| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K211511 |
07/01/2021 |
decimal Bolus |
.decimal, LLC |
Kevin Erhart |
| K210884 |
07/27/2021 |
1Derful HS, 1Derful HT |
1Derful, Inc |
Mohamad Alkassab |
| K210104 |
07/08/2021 |
SurroundScope System |
270Surgical Ltd. |
Avi Levy |
| K202727 |
07/23/2021 |
Peregrine Endoscopy System |
3NT Medical Ltd. |
Ehud Bendory |
| K210776 |
07/12/2021 |
Nitrile Examination Gloves |
5R MED Instruments (Chengdu) Co., Ltd. |
Yuzhang Pan |
| K211542 |
07/09/2021 |
PRIMO S |
A.T.S. Applicazione Tecnologie Speciali S.R.L. |
Livia Pillitteri |
| K201761 |
07/30/2021 |
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) |
Abbott Diabetes Care Inc. |
Ono Bacani |
| K211989 |
07/27/2021 |
Aveir Introducer |
Abbott Medical |
Bijal Jain |
| K210750 |
07/15/2021 |
Acumed Clavicle Hook Plating System |
Acumed LLC |
Janki Bhatt |
| K210480 |
07/06/2021 |
AcuPebble SA |
Acurable Limited |
Esther Rodriguez-Villegas |
| K211111 |
07/16/2021 |
SureMAX-SA Cervical Standalone System |
Additive Implants, Inc |
Jeff Horn |
| K210248 |
07/30/2021 |
Lab Bag with Fabric Pouch |
Advanced Medical Design Co., Ltd. |
Silvia Yeh |
| K210963 |
07/19/2021 |
ENNOVATE Spinal System |
Aesculap Implant Systems, LLC |
Paul Amudala |
| K211790 |
07/30/2021 |
DX-D Imaging Package with XD Detectors |
Agfa N.V. |
Wim Govaerts |
| K203441 |
07/02/2021 |
The Alma Hybrid Laser System |
Alma Lasers, Ltd. |
Avi Hirshnzon |
| K211249 |
07/23/2021 |
Altor Safety 3-Ply Surgical Mask (Model:62222) |
Altor Safety LLC |
Jared Scott |
| K210011 |
07/16/2021 |
JS Dental Lab Mouth Guard |
Ampower Dental Laboratories, LLC |
Dylan Hao |
| K210770 |
07/29/2021 |
Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor |
Andon Health Co., Ltd. |
Liu Yi |
| K210768 |
07/30/2021 |
Wrist Blood Pressure Monitor, Blood Pressure Monitor |
Andon Health Co., Ltd. |
Liu Yi |
| K202582 |
07/22/2021 |
Arthrex SynergyID Endoscopic Imaging System |
Arthrex Inc. |
Heli F. Chambi Infantas |
| K211325 |
07/27/2021 |
Senhance Surgical System |
Asensus Surgical, Inc. |
Taylor Fisher |
| K211688 |
07/22/2021 |
DC-Air and Athlos-1 and Athlos-Air |
Athlos Oy |
Konstantinos Spartiotis |
| K210477 |
07/26/2021 |
AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE |
AtriCure Inc. |
Melissa Smallwood |
| K211188 |
07/19/2021 |
xvision Spine system (XVS) |
Augmedics Ltd |
Tami Harel |
| K211493 |
07/09/2021 |
Monarch Platform |
Auris Health, Inc. |
Shikha Gola |
| K211592 |
07/16/2021 |
Avanti Orthopaedics Ulnar Shortening System |
Avanti Orthopaedics, Inc. |
J. Doug Patterson |
| K202208 |
07/30/2021 |
BeneHold Surgical Incise Drape with CHG antimicrobial |
Avery Dennison Belgie BVBA |
Lisa Bartakovics |
| K202825 |
07/29/2021 |
BTI Extra-Short Dental Implant System UnicCa |
B.T.I. Biotechnology Institute, S.L. |
Jose Roman Rivero |
| K210264 |
07/30/2021 |
BD PowerPiCC Catheter |
Bard Access Systems, Inc. |
Mary Strickland |
| K211933 |
07/15/2021 |
EleVation Breast Biopsy System |
Bard Peripheral Vascular |
Meghan McKelvey |
| K210127 |
07/02/2021 |
iQ200 System, iChemVELOCITY Automated Urine Chemistry System |
Beckman Coulter, Inc. |
Marisa Pugliese |
| K203359 |
07/28/2021 |
BD Flu+ Syringe |
Becton, Dickinson and Company |
Nikita Abirami Mahendra Kumar |
| K203659 |
07/08/2021 |
iSR'obot Mona Lisa 1.0 |
Biobot Surgical Pte Ltd |
Lim Yan Shin |
| K201675 |
07/09/2021 |
VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 ╡g/mL) |
bioMerieux, Inc. |
Debra Broyles |
| K203712 |
07/20/2021 |
The Slide |
Biotex, Inc. |
Wade Munsch |
| K203158 |
07/08/2021 |
BioWave BioWraps |
BioWave Corporation |
Bradford Siff |
| K210382 |
07/23/2021 |
Blustone Synergy Diamond SA Cervical System |
Blustone Synergy, LLC |
Tom Gentry |
| K211646 |
07/28/2021 |
FINE Osteotomy |
Bodycad Laboratories, Inc. |
Nadine Adia |
| K211223 |
07/21/2021 |
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System |
Boston Scientific Corporation |
Rachel Nankervis |
| K211939 |
07/22/2021 |
ExacTrac Dynamic |
Brainlab AG |
Chiara Cunico |
| K203262 |
07/01/2021 |
Cannula for Organ Perfusion |
Bridge to Life Ltd. |
Brett Schultz |
| K211107 |
07/09/2021 |
BTL-899 FP |
BTL Industries Inc. |
David Chmel |
| K210970 |
07/21/2021 |
Single-Use Surgical Mask Model FE2311B |
BYD Precison Manufacturer Co., Ltd. |
Yubo Guan |
| K203575 |
07/01/2021 |
GlidePath Retro Long-Term Hemodialysis Catheter |
C.R. Bard, Inc. |
Joan Bergstrom |
| K211633 |
07/22/2021 |
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR |
Canon Medical Systems Corporation |
Janine F. Reyes |
| K211991 |
07/28/2021 |
Catalyst R1 Reverse Shoulder System |
Catalyst OrthoScience, Inc. |
Dale Davison |
| K210719 |
07/20/2021 |
Change Healthcare Anatomical AI |
Change Healthcare Canada Company |
Chester McCoy |
| K211042 |
07/15/2021 |
Disposable Procedural Ear-loop Face Mask |
Changzhou DSB Medical Co., LTD |
Sunny Han |
| K210524 |
07/07/2021 |
Surgical Mask |
Changzhou Holymed Products Co., Ltd. |
Shan Shang |
| K201009 |
07/21/2021 |
CHIRAVAC Blood Collection Needles |
CHIRANA T. Injecta |
Zdenka Klbeckova |
| K210856 |
07/28/2021 |
Purism Disposable Surgical Mask |
Chuzhou Daddy's Choice Science and Technology Co., Ltd. |
Amie Yang |
| K212074 |
07/27/2021 |
ClariCT.AI |
ClariPi Inc. |
Hyun-Sook Park |
| K203591 |
07/02/2021 |
Single-use Medical Face Mask |
Conod Medical Co., Limited |
Carrie Wu |
| K211782 |
07/01/2021 |
ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 |
ControlRad, Inc |
Chris Fair |
| K211866 |
07/14/2021 |
Bencox THR System |
Corentec Co., Ltd. |
Seungri Kim |
| K201657 |
07/28/2021 |
Corin Ltd. Hip Products: TrinityÖ Acetabular System, TrinityÖ PLUS Acetabular Shell, MetaFixÖ Hip System, TriFitÖ CF and TS Hip Systems, TaperFitÖ Hip System, RevivalÖ Modular Hip System, MiniHipÖ, TrinityÖ Dual Mobility, MobiliT, BiPolar-i, OMNI MODÖ Hip |
Corin Ltd. |
Christina Rovaldi |
| K211951 |
07/23/2021 |
GI Genius |
Cosmo Artificial Intelligence - AI Ltd |
Nhan Ngo Dinh |
| K200096 |
07/15/2021 |
Crosstex VH2O2 Chemical Indicators |
Crosstex International, Inc. (A Cantel Medical Company) |
Pablo Martinez |
| K203534 |
07/21/2021 |
Surgical face mask (Model: Flat Ear Loop/CN102) |
Crown Name Disposable Hygiene Products Fty., Ltd. |
Ying Fang |
| K211317 |
07/29/2021 |
CRUXVIEW |
CRUXELL Corp. |
Boeun Bang |
| K211994 |
07/28/2021 |
Braun Silk.expert Mini |
CyDen Limited |
Adam Stephens |
| K202517 |
07/09/2021 |
Cytrellis Dermal Micro-Coring System |
Cytrellis Biosystems, Inc. |
Karen H. Cronholm |
| K203498 |
07/02/2021 |
LX9max |
Daesung Maref CO., LTD. |
Su Hyeon So |
| K211225 |
07/28/2021 |
MIS Ti-base abutment |
Dentsply Sirona |
Rebecca Sporer |
| K203694 |
07/22/2021 |
DELTA XTEND Reverse Shoulder System |
DePuy Ireland UC |
Jaclyn Cincotta |
| K201328 |
07/15/2021 |
Dexcom G6 Continuous Glucose Monitoring (CGM) System |
Dexcom, Inc. |
Maryam Amini |
| K203459 |
07/06/2021 |
SafeCross Transseptal Puncture and Introducer (TSP/I) System |
East End Medical I LLC |
Brij Maini |
| K212035 |
07/30/2021 |
FibroScan 230 |
Echosens |
Karine Bonenfant |
| K211547 |
07/15/2021 |
Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) |
Edma Group, LLC |
Vio Cretu |
| K211465 |
07/08/2021 |
HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform |
Edwards Lfesciences |
Chirag Shah |
| K203224 |
07/30/2021 |
Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform |
Edwards Lifesciences, LLC |
Lisa Gilman |
| K211395 |
07/28/2021 |
NIO-I |
Einstein Works LLC |
Roy Bachrach |
| K211491 |
07/12/2021 |
RadiForce RX370 |
EIZO Corporation |
Hiroaki Hashimoto |
| K210791 |
07/27/2021 |
Us2.v1 |
eko.ai Pte. Ltd. d/b/a Us2.ai |
James Hare |
| K211821 |
07/06/2021 |
DEKA Motus AZ |
El.En Electronic Engineering SPA |
Paolo Peruzzi |
| K211839 |
07/28/2021 |
Electrode Market Disposable Surface Electrodes |
Electrode Market Co.,Ltd. |
Seolmin Jeong |
| K203408 |
07/30/2021 |
Summit Patella Plating System |
Endeavor Orthopaedics, LLC |
John Alleman |
| K210761 |
07/16/2021 |
Velguard Surgical Face Mask |
Esstee Exports Health Care Division |
Zachary Wilson |
| K192971 |
07/08/2021 |
Nebulizer Kit |
Excellentcare Medical (Huizhou) Ltd. |
Chunyu Zhao |
| K211655 |
07/27/2021 |
aPROMISE |
EXINI Diagnostics AB |
Aseem Anand |
| K201473 |
07/16/2021 |
ExoAtlet-II |
ExoAtlet Asia Co. Ltd. |
Bret Bostock |
| K193352 |
07/21/2021 |
AbutmentCAD |
exocad GmbH |
Stefan Walter |
| K210468 |
07/23/2021 |
SC1 Handheld Ultrasound Imaging System (Model: SC1) |
FCU Co., Ltd. |
Lee Hee Yeon |
| K211291 |
07/19/2021 |
Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D |
Fiagon GmbH |
Dirk Mucha |
| K193490 |
07/08/2021 |
SensiTox C. difficile Toxin Test |
First Light Diagnostics, Inc. |
Joanne Spadoro |
| K212030 |
07/23/2021 |
Flex-ThreadÖ Distal Fibula lntramedullary Nail System |
Flower Orthopedics Corporation DBA Conventus Flower |
Amanda Pentecost |
| K210143 |
07/22/2021 |
Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) |
Foshan Nanhai Plus Medical CO LTD |
Eric Li |
| K210870 |
07/30/2021 |
MEO Med Disposable Medical Face Mask |
Fujian MEO Medical Technology Limited |
Zhuang Yan |
| K210159 |
07/23/2021 |
IntraLock System |
Fusion Orthopedics, LLC |
Whitney Rey |
| K211247 |
07/27/2021 |
PET VCAR |
GE Medical Systems SCS |
Elizabeth Mathew |
| K203496 |
07/14/2021 |
Nexo-Gide Bilayer Collagen Membrane |
Geistlich Pharma AG |
Marco Steiner |
| K201733 |
07/14/2021 |
Provident II Hip Stems |
Globus Medical Inc. |
Jennifer Antonacci |
| K202846 |
07/15/2021 |
TERA HARZ |
Graphy Inc. |
Tae-woo Kim |
| K211220 |
07/22/2021 |
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs |
Guangdong Kingfa Sci. & Tech. Co., Ltd. |
Xiaoge Yu |
| K202638 |
07/15/2021 |
Pain Therapy Device |
Guangzhou Xinbo Electronic Co., Ltd. |
Sammy Li |
| K210736 |
07/27/2021 |
doctorgram Stethoscope DES-I |
GV Concepts |
Ching-Kay Chow |
| K200915 |
07/09/2021 |
Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs |
GX Corporation Sdn Bhd |
Khon Pu Foo |
| K212052 |
07/23/2021 |
HMB32 Dialysis Solution |
Haemopharm Biofluids S.r.l. |
Francesca Curti |
| K202241 |
07/02/2021 |
LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) |
Hamilton Thorne, Inc. |
Donald Fournier |
| K201726 |
07/07/2021 |
Arterial Catheter |
Haolang Medical USA Corporation |
Lisa Xu |
| K202171 |
07/01/2021 |
Pulmogine Vibrating Mesh Nebulizer |
HCMed Innovations Co., Ltd. |
Yiling Lee |
| K211229 |
07/29/2021 |
Vinyl compound examination gloves |
Hebei Titans Hongsen Medical Technology Co., LTD. |
Feng Shuangyan |
| K210607 |
07/09/2021 |
PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro |
Heraeus Medical GmbH |
Ljuba Jaeckel |
| K211497 |
07/28/2021 |
Surgical Mask |
Honeywell Safety Products |
Ivy Pettis |
| K203431 |
07/28/2021 |
Disposable Ear Thermometer Probe Cover |
Huaian Zhongxin Packing Material Co., Ltd. |
Feng Zuo |
| K211012 |
07/23/2021 |
Nitrile Patient Examination Gloves |
Huayuan Medical Technology(Shangqiu) Co., Ltd. |
Huamei Wang |
| K211363 |
07/24/2021 |
Medical Face Mask |
HuBei Kangning Protective Products Co., Ltd. |
Zhao Yuxuan |
| K211818 |
07/07/2021 |
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System |
Hyperfine, Inc. |
Christine Kupchick |
| K211506 |
07/12/2021 |
PowerLook Density Assessment V4.0 |
iCAD, Inc. |
Heather Reed |
| K203108 |
07/16/2021 |
Ignite Stemless Anatomic Shoulder System |
Ignite Orthopedics LLC |
Matt Purdy |
| K210666 |
07/20/2021 |
Chest-CAD |
Imagen Technologies, Inc |
Robert Lindsey |
| K210469 |
07/27/2021 |
Insight Agile DRF |
Imaging Engineering, LLC |
George Jachode |
| K210431 |
07/15/2021 |
ReCross |
IMDS Operations B.V. |
Edwin Schulting |
| K203509 |
07/14/2021 |
SMART FINDER |
IMS Giotto S.p.A. |
Antonella Rossi |
| K210176 |
07/22/2021 |
FlowSaver Blood Filter |
Inari Medical |
Eben Gordon |
| K210877 |
07/19/2021 |
Evolve System with the T3 Applicator |
InMode Ltd. |
Amit Goren |
| K210492 |
07/12/2021 |
InMode RF Pro System |
InMode MD Ltd. |
Amit Goren |
| K203115 |
07/14/2021 |
ARVIS Surgical Navigation System |
Insight Medical Systems Inc. |
Nicholas R. van der Walt |
| K211052 |
07/08/2021 |
Straumann RidgeFit Implants |
Institut Straumann AG |
Viviana Horhoiu |
| K210016 |
07/27/2021 |
Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal |
Integra Lifesciences Corporation |
Blesson Abraham |
| K201147 |
07/19/2021 |
Elos« Intramedullary Nailing System |
Intrauma S.p.A. |
Piero Costa |
| K211316 |
07/23/2021 |
da Vinci SP Surgical System (SP1098) |
Intuitive Surgical, Inc. |
Connor McCarty |
| K202603 |
07/22/2021 |
Temp Pal |
iWEECARE Co., Ltd. |
Glen Tseng |
| K192739 |
07/13/2021 |
Electric Wheelchair [Models: JRWD6010/JRWD6012] |
Jerry Medical Instrument (Shanghai) Co., Ltd. |
Jianguo Chen |
| K210691 |
07/30/2021 |
Disposable Nitrile Medical Examination Glove |
Jiangsu Cureguard Glove Co., Ltd. |
Guo Hua |
| K210684 |
07/20/2021 |
Disposable Nitrile Medical Examination Glove |
Jiangsu Cureguard Glove Co., Ltd. |
Guo Hua |
| K211422 |
07/02/2021 |
Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown |
Jiangsu Medplus Non-woven Manufacturer Co., Ltd. |
Shuying An |
| K202570 |
07/02/2021 |
Insulin Syringe, Insulin Syringe with Safety Retractable |
Jiangsu Micsafe Medical Technology Co., Ltd |
Tony Yang |
| K210215 |
07/07/2021 |
Surgical Gowns |
Jiangsu Province Jianerkang Medical Dressing Co., Ltd |
Tang Hongfang |
| K210578 |
07/10/2021 |
Medical Nitrile Examination Gloves (Power free, Blue) |
Jiangxi Hongda Medical Equipment Group Ltd. |
Yang Qinghua |
| K210821 |
07/09/2021 |
Medical PVC Examination Gloves |
Jiangxi Hongda Medical Equipment Group Ltd. |
Yang Qinghua |
| K211239 |
07/17/2021 |
Vinyl Patient Examination Gloves |
Jiangxi Shengda Medical Technology Co., Ltd. |
Yun Gao |
| K211341 |
07/29/2021 |
Blue Nitrile Exam Gloves |
Jiangxi Surefine Medical Co., Ltd. |
Steve Zhu |
| K210723 |
07/12/2021 |
Nitrile Patient Examination Glove |
Jiangxi Zhonghong Pulin Medical Products Co.,Ltd. |
Zhou Ziyu |
| K203309 |
07/06/2021 |
NUVO CF Implant System |
JJGC Ind·stria e ComΘrcio de Materiais Dentßrios SA |
Mariana Soares Hartmann |
| K211007 |
07/01/2021 |
EZ-TRAXTM Persona Knee Containment Device |
K1 Medical LLC |
Walt Oko |
| K203198 |
07/06/2021 |
KARL STORZ Metal Sterilization Trays |
Karl Storz Endoscopy America Inc |
Leigh Spotten |
| K211393 |
07/02/2021 |
Selethru(TM) NC PTCA Balloon Dilatation Catheter |
Kossel Medtech (Suzhou) Co., Ltd. |
Maggie Xu |
| K210115 |
07/29/2021 |
FiteBac CC OrthoSeal |
Largent Health, LLC |
Kirk Kimmerling |
| K201835 |
07/08/2021 |
PRE-SURE |
Lazarus, 3D, Inc |
Smriti Zanevald |
| K211192 |
07/20/2021 |
Grivamax Family of Lasers, Models 272 and 148 |
Leana Orders, Inc |
Leonid Krits |
| K201844 |
07/14/2021 |
Surgical Face Mask, Surgical Mask |
Lear Corporation |
Ryan Facer |
| K203168 |
07/20/2021 |
LifeLens Wireless ECG Monitor |
LifeLens Technologies, Inc. |
Landy Toth |
| K210103 |
07/16/2021 |
SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX |
Lifelong Meditech Private Limited |
Hamendra Nath Srivastava |
| K202868 |
07/21/2021 |
LifeSignals Multi-Parameter Remote Monitoring Platform |
LifeSignals, Inc. |
Saravanan Balasubramanian |
| K211938 |
07/13/2021 |
Physica LMC Knee System |
LimaCorporate |
Roberto Gabetta |
| K210717 |
07/12/2021 |
Bone Screws dia. 5,0 mm |
LimaCorporate S.p.A. |
Antonia Trevisan |
| K211514 |
07/15/2021 |
Longeviti PorousFit implant |
Longeviti Neuro Solutions, LLC |
Heather Hourihan |
| K211402 |
07/30/2021 |
Powersculp laser lipolysis system |
Lotuxs Medtech (Suzhou) Co., Ltd. |
Na Wu |
| K203728 |
07/14/2021 |
Darwin |
Luvo Medical Technologies, Inc |
Gregory Berzak |
| K210129 |
07/20/2021 |
RF Thermal System |
Luvo Medical Technologies, Inc |
Gregory Berzak |
| K201160 |
07/23/2021 |
HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) |
M.I. Tech Co., Ltd |
Inae Kim |
| K211574 |
07/09/2021 |
Extreme X8 |
Magic Mobility |
Alex Suen |
| K211664 |
07/29/2021 |
GMK Sphere Revision |
Medacta International S.A. |
Stefano Baj |
| K211386 |
07/23/2021 |
MySpine WebPlanner & MyBalance |
Medacta International SA |
Stefano Baj |
| K201740 |
07/07/2021 |
Hydrozid |
MediLink A/S |
Cristina Teixeira |
| K210415 |
07/22/2021 |
QSM software, QSMetric |
Medimagemetric LLC |
Yi Wang |
| K211944 |
07/22/2021 |
Medline UNITE« Digital Fusion Screw System |
Medline Industries, Inc. |
Jennifer Mason |
| K203556 |
07/12/2021 |
Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables |
Medtronic , Inc. |
Alexandra Theisen |
| K201100 |
07/15/2021 |
Bio-Medicus Life Support Catheter and Introducer |
Medtronic Inc. |
Juli Rubin |
| K211442 |
07/08/2021 |
StealthStation Spinous Process Clamps |
Medtronic Navigation |
Victoria Baldock |
| K211958 |
07/21/2021 |
CD Horizon Spinal System |
Medtronic Sofamor Danek USA, Inc. |
Kelly McDonnell |
| K212008 |
07/22/2021 |
Reveal LINQ Insertable Cardiac Monitor |
Medtronic. Inc. |
Andrea Artman |
| K211525 |
07/16/2021 |
SwiftNINJA Steerable Microcatheter |
Merit Medical Systems, Inc. |
Luke Meidell |
| K211643 |
07/26/2021 |
Vision Monitor - MonpackONE |
Metrovision |
Jacques Charlier |
| K203432 |
07/07/2021 |
Axium Detachable Coil; Axium Prime Detachable Coil |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Bhavika Patel |
| K211990 |
07/27/2021 |
Rist 071 Radial Access Guide Catheter |
Micro Therapeutics, Inc., d/b/a ev3 Neurovascular |
Amnon Talmor |
| K211984 |
07/25/2021 |
MASC Surgical Mask |
Mid-America Safety Corp. |
Yunxiang (Phil) Fan |
| K211901 |
07/21/2021 |
MolecuLightDX |
MolecuLight Inc. |
Jordan John |
| K203369 |
07/01/2021 |
Avance Solo Negative Pressure Wound Therapy (NPWT) System |
Molnlycke Health Care US, LLC |
Megan Bevill |
| K211489 |
07/28/2021 |
Dental Impression Material |
Nanchang Dental Bright Technology Co., Ltd |
Justin Qin |
| K201262 |
07/09/2021 |
Microwave Therapeutic System |
Nanjing ECO Microwave System Co., Ltd |
Hong Wei |
| K201265 |
07/23/2021 |
Disposable Microwave Therapeutic Antennas |
Nanjing ECO Microwave System Co., Ltd. |
Hong Wei |
| K210012 |
07/09/2021 |
Tamarin Blue PTCA RX Dilatation Catheter |
Natec Medical Ltd. |
Roy Devassy Pallippatt |
| K202780 |
07/30/2021 |
Sectum |
Neauvia North America |
Misty Williams |
| K210903 |
07/23/2021 |
IS Multi Unit Abutment System |
Neobiotech Co., Ltd. |
Young-Ku Heo |
| K211129 |
07/28/2021 |
Neocis Guidance System (NGS) with Intraoral Fiducial Array |
Neocis Inc. |
William Tapia |
| K211338 |
07/30/2021 |
EMBOTRAP III Revascularization Device |
Neuravi Ltd. |
Niall Fox |
| K211788 |
07/08/2021 |
HALO |
Nico.Lab B.V. |
Merel Boers |
| K203435 |
07/16/2021 |
Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System |
Nihon Kohden Corporation |
Sandra Gadeyne |
| K200983 |
07/14/2021 |
Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine |
Ningbo Hesi Electric Co., Ltd |
Ma LuLu |
| K203148 |
07/08/2021 |
Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030) |
Ningbo Youhe Electrical Appliance Technology Co., Ltd. |
Huang Yun Jun |
| K211380 |
07/30/2021 |
Elexir |
Nu Eyne Co., Ltd. |
Dong Seong Lee |
| K211910 |
07/19/2021 |
Z-6 Atrioseptostomy Catheter |
NuMED, Inc. |
Nichelle LaFlesh |
| K210574 |
07/29/2021 |
NuVasive Pulse System |
NuVasive, Incorporated |
Manthan Damani |
| K202304 |
07/14/2021 |
NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) |
NYU Langone Medical Center |
Matija Snuderl |
| K210688 |
07/21/2021 |
AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown |
O&M Halyard, Inc |
Kimberly Lewis |
| K211932 |
07/27/2021 |
Fixxsure Anterior Lumbar Plate and Screw System |
Oak Tree Engineering, LLC. |
Douglas W Neary |
| K202989 |
07/14/2021 |
Myopia Master |
OCULUS OptikgerΣte GmbH |
Eckhard Loh |
| K211677 |
07/28/2021 |
ELEOS Limb Salvage System |
Onkos Surgical |
Matthew (Matt) Vernak |
| K211792 |
07/16/2021 |
StitchKit |
Origami Surgical Inc . |
John Gillespie |
| K203023 |
07/14/2021 |
Pisces Spinal System |
Ortho Development Corporation |
Divya Palan |
| DEN200039 |
07/12/2021 |
InSpace Subacromial Tissue Spacer System |
Ortho-Space Ltd. |
Katie Farraro |
| K211710 |
07/30/2021 |
Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screw |
Orthofix Inc. |
Jacki Koch |
| K210653 |
07/07/2021 |
ONE Planner Hip |
Orthosoft d/b/a Zimmer CAS |
Paul Hardy |
| K203562 |
07/13/2021 |
Finetest Lite Blood Glucose Monitoring System |
Osang Healthcare Co., Ltd. |
Ik-Hyeon Kim |
| K210097 |
07/02/2021 |
Estar-Z |
Osstem Implant Co., Ltd. |
Jungmin Yoo |
| K210579 |
07/22/2021 |
WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System |
OTU Medical Inc. |
Geping Liu |
| K211906 |
07/20/2021 |
Vital Signs |
Oxehealth Limited |
Hugh Lloyd-Jukes |
| K203700 |
07/30/2021 |
Thermo Scientific Oxoid Cefiderocol Disc (30 ╡g) FDC30 |
Oxoid Limited (Part of Thermo Fisher Scientific) |
Philip Brame |
| K210412 |
07/26/2021 |
Pac-Dent Ceramic Nanohybrid Resin |
Pac-Dent, Inc. |
Jingtian Peng |
| K210189 |
07/28/2021 |
Pac-Dent Denture Base Resin |
Pac-Dent, Inc. |
Jingtian Peng |
| K210186 |
07/16/2021 |
PacBond One |
Pac-Dent, Inc. |
Tom Peng |
| K202922 |
07/08/2021 |
END 200 Endoscopic Tubeset |
Palliare Ltd. |
John OÆDea |
| K203003 |
07/07/2021 |
Pantheon IBFD |
Pantheon Spinal |
Dave Lamb |
| K211002 |
07/07/2021 |
Grappler Suture Anchor System |
Paragon 28, Inc. |
Haylie Hertz |
| K211411 |
07/01/2021 |
Penumbra System (RED 68 Reperfusion Catheter) |
Penumbra, Inc. |
Micaela Victoria |
| K193622 |
07/06/2021 |
TRIOCLEAR System |
Perfection Aligner System Hong Kong Limited |
Alwin Ngai |
| K202067 |
07/14/2021 |
EliA SmDP-S |
Phadia AB |
Carina Magnusson |
| K200129 |
07/26/2021 |
OncoMate MSI Dx Analysis System |
Promega Corporation |
Ron Wheeler |
| K210059 |
07/21/2021 |
Promisemed Insulin Pen Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K201326 |
07/27/2021 |
Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair |
Psychemedics Corporation |
Neil Stowe |
| K203796 |
07/30/2021 |
Firefly Needleless Connector |
PuraCath Medical, Inc |
Julia Rasooly |
| K211222 |
07/30/2021 |
qER-Quant |
Qure.ai Technologies |
Pooja Rao |
| K210664 |
07/27/2021 |
DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) |
Ra Medical Systems, Inc. |
Jami Miller |
| K211088 |
07/09/2021 |
Grosz Play Feel |
RB Health (US) LLC |
Elizabeth Viguerie |
| K210349 |
07/20/2021 |
TKO Composite Bite Turbo Gel |
Reliance Orthodontic Products, Inc |
Christine Cook |
| K210945 |
07/08/2021 |
Ultra SEP |
Reliance Orthodontic Products, Inc |
Christine Cook |
| K210602 |
07/09/2021 |
AortaSTAT Occlusion Device |
RenalPro Medical, Inc. |
James Twitchell |
| K210386 |
07/12/2021 |
Magneto Nasal Mask |
Respironics, Inc. |
Anna Danley |
| K210199 |
07/02/2021 |
RICOH MEG |
Ricoh Company, Ltd. |
Satoshi Yuuki |
| K211302 |
07/20/2021 |
Elecsys Syphilis |
Roche Diagnostics |
Bin Sun |
| K210635 |
07/27/2021 |
Route 92 Medical Full Length 088 Access System |
Route 92 Medical Inc. |
Kirsten Valley |
| K210713 |
07/09/2021 |
HM70 EVO Diagnostic Ultrasound System |
Samsung Medison CO., LTD. |
Jee Young Ju |
| K210326 |
07/01/2021 |
Bravo G4 Chamber Autoclave |
SciCan Ltd. |
Teresa Boyce |
| K210379 |
07/28/2021 |
Broncho Videoscope System |
Scivita Medical Technology Co., Ltd. |
Ruqin Wu |
| K210497 |
07/07/2021 |
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 |
| K210409 |
07/28/2021 |
Disposable Surgical Face Mask |
Shandong Zhushi Pharmaceutical Group Co., Ltd |
Junhui Zhu |
| K201706 |
07/22/2021 |
KDL Micro catheter |
Shanghai Kindly Medical Instruments Co., Ltd. |
Xu Jianhai |
| K210380 |
07/08/2021 |
Medical surgical mask |
Shantou T&K Medical Equipment Factory Co.,Ltd |
Wan Li |
| K211455 |
07/28/2021 |
Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors |
Shen Wei USA Inc. |
Cheryl Reep |
| K202296 |
07/23/2021 |
Infrared Forehead Thermometer, Model BSX976 |
Shenzhen BSX Technology Electronics Co., Ltd. |
Lijuan Du |
| K202741 |
07/07/2021 |
Infrared Forehead Thermometer |
Shenzhen Combei Technology Co., Ltd. |
Kevin Fong |
| K202390 |
07/14/2021 |
Aduro Light Beauty Mask |
Shenzhen Kaiyan Medical Co Ltd |
Alain Dijkstra |
| K203271 |
07/21/2021 |
Aduro light therapy Handheld |
Shenzhen Kaiyan Medical CO LTD |
Alain Dijkstra |
| K203214 |
07/22/2021 |
DemarkQ WOW, DemarkQ POP |
Shenzhen Kaiyan Medical Co Ltd |
Alain Dijkstra |
| K211337 |
07/01/2021 |
DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
Zhang Wei |
| K210311 |
07/23/2021 |
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 |
| K211264 |
07/30/2021 |
Disposable Nitrile Examination Gloves |
Shenzhen Shiqiao Science and Technology Co. LTD |
Mikki Wan |
| K210154 |
07/30/2021 |
Labat series Diagnostic Ultrasound System |
Shenzhen Wisonic Medical Technology Co.,Ltd. |
Jiang Xiaosan |
| K211094 |
07/08/2021 |
Nerve and Muscle Stimulator |
Shenzhen XFT Medical Limited |
Cindy Peng |
| K211177 |
07/17/2021 |
Powder Free Vinyl Patient Examination Gloves |
Shijiazhuang Hongjun Plastic Manufacture Co., Ltd. |
Lv Zhanmin |
| K202060 |
07/23/2021 |
Disposable IV catheter |
Shinva Ande Healthcare Apparatus Co., Ltd. |
Liang Wanjie |
| K193047 |
07/14/2021 |
N Latex FLC kappa, N Latex FLC lambda |
Siemens Healthcare Diagnostics Products GmbH |
Christine Perkins |
| K193397 |
07/16/2021 |
ADVIA Centaur« Digoxin assay |
Siemens Healthcare Diagnostics, Inc. |
Anoop Joy |
| K200210 |
07/13/2021 |
ADVIA Centaur« Total hCG assay |
Siemens Healthcare Diagnostics, Inc. |
Mey Lyn Vasquez |
| K200256 |
07/02/2021 |
ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay |
Siemens Healthcare Diagnostics, Inc. |
Julie Warren |
| K211379 |
07/30/2021 |
syngo.via RT Image Suite |
Siemens Medical Solutions USA Inc. |
Clayton Ginn |
| K211859 |
07/20/2021 |
ACUSON Sequoia Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc |
Sulgue Choi |
| K210611 |
07/01/2021 |
MAGNETOM Free.Max |
Siemens Medical Solutions USA, Inc. |
Andrew Turner |
| K203411 |
07/22/2021 |
syngo.CT Skull Unfolding |
Siemens Medical Solutions USA, Inc. |
Tabitha Estes |
| K210862 |
07/29/2021 |
Hemafuse System |
Sisu Global Health |
Gillian Henker |
| K202918 |
07/14/2021 |
OsteoSyncÖ Ti Dental Mesh |
Sites Medical, LLC |
Greg Stalcup |
| K211131 |
07/29/2021 |
Disposable Nitrile Medical Examination Glove |
Siyang Threeguard Medical Supplies Co.,Ltd. |
Guo Hua |
| K210938 |
07/30/2021 |
PowerDot PD-01MT2 Muscle Stimulator |
Smartmissimo Technologies Pte Ltd |
Alexey Pisarev |
| K211548 |
07/19/2021 |
POLARSTEM Calcar Reamer Guide |
Smith & Nephew, Inc. |
Pamela Hopkins |
| K203175 |
07/22/2021 |
POLARSTEM Cemented Femoral Stem |
Smith & Nephew, Inc. |
Brad Sheals |
| K210953 |
07/29/2021 |
SMART Taylor Spatial Frame |
Smith & Nephew, Inc. |
Thomas Fearnley |
| K210910 |
07/01/2021 |
Snore Bandit |
SnoreBandit LLC |
Garry Thynne |
| K211946 |
07/16/2021 |
Soniquence Reusable Bipolar Cable |
Soniquence, LLC |
Suzanne Lucas |
| K211495 |
07/12/2021 |
EOS PMP |
Sorin Group Italia S.R.L |
Luigi Vecchi |
| K203753 |
07/29/2021 |
Straumann Surgical Cassettes |
Straumann USA, LLC |
Chanrasmey White |
| K201887 |
07/23/2021 |
VS Newborn Heart Rate Monitor |
SurePulse Medical Limited |
James Carpenter |
| K211492 |
07/30/2021 |
Pounce Thrombectomy System |
Surmodics, Inc. |
Holly Ramirez |
| K211014 |
07/28/2021 |
Portray |
Surround Medical Systems |
Elizabeth Sullivan |
| K210244 |
07/12/2021 |
Disposable Medical Face Mask |
Suzhou Bolisi Medical Technology Co., Ltd |
Hong Xu |
| K203347 |
07/02/2021 |
Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask |
Suzhou Yuyue Medical Technology Co., Ltd. |
Sun Wei |
| K203800 |
07/02/2021 |
SyntrFuge System |
Syntr Health Technologies, Inc. |
Ahmed Zobi |
| K211861 |
07/28/2021 |
TAIJI Professional Series Level 3 Surgical Face Mask |
Taiji Medical Supplies, Inc. |
Katherine Giannamore |
| K210185 |
07/23/2021 |
CardioCurve Steerable Sheath |
Talon Surgical |
Jay Muse |
| K211262 |
07/24/2021 |
Disposable Vinyl Nitrile Synthetic Gloves Powder Free |
Tangshan Hongyun Healthcare Products Co.,Ltd. |
Suying Le |
| K211480 |
07/08/2021 |
NubeX |
TechHeim Co., Ltd |
Weon Yong Lee |
| K202612 |
07/23/2021 |
Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL) |
Thermo Fisher Scientific |
Cynthia Knapp |
| K211602 |
07/23/2021 |
Klassic Knee System |
Total Joint Orthopedics, Inc. |
Chris Weaber |
| K211314 |
07/29/2021 |
OCS Lung Solution |
TransMedics, Inc. |
Miriam Provost |
| K200770 |
07/30/2021 |
Mini PCNL-System |
Trokamed GmbH |
Stefan Weiland |
| K202579 |
07/08/2021 |
TruAbutment DS, TruBase |
TruAbutment Inc. |
Eunjin Jang |
| K200575 |
07/09/2021 |
TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM |
TRUEMED GROUP LLC |
Nina Galeana Rodriguez |
| K211237 |
07/13/2021 |
UltraTemp Rez II |
Ultradent Products, Inc. |
Shawn L. Quigley |
| K210544 |
07/16/2021 |
Medtronic Extended infusion set |
Unomedical A/S |
Lone Sylvest Vestergaard Jepsen |
| K203672 |
07/01/2021 |
MAZIC Claro CAD and MAZIC Claro Press |
Vericom Co., Ltd. |
Yun Ki Kim |
| K211279 |
07/27/2021 |
Volpara Imaging Software |
Volpara Health Technologies Limited |
Ralph Highnam |
| K211761 |
07/30/2021 |
UltraLase Flexible CO2 Laser Waveguide |
W & R Investments, LLC dba Laser Engineering |
Robert I Rudko |
| K211968 |
07/22/2021 |
NIO+ Adult |
WaisMed Ltd |
Shifra Hoch |
| K211875 |
07/28/2021 |
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach |
William Cook Europe ApS |
Mie Dyrholm |
| K211874 |
07/28/2021 |
Gⁿnther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gⁿnther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gⁿnther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach |
William Cook Europe ApS |
Mie Dyrholm |
| K210267 |
07/08/2021 |
Disposable Surgical Mask |
Xiamen Eagledon Pharmaceutical Co., Ltd |
Aggie Zhang |
| K202954 |
07/02/2021 |
Disposable Surgical Mask |
Xiamen Probtain Medical Techology Co., Ltd |
Jianli Kang |
| K210686 |
07/21/2021 |
Nitrile Patient Examination Glove |
Yunnan Huazhiyuan Medical Technology Co., Ltd. |
Yun Gao |
| K211663 |
07/29/2021 |
Zap-X Radiosurgical System |
Zap Surgical Systems, Inc. |
Jim Talbot |
| K211113 |
07/12/2021 |
Zavation Spinal System |
Zavation Medical Products LLC |
Katie Motley |
| K211335 |
07/28/2021 |
Diode Laser Machine, Model Number: BM-100 |
Zhengzhou Bestview St Co., Ltd. |
Yangchun Jia |
| K210391 |
07/22/2021 |
Single-use medical face mask |
Zhuhai Herald Datanetics Limited. |
Jackson Leung |
| K210274 |
07/30/2021 |
Fingertip Pulse Oximeter |
Zhuhai Linte Medical Instrument Co., Ltd. |
Kezheng Ma |
| K203765 |
07/20/2021 |
ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray |
Zirkonzahn SRL |
Julian Steger |
