| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K211521 |
12/20/2021 |
3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG) |
3M Health Care Business Group |
Margaret Marsh |
| K212789 |
12/01/2021 |
Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) |
5R MED Instruments (CHENGDU) Co., Ltd. |
Yuzhang Pan |
| K202101 |
12/29/2021 |
GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Lev |
Accriva Diagnostics, Inc. |
Brian James |
| K210825 |
12/17/2021 |
Revitive Medic Coach (Model Number 5575AQ) |
Actegy, Ltd. |
Lawrence Brookfield |
| K213538 |
12/30/2021 |
Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens |
Acuity Polymers, Inc. |
James A Bonafini |
| K211572 |
12/13/2021 |
Aesculap Slim Clip Applier |
Aesculap, Inc |
Paul Amudala |
| K211949 |
12/09/2021 |
AirStrip ONE Web Client with Alarm Communication Management (ACM) |
AirStrip Technologies, Inc. |
JF Lancelot |
| K203523 |
12/25/2021 |
Fixone hybrid knotless anchor |
AJU Pharm Co., Ltd. |
Kim Tae Hoon |
| K212806 |
12/28/2021 |
Alcon (serafilcon A) soft contact lenses for daily wear |
Alcon Laboratories, Inc |
Alicia Plesnarski |
| K213443 |
12/15/2021 |
InsigniaÖ Anterior Cervical Plate System |
Alphatec Spine, Inc. |
Sandy Gill |
| K213460 |
12/10/2021 |
Invictus Spinal Fixation System |
Alphatec Spine, Inc. |
Sandy Gill |
| K211457 |
12/18/2021 |
Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) |
Ammex Corporation |
Sasitharan Nair |
| K213067 |
12/03/2021 |
Solero Microwave Tissue Ablation (MTA) System and Accessories |
AngioDynamics, Inc. |
Kasey E Newcomb |
| K213371 |
12/09/2021 |
Disposable Medical Nitrile Examination Gloves (Model:XYS-001) |
Anhui Xinyisheng Medical Technology Co.,Ltd |
Shyla Tang |
| K213176 |
12/13/2021 |
Disposable Nitrile Powder-Free Examination Gloves |
Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. |
Kitty Xu |
| K202818 |
12/16/2021 |
Voyant Fine Fusion Device (EB230) |
Applied Medical |
Blake Stacy |
| K213627 |
12/17/2021 |
RF Vapor System |
Aqua Medical, Inc. |
Scott McGill |
| K213916 |
12/16/2021 |
ArchForm Orthodontic Software System |
ArchForm, Inc |
Andrew S. Martz |
| K213638 |
12/10/2021 |
Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) |
Argon Medical Devices |
Ana Jimenez-Hughes |
| K213644 |
12/17/2021 |
Arthrex Knotless Mini TightRopes |
Arthrex Inc. |
Rebecca R Homan |
| K210817 |
12/08/2021 |
C&B 5.0 Hybrid |
Arum Dentistry Co., Ltd |
Yongsup Lee |
| K203723 |
12/10/2021 |
Branchor Balloon Guide Catheter |
Asahi Intecc Co., Ltd |
Yasuyuki Kawahara |
| K211898 |
12/08/2021 |
ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 |
Asahi Intecc Co., Ltd. |
Tomoya Eguchi |
| K193407 |
12/23/2021 |
Contour« next GEN Blood Glucose Monitoring System |
Ascensia Diabetes Care |
Colleen Burdel |
| K213076 |
12/20/2021 |
AspenMed+ |
Aspen Glove Sdn. Bhd. |
Iskandar Basha Bin Abdul Kadir |
| K212645 |
12/16/2021 |
AT |
AT Glove Engineering SDN. BHD |
L. A. Choong |
| K211452 |
12/02/2021 |
Encevis |
Austrian Institute of Technology GmbH |
Tilmann Kluge |
| K211786 |
12/03/2021 |
Independent Corneal Viewing Chamber (IVC-21) |
Bausch + Lomb, Incorporated |
Heather Christie |
| K212302 |
12/07/2021 |
BAYLAB 3-Ply Surgical Mask (BEACON I) |
Baylab USA, LLC |
Ashley Park |
| K213156 |
12/08/2021 |
BD Nano 2nd Gen Pen Needle |
Becton, Dickinson and Company |
Mark William |
| K210978 |
12/22/2021 |
BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle |
Becton, Dickinson and Company |
Nikita Abirami Mahendra Kumar |
| K211918 |
12/21/2021 |
iCOquit« Smokerlyzer« |
Bedfont Scientific Ltd |
Louise Bateman |
| K203695 |
12/17/2021 |
NObreath« |
Bedfont Scientific Ltd |
Louise Bateman |
| K212983 |
12/08/2021 |
Injectable Root Canal Bioceramic Sealer |
Beijing C-Root Dental Medical Devices Co., LTD. |
Bingmin Wu |
| K213411 |
12/22/2021 |
iSRÆobot Mona Lisa 2.0 |
Biobot Surgical Pte Ltd |
Lim Yan Shin |
| K213428 |
12/22/2021 |
EdgePro |
Biolase Inc. |
Ed Balcos |
| K212730 |
12/21/2021 |
BellaTek Encode Emergence Healing Abutments |
Biomet 3i LLC |
Krupal Patel |
| K212435 |
12/10/2021 |
Comprehensive Humeral Fracture Positioning Sleeves |
Biomet Inc. |
Aishwarya Pandey |
| K213208 |
12/23/2021 |
Twist Drills |
Biomet Microfixation |
Mark Wladkowski |
| K211847 |
12/20/2021 |
AdVance XP Male Sling System |
Boston Scientific Corporation |
Anuja Bhatt |
| K213422 |
12/14/2021 |
EkoSonic Endovascular Device, EKOS+ Endovascular Device |
Boston Scientific Corporation |
Ambreen Athar |
| K212420 |
12/16/2021 |
Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio |
Brainlab AG |
Chiara Cunico |
| K212840 |
12/11/2021 |
Nitrile Gloves (Model: NE01) |
BYD Auto Industry Company Limited |
Liu Jiangling |
| K212899 |
12/11/2021 |
Disposable Vinyl/Nitrile Blend Medical Examination Gloves |
Bytech(Dongtai) Co., Ltd. |
Wang Cheng |
| K210405 |
12/15/2021 |
ProTEC-USA EZDoff Gown |
Cadillac Products, Inc. |
Andrew Stone |
| K213728 |
12/15/2021 |
Serranator PTA Serration Balloon Catheter |
Cagent Vascular, LLC |
Carol Burns |
| K212492 |
12/20/2021 |
Frax 1940 for Nordlys and Frax Pro |
Candela Corporation |
Rina Ordonez |
| K211217 |
12/16/2021 |
Profound Matrix |
Candela Corporation |
Jeffrey Churchill |
| K213305 |
12/01/2021 |
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR |
Canon Medical Systems Corporation |
Janine F. Reyes |
| K202788 |
12/23/2021 |
Sonomed IV, Sonomed V |
Carci Industria E Comercio De Aparelhos Cirurgicos E Orto |
Orlando Orlandi |
| K211156 |
12/29/2021 |
CONVIVO In Vivo Pathology Suite |
Carl Zeiss Meditec AG |
Juergen Berger |
| K213705 |
12/21/2021 |
DRSplus |
CenterVue SpA |
Luca Scienza |
| K211022 |
12/22/2021 |
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims. |
Central Medicare Sdn Bhd |
Muhammad Abdul Rahman |
| K210827 |
12/14/2021 |
ZEPTO Precision Capsulotomy System |
Centricity Vision, Inc. |
Neal Hartman |
| K210744 |
12/14/2021 |
Surgical Mask |
Chongqing Pa Xijia Biotechnology Co., Ltd. |
Zheng Tao |
| K212716 |
12/27/2021 |
Dermoaroma Disposable Nitrile Examination Glove |
ChuZhou Harmony Gloves Medical Technology Co.,Ltd |
WeiHong Ou |
| K200943 |
12/17/2021 |
Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System |
CIRCA Scientific, LLC |
Fred Piazza |
| K213691 |
12/22/2021 |
Solas OR |
Cirdan Imaging Ltd |
Paul Matthews |
| K213140 |
12/22/2021 |
Claritas iPET |
Claritas HealthTech Pte Ltd |
Devika Dutt |
| K211277 |
12/16/2021 |
Theia NPWT Foam Wound Dressing Kit |
Clear Choice Therapeutics, Inc. |
Bret Batchelder |
| K213136 |
12/24/2021 |
CPL Surgical Face Mask |
Control Print Limited |
Pankaj Sharma |
| K193138 |
12/27/2021 |
Colibri System |
COPAN WASP S.r.l. |
Catalano Giovanna |
| K212034 |
12/09/2021 |
LOSPA TKR System |
Corentec Co., Ltd. |
Seungri Kim |
| K211561 |
12/05/2021 |
INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) |
Covidien, llc |
Megan Elliott |
| K212442 |
12/03/2021 |
Cydar EV (Series B) and Cydar EV Maps |
Cydar Ltd. |
Vanisha Mistry |
| K211039 |
12/15/2021 |
BIT-Motion |
DDE MRI Solutions LTD |
Moti Sokolov |
| K211772 |
12/06/2021 |
PMW01 Procedure Mask Level 1 |
Defender Safety Inc. |
Nahal Islam |
| K211804 |
12/06/2021 |
3Delta Crown |
DeltaMed GmbH |
Michael Zimmermann |
| K212548 |
12/06/2021 |
LUXEN CL Dental Liquid |
DENTALMAX Co., Ltd. |
Park Seung Bum |
| K212466 |
12/09/2021 |
LVivo Seamless |
DiA Imaging Analysis Ltd |
Michal Yaacobi |
| K212221 |
12/13/2021 |
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer |
Diazyme Laboratories Inc. |
Chao Dou |
| K203821 |
12/17/2021 |
Donagamex Blue Performance Protective Gown |
Dong Nai Garment Corporation (Donagamex) |
Bui The Kich |
| K210305 |
12/22/2021 |
Pulse Oximeter |
Dongguan Lingxin Technologies Co., LTD |
Cony Tang |
| K201764 |
12/09/2021 |
Infinity Acute Care System (IACS) Monitoring Solution |
Draeger Medical Systems, Inc. |
Tom Hirte |
| K210931 |
12/17/2021 |
Libby IAAA v1.0 |
Dyad Medical, Inc. |
Ronny Shalev |
| K212859 |
12/20/2021 |
First Relief |
DyAnsys, Inc. |
Srini Nageshwar |
| K211263 |
12/30/2021 |
Intrelief |
EasyMed Instruments Co., Ltd. |
Jeffery (Tingjie Wu) Wu |
| K213463 |
12/16/2021 |
NightOwl |
Ectosense nv |
Bart Van Pee |
| K212630 |
12/16/2021 |
Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo |
Ellex Medical Pty Ltd |
Rashmi Pillay |
| K211309 |
12/07/2021 |
endomina system |
Endo Tools Therapeutics S.A. |
Marine Rouyer |
| K213512 |
12/07/2021 |
DERMABOND PRINEO Skin Closure System |
Ethicon, Inc. |
Noorhidayah Norizan |
| K202510 |
12/10/2021 |
AMG PMP Infant |
Eurosets S.r.l. |
Katia Vescovini |
| K213116 |
12/03/2021 |
Everyway Incontinence Stimulation System |
Everyway Medical Instruments Co., Ltd. |
Paul Hung |
| K210077 |
12/17/2021 |
MED RF 4000 |
F Care Systems USA LLC |
Patrick Danciu |
| K210847 |
12/10/2021 |
UltraClear Fractional Laser System |
FA International, LP |
Sharon Timberlake |
| K212918 |
12/13/2021 |
Heat StimPlus |
Famidoc Technology Co., Ltd. |
Amos Zou |
| K212219 |
12/03/2021 |
AHI System |
Fifth Eye Inc. |
Jennifer A. Baird |
| K211560 |
12/10/2021 |
Airvo Nebulizer Adapter |
Fisher & Paykel Healthcare Limited |
Reena Daken |
| K213094 |
12/22/2021 |
ID-500 iRestore Hair Growth System |
Freedom Laser Therapy, Inc. |
Wei-Chih (Kevin) Chen |
| K212869 |
12/13/2021 |
Disposable Surgical Gown, Disposable Reinforced Surgical Gown |
Fugou County Shenxiang Manufacturing Co., LTD. |
Carina Si |
| K212950 |
12/02/2021 |
FUJIFILM Video Laparoscope EL-R740M30 |
FUJIFILM Corporaton |
Randy Vader |
| K213763 |
12/27/2021 |
Sonosite PX Ultrasound System |
FUJIFILM Sonosite, Inc. |
Anoush Frankian |
| K213715 |
12/17/2021 |
Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition |
GE Medical Systems,LLC |
Katelyn Rowley |
| K212914 |
12/22/2021 |
Glovmaster Nitrile Examination Glove Powder Free |
Glovmaster SDN. BHD. |
Zarina binti Hamid |
| K211531 |
12/17/2021 |
Cordless Prophy System, Model: i-Polish |
Guilin Woodpecker Medical Instrument Co., Ltd. |
Ning Jiakang |
| K203615 |
12/10/2021 |
Dental Scaler and Air Polisher |
Guilin Woodpecker Medical Instrument Co., Ltd. |
Yiwei Wang |
| K211159 |
12/30/2021 |
eco-x Series (eco-x, eco-x-s) |
HDX WILL Corp. |
Myoung-Joon Lee |
| K211114 |
12/15/2021 |
Will3D |
HDX WILL CORP. |
Kim In-Young |
| K212944 |
12/15/2021 |
Disposable Surgical Mask |
Heilongjiang Yinjia Medical Equipment Co., Ltd. |
Zhu Hongwei |
| K210331 |
12/21/2021 |
CardiaMend Pericardial and Epicardial Reconstruction Matrix |
Helios Cardio Inc. |
Yiannis Monovoukas |
| K212925 |
12/13/2021 |
Disposable Surgical Gown |
Henan Robestain Medical Products Co., Ltd. |
Yonghong Liu |
| K212802 |
12/02/2021 |
powder free nitrile examination glove - white, non-sterile |
Hong Seng Gloves Sdn Bhd |
Ho Chia Yao |
| K212804 |
12/01/2021 |
Powder free nitrile examination glove- blue, non-sterile |
Hong Seng Gloves Sdn Bhd |
Ho Chia Yao |
| K211629 |
12/08/2021 |
Infrared forehead thermometer LD-FT-100B |
Honsun (Nantong) Co., Ltd |
Iris Du |
| K213129 |
12/21/2021 |
Restoration Modular 115mm Conical Distal Stem |
Howmedica Osteonics Corp., dba Stryker Orthopaedics |
Allison Byrne |
| K212922 |
12/10/2021 |
Nitrile Examination Gloves |
HSK Medical Apparatus Foshan China Co. LTD |
Zhao Zhongheng |
| K213048 |
12/18/2021 |
Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) |
Huayuan Medical Technology(Shangqiu) Co., Ltd. |
Huamei Wang |
| K212398 |
12/15/2021 |
Surgical Face Mask (Non-sterile) |
Hubei Kimsoul Industrial Co., Ltd |
Faming Zhang |
| K213092 |
12/15/2021 |
Cellusheet, Cellufil |
Human Biosciences, Inc. |
Jigar Patel |
| K211209 |
12/17/2021 |
Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves |
Hycare International Co., Ltd |
Tippawan Phongpheaw |
| K212182 |
12/11/2021 |
Iconic Nitrile Glove |
Iconic Medicare Sdn Bhd |
Tan Cho Chia |
| K203647 |
12/22/2021 |
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay |
Immunalysis Corporation |
Wenying (Jessica) Zhu |
| K203564 |
12/22/2021 |
SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay |
Immunalysis Corporation |
Wenying (Jessica) Zhu |
| K212872 |
12/17/2021 |
Avenger Radial Head System |
In2Bones USA, LLC |
Christine Scifert |
| K213069 |
12/13/2021 |
CoLink NeoFuse Plating System |
In2Bones USA, LLC |
Christine Scifert |
| K213303 |
12/07/2021 |
Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42 |
Infraredx, Inc. |
Stephen Sum |
| K213397 |
12/17/2021 |
InkSpace Imaging Pediatric Body Array |
InkSpace Imaging, Inc. |
Peter Fischer |
| K212547 |
12/30/2021 |
Quick-Start Screws |
Innovate Orthopaedics Limited |
Alex Gutteridge |
| K212776 |
12/20/2021 |
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled |
Innovative Health, LLC. |
Rick Ferreira |
| K212088 |
12/23/2021 |
Integrity Implants Navigated Instruments |
Integrity Implants Inc. |
Lauren Kamer |
| K211721 |
12/02/2021 |
PS System |
Inter-Med, INC. |
Brett Arand |
| K211997 |
12/10/2021 |
8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads |
Intuitive Surgical, Inc. |
Amrit Jaggi |
| K213766 |
12/23/2021 |
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 |
| K213637 |
12/10/2021 |
JAZZ Solo sensor |
Jazz Imaging LLC dba JAZZ Imaging |
Todd C Miller |
| K212266 |
12/21/2021 |
FIX-C PEEK Anterior Cervical Interbody System |
Jeil Medical Corporation |
Dajung Lee |
| K202794 |
12/13/2021 |
Surgical face mask: F-Y1-A |
Jiande Chaomei Daily Chemicals Co., Ltd |
Zhu Lipin |
| K212639 |
12/08/2021 |
Disposable Medical Nitrile Examination Gloves (Non sterile) |
Jiangsu Nanfang Medical Co., Ltd |
Xia Li |
| K212921 |
12/24/2021 |
Nitrile Examination Golves Powder Free |
Jiangsu Standard Health Co.,Ltd |
Lu Tao |
| K210914 |
12/17/2021 |
Sterile Syringe for Single Use |
Jiangsu Suyun Medical Material Co., Ltd. |
Guangning Xu |
| K212919 |
12/15/2021 |
Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) |
Jiujiang Taixin Technology Co., Ltd. |
Li Xiaojie |
| K212827 |
12/06/2021 |
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs |
JR Engineering & Medical Technologies (M) SDN.BHD. |
Ganesan Subramaniam |
| K212985 |
12/16/2021 |
6MP Color LCD Monitor CL-S600 |
JVCKENWOOD Corporation |
Hideki Tengeiji |
| K213209 |
12/28/2021 |
EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device |
K1 Medical LLC |
Walt Oko |
| K213115 |
12/06/2021 |
CHENA-C Spacer System |
Kahtnu Surgical, Inc |
Craig Wilcox |
| K212907 |
12/02/2021 |
Aimanfun Lumea Comfort, A-2789/A-3588 |
Kam Yuen Plastic Products Ltd. |
Anna Dan |
| K201600 |
12/10/2021 |
Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28 |
Kangfu Medical Equipment Factory |
Jixiang Zhang |
| K212656 |
12/29/2021 |
Flexible Intubation Video Endoscope û Sterile (FIVE-S) |
KARL STORZ Endoscopy America |
Mario Trujillo |
| K213139 |
12/21/2021 |
SURGmatic S15 L Pro |
KaVo Dental GmbH |
Kerstin Henseler |
| DEN200005 |
12/03/2021 |
Klox Biophotonic LumiHeal System |
Klox Technlogies Inc. |
Daniela Jukic |
| K212616 |
12/16/2021 |
Koios DS |
Koios Medical, Inc. |
Patricia Setti-Laperch |
| K203743 |
12/10/2021 |
EXA |
Konica Minolta Healthcare Americas, Inc. |
Carolyn Russell |
| K212613 |
12/21/2021 |
Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue) |
Koon Seng Sdn Bhd |
Jennifer Yeo |
| K212573 |
12/08/2021 |
PicoLO Premium |
Laseroptek Co., Ltd. |
Hong Chu |
| K210968 |
12/21/2021 |
reVive Light Therapy Essentials |
LED Technologies, Inc. |
Lloyd Nelson |
| K210965 |
12/15/2021 |
reVive Light Therapy Essentials |
LED Technologies, Inc. |
Lloyd Nelson |
| K213266 |
12/03/2021 |
Inspan ScrewLES Fusion System |
LESpine Innovations, LLC |
John Sullivan |
| K212295 |
12/03/2021 |
21HQ513D |
LG Electronics Inc. |
Jinhwan Jun |
| K212137 |
12/10/2021 |
X-Clever |
LG Electronics.Inc |
Jin-Hwan Jun |
| K211865 |
12/20/2021 |
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Liao Ning Shangwei Medical Products Co., Ltd. |
Zhu Hongqing |
| K211378 |
12/16/2021 |
LM Surgical Mask Level 3, LM Surgical Mask Level 2, |
Liberty Mask LLC |
Will Kincaid |
| K212903 |
12/15/2021 |
SIMPACT Sacroiliac Joint Fixation System |
Life Spine, Inc. |
Angela Batker |
| K202848 |
12/14/2021 |
S2 Pigment Removal System |
Lightsense Technologies Ltd |
Deganit Barak |
| K202898 |
12/30/2021 |
Tzoar 207 Negative Pressure Wound Therapy (NPWT) System |
Lightstone Medical Products (Ningbo) Co Ltd |
Julian Zhu |
| K213381 |
12/17/2021 |
Physica system |
LimaCorporate S.p.A |
Ilaria Giannuzzi |
| K212500 |
12/03/2021 |
ArtiSential Trocar |
LivsMed Inc. |
Dong Wook Lee |
| K211487 |
12/08/2021 |
MAF Guard |
MAF Clothing Pvt Ltd Unit-3 |
Kirit Jagani |
| K212535 |
12/04/2021 |
Nitrile Powder Free Blue Examination Gloves, Non-Sterile |
Mah Sing Healthcare Sdn Bhd |
Azlan Hashim |
| K211959 |
12/01/2021 |
Milli Vaginal Dilator |
Materna Medical |
Kelly Ashfield |
| K202568 |
12/20/2021 |
Mpact« 3D Metal Implants - DMLS Technology |
Medacta International SA |
Stefano Baj |
| K212349 |
12/10/2021 |
Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves |
Medi Legion Sdn.Bhd |
N.S. Kumar |
| DEN200041 |
12/10/2021 |
Comfort Marker 2.0. |
Medical Precision B.V. |
Roland Kortenhorst |
| K210992 |
12/23/2021 |
Altech« Exhalation Valve (Single Limb and Dual Limb) |
Meditera Tibbi Malzeme San Ve TIC AS |
Cenk Kilic Kalkan |
| K212258 |
12/03/2021 |
Medline Cardiovascular Procedure Kit |
Medline Industries, Inc. |
Stephanie Augsburg |
| K211612 |
12/10/2021 |
Medline UNITE REFLEX Dynamic Discs |
Medline Industries, Inc. |
Jennifer Mason |
| K213155 |
12/15/2021 |
RT-Mind-AI |
MedMind Technology Co., Ltd. |
Shaobin Wang |
| K212397 |
12/22/2021 |
StealthStation S8 Cranial v2.0 |
Medtronic Navigation |
Carey Brenner |
| K212428 |
12/13/2021 |
Centerpiece Plate Fixation System |
Medtronic Sofamor Danek |
Diamond Wallace |
| K212524 |
12/08/2021 |
Anteralign Spinal System with Titan nanoLOCK Surface Technology |
Medtronic Sofamor Danek USA, INC. |
Elizabeth Hamilton |
| K213631 |
12/15/2021 |
Chocolate PTA Balloon Catheter |
Medtronic, Inc. |
Laura Hanson |
| K210976 |
12/23/2021 |
Curian Campy |
Meridian Bioscience, Inc. |
Heather Planck |
| K212817 |
12/15/2021 |
Merit Siege Vascular Plug |
Merit Medical System, Inc. |
Mark Mullaney |
| K212675 |
12/14/2021 |
Aspira Peritoneal Drainage System |
Merit Medical Systems, Inc. |
Jennifer Webb |
| K202822 |
12/15/2021 |
Helianthus |
Metaltronica Spa |
Gloria Pesce Delfino |
| K210099 |
12/21/2021 |
Meticuly Patient-Specific Titanium Mesh Implant |
Meticuly Co., Ltd. |
Peeranoot Lohwongwatana |
| K210388 |
12/13/2021 |
Non Sterile Nitrile Powder Free Examination Gloves û Blue, Green and Black color |
Mexpo International Inc. |
Tim Thai |
| K211172 |
12/17/2021 |
Single Use Electrosurgical Knife with Fluid Pump System |
Micro-Tech (Nanjing) Co., Ltd. |
Sally He |
| K210934 |
12/01/2021 |
Sphincterotome / short-wire compatible, Sterile Sphincterotome |
Micro-Tech (Nanjing) Co., Ltd. |
Sally He |
| K212852 |
12/06/2021 |
Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle |
Micro-Tech(Nanjing) Co., Ltd. |
Cecilia Sun |
| K212060 |
12/13/2021 |
neXus Ultrasonic Surgical Aspirator System |
Misonix Inc. |
John Salerno |
| K212402 |
12/16/2021 |
MIVI Q Distal Access Catheter |
MIVI Neuroscience, Inc. |
Janel Hurtado |
| K210559 |
12/19/2021 |
ATOZ Mini-Screw |
MK Meditech Inc. |
SungChul Moon |
| K202404 |
12/22/2021 |
BoneMRI |
MRIguidance B.V |
Roel Raatgever |
| K212867 |
12/11/2021 |
Medical Surgical Mask |
Nanchang Kanghua Health Materials Co., Ltd |
Jiamin Wang |
| K211750 |
12/20/2021 |
Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) |
National Bridge Industrial (S.Z.) Co., Ltd. |
Yang Haixiong |
| K212329 |
12/09/2021 |
Plasma IQ |
Neauvia North America, Inc |
Joy Willard |
| K210711 |
12/22/2021 |
Neocis Guidance System (NGS) with Yomi Plan v2.0.1 |
Neocis Inc. |
Dayana Manganese |
| K212340 |
12/17/2021 |
EMBOGUARD Balloon Guide Catheter |
Neuravi Limited |
Niall Fox |
| K213543 |
12/10/2021 |
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health |
Neuronetics, Inc |
Fred Cowdery |
| K202803 |
12/16/2021 |
Activmotion S DTO |
Newclip Technics |
Gaelle LUSSORI |
| K213301 |
12/21/2021 |
InCore Subtalar System |
Nextremity Solutions, Inc. |
Elise Fox |
| K213530 |
12/09/2021 |
Nextra CH Cannulated Hammertoe System |
Nextremity Solutions, Inc. |
Elise Fox |
| K212050 |
12/01/2021 |
NGM WAVE PLIF Cage |
NGMedical GmbH |
Stella Hahn |
| K213316 |
12/29/2021 |
Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM |
Nihon Kohden Corporation |
Sandra Gadeyne |
| K211458 |
12/30/2021 |
Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers |
Ningbo VeryKind Medical Device Co., Ltd. |
Pengfei Hong |
| K211109 |
12/21/2021 |
N1 TiUltra TCC Implant System |
Nobel Biocare Services AG |
Bernice Jim |
| K212932 |
12/18/2021 |
Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray |
Nobel Biocare Services AG |
Nick Lewis |
| K203714 |
12/23/2021 |
NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive C |
NuVasive, Incorporated |
Jessica LeBlanc |
| K212310 |
12/22/2021 |
EyeBOX (Model EBX-4) |
Oculogica, Inc. |
Rosina Samadani |
| K213207 |
12/22/2021 |
Sheath, Stopcock Accessory |
Olympus Winter & Ibe GmbH |
Katharina Campbell |
| K212890 |
12/13/2021 |
Nyquist.IQ |
Omega Medical Imaging, LLC |
John Newman |
| K212285 |
12/22/2021 |
Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android) |
Oriental Inspiration Limited |
Francis Ko |
| K211471 |
12/16/2021 |
Balanced Knee System Uni |
Ortho Development Corporation |
Divya Palan |
| K211086 |
12/21/2021 |
The ProgenÖ Trochanteric Nail System |
Ortho Development Corporation |
Divya Palan |
| K212381 |
12/06/2021 |
VersaTap, VersaLat, DueLock, VersaTi, MiniTi |
Ortho-Design (Pty) Ltd |
Dian Peach |
| K213596 |
12/21/2021 |
OSSIOfiber Compression Screw, 3.5mm |
OSSIO Ltd. |
Taly Lindner |
| K213733 |
12/16/2021 |
Ponto 5 SuperPower |
Oticon Medical AB |
Anja Ravn |
| K211770 |
12/25/2021 |
R3ACT Stabilization System |
Paragon 28, Inc. |
Haylie Hertz |
| K210871 |
12/17/2021 |
PDO Max Suture with Dual Needle |
PDO MAX, Inc. |
Giovanna McCarthy |
| K211448 |
12/06/2021 |
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses |
Pegavision Corporation |
Estela Lin |
| K212848 |
12/27/2021 |
Sterile Latex Surgical Gloves Powder Free |
Pentavest Holdings Sdn Bhd |
Teng Boon Joo |
| K210916 |
12/03/2021 |
PVmed Contouring Software |
Perception Vision Medical Technologies LTD.CO. |
Chuanji Huang |
| K212864 |
12/01/2021 |
dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T |
Philips Healthcare (Suzhou) Co., Ltd |
Seaman Shao |
| K212186 |
12/13/2021 |
Philips Radiology Smart Assistant |
Philips Medical Systems DMC GmbH |
Connie Pascual |
| K213016 |
12/28/2021 |
ATM Glove |
Phu Duc Huy Production Trading Services Corporation |
Tran Xuan Kiem |
| K212075 |
12/08/2021 |
ShurFit Lumbar Interbody System |
Precision Spine, Inc. |
Michael Dawson |
| K210241 |
12/03/2021 |
ImplaStation |
Prodigident, Inc. |
Andrii Gromov |
| K210212 |
12/15/2021 |
Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair |
Psychemedics Corporation |
Neil Stowe |
| K212740 |
12/02/2021 |
Puravita Medical Fold Flat Surgical Mask |
Puravita M, LLC |
Jefferson Nemelka |
| K203424 |
12/17/2021 |
Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 |
Qura S.r.l. |
Raffaella Tommasini |
| K212690 |
12/21/2021 |
qXR-BT |
Qure.ai Technologies |
Bunty Kundnani |
| K202175 |
12/02/2021 |
OxyLight 2.0 |
Raja Trading Company, Inc. |
Christine K. Powers |
| K203745 |
12/02/2021 |
AURORA Evacuator +Coag |
Rebound Therapeutics |
Naomi Gong |
| K200176 |
12/15/2021 |
FREEDOM Integrated Syringe Infusion System |
Repro-Med Systems, Inc., dba KORU Medical Systems |
Cynthia Lacatena |
| K213776 |
12/29/2021 |
LiverSmart |
Resonance Health Analysis Services Pty Ltd |
Mitchell Wells |
| K212351 |
12/15/2021 |
Revolution Peripheral Atherectomy System |
Rex Medical, L.P. |
Colin Valentis |
| K193081 |
12/17/2021 |
Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit |
Rheonix, Inc |
Richard Montagna |
| K212898 |
12/16/2021 |
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs |
Rimba Glove SND BHD |
Zahari Bin Darus |
| K211842 |
12/20/2021 |
Servator M SALF Solution |
S.A.L.F. spa |
Carmelo Gagliano |
| K212904 |
12/14/2021 |
SeaSpine WaveForm C Interbody System |
SeaSpine Orthopedics Corporation |
Hong Phan |
| K213359 |
12/09/2021 |
SeaSpine WaveForm, C Interbody System |
SeaSpine Orthopedics Corporation |
Hong Phan |
| K212603 |
12/22/2021 |
Non Absorbable Surgical Nylon Suture |
Shandong Haidike Medical Product Co., Ltd. |
Lili Xu |
| K212436 |
12/23/2021 |
NBR Synthetic Nitrile Examination Gloves |
Shandong Langtai International Trade Co., Ltd. |
Ping Wang |
| K212235 |
12/06/2021 |
Surgical Face Mask |
Shanghai Yunqing Industrial Co., Ltd. |
Hulin No Last Name Provided |
| K212924 |
12/13/2021 |
Nitrile Examination Gloves |
Shanxi Nacosa Medical Technology Co.,Ltd |
Lu Yingying |
| K213144 |
12/22/2021 |
Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors |
Shen Wei USA Inc. |
Cheryl Reep |
| K211185 |
12/20/2021 |
IPL Home Use Hair Removal Device |
Shenzhen Beauty Every Moment intelligent electric Co., Ltd. |
Luo Huajun |
| K213020 |
12/16/2021 |
IPL hair removal machine |
Shenzhen Borria Technology Co.,Ltd |
Li Zhenqiang |
| K213225 |
12/22/2021 |
Diode Laser System GP900A8, Diode Laser System GP900Q8 |
Shenzhen GSD Tech Co., Ltd. |
Huifang Yao |
| K213024 |
12/22/2021 |
Oren LED Perioral Light Therapy System |
Shenzhen Kaiyan Medical Co Ltd |
Alain Dijkstra |
| K211942 |
12/13/2021 |
Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) |
Shenzhen OSTO Technology Company Limited |
Li Yang |
| K211886 |
12/02/2021 |
Clivia series Diagnostic Ultrasound System |
Shenzhen Wisonic Medical Technology Co.Ltd. |
Jiang Xiaosan |
| K212085 |
12/11/2021 |
Siam NTD+ Nitrile Powder-Free Examination gloves |
Siam NTD Corporation Co., Ltd. |
Taweesak Waideemaneetrakoon |
| K213096 |
12/06/2021 |
Al-Rad Companion (Pulmonary) |
Siemens Medical Solutions USA, Inc. |
Alaine Medio |
| K213700 |
12/13/2021 |
MULTIX Impact, MULTIX Impact C |
Siemens Medical Solutions USA, Inc. |
Denise Adams |
| K213159 |
12/22/2021 |
Encore System |
Siesta Medical, Inc. |
Michael Kolber |
| K213045 |
12/21/2021 |
TearCare System |
Sight Sciences, Inc. |
Edward J. Sinclair |
| K212834 |
12/30/2021 |
Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) |
Siyang Threeguard Medical Supplies Co.,Ltd. |
Guo Hua |
| K202255 |
12/24/2021 |
Skypro, SP02 Mask (3) |
Skypro Medical Supplies Company |
Cyrus Wong |
| K203716 |
12/14/2021 |
PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System |
Smith and Nephew Medical Limited |
Steeve Lamvohee |
| K212770 |
12/21/2021 |
Vision |
SoftSmile, Inc. |
Khamzat Asabaev |
| DEN210024 |
12/21/2021 |
CavaClear Laser Sheath |
Spectranetics, Inc. |
Sondra Chandler |
| K212326 |
12/01/2021 |
AC Cream - Conductive paste |
Spes Medica S.r.l |
Giorgio Facco |
| K212781 |
12/15/2021 |
Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate |
Spinal Simplicity LLC |
Adam Rogers |
| K212706 |
12/13/2021 |
SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard |
Splintek, Inc. |
Thomas W. Brown |
| K212767 |
12/22/2021 |
SleepRight Select-Comfort Dental Guard |
Splintek, Inc. |
Thomas W. Brown |
| K212830 |
12/21/2021 |
CT3000Pro |
SRS Medical |
Lee Brody |
| K213479 |
12/23/2021 |
D▓RS and D▓RS 9090 |
Stephanix |
Sandie Perret |
| K212055 |
12/16/2021 |
Connected OR Hub with Device and Voice Control |
Stryker Corporation |
Eugene Perelshteyn |
| K213006 |
12/21/2021 |
Vinyl Examination Gloves |
Taian Hengchang Medical Technology Co.,Ltd. |
Jing Li |
| K210670 |
12/21/2021 |
BU-CAD |
TaiHao Medical Inc. |
Hsin Hung |
| K211773 |
12/02/2021 |
Single-use Surgical Mask |
Taiwan Seafood and Fish Corporation |
Eric Ly |
| K212538 |
12/14/2021 |
DESS Dental Implants |
Terrats Medical SL |
Roger Terrats |
| K212577 |
12/10/2021 |
DESS Dental Smart Solutions |
Terrats Medical SL |
Roger Terrats |
| K211078 |
12/21/2021 |
Progreat Lambda |
Terumo Clinical Supply Co., Ltd. |
Vaibhav Sivaramakrishan |
| K213531 |
12/20/2021 |
TR BAND Radial Compression Device |
Terumo Medical Corporation |
Liang Lu |
| K213073 |
12/29/2021 |
Goody Gloves, Wincare, TBG Gloves |
Thai Rubber Gloves Co., Ltd |
Chalongkwan Wongsasuthikul |
| K212438 |
12/07/2021 |
Comfortpro |
Thai Rubber Industry Company Limited |
Chawalit Tiyadechachai |
| K212850 |
12/10/2021 |
ComfortPro Blue Nitrile Examination Gloves Powder Free |
Thai Rubber Industry Company Limited |
Supawadee Phoungthong |
| K210126 |
12/03/2021 |
Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% |
The Ritedose Corporation |
Linda Valentine |
| K212155 |
12/21/2021 |
TheraFace LED |
Theragun, Inc. |
Jaime Sanchez |
| K201435 |
12/03/2021 |
Molecular Flow Simulations |
Therataxis, LLC |
Raghu Raghavan |
| K203741 |
12/20/2021 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml |
Thermo Fisher Scientific |
Cynthia Knapp |
| K211539 |
12/15/2021 |
Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| K203468 |
12/20/2021 |
TCAT TKA Instrument Tray |
THINK Surgical, Inc. |
George J. Prendergast |
| K212832 |
12/14/2021 |
TimeWaver Frequency |
TimeWaver Production GmbH |
Babak Jafarian |
| K210223 |
12/15/2021 |
Transcutaneous Electrical Nerve Stimulator |
Top-Rank Health Care Co.,Ltd. |
James Zhou |
| K210102 |
12/17/2021 |
Topwide Surgical Face Mask |
Topwide (Hubei) Medical Products Manufacturer |
Shoucheng Zhang |
| K213580 |
12/03/2021 |
Adapter Sleeve for BIOLOX« OPTION Femoral Head, +10.5mm head length |
Total Joint Othopedics, Inc. |
Chris Weaber |
| K203660 |
12/21/2021 |
TRI-matrix Implant Line |
TRI Dental Implants Int. AG |
Sandro Venanzoni |
| K210481 |
12/14/2021 |
Instant 20s Indicator |
True Indicating LLC |
Thomas Riha |
| K213547 |
12/23/2021 |
SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla |
TTK Healthcare Limited |
Daniel J S |
| K213407 |
12/16/2021 |
UltiCare Disposable Pen Needles |
UltiMed Incorporated |
Paul Lewis |
| K211691 |
12/22/2021 |
Ultrast Gel |
Ultrast, Inc. |
Howard Levine |
| K210004 |
12/10/2021 |
i8 Tanning Booth |
Ultrasun International B.V. |
Tim Leusink |
| K213275 |
12/20/2021 |
EchoGo Core (2.0) |
Ultromics Limited |
Jaco Jacobs |
| K203539 |
12/10/2021 |
Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) |
Unicoglobal, Inc. |
Yoonsok Park |
| K210147 |
12/22/2021 |
Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield |
Unicoglobal, Inc. |
Yoonsok Park |
| K211624 |
12/18/2021 |
USA Gloves Nitrile Powder Free Exam Gloves |
USA Gloves |
Zishan Momin |
| K200932 |
12/14/2021 |
Blood Collection Needles |
Vacutest Kima Srl |
Monica Vianello |
| K212176 |
12/10/2021 |
CINtec Histology |
Ventana Medical Systems, Inc. |
Stacci Cronk |
| K212958 |
12/14/2021 |
MRIdian Linac System |
ViewRay, Incorporated |
Sean Delaney |
| K213149 |
12/09/2021 |
VOCO Retraction Paste |
Voco GmbH |
M Th Plaumann |
| K212715 |
12/20/2021 |
Vy Spine ClariVy Cervical IBF System |
Vy Spine, LLC |
Jordan Hendrickson |
| K213394 |
12/10/2021 |
Vy SpineÖ VySpanÖ PCT System |
Vy Spine, LLC |
Jordan Hendrickson |
| K213219 |
12/23/2021 |
Vy SpineÖ VyWasherÖ Buttress System |
Vy Spine, LLC |
Jordan Hendrickson |
| K213628 |
12/16/2021 |
VBrain |
Vysioneer Inc. |
Vicki Lin |
| K210355 |
12/16/2021 |
Surgical Gown, Model: surgical gown-hp-3 |
Weihai Dishang Medical Technology Co., Ltd |
Ricky Xia |
| K213029 |
12/14/2021 |
Nitrile Examination Gloves (Powder free, Blue) |
Weihai Hongyu Nonwoven Fabric Products Co., Ltd. |
Dong Bin |
| K212807 |
12/03/2021 |
Surgical Masks |
Weihai Hongyu Nonwoven Fabric Products Co., Ltd. |
Bin Dong |
| K203343 |
12/21/2021 |
Wesper Lab |
Wesper Inc. |
Amir Reuveny |
| K212861 |
12/15/2021 |
Surgical Gown, Reinforced Surgical Gown |
Wuhan Zonsen Medical Products Co.,Ltd |
Cynthia Ye |
| K213456 |
12/21/2021 |
Xenco Medical Multilevel CerviKit |
Xenco Medical, LLC |
Jason Haider |
| K212574 |
12/14/2021 |
Surgical Face Mask |
Xiantao Deming Healthcare products Co., Ltd |
Gan Jing |
| K212578 |
12/02/2021 |
Nitrile disposable examination gloves |
Xingyu Medical Tech Co., Ltd. |
Cathrine Luan |
| K213051 |
12/18/2021 |
Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) |
Yunnan Huazhiyuan Medical Technology Co., Ltd. |
Yun Gao |
| K211803 |
12/15/2021 |
HealthPPT |
Zebra Medical Vision Ltd. |
Shlomit Cymbalista |
| K211755 |
12/01/2021 |
Electric Breast Pump |
Zhejiang Carebao Co., Ltd. |
Yan Xie |
| K202823 |
12/15/2021 |
Innomed NPWT Silicone Foam Dressing |
Zhejiang Longterm Medical Technology Co., LTD |
Chloie Zsang |
| K212059 |
12/17/2021 |
Surgical Face Mask |
Zhongshan Saifute Labor Protective Articles CO., LTD |
Qionghua Ke |
| K210842 |
12/10/2021 |
VerSys Cemented Revision/Calcar |
Zimmer, Inc. |
Rhonda Myer |
| K213031 |
12/20/2021 |
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console |
Zoll Circulation, Inc. |
Elizabeth Haines |
