| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K210098 |
06/25/2021 |
PuraStat-GI |
3-D Matrix, Inc. |
Lisa Spirio |
| K210457 |
06/21/2021 |
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 |
| K210458 |
06/08/2021 |
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System |
Abbott Medical |
Steve Vitale |
| K211232 |
06/25/2021 |
Apache Ultrasound System |
Aco Healthcare Co,. Ltd. |
Henry Huang |
| K210753 |
06/30/2021 |
KardiaMobile 6L |
AliveCor, Inc. |
Saket Bhatt |
| K203229 |
06/02/2021 |
NATRELLE INSPIRA Single Use Sizers for Gel Implants |
Allergan |
Kelly Carty |
| K202128 |
06/03/2021 |
Allmed Surgical Face Masks (Ear loops) |
Allmed Medical Products Co., LTD |
Vince Tian |
| K203626 |
06/04/2021 |
SureStrip Vitrification Straw, SureLock Vitrification Straw |
Allwin Medical Devices, Inc |
Digish Mehta |
| K210883 |
06/17/2021 |
aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8 |
Ambu A/S |
Gurpreet Kaur Rehal |
| K211440 |
06/02/2021 |
ASM-301 Level 3 Surgical Mask |
American Surgical Mask Company LLC |
Matt Brandman |
| K211062 |
06/08/2021 |
Medical Face Mask |
Ammex-Weida (Hubei) Health and Safety Products Co., Ltd |
Cai Mingqing |
| K201744 |
06/17/2021 |
Su2ura Approximation Device |
Anchora Medical, Ltd. |
Yoni Epstein |
| K211081 |
06/04/2021 |
AlphaVac Multipurpose Mechanical Aspiration (MMA) System |
AngioDynamics, Inc. |
Kasey E Newcomb |
| K210401 |
06/13/2021 |
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 |
| K210994 |
06/01/2021 |
Arthrex Beveled FT Screws |
Arthrex Inc. |
Rebecca R Homan |
| K210050 |
06/07/2021 |
Augmented VaultLock Glenoid |
Arthrex Inc. |
Ivette Galmez |
| K210423 |
06/24/2021 |
Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand |
Arthrocare Corporation |
Shruthi Bhat |
| K203375 |
06/24/2021 |
OVOMotion Reverse Shoulder Arthroplasty System |
Arthrosurface Inc. |
Dawn J. Wilson |
| K211193 |
06/25/2021 |
BD Prevue II Peripheral Vascular Vascular Access System |
Bard Access Systems, Inc, (C.R. Bard, Inc.) |
Fabio De Pasquale |
| K211410 |
06/04/2021 |
GlidePath 13F Long-Term Hemodialysis Catheter |
Bard Peripheral Vascular, Inc |
Joan Bergstrom |
| K210335 |
06/10/2021 |
Blood Administration Set |
Baxter Healthcare Corporation |
James L. Vangeisen |
| K210430 |
06/18/2021 |
Intravascular Extension Set |
Baxter Healthcare Corporation |
Meaghan Bonn |
| K200891 |
06/02/2021 |
BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System |
Becton, Dickinson and Company |
Kimberly Geisler |
| K211136 |
06/14/2021 |
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) |
BioMerieux, Inc |
Esther Hernandez |
| K211038 |
06/29/2021 |
Biophotas Celluma RESTORE |
Biophotas INC |
Patrick Johnson |
| K210220 |
06/18/2021 |
Kontact Dental Implant System |
BIOTECH DENTAL, SAS |
Delphine Mercier |
| K210889 |
06/25/2021 |
iLab Polaris Multi-Modality Guidance System |
Boston Scientific Corporation |
Rochell Aranha |
| K211469 |
06/10/2021 |
Callaly Tampliner |
Calla Lily Personal Care, Ltd. |
Shaun Knights |
| K210595 |
06/15/2021 |
SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers |
Camber Spine Technologies, LLC |
Donald W. Guthner |
| K211590 |
06/10/2021 |
Fiducial Marker |
Carbon Medical Technologies Inc. |
Eric Furlich |
| K202217 |
06/04/2021 |
Kendall NPWT Incision Management Device |
Cardinal Health |
Christine Kuntz-Nassif |
| K210656 |
06/24/2021 |
ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50╡g/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Pro |
Careplus (M) SDN BHD |
Lim Kwee Shyan |
| K210542 |
06/30/2021 |
aprevo Transforaminal IBF |
Carlsmed, Inc. |
Karen Liu |
| K201206 |
06/30/2021 |
Pivot Breath Sensor |
Carrot Inc. |
Sara Lippert |
| K203850 |
06/14/2021 |
CATS«-D Tonometer Prism |
CATS Tonometer LLC |
Nannon Roosa |
| K210986 |
06/10/2021 |
H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit |
CC Wellness LLC |
Marlent Perez |
| K210972 |
06/10/2021 |
H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two |
CC Wellness LLC |
Marlent Perez |
| K210613 |
06/04/2021 |
HIT Clear Aligner |
CDB Corporation |
Leah M Lehman |
| K201353 |
06/28/2021 |
CenterMed Patient Matched Assisted Surgical Planning (ASP) System |
CenterMed, Inc. |
Christine Yu |
| K210445 |
06/29/2021 |
Nordiwell Surprotect Face Mask |
Changzhou Combat Protective Equipment Co., Ltd. |
Yanmei Song |
| K202714 |
06/11/2021 |
Medical Face Mask |
Chongqing Chaoke Industry Development Co., Ltd. |
Liu Xincheng |
| K203818 |
06/11/2021 |
Replens Long-Lasting Vaginal Moisturizer |
Church & Dwight Co., Inc |
Supreet Sahota-Bhatti |
| K210814 |
06/14/2021 |
Coconu Water Based Personal Lubricant |
Coconu, LLC. |
Taylor Warnick |
| DEN200069 |
06/02/2021 |
Cognoa ASD Diagnosis Aid |
Cognoa, Inc. |
Sophie Dessalle |
| K211259 |
06/24/2021 |
Renamel Bulkfill |
Cosmedent, Inc |
Gary Chuven |
| K211044 |
06/16/2021 |
Sublime Radial Access 018 RX Dilatation Catheter |
Creagh Medical Ltd. (a wholly owned subsidiary of Surmodics, |
Holly Ramirez |
| K203657 |
06/25/2021 |
Vu-Path Ultrasound System |
Crystalline Medical |
Ivan Ma |
| K210604 |
06/03/2021 |
Intellihab System |
CyMedica Orthopedics, Inc. |
Kereshmeh Shahriari |
| K210881 |
06/22/2021 |
M Series Phototherapy Equipment |
Daavlin Distributing Co. |
Michele Thiel |
| K203019 |
06/22/2021 |
LF900 |
DaeSung Maref Co., Ltd |
So Su Hyeon |
| K193301 |
06/21/2021 |
coDiagnostiX |
Dental Wings GmbH |
Angelika HΣhnel |
| K210080 |
06/04/2021 |
Dentis s-Clean s-Line Mini |
Dentis Co., Ltd. |
Gyu Ri Kim |
| K210886 |
06/17/2021 |
MIS Lance+ Conical Connection Dental Implant System |
Dentsply Sirona |
Karl J Nittinger |
| K211051 |
06/02/2021 |
DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) |
DePuy Synthes |
Stacey Bonnell |
| K210421 |
06/28/2021 |
Diafil & Diafil Capsule |
Diadent Group International |
Kab Sun Lee |
| K203629 |
06/10/2021 |
IDx-DR |
Digital Diagnostics Inc. |
Ashley Miller |
| K210372 |
06/07/2021 |
Disposable Surgical Mask |
Dongguan Shin Yi Healthcare Products Factory |
Zhao Shuge |
| K210375 |
06/21/2021 |
Powder Free Blue Nitrile Examination Glove |
Duramitt sdn Bhd |
Terence Lim |
| K210500 |
06/11/2021 |
Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD |
Elekta Limited |
Lorenzo Muratori |
| K210034 |
06/16/2021 |
EnsoSleep |
EnsoData, Inc. |
Sigrid Schoepel |
| K211101 |
06/14/2021 |
E-Temp |
EnvisionTEC GmbH |
Ruediger van Bernum |
| K203388 |
06/04/2021 |
Disposable medical mask |
Everwin Toys (Dongguan)., Ltd. |
Huang Zibin |
| K203802 |
06/07/2021 |
X-Pac Expandable Lumbar Cage System |
Expanding Innovations, Inc |
Robert Jaramillo |
| K210909 |
06/24/2021 |
easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use |
Ezisurg Medical Co., Ltd. |
Jingtian Ren |
| K203569 |
06/11/2021 |
Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants |
FCI (France Chirurgie Instrumentation) SAS |
Thierry Fetick |
| K210281 |
06/17/2021 |
Fist Assist Devices Model FA-1 |
Fist Assist Devices, LLC |
Tej Singh |
| K202991 |
06/22/2021 |
Fotona XPulse Pro Laser Platform |
Fotona d.o.o. |
Marko Berdajs |
| K203717 |
06/30/2021 |
Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 |
FUJIFILM Corporaton |
Randy Vader |
| K211215 |
06/22/2021 |
SenoBright HD |
GE Healthcare |
Florian Akpakpa |
| K211216 |
06/09/2021 |
Vivid S60N / Vivid S70N |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Tracey Ortiz |
| K210948 |
06/24/2021 |
Omnilux CLEAR |
GlobalMed Technologies |
Lisa Thorson |
| K210014 |
06/04/2021 |
Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) |
Guandong Genial Technology CO., LIMITED |
Jun Yu |
| K203200 |
06/16/2021 |
Disposable Medical Surgical Face Mask |
Guangdong Haiou Medical Apparatus Co., Ltd. |
Zhang Zhuo Xuan |
| K202766 |
06/11/2021 |
EOS Air Cleaner |
Guangzhou Ajax Medical Equipment Co., Ltd. |
Atwood Lee |
| K211535 |
06/17/2021 |
Sonata Transcervical Fibroid Ablation System 2.2 |
Gynesonics, Inc. |
Christine Ehmann |
| K211401 |
06/03/2021 |
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) |
Gyrus ACMI, Inc. |
Julie Acker |
| K193383 |
06/07/2021 |
SnugKap |
HeadStart, Ltd. |
James McCartney |
| K211303 |
06/04/2021 |
Avon Patello-femoral Joint Prosthesis |
Howmedica Osteonics Corp., dba Stryker Orthopaedics |
Shraddha More |
| K211028 |
06/04/2021 |
Nitrile Patient Examination Gloves |
Huayuan Medical Technology(Shangqiu) Co., Ltd. |
Huamei Wang |
| K210150 |
06/02/2021 |
Disposable Medical mask |
Hubei Wanli Protective Products Co., Ltd. |
Andy Wen |
| K210767 |
06/10/2021 |
Surgical Masks, Model:FE-1 |
Hunan Triplex Precision Medical Devices Co., Ltd |
Huang Kai |
| K211272 |
06/22/2021 |
ICOONE Laser Med (also referred to as ICOONE Medical laser) |
I-Tech Industries SRL |
Gianfranco Tudico |
| K211476 |
06/08/2021 |
ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing |
Imperative Care Inc. |
Teri Nguyen |
| K211336 |
06/16/2021 |
Disposable Vinyl Examination Glove |
Inner Mongolia Cureguard Medical Materials Co., Ltd. |
Guo Hua |
| K193604 |
06/16/2021 |
Aptiva Celiac Disease IgA Reagent |
Inova Diagnostics, Inc. |
Andrea Seaman |
| K210855 |
06/21/2021 |
Straumann BLX Implant System |
Institut Straumann AG |
Viviana Horhoiu |
| K203456 |
06/23/2021 |
Straumann CARES M-Series CAD/CAM System |
Institut Straumann AG |
Gordon Dodds |
| K211595 |
06/23/2021 |
da Vinci SP Surgical System (SP1098) |
Intuitive Surgical, Inc. |
Connor McCarty |
| K203720 |
06/22/2021 |
MICROMATE |
ISYS Medizintechnik GMBH |
Michael Vogele |
| K202855 |
06/21/2021 |
Orthodontic Facemask |
ITA.O Italian Orthodontic System S.r.l. |
Alessandra Ferroni |
| K211252 |
06/25/2021 |
Nitrile Glove |
Jiangsu Dihong Industry and Trade Co., Ltd. |
Sue Chen |
| K211045 |
06/23/2021 |
Synthetic Vinyl Examination Gloves |
Jiangsu Huayuan Medical Technology Co., Ltd. |
Yun Gao |
| K200466 |
06/14/2021 |
Manual Wheelchair (Model W28) |
Jiangsu Jumao X-Care Medical Equipment Co., Ltd. |
Weixia Shi |
| K210429 |
06/02/2021 |
Disposable Surgical Face Mask |
Jiangxi Heying Pharmaceutical Co., Ltd |
Junzheng Liu |
| K211695 |
06/23/2021 |
Valkyrie Thoracic Fixation System |
JM Longyear Manufacturing, LLC d/b/a Able Medical Devices |
Wade DePas |
| K211656 |
06/25/2021 |
3D Echo v1.1 |
JointVue LLC |
Maja Ward |
| K203704 |
06/04/2021 |
Surgical face mask |
Juntech(Jiaxing)Healthcare Materials Co,.Ltd |
Cam Sun |
| K203733 |
06/29/2021 |
12MP Color Digital Mammography LCD Monitor CL-S1200 |
JVCKENWOOD Corporation |
Hideki Tengeiji |
| K203244 |
06/15/2021 |
CellChek 20 rc |
Konan Medical, Inc. |
Runa Emura |
| K210504 |
06/11/2021 |
PANAVIA Veneer LC |
Kuraray Noritake Dental Inc. |
Yasujiro Ohara |
| K202551 |
06/24/2021 |
Cor-Knot Micro |
LSI Solutions, Inc. |
Christopher B. Miller |
| K203756 |
06/10/2021 |
Disposable Surgical Mask |
Lucky Textile Industrial(Wuxi) Co.,Ltd. |
Grace Tai |
| K211372 |
06/02/2021 |
Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) |
Mahana Therapeutics Inc. |
Jean-Noel Courvoisier |
| K202196 |
06/24/2021 |
BioFire RP2.1/RP2.1plus Control Panel M441 |
Maine Molecular Quality Controls, Inc. |
Joan Gordon |
| K203215 |
06/11/2021 |
Radius T wearable thermometer |
Masimo Corporation |
Sindura Penubarthi |
| K201309 |
06/04/2021 |
ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium |
MECTA Corporation |
Adrian Kettering |
| K210138 |
06/25/2021 |
iTind System |
Medi-Tate Ltd. |
Lihi Liviatan |
| K211596 |
06/23/2021 |
CD Horizon Spinal System |
Medtronic |
Diamond Wallace |
| K211441 |
06/09/2021 |
Navigated Anterolateral Disc Prep Instruments |
Medtronic Sofamor Danek USA, INC. |
Alex Underberg |
| K210484 |
06/11/2021 |
LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System |
Medtronic, Inc. |
Dianna L Johannson |
| K210161 |
06/22/2021 |
AnyOne Onestage Implant System |
MegaGen Implant Co., Ltd. |
You Jung Kim |
| K211310 |
06/16/2021 |
AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) |
Megine Industries Sdn Bhd |
Benjamin Ng Soong Jing |
| K201493 |
06/10/2021 |
Spirometer |
MeHow Innovative Ltd |
Gloria Sun |
| K210904 |
06/30/2021 |
Metapaste Plus |
Meta Biomed Co., Ltd. |
Suk Song Oh |
| K210591 |
06/09/2021 |
Palm Bladder Scanner - PBSV7.1 |
Mianyang Meike Electronic Equipment Co., Ltd. |
Wenjun Zhao |
| K211297 |
06/24/2021 |
SMARTRELEASE Endoscopic Soft Tissue Release System |
MicroAire Surgical Instruments |
Glenn Gerstenfeld |
| K202718 |
06/16/2021 |
Qmenta Care Platform Family |
Mint Labs, Inc., d/b/a. QMENTA |
Paulo Rodrigues |
| K210920 |
06/16/2021 |
iBOT Personal Mobility Device (iBOT PMD) |
Mobius Mobility |
Joseph Sullivan |
| K210882 |
06/22/2021 |
MolecuLight I:X |
MolecuLight Inc. |
Jordan John |
| K202523 |
06/24/2021 |
TMJ Relax |
Moonwalker Innovations Inc |
Charles Sutera |
| K201196 |
06/25/2021 |
Scooter (Model: FDB01) |
Nanjing Jin Bai He Medical Apparatus Co., Ltd |
Dandan Yang |
| K202897 |
06/24/2021 |
Natural Cycles |
Natural Cycles Nordic AB |
Raoul Scherwitzl |
| K210700 |
06/17/2021 |
NaviNetics D1 Stereotactic System |
NaviNetics, Inc |
Patrick Gora |
| K210021 |
06/11/2021 |
Axon Therapy |
NeuraLace Medical, Inc. |
Joe Milkovits |
| K211250 |
06/21/2021 |
VisionPort System |
New View Surgical, Inc. |
Bryce Klontz |
| K211025 |
06/30/2021 |
Oral/Enteral Syringe with ENFit connector |
Ningbo Tianyi Medical Appliance Co., Ltd. |
Wenyu Zhang |
| K202813 |
06/14/2021 |
URO-TOUCH 9 French Probe |
Northgate Technologies Inc. |
Todd Gatto |
| K210258 |
06/23/2021 |
NovoFine |
Novo Nordisk Inc. |
Hiral Palkhiwala Shah |
| K210587 |
06/28/2021 |
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile |
Onetexx SDN BHD |
Freddy Low |
| K210775 |
06/28/2021 |
White Nitrile Powder Free Patient Examination Glove, Non Sterile |
Onetexx SDN BHD |
Freddy Low |
| K203815 |
06/09/2021 |
ELEOS Limb Salvage System with BioGrip |
Onkos Surgical |
Matthew (Matt) Vernak |
| K210627 |
06/03/2021 |
Breezeway II |
Oscor Inc. |
Doug Myers |
| K202806 |
06/17/2021 |
Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) |
OSTEONIC Co., Ltd. |
Da Kyung Ham |
| K202763 |
06/04/2021 |
Fix2Lock (PEEK Self Punching) |
Osteonic Co., Ltd. |
Da Kyung Ham |
| K202663 |
06/07/2021 |
Suture Wing |
Osteonic Co., Ltd. |
Dakyung Ham |
| K211473 |
06/04/2021 |
Micro C Medical Imaging System, M01 |
OXOS Medical, Inc. |
Evan Ruff |
| K210869 |
06/28/2021 |
Phantom Hindfoot TTC/TC Nail System |
Paragon 28, Inc. |
Haylie Hertz |
| K203514 |
06/17/2021 |
Precise Position |
Philips Healthcare (Suzhou) Co., Ltd. |
Shiguang An |
| K210560 |
06/30/2021 |
Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph |
Philips Medical Systems |
Hong Zhu |
| K211408 |
06/23/2021 |
CervAlign« Anterior Cervical Plate System |
Pioneer Surgical Technology, Inc. |
Jaclyn Holli |
| K211108 |
06/04/2021 |
Prudent 1717, Prudent 1417, Prudent 1212 |
PIXXGEN Corporation |
Young Kim |
| K211191 |
06/24/2021 |
Virtual C DRF Digital Imaging System |
Portavision Medical LLC |
Terry Ancar |
| K211520 |
06/15/2021 |
Amerishield Surgical Mask |
PremiumEStore, LLC |
Brent Dillie |
| K210694 |
06/16/2021 |
Silent Nite Sleep Appliance with the Glidewell Hinge |
Prismatik Dentalcraft, Inc. |
Herbert Schoenhoefer |
| K211293 |
06/25/2021 |
Safety Winged Blood Collection Sets |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K210866 |
06/21/2021 |
Steri-Dot Process Indicator |
Propper Manufacturing Co., Inc. |
Andrew Sharavara |
| K201228 |
06/25/2021 |
Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair |
Psychemedics Corporation |
Neil Stowe |
| K202580 |
06/07/2021 |
Disposable Surgical Mask |
Qingdao Likangyuan Medical Device Co., Ltd. |
Ying Xu |
| K200722 |
06/03/2021 |
PCA-C1 series Patient Cable |
QT Medical, Inc. |
Ruey-Kang Chang |
| K203057 |
06/30/2021 |
Quantum Perfusion Arterial Cannula Graft |
Qura S.r.l. |
Raffaella Tommasini |
| K202902 |
06/21/2021 |
2430MCA with Xmaru W |
Rayence Co., Ltd |
Kee Dock Kim |
| K210645 |
06/29/2021 |
RayStation 10.1 |
RaySearch Laboratories AB (publ) |
David Hedfors |
| K202828 |
06/04/2021 |
Surgical Green Laser System |
Realton (Suzhou) Medical Technology Co., Ltd. |
Mingzhu Liu |
| K201314 |
06/17/2021 |
Restor3d Utility Wedge |
restor3d, Inc. |
Michaela Pigue |
| K203190 |
06/02/2021 |
Surgical Face Mask |
RFX+CARE Manufactoring Co., Ltd. |
Zhou Xiufeng |
| K203725 |
06/23/2021 |
S.I.N. Dental Implant System |
S.I.N.- Sistema de Implante Nacional S.A. |
Denise Domiciano |
| K210840 |
06/22/2021 |
Disposable Surgical Mask |
Safeway Industry Healthcare. |
Cai Zhimin |
| K210015 |
06/10/2021 |
Surgical Face Mask |
Sample King Manufacturing Ltd |
Forest Cao |
| K210959 |
06/24/2021 |
RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System |
Samsung Medison CO., LTD. |
Scully Kim |
| K210404 |
06/02/2021 |
Transpara 1.7.0 |
ScreenPoint Medical B.V. |
Umar Waqas |
| K211606 |
06/23/2021 |
Mariner Deformity System |
SeaSpine Orthopedics Corporation |
Jesse Albright |
| K210583 |
06/02/2021 |
SeaSpine WaveFormÖ A Interbody System |
SeaSpine Orthopedics Corporation |
Aly Alvarez |
| K210518 |
06/14/2021 |
Surgical Face Mask |
Shandong Haidike Medical Products Co., Ltd. |
Lili Xu |
| K210522 |
06/10/2021 |
Disposable Vinyl Examination Gloves |
Shandong Shengshixincheng Medical Science & Technology Co., |
Ping Wang |
| K201737 |
06/21/2021 |
Posterior Spinal Fixation System |
Shanghai REACH Medical Instrument Co., Ltd |
Mingsha Ye |
| K203410 |
06/28/2021 |
ENFit Disposable Enteral Syringe |
Shantou Wealy Medical Instrument Co., Ltd. |
Yang Songling |
| K202085 |
06/21/2021 |
Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green |
Shen Wei USA Inc. |
Cheryl Reep |
| K210364 |
06/17/2021 |
Migraine Tens Digital Pain Reliever |
Shenzhen Dongdixin Technology Co., Ltd. |
Siping Yuan |
| K201397 |
06/14/2021 |
Ultrasonic Mesh Nebulizer |
Shenzhen Ivankaca Technology Co., Ltd |
Sam Wong |
| K210416 |
06/10/2021 |
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 |
| K210699 |
06/10/2021 |
Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound Syst |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
Hao Yixuan |
| K210756 |
06/11/2021 |
Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H |
Shenzhen OSTO Technology Company Limited |
Li Yang |
| K202126 |
06/08/2021 |
Disposable Surgical Mask |
Shenzhen Peninsula Medical Co. Ltd |
Zhang Sudi |
| K202440 |
06/17/2021 |
Infrared Thermometer |
Shenzhen Sonida Digital Technology Co., Ltd |
Vivi Wey |
| K211459 |
06/10/2021 |
syngo.via MI WorkFlows, Scenium, syngo MBF |
Siemens Medical Solutions USA, Inc. |
Clayton Ginn |
| K203779 |
06/10/2021 |
Symmetric Total Knee System |
Signal Medical Corporation |
Dora Culton |
| K210837 |
06/29/2021 |
Smith & Nephew Plates and Screws |
Smith & Nephew, Inc. |
Thomas Fearnley |
| K210652 |
06/02/2021 |
6MS Invisible Aligner |
SMS OPCO, LLC |
Bruce Page |
| K210044 |
06/30/2021 |
Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System |
Spinal Elements, Inc. |
Julie Lamothe |
| K211323 |
06/03/2021 |
ASTRA Spine System |
SpineCraft, LLC |
Ami Akallal-Asaad |
| K210843 |
06/29/2021 |
STAGE |
SpinTech, Inc. |
Kay Fuller |
| K210437 |
06/29/2021 |
Standard Bougie, 38 Fr. |
Standard Bariatrics |
Michelle Schnell |
| K201806 |
06/23/2021 |
Reprocessed PentaRay Nav eco High-Density Mapping Catheter |
Sterilmed Inc. (Johnson and Johnson) |
Jan Flegeau |
| K202964 |
06/18/2021 |
iBed Wireless with iBed Mobile |
Stryker Corporation |
Cathy Friday |
| K211490 |
06/09/2021 |
Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 |
Stryker Corporation |
John Chesney |
| K210377 |
06/30/2021 |
Stryker iBur hubs and cutting accessories |
Stryker Corporation |
Alison Garrad |
| K211238 |
06/25/2021 |
SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement |
Stryker Instruments |
Susanne Galin |
| K203645 |
06/29/2021 |
Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40 |
SuperSonic Imagine |
Jacques Souquet |
| K210495 |
06/18/2021 |
Port Access System |
Surgical Innovations Limited |
Stephen Seed |
| K201914 |
06/07/2021 |
HRVWatch-Mini Wrist Monitor |
Taiwan Scientific Corporation |
D.C. Sun |
| K200694 |
06/04/2021 |
Perfect EMS |
TensCare Ltd. |
Andrew Brown |
| K211623 |
06/24/2021 |
THD Procto Software System |
THD SpA |
Maurizio Pantaleoni |
| K211061 |
06/10/2021 |
BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240) |
Thrombolex, Inc. |
Amy Katsikis |
| K201842 |
06/04/2021 |
TruBase S |
TruAbutment Inc. |
HoSu Lee |
| K203400 |
06/14/2021 |
Corrugated tube with mouthpiece accessory |
Trudell Medical International |
Marianne Tanton |
| K210641 |
06/07/2021 |
Disposable Medical Mask |
Tuosheng Protective Products (Ningbo) Co., Ltd |
Nanping Yuan |
| K210512 |
06/30/2021 |
LUMINELLE DTx System |
Uvision360, Inc. |
Allison London Brown |
| K203590 |
06/24/2021 |
Perfit FS Dental Zirconia Fully Sintered Block |
Vatech Acucera, Inc. |
Kyung Wook Kwon |
| K201428 |
06/24/2021 |
Powder Free Black Nitrile Examination Glove |
Vietglove Corporation |
Pham Ngoc Thanh |
| K211518 |
06/14/2021 |
2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System |
Volcano AtheroMed, Inc. |
Jean Chang |
| K202596 |
06/04/2021 |
Insulia Diabetes Management Companion |
Voluntis, S.A. |
Kevin Howard |
| K210899 |
06/21/2021 |
LINK Embrace Shoulder System- Anatomical Configuration |
Waldemar Link GmbH & Co. KG |
Stefanie Fuchs |
| K211768 |
06/30/2021 |
LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE |
Waldemar Link GmbH & Co. KG |
Stefanie Fuchs |
| K200942 |
06/01/2021 |
Well-Life Garment Electrodes (GM Series) |
Well-Life Healthcare Limited |
Jenny Hsieh |
| K203030 |
06/11/2021 |
POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
WRP ASIA PACIFIC SDN BHD |
Saravanan Ramasamy |
| K210433 |
06/07/2021 |
Surgical Face Mask (Ear loops and Tie-on) |
Wuhan Dymex Healthcare Co., Ltd. |
Niki Wang |
| K202893 |
06/18/2021 |
Transcutaneous Electrical Nerve Stimulator |
Wuxi Jiajian Medical Instrument Co., Ltd |
Caihong Sun |
| K201935 |
06/22/2021 |
Air Pressure Therapy System |
Xiamen Weiyou Intelligent Technology Co.,Ltd |
Yong Sun |
| K210954 |
06/29/2021 |
Synergy |
YRS Group Inc. |
Doris Dong |
| K211306 |
06/24/2021 |
LABYRINTH |
Zavation Medical Products LLC |
Colby Williams |
| K203732 |
06/11/2021 |
Surgical Face Mask |
Zhuhai Gaoge Medical Technology Co., Ltd. |
Xiangliang Cheng |
