
Wrap Accessory Electrodes |
Hi-Dow International Inc. |
Eric Chen |
| K214078 |
12/27/2021 |
SilkÆn Toothwave |
Home Skinovations Ltd. |
Amit Goren |
| K214087 |
12/27/2021 |
Medical Face Mask |
Hubei Medlink Healthcare Co., Ltd |
Sophie Liu |
| K214085 |
12/27/2021 |
Disposable Medical Mask |
Hubei Wanli Protective Products Co. Ltd |
Andy Wen |
| K213832 |
12/09/2021 |
AAMI3 Isolation Gown |
Hubei Xinxin Non-woven Co., Ltd. |
Nicole Jin |
| K214116 |
12/30/2021 |
AAMI4 Isolation Gown |
Hubei Xinxin Non-woven Co.,Ltd. |
Nicole Jin |
| K210487 |
02/19/2021 |
MIPLNI YK-244 Disposable Surgical Mask |
Hunan Yuankang Biological Technology Co., Ltd |
Kylin Rui Chen |
| K213820 |
12/08/2021 |
BALTEUM - ONEÖ Lumbar Plate System |
Huvexel Co., Ltd |
Sung Kyu Hur |
| K210572 |
02/26/2021 |
Neurodyn V2.0, Neurodyn Aussie V2.0 |
Ibramed Equipamentos Medicos |
Fabio Alexandre Pinto |
| K210478 |
02/19/2021 |
8mm Monopolar Curved Scissors |
Iconocare Health |
Rick Ferreira |
| K213830 |
12/08/2021 |
Home use hair removal device, model: Precise Touch Pro |
Iluminage Beauty Co., Limited |
Jacky Lee |
| K210469 |
02/16/2021 |
Insight Agile DRF |
Imaging Engineering, LLC |
George Jachode |
| K210431 |
02/12/2021 |
ReCross |
IMDS Operations B.V. |
Edwin Schulting |
| K213890 |
12/13/2021 |
IMICRYL Impression Materials |
IMICRYL Dis Malzemeleri San. Ve Tic. A.S. |
Husamettin Sonmez |
| K210473 |
02/17/2021 |
Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) |
Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. |
Hⁿsamettin Sonmez |
| K210543 |
02/24/2021 |
IM007 |
Implicity, Inc. |
David Perlmutter |
| K210492 |
02/19/2021 |
InMode RF Pro System |
InMode MD Ltd. |
Amit Goren |
| K210422 |
02/11/2021 |
INTAI Surgical Mask (non-sterile) |
INTAI Technology Corp. |
Dale Chang |
| K213823 |
12/08/2021 |
Intera Refill Kit |
Intera Oncology, Inc. |
Michael Gaisford |
| K214095 |
12/28/2021 |
da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments |
Intuitive Surgical, Inc. |
Kunal Gunjal |
| K213766 |
12/01/2021 |
dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T |
Invivo Corporation |
Ann Lebar |
| K210316 |
02/03/2021 |
Mars 1417X Wireless Digital Flat Panel Detector |
iRay Technology Taicang Ltd. |
Meng Li |
| K210314 |
02/03/2021 |
Mars1717X Wireless Digital Flat Panel Detector |
iRay Technology Taicang Ltd. |
Meng Li |
| K210312 |
02/03/2021 |
PlutoX Digital Intraoral X-Ray Imaging System |
iRay Technology Taicang Ltd. |
Wei Pan |
| K210536 |
02/24/2021 |
Irrisept Antimicrobial Wound Lavage |
Irrimax Corporation |
Christy Coleman |
| K210290 |
02/02/2021 |
JACE Medical Thoracic Plating System |
JACE Medical, LLC |
Scott Steffensmeier |
| K210270 |
02/01/2021 |
Medical Endoscope Image Processing System |
Jiangsu Jiyuan Medical Technology Co., Ltd. |
Zong Yunfeng |
| K213912 |
12/15/2021 |
Disposable Medical Nitrile Examination Gloves |
Jiangsu Maolin Medical Technology Co., Ltd |
Yuan Mao |
| K213914 |
12/15/2021 |
Injection Needle |
Jiangsu Vedkang Medical Science and Technology Co.,Ltd |
Ting Tang |
| K213825 |
12/08/2021 |
Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A |
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. |
Wei Yan |
| K210429 |
02/12/2021 |
Disposable Surgical Face Mask |
Jiangxi Heying Pharmaceutical Co., Ltd |
Junzheng Liu |
| K210578 |
02/26/2021 |
Medical Nitrile Examination Gloves (Power free, Blue) |
Jiangxi Hongda Medical Equipment Group Ltd. |
Yang Qinghua |
| K214017 |
12/22/2021 |
Examination gloves-Type A(Latex gloves) |
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd |
Jenny Huang |
| K210304 |
02/03/2021 |
Surgical Mask |
Jin Pin Electrical CO., LTD. Zhuhai S.E.Z. |
Rongfeng Yu |
| K214051 |
12/27/2021 |
Neodent Implant System-Helix NGM Compact Surgical Kit Cases |
JJGC Ind·stria e ComΘrcio de Materiais Dentßrios S.A. |
Thais Barboza |
| K210336 |
02/05/2021 |
Neodent Implant System - Zirconia Implant System |
JJGC Industria e Comercio de Materiais Dentarios SA |
Mariana Soares Hartmann |
| K210345 |
02/05/2021 |
2MP Monochrome LCD Monitor MS-S200 |
Jvckenwood Corporation |
Hideki Tengeiji |
| K213904 |
12/14/2021 |
Kerecis Oral |
Kerecis |
Gudmundur Fertram Sigurjonsson |
| K214012 |
12/22/2021 |
Straight Arm DDR |
Konica Minolta Healthcare Americas, Inc |
Jan Maniscalco |
| K214030 |
12/23/2021 |
Universal DR 1748 |
Konica Minolta Healthcare Americas, Inc. |
Jan Maniscalco |
| K213908 |
12/14/2021 |
SKR 3000 |
Konica Minolta, INC. |
Tsutomu Fukui |
| K214109 |
12/29/2021 |
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
Kontour(XiÆan) Medical Technology Co., Ltd. |
Rongrong Cong |
| K210504 |
02/22/2021 |
PANAVIA Veneer LC |
Kuraray Noritake Dental Inc. |
Yasujiro Ohara |
| K213959 |
12/17/2021 |
MagnetOs Flex Matrix |
Kuros Biosciences BV |
Sonja van der Meer |
| K213860 |
12/10/2021 |
ArthroFree Wireless Surgical Camera System |
Lazurite Holdings LLC |
Patrick Polito |
| K214049 |
12/27/2021 |
Leaseir MHR Xcell |
Leaseir Technologies S.L.U. |
Pablo Boto |
| K210432 |
02/12/2021 |
LELTEK Ultrasound Imaging System (Model: LU700 Series) |
Leltek Inc |
Jessie Wang |
| K214044 |
12/27/2021 |
14HQ901G-B |
LG Electronics Inc. |
Jinhwan Jun |
| K210549 |
02/25/2021 |
ARx Spinal System |
Life Spine, Inc. |
Angela Batker |
| K213785 |
12/06/2021 |
SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid |
LimaCorporate |
Roberto Gabetta |
| K210554 |
02/25/2021 |
Physica system |
Limacorporate S.p.A. |
Giuseppe Valenti |
| K213772 |
12/02/2021 |
LM-9300 Plus Lithotripter |
Lite-Med Inc. |
Walt Hsu |
| K214110 |
12/29/2021 |
Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs |
Mah Sing Healthcare Sdn Bhd |
Sazalinda Musa |
| K210284 |
02/02/2021 |
ManaSport |
ManaMed, Inc. |
Trevor Theriot |
| K214120 |
12/30/2021 |
GSS610N21 Series Steam Sterilizer |
Maquet GmbH |
Holger Ullrich |
| K210545 |
02/25/2021 |
Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine |
Marci Beauty Inc |
Shaul Rappaport |
| K214072 |
12/27/2021 |
Masimo O3 Regional Oximeter System |
Masimo Corporation |
Kertana Shankar |
| K214115 |
12/30/2021 |
MightySat -OTC |
Masimo Corporation |
Kertana Shankar |
| K210456 |
02/16/2021 |
Ligament Staple |
Medacta International SA |
Stefano Baj |
| K210427 |
02/11/2021 |
M.U.S.T. Midline Cortical (MC) Screw System |
Medacta International SA |
Stefano Baj |
| K210263 |
02/01/2021 |
Mpres Neck Preserving Stem |
MEDACTA INTERNATIONAL, SA |
Stefano Baj |
| K214112 |
12/30/2021 |
Invia Ease Negative Pressure Wound Therapy (NPWT) System |
Medela AG |
Mike McAndrew |
| K210461 |
02/16/2021 |
End Cap |
Medical Components Inc. (Medcomp) |
Patrick McDonald |
| K213934 |
12/16/2021 |
Pro Guard Nitrile Powder Free Examination Glove |
Medical Glove Co., Ltd |
Teoh Choh Shee |
| K210470 |
02/17/2021 |
C-CURVE Interbody Fusion Device |
Medicrea International S. A. |
Karine Trogneux |
| K210415 |
02/11/2021 |
QSM software, QSMetric |
Medimagemetric LLC |
Yi Wang |
| K214050 |
12/27/2021 |
ENT Nasopharyngoscope and Accessories |
Medimaging Integrated Solution Inc. (MiiS) |
Jung-Yi Yen |
| K210286 |
02/02/2021 |
Cure 2.0 Anterior Cervical Plate (ACP) System |
Meditech Spine, LLC |
Bruce Dunaway |
| K213833 |
12/09/2021 |
SCOPE BUDDY PLUS Endoscope Flushing Aid |
Medivators Inc |
Mark Arnold |
| K214108 |
12/29/2021 |
Medline Orbis Chemo Surgical Gown |
Medline Industries LP |
Adam Ostrower |
| K210526 |
02/23/2021 |
Medline Cautery Tip Cleaner |
Medline Industries, Inc. |
Matt Clausen |
| K210482 |
02/19/2021 |
Medline UNITE REFLEX Nitinol Staple System |
Medline Industries, Inc. |
Jennifer Mason |
| K214025 |
12/22/2021 |
PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter |
Medos International Sarl |
Ivenette Guzman |
| K213978 |
12/20/2021 |
TELIGEN System |
Medos International, SARL |
Daria Bochenek |
| K214065 |
12/27/2021 |
ROSA ONE Brain application |
Medtech S.A.S |
Paul Hardy |
| K210414 |
02/11/2021 |
CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown |
Medtecs (Taiwan) Corp. |
William Yang |
| K210449 |
02/16/2021 |
InfinityÖ OCT System, PASS OCT« Spinal System |
Medtronic |
Shweta Sharma |
| DEN210003 |
02/03/2021 |
SureTune4 Software |
Medtronic Neuromodulation |
Teal Bjoraker |
| K214010 |
12/22/2021 |
Anteralign Spinal System with Titan nanoLOCK Surface Technology |
Medtronic Sofamor Danek USA |
Elizabeth Hamilton |
| K214011 |
12/22/2021 |
CatalyftÖ PL Expandable Interbody System Navigated Instruments, AnteralignÖ TL Spinal System with Titan nanoLOCKÖ Surface Technology Navigated Instruments, and CD HorizonÖ SoleraÖ VoyagerÖ Spinal System Navigated, Guided, and Powered Drivers |
Medtronic Sofamor Danek USA, INC. |
Alex Underberg |
| K210425 |
02/11/2021 |
Catalyft PL Expandable Interbody System |
Medtronic Sofamor Danek, USA Inc. |
Alex Underberg |
| K210484 |
02/19/2021 |
LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System |
Medtronic, Inc. |
Dianna L Johannson |
| K210420 |
02/11/2021 |
Goblin and Goblin LS Pedicle Screw Systems |
Medynus Inc. |
David Shin |
| K214053 |
12/27/2021 |
Amputee Garment for use with Lympha Press Optimal Plus |
Mego Afek AC Ltd. |
Ilan Sharon |
| K210339 |
02/05/2021 |
Bullfrog Micro-Infusion Device |
Mercator MedSystems, Inc. |
Kirk P. Seward |
| K213845 |
12/09/2021 |
HeRO Graft |
Merit Medical Systems, Inc. |
Susan Christensen |
| K210475 |
02/17/2021 |
EQ-M |
Meta Systems Co., Ltd |
Yang Ho Dong |
| K210388 |
02/09/2021 |
Non Sterile Nitrile Powder Free Examination Gloves û Blue, Green and Black color |
Mexpo International Inc. |
Tim Thai |
| K214056 |
12/27/2021 |
Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) |
Mezorrison Medical Technology (Dongying) Co., Ltd. |
Ping Chen |
| K210567 |
02/26/2021 |
Ultrasonic Surgical System |
Miconvey Technologies Co., Ltd. |
Kang Li |
| K213782 |
12/03/2021 |
Single-Use Video Bronchoscopes, Digital Controller |
Micro-Tech (Nanjing) Co., Lts |
Sally He |
| K213875 |
12/13/2021 |
DRI TM Tricyclics Serum Tox Assay |
Microgenics Corporation |
Pranjali Shinde |
| K213873 |
12/13/2021 |
SkyWalker Total Knee System |
MicroPort NaviBot International LLC |
Mike Manor |
| K213816 |
12/07/2021 |
MPO Hip Instruments |
MicroPort Orthopedics Inc. |
Gillen Gonzales |
| K213817 |
12/07/2021 |
MPO Knee Instruments; MPO PROPHECY Knee Instruments |
MicroPort Orthopedics Inc. |
Gillen Gonzales |
| K214024 |
12/22/2021 |
SOFIA 88 Catheter |
MicroVention, Inc. |
Alick Tan |
| K210528 |
02/23/2021 |
IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit |
Millennium Medical Technologies Inc (DBA Cellmyx) |
Wangzhong Sheng |
| K213976 |
12/20/2021 |
Contour ProtΘgΘAI |
MIM Software Inc. |
Lynn Hanigan |
| K210479 |
02/19/2021 |
IMPACT and X-Ranger |
MinXray, Inc. |
Keith Kretchmer |
| K213771 |
12/02/2021 |
Merlin Aspiration System |
MIVI Neurovascular, Inc. |
Janel Hurtado |
| K210559 |
02/25/2021 |
ATOZ Mini-Screw |
MK Meditech Inc. |
SungChul Moon |
| K213790 |
12/06/2021 |
Aluminum back folding wheelchair SYIV 100-LQXAL2482-407 |
Mobility Source Medical Technology Co., Ltd. |
Evan Wong |
| K210315 |
02/03/2021 |
Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps |
Modern Medical Equipment Manufacturing, LTD. |
Jerry Cheung |
| K213840 |
12/09/2021 |
MolecuLight I:X |
MolecuLight, Inc. |
Jordan John |
| K213872 |
12/13/2021 |
ComPAS2 |
Morgan Scientific, Inc. |
Deborah Cornish |
| K210525 |
02/23/2021 |
MY01 Continuous Compartmental Pressure Monitor |
MY01 Inc. |
Charles Allan |
| K213925 |
12/16/2021 |
MyoCycle MC-2 (Home / Home + / Pro / Pro +) |
Myolyn, LLC |
Matthew Bellman |
| K213944 |
12/17/2021 |
HealthOST |
NanoxAI Ltd. |
Shlomit Cymbalista |
| K210575 |
02/26/2021 |
HDF Assist Mudule, HDF Infusion Set and Substitution Filter |
Nephros |
Vashone R Thomas |
| K213813 |
12/07/2021 |
DuraFuse Clip and Applier System |
NeuraMedica Inc |
Rachel Dreilinger |
| K210358 |
02/08/2021 |
Neurescue device |
Neurescue Aps |
Habib Forest |
| K213969 |
12/20/2021 |
VisionAir Patient-Specific Airway Stent |
New COS Inc. DBA VisionAir Solutions |
Keith Grafmeyer |
| K210256 |
02/01/2021 |
CiRx (R) Surgical Mask |
Ningbo Shun Ye Medical Company, Ltd. |
Frank Yu |
| K213786 |
12/06/2021 |
CiRX Single use electrosurgical pencil with non-coated and coated electrode |
Ningbo Shun Ye Medical Company, Ltd. |
Ding Feng Yu |
| K210356 |
02/08/2021 |
Noris Medical Dental Implants System |
Noris Medical Ltd |
Simha Sibony |
| K210258 |
02/01/2021 |
NovoFine |
Novo Nordisk Inc. |
Hiral Palkhiwala Shah |
| K210310 |
02/03/2021 |
CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit |
Nuance Medical, LLC |
Neal Hartman |
| K213942 |
12/17/2021 |
Esteya |
Nucletron B.V. |
Kiran Jose |
| K213915 |
12/15/2021 |
BIB Stent Placement Catheter |
NuMED Inc. |
Nichelle LaFlesh |
| K210439 |
02/12/2021 |
NuVasive MOD-EX XLIF Interbody System |
NuVasive, Incorporated |
Manthan J. Damani |
| K210271 |
02/01/2021 |
NuVasive Modulus ALIF System |
NuVasive, Incorporated |
Jessica LeBlanc |
| K210574 |
02/26/2021 |
NuVasive Pulse System |
NuVasive, Incorporated |
Manthan Damani |
| K210424 |
02/11/2021 |
Quantum Anterior Cervical Plate |
Nvision Biomedical Technologies, Inc. |
Diana Langham |
| K213937 |
12/16/2021 |
Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution |
O & M Halyard, Inc. |
Steven Dowdley |
| K213929 |
12/16/2021 |
Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid |
O & M Halyard, Inc. |
Steven Dowdley |
| K213988 |
12/20/2021 |
SOFT PLUG Extended Duration 180 Tapered Canalicular Plug |
Oasis Medical, Inc |
James Christensen |
| K210540 |
02/24/2021 |
Ohlendorf Clear Aligner |
Ohlendorf Appliance Laboratory |
Kevin Ohlendorf |
| K210588 |
02/26/2021 |
Black Nitrile Powder Free Patient Examination Glove, Non Sterile |
Onetexx SDN BHD |
Freddy Low |
| K210366 |
02/08/2021 |
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile |
Onetexx SDN BHD |
Freddy Low |
| K210587 |
02/26/2021 |
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile |
Onetexx SDN BHD |
Freddy Low |
| DEN210058 |
12/30/2021 |
ELEOSxÖ Limb Salvage System |
Onkos Surgical |
Matthew (Matt) Vernak |
| K213854 |
12/10/2021 |
SavvyWire |
Opsens Inc. |
Marc Chaunet |
| K213951 |
12/17/2021 |
FORZA XP Expandable Spacer System |
Orthofix US LLC |
Natalia Volosen |
| K213905 |
12/14/2021 |
ONX Large External Fixation System |
OrthoNovis, Inc. |
Ken West |
| K213935 |
12/16/2021 |
PISCES-SA Standalone ALIF Interbody System |
Osseus Fusion Systems |
Jonathan Rosen |
| K210360 |
02/08/2021 |
Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models) |
Osteonic Co., Ltd |
Na Young Kang |
| K210579 |
02/26/2021 |
WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System |
OTU Medical Inc. |
Geping Liu |
| K210399 |
02/10/2021 |
Unifine SafeControl |
Owen Mumford Ltd |
Darren Mansell |
| K214007 |
12/22/2021 |
HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap |
Owens & Minor (O&M) Halyard, Inc. |
Anureet Singh |
| K210412 |
02/11/2021 |
Pac-Dent Ceramic Nanohybrid Resin |
Pac-Dent, Inc. |
Jingtian Peng |
| K213982 |
12/20/2021 |
Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires |
Pacific Instruments |
Tracy Sullivan |
| K210390 |
02/09/2021 |
Apex 3D Total Ankle Replacement System |
Paragon 28, Inc. |
Haylie Hertz |
| K210259 |
02/01/2021 |
Parkell Self-Adhesive Cement |
Parkell, Inc |
La-Shaunda Joseph |
| K210369 |
02/08/2021 |
Powder Free Nitrile Examination Glove |
Pastel Glove Sdn Bhd |
Siou Wei Law |
| K210365 |
02/08/2021 |
Second Opinion |
Pearl Inc. |
Bill Birdsall |
| K214080 |
12/27/2021 |
Pentaflush |
PENTAFERTE ITALIA S.R.L. |
Rosa Di Gioia |
| K210485 |
02/19/2021 |
PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family) |
PENTAX of America, Inc. |
William Goeller |
| K210323 |
02/04/2021 |
Indigo Aspiration System - Lightning Aspiration Tubing |
Penumbra, Inc. |
Micaela Victoria |
| K214048 |
12/27/2021 |
Millipede 088 Access Catheter |
Perfuze Ltd. |
Anne-Marie Gannon |
| K213960 |
12/17/2021 |
LiverMultiScan v5 (LMSv5) |
Perspectum |
Wigley Ioan |
| K210560 |
02/25/2021 |
Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph |
Philips Medical Systems |
Hong Zhu |
| K214081 |
12/27/2021 |
MRCAT Head & Neck |
Philips Oy |
Janne Marvola |
| K213922 |
12/15/2021 |
FX SPS |
Pixee Medical |
Agathe Joet |
| K210444 |
02/16/2021 |
EZ-Injec LDV Sterile Safety Needle |
Poonglim Pharmatech Inc. |
Cho Hee Min |
| K210443 |
02/16/2021 |
PLPT LDV (Low Dead Volume) Sterile Syringe |
Poonglim Pharmatech Inc. |
Cho Hee Min |
| K214002 |
12/21/2021 |
CRYOcheck Chromogenic Factor IX |
Precision BioLogic Inc. |
Karen Black |
| K210344 |
02/05/2021 |
inVisionOS |
PrecisionOS Technology Inc. |
Danny Goel |
| K213841 |
12/09/2021 |
ENEO TOTALE (Model: ENEOT947) |
Premier North America Inc. |
Ellis Tamari |
| K214100 |
12/29/2021 |
Luminice |
Premier North America Inc. |
Ellis Tamari |
| K210450 |
02/16/2021 |
BBX-PET Scanner |
Prescient Imaging, LLC |
Farhad Daghighian |
| K210328 |
02/04/2021 |
SafeSept Blunt Needle |
Pressure Products Medical Device Manufacturing LLC |
Andrew Amour |
| K213765 |
12/01/2021 |
Glidewell 3DP Denture Base Resin |
Prismatik Dentalcraft, Inc. |
Jiahe Li |
| K214102 |
12/29/2021 |
Glidewell Appliance Resin, Hard/Soft |
Prismatik Dentalcraft, Inc. |
Jiahe Li |
| K210298 |
02/03/2021 |
GR-14 Resin System |
Pro3dure Medical GmbH |
Frank Gischer |
| DEN210056 |
12/08/2021 |
Procise IFX |
ProciseDx Inc. |
Kurtis R. Bray |
| K210553 |
02/25/2021 |
Steam-Dot Process Indicator |
Propper Manufacturing Co., Inc. |
Andrew Sharavara |
| K213803 |
12/06/2021 |
FIBERGRAFT Aeridyan Matrix Bone Graft Substitute |
Prosidyan, Inc |
Charanpreet S. Bagga |
| K213862 |
12/10/2021 |
HD60 Series Ultrasound Diagnostic System |
Qingdao Hisense Medical Equipment Co., Ltd |
Yalan Wu |
| K210371 |
02/08/2021 |
Portable Oxygen Concentrator, model: P2-E6 |
Qingdao Kingon Medical Science and Technology Co., Ltd. |
Zhang Benrong |
| K213846 |
12/10/2021 |
Q2 Blood Administration Sets |
Quest Medical, Inc. |
Tosan Eweka |
| K214035 |
12/23/2021 |
LAITEST Medical Face Mask |
R&R Medical Corporation Ltd |
Wilson Chang |
| K214062 |
12/27/2021 |
Radialis PET Camera |
Radialis Inc. |
Michael Waterston |
| K213892 |
12/14/2021 |
Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine |
RB Health (US) LLC |
Joseph Macfarlane |
| K210349 |
02/08/2021 |
TKO Composite Bite Turbo Gel |
Reliance Orthodontic Products, Inc |
Christine Cook |
| K213836 |
12/09/2021 |
Intracept Intraosseous Nerve Ablation System |
Relievant Medsystems, Inc. |
Thomas A Slater |
| K213913 |
12/15/2021 |
leva Pelvic Health System |
Renovia Inc. |
Jim O'Connor |
| K214045 |
12/27/2021 |
FreedomEdge Syringe Infusion System |
Repro-Medical System, Inc., dba Koru Medical Systems |
Christopher Pazdan |
| K213776 |
12/02/2021 |
LiverSmart |
Resonance Health Analysis Services Pty Ltd |
Mitchell Wells |
| K214096 |
12/28/2021 |
Respire Clear |
Respire Medical, LLC |
David Walton |
| K210386 |
02/09/2021 |
Magneto Nasal Mask |
Respironics, Inc. |
Anna Danley |
| K214022 |
12/22/2021 |
Accu-Chek Softclix Blood Lancing System |
Roche Diabetes Care, Inc. |
Cameron Smith |
| K210546 |
02/25/2021 |
Elecsys proBNP II, Elecsys proBNP II STAT |
Roche Diagnostics |
Jane Phillips |
| K210385 |
02/09/2021 |
cobas Cdiff nucleic acid test for use on the cobas Liat System |
Roche Molecular Systems, Inc. |
Gaila Balniene |
| K213822 |
12/08/2021 |
cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System |
Roche Molecular Systems, Inc. |
Kaitlyn Hameister |
| K213804 |
12/06/2021 |
cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems |
Roche Molecular Systems, Inc. |
Rita Hoady |
| K210509 |
02/22/2021 |
Rocket Platinum Cured Cathter |
Rocket Medical Plc |
Tracy Charlton |
| K210535 |
02/24/2021 |
UltraLight LED System |
Rohrer Aesthetics, LLC |
Mark Rohrer |
| K214094 |
12/28/2021 |
ROKI Surgical Mask |
ROKI Co., Ltd. |
Takamasa Murata |
| K213975 |
12/20/2021 |
KEOPS Balance Analyzer 3D |
S.M.A.I.O |
Jean-Charles Roussouly |
| K210636 |
02/19/2021 |
Morpheus |
S4S UK Ltd. |
Matthew Everatt |
| K213897 |
12/14/2021 |
Pro M Class |
Saeyang Microtech Co., Ltd. |
Chang Hun Jeon |
| K210426 |
02/11/2021 |
HS40 Diagnostic Ultrasound System |
Samsung Medison CO., LTD. |
Ju Jee Young |
| K210326 |
02/04/2021 |
Bravo G4 Chamber Autoclave |
SciCan Ltd. |
Teresa Boyce |
| K214057 |
12/27/2021 |
STATIM 6000B Vacuum Autoclave |
SciCan Ltd. |
Teresa Boyce |
| K213761 |
12/01/2021 |
Joule diVa System |
Sciton, Inc |
Jay M Patel |
| K210379 |
02/09/2021 |
Broncho Videoscope System |
Scivita Medical Technology Co., Ltd. |
Ruqin Wu |
| K210404 |
02/10/2021 |
Transpara 1.7.0 |
ScreenPoint Medical B.V. |
Umar Waqas |
| K214118 |
12/30/2021 |
Riva Cem Automix |
SDI Limited |
Antonella Kotefski |
| K210497 |
02/22/2021 |
SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aòPOD-L NanoMetalene, SeaSpine Vu eòPOD System, SeaSpine Vu aòPOD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervic |
SeaSpine Orthopedics Corporation |
Aly Alvarez |
| K210583 |
02/26/2021 |
SeaSpine WaveFormÖ A Interbody System |
SeaSpine Orthopedics Corporation |
Aly Alvarez |
| K210570 |
02/26/2021 |
TraumaGuard Intra-abdominal Pressure Sensing System |
Sentinel Medical Technologies, LLC |
Robert Mueller |
| K210518 |
02/23/2021 |
Surgical Face Mask |
Shandong Haidike Medical Products Co., Ltd. |
Lili Xu |
| K213994 |
12/21/2021 |
Flexible Block |
Shandong Huge Dental Material Corporation |
Maggie Zheng |
| K210520 |
02/23/2021 |
Disposable Synthetic Examination Gloves |
Shandong Shengshixincheng Medical Science & Technology Co., |
Ping Wang |
| K210522 |
02/23/2021 |
Disposable Vinyl Examination Gloves |
Shandong Shengshixincheng Medical Science & Technology Co., |
Ping Wang |
| K210409 |
02/11/2021 |
Disposable Surgical Face Mask |
Shandong Zhushi Pharmaceutical Group Co., Ltd |
Junhui Zhu |
| K210510 |
02/22/2021 |
Disposable Surgical Gown |
Shandong Zhushi Pharmaceutical Group Co., Ltd |
Junhui Zhu |
| K210313 |
02/03/2021 |
EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter |
Shanghai MicroPort EP MedTech Co., Ltd. |
Xia Tian |
| K210418 |
02/11/2021 |
HYPER Focus |
Shanghai United Imaging Healthcare Co.,Ltd. |
Xin Gao |
| K210317 |
02/03/2021 |
Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System |
Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) |
Flower Cai |
| K210318 |
02/03/2021 |
Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System |
Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) |
Flower Cai |
| K210380 |
02/09/2021 |
Medical surgical mask |
Shantou T&K Medical Equipment Factory Co.,Ltd |
Wan Li |
| K210448 |
02/16/2021 |
Adhesive Electrode |
Shaoxing Yingtuo Healthcare Co.,Ltd. |
Haze XU |
| K213884 |
12/13/2021 |
Disposable EEG cable |
Shenzhen Changke Connect Electronics Co., Ltd. |
Yahui Zhou |
| K210364 |
02/08/2021 |
Migraine Tens Digital Pain Reliever |
Shenzhen Dongdixin Technology Co., Ltd. |
Siping Yuan |
| K213835 |
12/09/2021 |
TENS & EMS Device |
Shenzhen Jian feng Electronic Technology Co. Ltd. |
Feng Wen |
| K210435 |
02/12/2021 |
Automatic Arm Electronic Blood Pressure Monitor |
Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. |
Aaron Lin |
| K210441 |
02/12/2021 |
Incontinence Probe |
Shenzhen Med-link Electronics Tech Co, Ltd |
Yongfen Yang |
| K210416 |
02/11/2021 |
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
Shi Jufang |
| K213799 |
12/06/2021 |
N Series Patient Monitors |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
Li Lei |
| K210311 |
02/03/2021 |
Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7. |
Shenzhen Mismon Technology Co., Ltd. |
Rain Yip |
| K214113 |
12/30/2021 |
Hand-held IPL device(JOVS Graphene Hair Removal Device) |
Shenzhen Qianyu Technology Co., Ltd. |
Kunming Lin |
| K214008 |
12/22/2021 |
Dental diode laser |
Shenzhen Soga Technology Co., Ltd. |
Tse Adrian |
| K210373 |
02/08/2021 |
Clear Aligners |
Shenzhen Yinuo Dental Technology Co.LTD |
Mo Yuyum |
| K214003 |
12/21/2021 |
Dental Zirconia Pre-shaded Block |
Shenzhen Yurucheng Dental Materials Co., Ltd. |
Fiya Liao |
| K214005 |
12/21/2021 |
Zirconia Dental Ceramics |
Shenzhen Yurucheng Dental Materials Co., Ltd. |
Fiya Liao |
| K213984 |
12/20/2021 |
Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) |
ShenZhen ZhengKang Technology Co., Ltd. |
Huayong Yang |
| K213965 |
12/20/2021 |
BeautiBond Xtreme |
Shofu Dental Corporation |
Mauro Malzyner |
| K210533 |
02/24/2021 |
Inset Reverse Total Shoulder System |
Shoulder Innovations, Inc. |
Don Running |
| K210489 |
02/19/2021 |
SICtapered & SICvantage tapered |
SIC invent AG |
Cretia Arlene McNett |
| K210262 |
02/01/2021 |
Biograph Vision Quadra PET/CT System |
Siemens Medical Solutions USA, Inc. |
Alaine Medio |
| K210309 |
02/03/2021 |
Cios Select (VA21) Flat Panel |
Siemens Medical Solutions USA, Inc. |
Cordell Fields |
| K210307 |
02/03/2021 |
Cios Select (VA21) Image Intensifier |
Siemens Medical Solutions USA, Inc. |
Cordell Fields |
| K213805 |
12/06/2021 |
MAGNETOM Vida |
Siemens Medical Solutions USA, Inc. |
Karthik Pillai |
| K210557 |
02/25/2021 |
Symbia VA10A Family |
Siemens Medical Solutions USA, Inc. |
Tabitha Estes |
| K214019 |
12/22/2021 |
syngo.CT Extended Functionality |
Siemens Medical Solutions USA, Inc. |
Alaine Medio |
| K214124 |
12/30/2021 |
AlloX2 Pro Tissue Expanders |
Sientra, Inc. |
Denise Daljes |
| K213895 |
12/14/2021 |
Distal Humerus Plating System |
Skeletal Dynamics, Inc. |
Alexandra Rodriguez |
| K210269 |
02/01/2021 |
PowerDot PD-01MT2 Muscle Stimulator |
Smartmissimo Technologies Pte Ltd |
Alexey Pisarev |
| K213943 |
12/17/2021 |
SmartSurgN Visualization System |
SmartSurgN Incorporated |
Cathy Mantor |
| K210566 |
02/26/2021 |
LEGION Porous CR Narrow Femoral Components |
Smith & Nephew, Inc. |
Michelle Huettner |
| K213874 |
12/13/2021 |
MAVERICK External Fixation System |
Smith & Nephew, Inc. |
Brad Sheals |
| K213827 |
12/08/2021 |
TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) |
Smith & Nephew, Inc. |
Stephanie Rincones |
| K213853 |
12/10/2021 |
RENASYSÖ-WF White Foam NPWT Dressing Small; RENASYSÖ-WF White Foam NPWT Dressing Large |
Smith and Nephew Medical Limited |
Jean-Marie Steeve |
| K210354 |
02/08/2021 |
SNUCONE Bone Level Implant System |
SNUCONE Co., LTD. |
Ji Eun Song |
| K210341 |
02/05/2021 |
One Step Pregnancy Test |
SPD Swiss Precision Diagnostics GmbH |
Joanne Scaife |
| K214076 |
12/27/2021 |
EsCem |
SPIDENT CO., LTD. |
J.M. Ahn |
| K214071 |
12/27/2021 |
Hexa-Temp |
SPIDENT CO., LTD. |
J.M. Ahn |
| K210472 |
02/17/2021 |
SPINEART Navigation Instrument System |
Spineart |
Franck Pennesi |
| K213876 |
12/13/2021 |
Spineology Navigation Instruments |
Spineology Inc. |
Andrew Adams |
| K210359 |
02/08/2021 |
Hexanium TLIF |
SpineVision SAS |
Arnaud Brisard |
| K210437 |
02/12/2021 |
Standard Bougie, 38 Fr. |
Standard Bariatrics |
Michelle Schnell |
| K210278 |
02/01/2021 |
Titan SGS |
Standard Bariatrics |
Alison Sathe |
| K210342 |
02/05/2021 |
BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor |
STERIS Corporation |
Carroll Martin |
| K213881 |
12/13/2021 |
Celerity Incubator |
STERIS Corporation |
Gregory Land |
| K213859 |
12/10/2021 |
Stronghold Group Nitrile Examination Glove, Powder Free |
Stronghold Group LLC |
David Henderson |
| K214046 |
12/27/2021 |
780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable |
Stryker |
Michelle Hughes |
| K210584 |
02/26/2021 |
SDC3 HD Information Management System with Wireless Device Control Capability |
Stryker |
Divya Sekar |
| K213824 |
12/08/2021 |
Sonopet iQ Ultrasonic Aspirator System |
Stryker Corporation |
Thomas Flannelly |
| K210377 |
02/09/2021 |
Stryker iBur hubs and cutting accessories |
Stryker Corporation |
Alison Garrad |
| K210582 |
02/26/2021 |
EasyClip« and EasyClip« Xpress |
Stryker GmbH |
Danielle Jannuzzi Madureira |
| K213777 |
12/03/2021 |
Stryker Resorbable Fixation System |
Stryker Leibinger Micro Implants |
Gregory Gohl |
| K210502 |
02/22/2021 |
Trevo NXT ProVue Retriever |
Stryker Neurovascular |
Rebecca Rosman |
| K213921 |
12/15/2021 |
Microthin Natural Rubber Latex Condom |
Suretex Limited |
KC Nguyen |
| K210495 |
02/22/2021 |
Port Access System |
Surgical Innovations Limited |
Stephen Seed |
| K210488 |
02/19/2021 |
Ultrasonic Surgical & Electrosurgical Generator |
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. |
Guofang Ma |
| K214097 |
12/28/2021 |
Explorer Air II |
SurgVision GmbH |
Daniela Mahan |
| K210562 |
02/25/2021 |
HRSpheres Narrow-Size Embolic Microspheres |
Suzhou Hengrui Hongyuan Medical Co., Ltd. |
Qianqian Zhang |
| K214090 |
12/28/2021 |
Back 3 COLOR |
SWIMS America Corp |
Matthieu Commeau |
| K213974 |
12/20/2021 |
GEM FLOW COUPLER Monitor (GEM1020M-2) |
Synovis Micro Companies Alliance, Inc. |
Russell Pagano |
| K210408 |
02/11/2021 |
DePuy Synthes Variable Angle Locking Patella Plating System |
Synthes (USA) Products, LLC |
Enrico Gindro |
| K210346 |
02/08/2021 |
Sysmex XW-100 Automated Hematology Analyzer |
Sysmex America, INC. |
Sharita Brooks |
| K210498 |
02/22/2021 |
Betta Link Knotless Implant System |
T.A.G. Medical Products Corporation, Ltd |
Shlomi Dines |
| K214070 |
12/27/2021 |
OviTex PRS (Long Term Resorbable) |
TELA Bio |
John Urtz |
| K210294 |
02/02/2021 |
One Touch Spiral Condom |
Thai Nippon Rubber Industry Public Company Limited |
Ryosuke Takamiya |
| K210558 |
02/25/2021 |
LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber |
Thayer Medical Corporation |
Christine Woeppel |
| K210529 |
02/23/2021 |
Dr. Yglo Wart Remover |
The OTC Lab Healthcare B.V. |
Albert Swane |
| K210451 |
02/16/2021 |
OrthoGold 100 |
Tissue Regeneration Technologies, LLC |
John Warlick |
| K210396 |
02/10/2021 |
Harmony Referral System |
Topcon Healthcare Solutions EMEA Oy |
Ramya Sundaram |
| K214054 |
12/27/2021 |
TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 |
TP Orthodontics, Inc. |
Cristiane Muller |
| K214107 |
12/29/2021 |
XO CROSS CORONARY Support Catheter |
Transit Scientific, LLC |
Jennifer Arnold |
| K210322 |
02/04/2021 |
XO Cross Support Catheter |
Transit Scientific, LLC |
Jenifer Arnold |
| K214106 |
12/29/2021 |
QuikPass Catheter |
Traverse Vascular, Inc. |
Greg Geissinger |
| K210580 |
02/26/2021 |
InnovaMatrix FS |
Triad Life Sciences, Inc. |
Jon G. Hargis |
| K213961 |
12/20/2021 |
TruAbutment DS, TruBase |
TruAbutment Inc. |
Hyeonhwa An |
| K210481 |
02/19/2021 |
Instant 20s Indicator |
True Indicating LLC |
Thomas Riha |
| K214114 |
12/30/2021 |
Prodigy Thrombectomy System |
Truvic Medical Inc. |
Micheal Buck |
| K210573 |
02/26/2021 |
Velofix SA Cervical Cage |
U&I Corporation |
Jee-Ae Bang |
| K210541 |
02/24/2021 |
ulrichINJECT CT motion |
ulrich GmbH & Co. KG |
Sven Erdmann |
| K210550 |
02/25/2021 |
VALO Grand Corded and Accessory Lenses |
Ultradent Products, Inc |
Adam Black |
| K210513 |
02/23/2021 |
UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2 |
Universal Incorporation |
Mei-Hui Huang |
| K210544 |
02/24/2021 |
Medtronic Extended infusion set |
Unomedical A/S |
Lone Sylvest Vestergaard Jepsen |
| K210512 |
02/23/2021 |
LUMINELLE DTx System |
Uvision360, Inc. |
Allison London Brown |
| K213880 |
12/13/2021 |
Custom Stable Rigid Gas Permeable Scleral Contact Lens |
Valley Contax, Inc. |
Josh Adams |
| K213927 |
12/16/2021 |
Respiratory Gating for Scanners v2.0 |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K213977 |
12/20/2021 |
TrueBeam, TrueBeam STx, Edge, VitalBeam |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K210329 |
02/04/2021 |
Green X 18(Model : PHT-75CHS) |
Vatech Co., Ltd |
Daniel Kim |
| K213815 |
12/07/2021 |
SiJoin«T3 |
VGI Medical, Inc. |
Tov Vestgaarden |
| K213795 |
12/06/2021 |
Videa Caries Assist |
VideaHealth, Inc |
Florian Hillen |
| K210265 |
02/01/2021 |
VS3 Iridium Sytem |
Visionsense Ltd. |
Nancy Sauer |
| K213869 |
12/13/2021 |
EmbryoSlide+ ic8 dish |
Vitrolife A/S |
Belinda Dueholm |
| K213814 |
12/07/2021 |
Viveve 2.0 System |
Viveve, Inc. |
Kevin Robison |
| K210300 |
02/03/2021 |
VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System |
VueSonic, LLC |
Sheri Ker |
| K210327 |
02/04/2021 |
First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup |
W.H.P.M., Inc. |
John Wan |
| K213770 |
12/02/2021 |
SP-CL Hip Stem and LCU Hip System |
Waldemar Link GmbH & Co. KG |
Pia Mⁿller |
| K213900 |
12/14/2021 |
WAVi SCAN EEG System and Accessories |
WAVi Co. |
David Oakley |
| K214073 |
12/27/2021 |
eWave Monitor |
WearLinq, Inc. |
Konrad Morzkowski |
| K210348 |
02/08/2021 |
Disposable Medical Surgical Mask |
Weihai Dishang Medical Technology Co., Ltd |
Ricky Xia |
| K210355 |
02/08/2021 |
Surgical Gown, Model: surgical gown-hp-3 |
Weihai Dishang Medical Technology Co., Ltd |
Ricky Xia |
| K214088 |
12/28/2021 |
Disposable Surgical Gown |
Weihai Hongyu Nonwoven Fabric Products Co., Ltd. |
Bin Dong |
| K210491 |
02/19/2021 |
CW120N |
Wide Corporation |
YeoJin Yun |
| K210493 |
02/19/2021 |
CX30N (CX30PQX) |
Wide Corporation |
YeoJin Yun |
| K210466 |
02/16/2021 |
Silver Gelling Fiber Dressing |
Winner Medical Co., Ltd. |
Haoyuan He |
| K210330 |
02/04/2021 |
Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant |
WRP Asia Pacific SDN BHD |
Zahari Bin Darus |
| K210433 |
02/12/2021 |
Surgical Face Mask (Ear loops and Tie-on) |
Wuhan Dymex Healthcare Co., Ltd. |
Niki Wang |
| K210440 |
02/12/2021 |
Disposable Sampler Inactivated Transport Media, Nest ITM |
Wuxi Nest Biotechnology Co., Ltd. |
Cheng Zhiwei |
| K210288 |
02/02/2021 |
Disposable Manual Resuscitator |
Xiamen Compower Medical Tech. Co., Ltd. |
Lifen Chen |
| K210267 |
02/01/2021 |
Disposable Surgical Mask |
Xiamen Eagledon Pharmaceutical Co., Ltd |
Aggie Zhang |
| K213806 |
12/06/2021 |
Disposable Medical Face Mask |
Xiantao Zhibo Nonwoven Products Co., Ltd |
Fen Peng |
| K213920 |
12/15/2021 |
Kangbeier Surgical Mask (Model: KBR-1001) |
Xinxiang Kangbeier Medical Technology Co., Ltd. |
Shaoju Tian |
| K210257 |
02/01/2021 |
Xoran Workstation, Model 10050 |
Xoran Technologies LLC |
Mark McGarrow |
| K213893 |
12/14/2021 |
Comfort Gown, Safewear Gown |
Xuchang Zhengde Environstar Medical Products Co., Ltd. |
Vincent Yu |
| K210463 |
02/16/2021 |
Thermoplastic Elastomer (TPE) Hybrid Examination Glove |
Xuzhou Full Sun Medical Products Ltd. |
Hsun-Hui Huang |
| K213789 |
12/06/2021 |
Intelligence LaserComb |
Yibin Yingtong Intelligent Technology Co.,Ltd. |
Pengcheng Pan |
| K213891 |
12/14/2021 |
RealNow |
YIWEI Medical Technology Co., Ltd |
Eric Ke |
| K210516 |
02/23/2021 |
Clicky Cross |
Yomura Technologies Inc. |
David Lee |
| K213986 |
12/20/2021 |
CerebralGo Plus |
Yukun (Beijing) Technology Co., Ltd |
Wang Qi |
| K213983 |
12/20/2021 |
Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear |
Yung Sheng Optical Co., Ltd |
Wen-Han Chen |
| K210460 |
02/16/2021 |
NitriTec Vinyl Glove Powder Free Blue |
Zhonghong Pulin Medical Products Co.,Ltd. |
Jia Yongmin |
| K210391 |
02/10/2021 |
Single-use medical face mask |
Zhuhai Herald Datanetics Limited. |
Jackson Leung |
| K210274 |
02/01/2021 |
Fingertip Pulse Oximeter |
Zhuhai Linte Medical Instrument Co., Ltd. |
Kezheng Ma |
| K214060 |
12/27/2021 |
LANDMARK REBOA Catheter |
Zien Medical Technologies, Inc. |
Tim Nieman |
| K210275 |
02/01/2021 |
Polaris Spinal System |
Zimmer Biomet Spine, Inc |
Anjanet Mort |
| K213856 |
12/10/2021 |
Identity Shoulder System |
Zimmer Inc. |
Patricia Sandborn Beres |
| K210551 |
02/25/2021 |
Persona Revision Knee System |
Zimmer, Inc. |
Romil Sheth |
| DEN210004 |
02/16/2021 |
Zuno Smart Sterilization Container |
Zuno Medical, Inc. |
Allan McNichol |
