| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K210884 |
03/25/2021 |
1Derful HS, 1Derful HT |
1Derful, Inc |
Mohamad Alkassab |
| K210603 |
03/01/2021 |
3M Bair Hugger Temperature Management System (Model 675) |
3M Company |
Brian Kleiber |
| K210605 |
03/01/2021 |
3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation |
3M Company |
Hilary Hovde |
| K210776 |
03/15/2021 |
Nitrile Examination Gloves |
5R MED Instruments (Chengdu) Co., Ltd. |
Yuzhang Pan |
| K210943 |
03/30/2021 |
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) |
Abbott Diabetes Care Inc. |
Ono Bacani |
| K210633 |
03/03/2021 |
Amylase2 |
Abbott Ireland Diagnostics Division |
Magdalena Suszko |
| K210596 |
03/01/2021 |
ARCHITECT Toxo IgG |
Abbott Laboratories |
Linda Sohn |
| K210958 |
03/31/2021 |
i-STAT CHEM8+ cartridge with the i-STAT 1 System |
Abbott Point of Care Inc. |
Maria Figueroa |
| K210825 |
03/19/2021 |
Revitive Medic Coach (Model Number 5575AQ) |
Actegy, Ltd. |
Lawrence Brookfield |
| DEN210013 |
03/30/2021 |
OsteoProbe |
Active Life Scientific, Inc. |
Alexander Proctor |
| K210750 |
03/12/2021 |
Acumed Clavicle Hook Plating System |
Acumed LLC |
Janki Bhatt |
| K210685 |
03/08/2021 |
AcQCross Qx Integrated Transseptal Dilator/Needle |
Acutus Medical Inc. |
Sarah Clay |
| K210766 |
03/15/2021 |
AcQMap 3D Imaging and Mapping Catheter, Model 900009 |
Acutus Medical, Inc. |
Karla Schaffner |
| K210680 |
03/08/2021 |
AcQMap High Resolution Imaging and Mapping System |
Acutus Medical, Inc. |
Sindhu Sridhar |
| K210850 |
03/22/2021 |
ADAS 3D |
Adas3D Medical S.L |
Antonio Riu |
| K210963 |
03/31/2021 |
ENNOVATE Spinal System |
Aesculap Implant Systems, LLC |
Paul Amudala |
| K210973 |
03/31/2021 |
MammaPrint FFPE NGS Kit |
Agendia Inc. |
Marcelo Trevino |
| K210937 |
03/29/2021 |
Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 |
Alicn Medical Shenzhen, Inc. |
Fang Meisong |
| K210753 |
03/15/2021 |
KardiaMobile 6L |
AliveCor, Inc. |
Saket Bhatt |
| K210820 |
03/19/2021 |
EAGLE EDGE AXR90 and AXR120 |
Alliage S/A Industrias Medico Odontol≤gica |
Daniel Camargo |
| K210887 |
03/25/2021 |
Altus Spine Sochi OCT Spinal System |
Altus Partners, LLC |
Mark Melton |
| DEN210006 |
03/04/2021 |
Hemolung Respiratory Assist System |
ALung Technologies, Inc. |
Joe Argyros |
| K210883 |
03/25/2021 |
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 |
| K210730 |
03/11/2021 |
Nitrile Patient Examination Glove |
American Performance Polymers, LLC |
Richard Renehan |
| K210701 |
03/09/2021 |
CATALYS Precision Laser System |
AMO Manufacturing USA, LLC |
Laarni Ricafort |
| K210770 |
03/15/2021 |
Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor |
Andon Health Co., Ltd. |
Liu Yi |
| K210768 |
03/15/2021 |
Wrist Blood Pressure Monitor, Blood Pressure Monitor |
Andon Health Co., Ltd. |
Liu Yi |
| K210917 |
03/29/2021 |
Single Use Injection Needle |
Anrei Medical (Hangzhou) Co., Ltd. |
Huibing Yang |
| K210660 |
03/04/2021 |
Stone Retrieval Balloon Catheter |
Anrei Medical (Hangzhou) Co., Ltd. |
Huibing Yang |
| DEN210014 |
03/30/2021 |
EaseVRx |
AppliedVR, Inc. |
Jafar Shenasa |
| K210817 |
03/18/2021 |
C&B 5.0 Hybrid |
Arum Dentistry Co., Ltd |
Yongsup Lee |
| K210687 |
03/08/2021 |
CONTOUR« NEXT ONE Blood Glucose Monitoring System |
Ascensia Diabetes Care |
Stacie Geffner-Atiya |
| K210634 |
03/03/2021 |
MCL 31 Dermablate System |
Asclepion Laser Technologies GmbH |
Dania Di Pietro Paolo |
| K210727 |
03/11/2021 |
HotDog Warming Mattress + Return Electrode |
Augustine Temperature Management LLC |
Temi Ogunse |
| K210792 |
03/15/2021 |
Auxein Nailing System |
Auxein Medical Private Limited |
Rahul Luthra |
| K210631 |
03/03/2021 |
Avitus(r) Bone Harvester |
Avitus Orthopaedics, Inc. |
Maxim Budyansky |
| K210590 |
03/01/2021 |
Axis Spine Technologies ALIF |
Axis Spine Technologies Ltd |
Edwin Lindsay |
| K210797 |
03/16/2021 |
Bio-MEM Ti Reinforced Membrane |
B&Medi Co., Ltd. |
Taesu Kwon |
| K210751 |
03/12/2021 |
S.E.A.L. Hemostatic Wound Spray |
BC3 Technologies Inc |
Wayne L. Grube |
| K210663 |
03/05/2021 |
Dermatological Diode Laser Systems |
Beijing HuaCheng Taike Technology Co., Ltd. |
Li Yi |
| K210815 |
03/18/2021 |
Disposable Face Mask |
Biobase Scientific (Shandong) Co., Ltd. |
Qingxiang Hou |
| K210665 |
03/05/2021 |
Nerve Tape |
BioCircuit Technologies, Incorporated |
Jack Griffis |
| K210757 |
03/15/2021 |
ETEST Fosfomycin (FO) (0.032-512 ╡g/mL) |
bioMerieux SA |
Marine Taravant |
| K210793 |
03/16/2021 |
VIDAS NEPHROCHECK |
bioMΘrieux SA |
Julien Thao My |
| K210949 |
03/30/2021 |
Foundation Dermal Regeneration Scaffold (DRS) Solo |
Bionova Medical Inc. |
Alex Greene |
| K210867 |
03/23/2021 |
NuEra Tight RF, NuEra Tight RF Plus |
BIOS s.r.l. |
Eliana Russo |
| K210924 |
03/29/2021 |
e-Celsius Medical System |
BodyCAP |
SΘbastien Moussay |
| K210925 |
03/29/2021 |
Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber |
Boston Scientific |
Rebecca Perrine |
| K210889 |
03/25/2021 |
iLab Polaris Multi-Modality Guidance System |
Boston Scientific Corporation |
Rochell Aranha |
| K210608 |
03/01/2021 |
LUX-Dx Insertable Cardiac Monitor |
Boston Scientific Corporation |
Melissa Klamerus |
| K210970 |
03/31/2021 |
Single-Use Surgical Mask Model FE2311B |
BYD Precison Manufacturer Co., Ltd. |
Yubo Guan |
| K210598 |
03/01/2021 |
Pediatric Nasogastric Feeding Tubes - Single ENFit Port |
CAIR LGL |
Irving L. Wiesen |
| K210595 |
03/01/2021 |
SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers |
Camber Spine Technologies, LLC |
Donald W. Guthner |
| K210900 |
03/26/2021 |
Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 |
Canon Medical Systems Corporation |
Paul Biggins |
| K210747 |
03/12/2021 |
Caption Interpretation Automated Ejection Fraction Software |
Caption Health |
Sam Surette |
| K210716 |
03/10/2021 |
CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments |
CarboFix Orthopedics Ltd. |
Hila Wachsler-Avrahami |
| K210724 |
03/10/2021 |
ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves wit |
Careplus (M) SDN BHD |
Lim Kwee Shyan |
| K210656 |
03/04/2021 |
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 |
| K210972 |
03/31/2021 |
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 |
03/01/2021 |
HIT Clear Aligner |
CDB Corporation |
Leah M Lehman |
| K210827 |
03/19/2021 |
ZEPTO Precision Capsulotomy System |
Centricity Vision, Inc. |
Neal Hartman |
| K210951 |
03/30/2021 |
Leonardo Mini Blue |
CeramOptec GmbH |
Roland Dreschau |
| K210805 |
03/17/2021 |
Ceribell Instant EEG Headband |
Ceribell, Inc. |
Raymond Woo |
| K210719 |
03/10/2021 |
Change Healthcare Anatomical AI |
Change Healthcare Canada Company |
Chester McCoy |
| K210936 |
03/29/2021 |
Elvie Stride |
Chiaro Technology Limited |
Carre King |
| K210618 |
03/01/2021 |
Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series |
Chongqing Jinshan Science & Technology Co., Ltd. |
Qing Xu |
| K210785 |
03/16/2021 |
Disposable Surgical Gowns |
Chongqing Litai Fashion Group Limited Company |
David Ni |
| K210744 |
03/12/2021 |
Surgical Mask |
Chongqing Pa Xijia Biotechnology Co., Ltd. |
Zheng Tao |
| K210856 |
03/23/2021 |
Purism Disposable Surgical Mask |
Chuzhou Daddy's Choice Science and Technology Co., Ltd. |
Amie Yang |
| K210947 |
03/30/2021 |
Navident |
ClaroNav Inc |
Tal Bresler Stramer |
| K210814 |
03/17/2021 |
Coconu Water Based Personal Lubricant |
Coconu, LLC. |
Taylor Warnick |
| K210809 |
03/17/2021 |
iTotal« IdentityÖ Cruciate Retaining (CR) Knee Replacement System (KRS) |
Conformis, Inc. |
Mary Kruitwagen |
| K210734 |
03/11/2021 |
Endovascular Dilator and Sets |
Cook Incorporated |
Michael Venezia |
| K210626 |
03/02/2021 |
SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter |
Cordis Corporation |
Wai Morgan |
| K210614 |
03/01/2021 |
BENCOX Mirabo Z Cup Cortinium |
Corentec Co.,Ltd. |
Yoorim Bae |
| K210831 |
03/19/2021 |
OnQ Neuro |
CorTechs Labs, Inc |
Kora Marinkovic |
| K210695 |
03/08/2021 |
CPM Medical Consultants Tibial Revision Knee System |
CPM Medical Consultants, LLC. |
Andy Rynearson |
| K210604 |
03/01/2021 |
Intellihab System |
CyMedica Orthopedics, Inc. |
Kereshmeh Shahriari |
| K210881 |
03/25/2021 |
M Series Phototherapy Equipment |
Daavlin Distributing Co. |
Michele Thiel |
| K210705 |
03/09/2021 |
Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3 |
Defender Safety Inc. |
Nahal Islam |
| K210886 |
03/25/2021 |
MIS Lance+ Conical Connection Dental Implant System |
Dentsply Sirona |
Karl J Nittinger |
| K210610 |
03/01/2021 |
PrimeTaper EV Dental Implant |
Dentsply Sirona, Inc. |
Karl J Nittinger |
| K210752 |
03/15/2021 |
HydroMARK Breast Biopsy Site Marker |
Devicor Medical Products, Inc. |
Diane Sung |
| K210911 |
03/29/2021 |
WOLF Thrombectomy System, 14F |
DeVoro Medical, Inc. |
Michael P Wallace |
| K210828 |
03/19/2021 |
DIOnavi-Denture02 |
DIO Corporation |
Ji-Ae Park |
| K210940 |
03/29/2021 |
LuxaPrint Ortho Plus |
DMG Digital Enterprises SE |
Stephan Schafer |
| K210931 |
03/29/2021 |
Libby IAAA v1.0 |
Dyad Medical, Inc. |
Ronny Shalev |
| K210791 |
03/16/2021 |
Us2.v1 |
eko.ai Pte. Ltd. d/b/a Us2.ai |
James Hare |
| K210681 |
03/08/2021 |
SiteSeal SV |
Ensite Vascular |
Thomas Reidy |
| K210761 |
03/15/2021 |
Velguard Surgical Face Mask |
Esstee Exports Health Care Division |
Zachary Wilson |
| K210909 |
03/29/2021 |
easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use |
Ezisurg Medical Co., Ltd. |
Jingtian Ren |
| K210847 |
03/22/2021 |
UltraClear Fractional Laser System |
FA International, LP |
Sharon Timberlake |
| K210870 |
03/24/2021 |
MEO Med Disposable Medical Face Mask |
Fujian MEO Medical Technology Limited |
Zhuang Yan |
| K210625 |
03/02/2021 |
JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve |
FUJIFILM medwork GmbH |
Randy Vader |
| K210790 |
03/16/2021 |
Lateralized and Augmented Baseplates |
FX Shoulder USA, Inc. |
Kathy Trier |
| K210890 |
03/25/2021 |
GPS Cervical Spacers |
G Surgical LLC |
Donald Grafton |
| K210807 |
03/17/2021 |
FlightPlan for Liver |
GE Medical Systems SCS |
Ning Wen |
| K210948 |
03/30/2021 |
Omnilux CLEAR |
GlobalMed Technologies |
Lisa Thorson |
| K210912 |
03/29/2021 |
Excelsius3D |
Globus Medical Inc. |
Kelly Baker |
| K210693 |
03/08/2021 |
PLEXR PLUS |
GMV S.r.l. |
Andrea Cancelli |
| K210868 |
03/23/2021 |
Nitrile Examination Gloves Powder Free (Blue) |
Great Eco Glove Sdn. Bhd. |
Soh Wei Li |
| K210860 |
03/23/2021 |
Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 |
GRI-Alleset, Inc |
Martin Paugh |
| K210736 |
03/11/2021 |
doctorgram Stethoscope DES-I |
GV Concepts |
Ching-Kay Chow |
| K210749 |
03/12/2021 |
Empty EVA Bag |
Haemotronic S.p.a. |
Franciosi Paola |
| K210944 |
03/30/2021 |
Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue) |
Harbour Health LLC |
Jared Koenig |
| K210607 |
03/01/2021 |
PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro |
Heraeus Medical GmbH |
Ljuba Jaeckel |
| K210893 |
03/25/2021 |
Restoration Anatomic Shell |
Howmedica Osteonics Corp. a.k.a. Stryker Orthopaedics |
Alexandra Kirby |
| K210718 |
03/10/2021 |
LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing |
Huizhou Foryou Medical Devices Co., Ltd. |
Junfeng Zhang |
| K210767 |
03/15/2021 |
Surgical Masks, Model:FE-1 |
Hunan Triplex Precision Medical Devices Co., Ltd |
Huang Kai |
| K210935 |
03/29/2021 |
I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) |
I.T.S. GmbH |
Florian Grill |
| K210666 |
03/05/2021 |
Chest-CAD |
Imagen Technologies, Inc |
Robert Lindsey |
| K210726 |
03/11/2021 |
ImmersiveTouch |
ImmersiveTouch, Inc. |
P. Pat Banerjee |
| K210678 |
03/05/2021 |
implaFit« hip stems |
implantcast, GmbH |
Juliane Hoppner |
| K210689 |
03/08/2021 |
ClotTriever Thrombectomy System |
Inari Medical, Inc. |
Larry Boucher |
| K210763 |
03/15/2021 |
Inman Digital Clear Aligners |
Inman Orthodontic Laboratories, Inc. |
Donal P. Inman |
| K210877 |
03/24/2021 |
Evolve System with the T3 Applicator |
InMode Ltd. |
Amit Goren |
| K210655 |
03/04/2021 |
Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter |
Innovative Health, LLC. |
Rick Ferreira |
| K210816 |
03/18/2021 |
True Tulip, True M.I.S. |
Innovative Surgical Designs, Inc. |
Jon Rinehart |
| K210811 |
03/17/2021 |
Dynamyx Digital Pathology Software |
Inspirata, Inc. |
Richard Morroney |
| K210855 |
03/23/2021 |
Straumann BLX Implant System |
Institut Straumann AG |
Viviana Horhoiu |
| K210808 |
03/17/2021 |
Instylla Microcatheter 1.2 |
Instylla, Inc. |
Jennifer Greer |
| K210942 |
03/30/2021 |
MicroFrance Monopolar and Bipolar Electrosurgical Instruments |
Integra MicroFrance |
Malena Zammetti |
| K210629 |
03/02/2021 |
SecurAcath |
Interrad Medical Inc |
Denise Lenz |
| K210918 |
03/29/2021 |
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System |
Intuitive Surgical, Inc. |
Connor McCarty |
| DEN210011 |
03/29/2021 |
Invitae Common Hereditary Cancers Panel |
Invitae Corporation |
Elaine Cull |
| K210804 |
03/17/2021 |
Adhese Universal DC, Cention Primer |
Ivoclar Vivadent, AG |
Sandra Cakebread |
| K210684 |
03/08/2021 |
Disposable Nitrile Medical Examination Glove |
Jiangsu Cureguard Glove Co., Ltd. |
Guo Hua |
| K210691 |
03/08/2021 |
Disposable Nitrile Medical Examination Glove |
Jiangsu Cureguard Glove Co., Ltd. |
Guo Hua |
| K210914 |
03/29/2021 |
Sterile Syringe for Single Use |
Jiangsu Suyun Medical Material Co., Ltd. |
Guangning Xu |
| K210622 |
03/02/2021 |
Single-Use Medical Face Mask |
Jiangxi Hongda Medical Equipment Group Co., Ltd. |
Xiaohua Yang |
| K210821 |
03/19/2021 |
Medical PVC Examination Gloves |
Jiangxi Hongda Medical Equipment Group Ltd. |
Yang Qinghua |
| K210723 |
03/10/2021 |
Nitrile Patient Examination Glove |
Jiangxi Zhonghong Pulin Medical Products Co.,Ltd. |
Zhou Ziyu |
| K210845 |
03/22/2021 |
Disposable Surgical Mask (Model: YYKZ-01) |
Jiaxing Amazing Travel-Ware CO.,LTD |
Jiang Tao |
| K210930 |
03/29/2021 |
ACUVUE« OASYS MAX 1-DAY Contact Lenses (senofilcon A) |
Johnson & Johnson Vision Care, Inc. |
Jamie Frenz-Ross |
| K210638 |
03/03/2021 |
i-ED COIL System |
Kaneka Medical America LLC |
Audra Bogucki |
| K210854 |
03/23/2021 |
Enteral Feeding Set |
KB Medical (Group) Inc. |
Chunsheng Sheng |
| K210731 |
03/11/2021 |
KLS Martin Individual Patient Solutions |
KLS-Martin L.P. |
Jennifer Damato |
| K210741 |
03/12/2021 |
KLS Martin Neuro Rongeurs |
KLS-MARTIN L.P. |
Jennifer Damato |
| K210619 |
03/01/2021 |
SKR 3000 |
Konica Minolta, Inc. |
Tsutomu Fukui |
| K210885 |
03/25/2021 |
Dayspring |
Koya Medical, Inc. |
Andy Doraiswamy |
| K210957 |
03/30/2021 |
Kubec Xpert 80 Radiography System |
KUB Technologies, Inc. |
Chester Lowe |
| K210956 |
03/30/2021 |
Kubtec Mozart (XPERT42) |
KUB Technologies, Inc. |
Chester Lowe |
| K210955 |
03/30/2021 |
Kubtec Mozart Supra (XPERT 84) Radiography System |
KUB Technologies, Inc. |
Chester Lowe |
| K210965 |
03/31/2021 |
reVive Light Therapy Essentials |
LED Technologies, Inc. |
Lloyd Nelson |
| K210968 |
03/31/2021 |
reVive Light Therapy Essentials |
LED Technologies, Inc. |
Lloyd Nelson |
| K210717 |
03/10/2021 |
Bone Screws dia. 5,0 mm |
LimaCorporate S.p.A. |
Antonia Trevisan |
| K210616 |
03/01/2021 |
Longeviti PMMA Static Cranial Implant |
Longeviti Neuro Solutions, LLC |
Heather Hourihan |
| K210851 |
03/22/2021 |
DiLumen Endolumenal Interventional Platform (DiLumen) |
Lumendi, LLC |
Dennis Daniels |
| DEN210005 |
03/01/2021 |
Luminopia One |
Luminopia, Inc. |
Scott Xiao |
| K210823 |
03/19/2021 |
LYMA Laser |
LYMA Life Ltd. |
Simon Goff |
| K210859 |
03/23/2021 |
NextARÖ Spine Platform |
Medacta International, SA |
Stefano Baj |
| K210759 |
03/15/2021 |
Solo, Swing Maxi |
Medela LLC |
Mike McAndrew |
| K210822 |
03/19/2021 |
DeepRhythmAI |
Medicalgorithmics S.A. |
Marek Dziubinski |
| K210758 |
03/15/2021 |
Q Patch |
Medicalgorithmics S.A. |
Maciej Gamrot |
| K210755 |
03/15/2021 |
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) |
Meditech Gloves SDN BHD |
Effendi Tenang |
| K210838 |
03/22/2021 |
PROWLER SELECT PLUS; PROWLER EX |
Medos International SARL |
Samuel Shimp |
| K210728 |
03/11/2021 |
CONDUIT Instruments |
Medos International, SARL |
Christine Cahillane |
| K210637 |
03/03/2021 |
CD HorizonÖ Spinal System |
Medtronic |
Shweta Sharma |
| K210714 |
03/10/2021 |
Extended Reservoir |
Medtronic MiniMed, Inc. |
Prerna Singh |
| K210841 |
03/22/2021 |
NuVent Eustachian Tube Dilation Balloon |
Medtronic Xomed, Inc. |
Matthew Harmon |
| K210826 |
03/19/2021 |
Healing Abutment, Cover Screw |
MegaGen Implant Co., Ltd. |
You Jung Kim |
| K210904 |
03/26/2021 |
Metapaste Plus |
Meta Biomed Co., Ltd. |
Suk Song Oh |
| K210789 |
03/16/2021 |
EQ-PEX |
Meta Systems Co., Ltd. |
Hyejin Park |
| K210591 |
03/01/2021 |
Palm Bladder Scanner - PBSV7.1 |
Mianyang Meike Electronic Equipment Co., Ltd. |
Wenjun Zhao |
| K210934 |
03/29/2021 |
Sphincterotome / short-wire compatible, Sterile Sphincterotome |
Micro-Tech (Nanjing) Co., Ltd. |
Sally He |
| K210632 |
03/03/2021 |
Contour ProtegeAI |
MIM Software Inc. |
Lynn Hanigan |
| K210800 |
03/16/2021 |
IO Expandable Lumbar Interbody Fusion System |
MiRus, LLC |
Jordan Bauman |
| K210920 |
03/29/2021 |
iBOT Personal Mobility Device (iBOT PMD) |
Mobius Mobility |
Joseph Sullivan |
| K210882 |
03/25/2021 |
MolecuLight I:X |
MolecuLight Inc. |
Jordan John |
| K210600 |
03/01/2021 |
MOLLI |
MOLLI Surgical, Inc. |
Fazila Seker |
| K210969 |
03/31/2021 |
Nulife |
MRK Healthcare Pvt Ltd |
Anil R Dave |
| K210700 |
03/09/2021 |
NaviNetics D1 Stereotactic System |
NaviNetics, Inc |
Patrick Gora |
| K210674 |
03/05/2021 |
Shoulder Pacemaker |
NCS Lab Srl |
Matteo Mantovani |
| K210903 |
03/26/2021 |
IS Multi Unit Abutment System |
Neobiotech Co., Ltd. |
Young-Ku Heo |
| K210711 |
03/10/2021 |
Neocis Guidance System (NGS) with Yomi Plan v2.0.1 |
Neocis Inc. |
Dayana Manganese |
| K210915 |
03/29/2021 |
Pathfinder Endoscope Cap |
Neptune Medical, Inc. |
Alex Tilson |
| K210621 |
03/02/2021 |
Oral/Enteral Syringe |
Ningbo Tianyi Medical Appliance Co., Ltd. |
Wenyu Zhang |
| K210706 |
03/10/2021 |
Nitrile Examination Gloves |
Niujian Technology Co., Ltd. |
Xiuqiang Zhou |
| K210852 |
03/22/2021 |
Noris Medical Dental Implants System - Cortical |
Noris Medical Ltd |
Simha Sibony |
| K210801 |
03/17/2021 |
AXINON« LDL-p Test System |
numares AG |
Stefanie Dukorn |
| K210688 |
03/08/2021 |
AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown |
O&M Halyard, Inc |
Kimberly Lewis |
| K210651 |
03/04/2021 |
Resection Electrodes with HF cable |
Olympus Winter & Ibe GmbH |
Katharina Campbell |
| K210593 |
03/01/2021 |
Onera Sleep Test System (Onera STS) |
Onera B.V. |
Ruben de Francisco Martin |
| K210775 |
03/15/2021 |
White Nitrile Powder Free Patient Examination Glove, Non Sterile |
Onetexx SDN BHD |
Freddy Low |
| K210658 |
03/04/2021 |
Volition Plating System |
Ortho Solutions UK Ltd |
Andy Leither |
| K210858 |
03/23/2021 |
VITROS Chemistry Products PHBR Slides |
Ortho-Clinical Diagnostics, Inc. |
Darlene Phillips |
| K210667 |
03/05/2021 |
FIREBIRD SI Fusion System |
Orthofix Inc. |
Jacki Koch |
| K210653 |
03/04/2021 |
ONE Planner Hip |
Orthosoft d/b/a Zimmer CAS |
Paul Hardy |
| K210627 |
03/02/2021 |
Breezeway II |
Oscor Inc. |
Doug Myers |
| K210754 |
03/15/2021 |
Cannulated Fasteners and Nuts |
OsteoCentric Technologies |
Todd Evans |
| K210921 |
03/29/2021 |
TaiChiB |
Our United Corporation |
Qi Liu |
| K210782 |
03/16/2021 |
Tablo Cartridge |
Outset Medical, Inc. |
Jennifer Mascioli-Tudor |
| K210873 |
03/24/2021 |
Thermo Scientific Oxoid Lefamulin Disc (20╡g) LMU20 |
Oxoid Limited (part of Thermo Fisher Scientific) |
Philip Brame |
| K210894 |
03/25/2021 |
SIDDHARTH-II; IMPACT |
Panacea Medical Technologies Pvt.Ltd |
Valli G |
| K210869 |
03/23/2021 |
Phantom Hindfoot TTC/TC Nail System |
Paragon 28, Inc. |
Haylie Hertz |
| K210871 |
03/24/2021 |
PDO Max Suture with Dual Needle |
PDO MAX, Inc. |
Giovanna McCarthy |
| K210764 |
03/15/2021 |
Flyte |
Pelvital USA, Inc. |
Dale Wahlstrom |
| K210928 |
03/29/2021 |
PENTAX Medical Video Bronchoscope EB11-J10 |
PENTAX of America, Inc. |
William Goeller |
| K210710 |
03/10/2021 |
PENTAX Medical Video Duedenoscope ED34-i10T2 |
PENTAX of America, Inc. |
William Goeller |
| K210916 |
03/29/2021 |
PVmed Contouring Software |
Perception Vision Medical Technologies LTD.CO. |
Chuanji Huang |
| K210902 |
03/26/2021 |
EliA Ro52, EliA Ro60 |
Phadia AB |
Sheryl Skinner |
| K210692 |
03/08/2021 |
DigitalDiagnost |
Philips Medical Systems DMC GmbH |
Supriya Dalvi |
| K210880 |
03/24/2021 |
Vereos PET/CT |
Philips Medical Systems Nederland B.V. |
Nimit Shah |
| K210760 |
03/15/2021 |
Precise Image |
Philips Medical Systems Nederland, B.V. |
Michael Chilbert |
| K210906 |
03/26/2021 |
IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4 |
Philips Medizin Systeme Boeblingen GmbH |
Monica da Silva |
| K210725 |
03/10/2021 |
Nitrile Patient Examination Glove |
PingAn Medical Products Co.,Ltd. |
Zhou Ziyu |
| K210694 |
03/08/2021 |
Silent Nite Sleep Appliance with the Glidewell Hinge |
Prismatik Dentalcraft, Inc. |
Herbert Schoenhoefer |
| K210946 |
03/30/2021 |
Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K210712 |
03/10/2021 |
Verifine Mechanical Safety Insulin Syringe |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K210866 |
03/23/2021 |
Steri-Dot Process Indicator |
Propper Manufacturing Co., Inc. |
Andrew Sharavara |
| K210661 |
03/04/2021 |
SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset |
Quanta Dialysis Technologies Ltd |
Sam Drew |
| K210664 |
03/05/2021 |
DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) |
Ra Medical Systems, Inc. |
Jami Miller |
| K210919 |
03/29/2021 |
AcuityDRe |
Radmedix LLC |
Gabriel Issa |
| K210645 |
03/03/2021 |
RayStation 10.1 |
RaySearch Laboratories AB (publ) |
David Hedfors |
| K210874 |
03/24/2021 |
Reliance Spinal Screw System |
Reliance Medical Systems, LLC |
Bret M Berry |
| K210945 |
03/30/2021 |
Ultra SEP |
Reliance Orthodontic Products, Inc |
Christine Cook |
| K210602 |
03/01/2021 |
AortaSTAT Occlusion Device |
RenalPro Medical, Inc. |
James Twitchell |
| K210844 |
03/22/2021 |
DreamWear Silicone Pillows Mask |
Respironics, Inc. |
Steve Lawrie |
| K210676 |
03/05/2021 |
XSTAT 30 Pouch |
RevMedx, Inc. |
Amy K Pointer |
| K210901 |
03/26/2021 |
Elecsys Vitamin D total III |
Roche Diagnostics |
Jamie Ferguson |
| K210635 |
03/03/2021 |
Route 92 Medical Full Length 088 Access System |
Route 92 Medical Inc. |
Kirsten Valley |
| K210840 |
03/22/2021 |
Disposable Surgical Mask |
Safeway Industry Healthcare. |
Cai Zhimin |
| K210713 |
03/10/2021 |
HM70 EVO Diagnostic Ultrasound System |
Samsung Medison CO., LTD. |
Jee Young Ju |
| K210959 |
03/31/2021 |
RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System |
Samsung Medison CO., LTD. |
Scully Kim |
| K210864 |
03/23/2021 |
Safety Pen Needle |
Sandstone Medical (Suzhou) Inc. |
Juanjuan Sun |
| K210601 |
03/01/2021 |
Plato 17 Microcatheter |
Scientia Vascular LLC |
Amy McManus |
| K210623 |
03/02/2021 |
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 |
Sebia |
Karen Anderson |
| K210654 |
03/04/2021 |
EnCor Breast Biopsy Probe with Rinse Tube |
SenoRx, Inc. |
Jessica Myer |
| K210897 |
03/25/2021 |
Disposable Nitrile Examination Gloves |
Shandong DS Safety Technology Co., Ltd. |
Summer Feng |
| K210777 |
03/15/2021 |
Powder Free Nitrile Patient Examination Gloves, Blue Color |
Shandong Jieshi Medical Products Co.,Ltd |
Li Biao |
| K210774 |
03/15/2021 |
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Shandong Jieshi Medical Products Co.,Ltd |
Li Biao |
| K210779 |
03/15/2021 |
Powder Free Nitrile Patient Examination Gloves, Blue Color |
Shandong Shangwei Medical Products Co.,Ltd |
Li Hua |
| K210780 |
03/15/2021 |
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Shandong Shangwei Medical Products Co.,Ltd |
Li Hua |
| K210643 |
03/03/2021 |
Disposable Surgical Face Mask |
Shandong Zhushi Pharmaceutical Group Co., Ltd |
Junhui Zhu |
| K210857 |
03/23/2021 |
Personal Lubricant |
Shenzhen Huanqiu Xuebao Technology Co., Ltd. |
Jiao Li |
| K210699 |
03/09/2021 |
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 |
03/15/2021 |
Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H |
Shenzhen OSTO Technology Company Limited |
Li Yang |
| K210878 |
03/24/2021 |
Surgical Face Mask (Model: CM2006, CM2008, A88) |
Shenzhen RealTone Medical Appliance Co., Ltd. |
Wei Zhou |
| K210848 |
03/22/2021 |
Sure-Fine Insulin Syringes |
Shina Med Corporation |
Jeong Ho Ryu |
| K210813 |
03/17/2021 |
Medical Surgical Mask |
Sichuan Pharmaceutical. Inc. |
Yunrui Zhang |
| K210908 |
03/29/2021 |
Surgical Mask |
Sichuan Prius Biotechnology Co., Ltd. |
Yan Liu |
| K210743 |
03/12/2021 |
ACUSON Redwood Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc |
Sulgue Choi |
| K210611 |
03/01/2021 |
MAGNETOM Free.Max |
Siemens Medical Solutions USA, Inc. |
Andrew Turner |
| K210707 |
03/10/2021 |
OnGuard2 Chemfort Closed Administration (CADM) |
Simplivia Healthcare LTD. |
Shay Shaham |
| K210862 |
03/23/2021 |
Hemafuse System |
Sisu Global Health |
Gillian Henker |
| K210913 |
03/29/2021 |
V12 PRO |
SLK Medical GmbH |
Matthew Reid |
| K210938 |
03/29/2021 |
PowerDot PD-01MT2 Muscle Stimulator |
Smartmissimo Technologies Pte Ltd |
Alexey Pisarev |
| K210784 |
03/16/2021 |
Extended HA Half Pins |
Smith & Nephew, Inc. |
Thomas Fearnley |
| K210953 |
03/30/2021 |
SMART Taylor Spatial Frame |
Smith & Nephew, Inc. |
Thomas Fearnley |
| K210837 |
03/22/2021 |
Smith & Nephew Plates and Screws |
Smith & Nephew, Inc. |
Thomas Fearnley |
| K210833 |
03/19/2021 |
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula |
Smiths Medical ASD, Inc. |
Nancy DeAngelo |
| K210652 |
03/04/2021 |
6MS Invisible Aligner |
SMS OPCO, LLC |
Bruce Page |
| K210910 |
03/29/2021 |
Snore Bandit |
SnoreBandit LLC |
Garry Thynne |
| K210964 |
03/31/2021 |
Resonic Rapid Acoustic Pulse Device |
Soliton Inc. |
Leslie Honda |
| K210682 |
03/08/2021 |
SOTA Cloud Imaging |
Sota Precision Optics, Inc. dba SOTA Imaging |
Edward Johansen |
| K210839 |
03/22/2021 |
SoundBite Crossing System - Peripheral (14P) |
Soundbite Medical Solutions, Inc. |
Dominique Abecassis |
| K210923 |
03/29/2021 |
Southern Implants Instrument Trays |
Southern Implants (Pty) Ltd |
Lauranda G Breytenbach |
| K210669 |
03/05/2021 |
Quantum Mini Ventilation Module |
Spectrum Medical Ltd. |
Colleen Powell |
| K210843 |
03/22/2021 |
STAGE |
SpinTech, Inc. |
Kay Fuller |
| K210745 |
03/12/2021 |
Heel Incision Safety Lancet |
SteriLance Medical (Suzhou) Inc. |
Yuan Jie |
| K210737 |
03/11/2021 |
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate |
STERIS Corporation |
Jennifer Nalepka |
| K210861 |
03/23/2021 |
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) |
Stryker GmbH |
Jonathan Schell |
| K210836 |
03/22/2021 |
InstruSafe Instrument Protection System |
Summitt Medical LLC |
Debra Kridner |
| K210670 |
03/05/2021 |
BU-CAD |
TaiHao Medical Inc. |
Hsin Hung |
| K210898 |
03/26/2021 |
Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue) |
Tangshan Lanhai Medical Supplies Co., Ltd. |
Li Ruidong |
| K210628 |
03/02/2021 |
X-FLO Fluid Management System |
Thermedx, LLC |
Daniel Marijian |
| K210668 |
03/05/2021 |
TSolution One Total Knee Application |
THINK Surgical, Inc. |
Meliha Mulalic |
| K210615 |
03/01/2021 |
Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) |
Thompson Surgical Instruments Inc. |
Tiffany Irwin |
| K210832 |
03/19/2021 |
EVOCLEAN CLEANsert Ultrasonic Insert |
TTBIO CORP. |
Sheng-Chieh Su |
| K210641 |
03/03/2021 |
Disposable Medical Mask |
Tuosheng Protective Products (Ningbo) Co., Ltd |
Nanping Yuan |
| K210961 |
03/31/2021 |
U2 Total Knee System, XPE Tibial Insert, PS PLUS |
United Orthopedic Corporation |
Lois Ho |
| K210818 |
03/18/2021 |
TrueCare Biomedix Tamper Evident Cap |
US Infusion Inc. D/B/A Truecare Biomedix-USA |
Abbey Kramarz |
| K210835 |
03/22/2021 |
Identify |
Varian Medical Systems Inc. |
Peter J. Coronado |
| K210647 |
03/03/2021 |
SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter |
Vascular Solutions LLC |
Steph Pahl |
| DEN210012 |
03/30/2021 |
vPatch |
Virility Medical |
Bosmat Friedman |
| K210971 |
03/31/2021 |
EnteraLoc Flow |
Vonco Products |
Christie Marr |
| K210609 |
03/01/2021 |
AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens |
VP Optics |
Daniel Yoon |
| K210772 |
03/15/2021 |
3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) |
VR Vertical LLC dba XRGO |
Matthew DiPalma |
| K210830 |
03/19/2021 |
VUZE System |
VUZE Medical Ltd. |
David Tolkowsky |
| K210748 |
03/12/2021 |
Well-life TM Pen Needles, Well-life TM Safety Pen Needles |
W. L. Med Co., Ltd. |
Ha Tae Joo |
| K210899 |
03/26/2021 |
LINK Embrace Shoulder System- Anatomical Configuration |
Waldemar Link GmbH & Co. KG |
Stefanie Fuchs |
| K210671 |
03/05/2021 |
Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107 |
Weony (Shenzhen) Technology Co., Ltd. |
Autumn Liu |
| K210675 |
03/05/2021 |
EasyWhip |
Winter Innovations, Inc. |
Lia Winter |
| K210810 |
03/17/2021 |
Steiking Packaging for Medical Devices |
Wipak OY |
Mira Santala |
| K210929 |
03/29/2021 |
MagiCath II |
Woo Young Medical Co., Ltd. |
Jenny Cho |
| K210679 |
03/08/2021 |
Medical Face Mask |
Wuxi Yushou Medical Appliances Co.,Ltd. |
Xiaoling Dai |
| K210967 |
03/31/2021 |
Air Pressure Therapy System: VU-IPC06 |
Xiamen Weiyou Intelligent Technology Co., Ltd. |
Yong Sun |
| K210698 |
03/08/2021 |
ECOMA Level 2 Disposable Surgical Mask with Ear Loops |
Xianning Eco Medical Articles Co., Ltd. |
Wei Zhou |
| K210954 |
03/30/2021 |
Synergy |
YRS Group Inc. |
Doris Dong |
| K210933 |
03/29/2021 |
YSI 2900C Biochemistry Analyzer |
YSI Inc. |
Eric Lute |
| K210686 |
03/08/2021 |
Nitrile Patient Examination Glove |
Yunnan Huazhiyuan Medical Technology Co., Ltd. |
Yun Gao |
| K210799 |
03/16/2021 |
Powder Free Vinyl Patient Examination Gloves |
Yunnan Huazhiyuan Medical Technology Co., Ltd. |
Yun Gao |
| K210829 |
03/19/2021 |
Persona Revision Knee System Femoral Metaphyseal Cones |
Zimmer, Inc. |
Romil Sheth |
| K210842 |
03/22/2021 |
VerSys Cemented Revision/Calcar |
Zimmer, Inc. |
Rhonda Myer |
