| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K220780 |
03/17/2022 |
ROVO Mechanical Thrombectomy Device |
2MG, Inc |
Ted Karmon |
| K220822 |
03/21/2022 |
3D-SHAPER |
3D-Shaper Medical S.L |
Ludovic Humbert |
| K220942 |
03/31/2022 |
3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) |
3M Company |
Yumi Wackerfuss |
| K220660 |
03/07/2022 |
Prevena Restor Adapti-Form Dressing |
3M Health Care Business Group |
Teri Feeley |
| K220801 |
03/18/2022 |
ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 |
Abbott Diagnostics Scarborough, Inc. |
Jessica Stahle |
| K220634 |
03/04/2022 |
NC TREK NEO Coronary Dilatation Catheter |
Abbott Vascular |
Nishi Singh |
| K220772 |
03/16/2022 |
HydroMID 4F Single Lumen Midline Catheter |
Access Vascular, Inc. |
Brian M. Hanley |
| K220890 |
03/28/2022 |
IO Needle Safety Sheath |
Actuated Medical, Inc |
Douglas R. Dillon |
| K220833 |
03/22/2022 |
Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL |
Acuitive Technologies, Inc. |
Matthew Poggie |
| K220784 |
03/17/2022 |
AcQMap High Resolution Imaging and Mapping System |
Acutus Medical, Inc. |
Sindhu Sridhar |
| K220622 |
03/03/2022 |
Hailie Sensor NF0106 |
Adherium (NZ) Ltd |
Geoff Feakes |
| K220624 |
03/03/2022 |
AI4CMR v1.0 |
AI4MedImaging Medical Solutions S.A. |
Carla Almeida |
| K220709 |
03/10/2022 |
BriefCase |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K220730 |
03/14/2022 |
allFlex Ureteral Catheters, Krait Ureteral Catheters |
Allwin Medical Devices, Inc |
Digish Mehta |
| K220781 |
03/17/2022 |
ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter |
Allwin Medical Devices, Inc |
Digish Mehta |
| K220763 |
03/16/2022 |
ALPCO Calprotectin Immunoturbidimetric Assay |
ALPCO |
Chris Wisherd |
| K220782 |
03/17/2022 |
IdentiTiÖ Porous Ti Interbody System, IdentiTiÖ NanoTecÖ Interbody System, TranscendÖ PEEK Interbody System, TranscendÖ NanoTecÖ Interbody System, IdentiTiÖ ALIF Standalone Interbody System, IdentiTiÖ NanoTecÖ ALIF Standalone Interbody System, IdentiTiÖ C |
Alphatec Spine, Inc. |
Andrew Zhang |
| K220857 |
03/23/2022 |
X-CUBE 50, X-CUBE 60 |
Alpinion Medical Systems Co., Ltd. |
Boyeon Cho |
| K220606 |
03/02/2022 |
Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 |
Ambu A/S |
Gurpreet Kaur Rehal |
| K220825 |
03/21/2022 |
Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves |
American Nitrile Operations LLC |
Stephen Perrin |
| K220900 |
03/28/2022 |
Safety Blood Collection Needles with/without Needle Holder |
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. |
Bingyi Xiang |
| K220876 |
03/25/2022 |
AOK 95A Medical Mask (20200049) |
AOK Tooling Limited |
Francis Nithyananthan |
| K220835 |
03/22/2022 |
Arkligners |
Arklign Laboratories |
Rex Ho |
| K220759 |
03/15/2022 |
Armis VeriCyn Wound Wash |
Armis Biopharma, Inc. |
Angela Mallery |
| K220663 |
03/07/2022 |
AccuCTP |
ArteryFlow Technology Co., Ltd. |
Jianping Xiang |
| K220880 |
03/25/2022 |
Arthrex BioSuture |
Arthrex Inc. |
Stacy Valdez |
| K220839 |
03/23/2022 |
Arthrex Compression FT Pins |
Arthrex Inc. |
Rebecca R. Homan |
| K220937 |
03/31/2022 |
Arthrex Mini Fragment System |
Arthrex Inc. |
Stacy Valdez |
| K220715 |
03/11/2022 |
ARTSMedia In Vitro Culture Medium (AM-IVC Medium) |
ARTSMedia Denmark ApS |
Lotte Stroebech |
| K220633 |
03/04/2022 |
MICROLET NEXT lancing device, MICROLET Lancet |
Ascensia Diabetes Care US Inc |
Sangram Yadav |
| K220889 |
03/28/2022 |
Senhance Surgical System |
Asensus Surgical, Inc. |
Casey Hinckley |
| K220678 |
03/08/2022 |
APX-24 Portable X-ray System |
Aspenstate INC |
Albert Kim |
| K220903 |
03/28/2022 |
WebCeph |
AssembleCircle Corp. |
Jang Hoon Kim |
| K220905 |
03/28/2022 |
xvision Spine System |
Augmedics Ltd. |
Contact Title |
| K220941 |
03/31/2022 |
HotDog Temperature Management System |
Augustine Temperature Management |
Garrett Augustine |
| K220938 |
03/31/2022 |
Nova HD+ |
Aura Wellness, LLC |
Scott Blomberg |
| K220610 |
03/03/2022 |
SOLO-L |
Aurora Spine Inc |
Laszlo Garamszegi |
| K220588 |
03/01/2022 |
Avanos* CORTRAK* 2 Enteral Access System (EAS) |
Avanos Medical Inc |
Nikin Desai |
| K220856 |
03/23/2022 |
Vial Adapter ╪13mm |
Avenir Performance EuropΘenne Medical (APEM) |
Bruno Bertholet |
| K220854 |
03/23/2022 |
TrachCuff Cuff Controller |
AW Technologies ApS |
Adam Hansen |
| K220756 |
03/15/2022 |
Introcan Safety 2 IV Catheter |
B.Braun Medical Inc. |
Tracy Larish |
| K220626 |
03/04/2022 |
Introcan Safety IV Catheter |
B.Braun Medical Inc. |
Tracy Larish |
| K220699 |
03/10/2022 |
Prestige Coil System |
Bait USA, LLC |
Michael Peters |
| K220613 |
03/03/2022 |
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia |
Bausch & Lomb Incorporated |
Barbara Klube-Falso |
| K220767 |
03/16/2022 |
TeleScan |
BB Imaging |
Blanca Lesmes |
| K220584 |
03/01/2022 |
BD Cathena Safety IV Catheter |
Becton Dickinson Infusion Therapy Systems Inc. |
Paul Holman |
| K220607 |
03/02/2022 |
BD MAX Enteric Viral Panel |
Becton, Dickinson and Company |
Joseph Basore |
| K220916 |
03/30/2022 |
iLet« Dosing Decision Software |
Beta Bionics, Inc. |
Vikram Verma |
| K220653 |
03/07/2022 |
Astroglide Glycerin & Paraben Free |
BioFilm Inc. |
Kevin Jamil |
| K220870 |
03/25/2022 |
BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel |
BioFire Defense, LLC |
Cynthia Pillips |
| K220805 |
03/18/2022 |
VITEK 2 AST-Gram Positive Cefoxitin Screen |
bioMerieux, Inc |
Debra Broyles |
| K220803 |
03/18/2022 |
VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 ╡g/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 ╡g/mL), VITEK 2 AST-GP Moxifloxacin |
bioMerieux, Inc |
Cherece L. Jones |
| K220866 |
03/25/2022 |
EKOS+ Endovascular Device |
Boston Scientific |
Daniel Root |
| K220629 |
03/04/2022 |
Emerge Monorail PTCA Dilatation Catheter |
Boston Scientific |
Aoife O'Flaherty |
| K220796 |
03/18/2022 |
IntellaMap Orion High Resolution Mapping Catheter |
Boston Scientific Corporation |
Melissa Schneider |
| K220652 |
03/07/2022 |
Knee 3 |
Brainlab AG |
Chiara Cunico |
| K220819 |
03/21/2022 |
BrainsWay Deep TMS System |
BrainsWay Ltd. |
Ahava Stein |
| K220704 |
03/10/2022 |
Serranator PTA Serration Balloon Catheter |
Cagent Vascular, LLC |
Carol Burns |
| K220853 |
03/23/2022 |
PicoWay Laser System |
Candela Corporation |
Danielle Gibboney |
| K220859 |
03/24/2022 |
Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black) |
Careglove Global SDN BHD |
Lim Kwee Shyan |
| K220664 |
03/07/2022 |
NewTom 7G |
CEFLA S.C. |
Lorenzo Bortolotti |
| K220614 |
03/03/2022 |
MEDOJECT fine Pen Needles |
Chirana T. Injecta |
Zdenka Klbeckova |
| K220922 |
03/31/2022 |
Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit |
Cochlear Americas |
Samata Veluvolu |
| K220757 |
03/15/2022 |
Argo Knotless SP Anchor |
CONMED Corporation |
Dionne Sanders |
| K220736 |
03/14/2022 |
Consolidated HC Steam Sterilizer |
Consolidated Machine Corp. |
Arthur Trapotsis |
| K220654 |
03/07/2022 |
ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire |
Cordis Corporation |
Dunia Bram |
| K220797 |
03/18/2022 |
FootHold System |
CrossRoads Extremity Systems, LLC |
Kim Strohkirch |
| K220766 |
03/16/2022 |
eMurmur Heart AI |
CSD Labs GmbH |
Andreas Reinisch |
| K220604 |
03/02/2022 |
EXTesia Introducer Sheath Set |
Curatia Medical Co. |
Jessica Chiu |
| K220738 |
03/14/2022 |
Motive Knee Wrap |
CyMedica Orthopedics, Inc. |
Kereshmeh Shahriari |
| K220840 |
03/23/2022 |
1 Series Phototherapy Equipment |
Daavlin Distributing Co. |
Michele Thiel |
| K220834 |
03/22/2022 |
Powder Free Nitrile Examination Glove |
DAXWELL, LLC |
Frank Zhang |
| K220841 |
03/23/2022 |
PrimeTaper EV Dental Implants ╪3.0, DS Implants abutments with EV connection (XS) |
Dentsply Sirona |
Courtney Clark |
| K220791 |
03/18/2022 |
Surgical and Prosthetic Trays |
Dentsply Sirona |
Courtney Clark |
| K220804 |
03/18/2022 |
Dia-X Bond Universal |
Diadent Group International |
Kab Sun Lee |
| K220871 |
03/25/2022 |
Nautilus |
Dornier MedTech America, Inc |
John Hoffer |
| K220921 |
03/30/2022 |
Metal Bone Screw |
Double Medical Technology Inc. |
Yan Zuo |
| K220591 |
03/01/2022 |
Proxima |
Dynasthetics LLC |
Joseph Orr |
| K220627 |
03/04/2022 |
SURGIVISIO Device |
Ecential Robotics |
Mathilde Saulpic |
| K220943 |
03/31/2022 |
Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim |
ECO Medi Glove Sdn.Bhd. |
Suresh Kumar |
| K220695 |
03/09/2022 |
Elite Biomedical Solutions Dose Request Cord |
Elite Biomedical Solutions |
Brenda Compliment |
| K220867 |
03/25/2022 |
Tapestry Biointegrative Implant |
Embody, Inc. |
Brianna Schehr |
| K220609 |
03/02/2022 |
Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color) |
Encompass Industries Sdn. Bhd. |
Nur Atikah binti Muhammad Muhyiddin |
| K220908 |
03/29/2022 |
Ensol EnTM Specimen Collection and Transport System |
Ensol Biosciences Inc. |
Cheol-Min Lee |
| K220894 |
03/28/2022 |
SmileGuard |
EnvisionTEC GmbH |
Ruediger Van Bernum |
| K220665 |
03/07/2022 |
Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile |
Excellent Medical Technology Group Co., Ltd. |
Kenney Song |
| K220590 |
03/01/2022 |
aPROMISE X |
EXINI Diagnostics AB |
Aseem Anand |
| K220655 |
03/07/2022 |
X-Pac Expandable Lumbar Cage System |
Expanding Innovations, Inc |
Robert Jaramillo |
| K220892 |
03/28/2022 |
ExsoMed INnate NanoTM Lag Screw System |
ExsoMed Corp. |
Reinhold Toerek |
| K220725 |
03/14/2022 |
HPR45i |
F Care Systems USA LLC |
Patrick Danciu |
| K220758 |
03/15/2022 |
e-Ortho Shoulder Software v1.1 |
FH Industrie |
Oscar Ramirez |
| K220703 |
03/10/2022 |
F&P 950 Respiratory Humidifier |
Fisher & Paykel Healthcare |
Reena Daken |
| K220831 |
03/22/2022 |
Dental Implantation Systems, Dental Electrical Motors |
Foshan COXO Medical Instrument Co., Ltd. |
Yongjian Zheng |
| K220829 |
03/22/2022 |
Endo Motor |
Foshan COXO Medical Instrument Co., Ltd. |
Yongjian Zheng |
| K220826 |
03/22/2022 |
LED Curing Light |
Foshan COXO Medical Instrument Co., Ltd. |
Yongjian Zheng |
| K220827 |
03/22/2022 |
Electric Wheelchair |
Foshan Dahao Medical Technology Co.,Ltd |
Bao Yi Xie |
| K220721 |
03/14/2022 |
FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K220851 |
03/23/2022 |
Venue |
GE Medical Systems |
Lee Bush |
| K220848 |
03/23/2022 |
Venue Fit |
GE Medical Systems |
Lee Bush |
| K220732 |
03/14/2022 |
Mural Perinatal Surveillance |
GE Medical Systems Information Technologies, Inc. |
Brandon O'Shea |
| K220882 |
03/25/2022 |
Vivid E80, Vivid E90, Vivid E95 |
GE Medical Systems Ultrasound and |
Tracey Ortiz |
| K220800 |
03/18/2022 |
Venue Go |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Lee Bush |
| K220940 |
03/31/2022 |
EchoPAC Software Only, EchoPAC Plug-in |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K220619 |
03/03/2022 |
Vivid S60N, Vivid S70N |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K220659 |
03/07/2022 |
AUTOBAHN(R) EVO Femoral Nails |
Globus Medical Inc. |
Jennifer Antonacci |
| K220917 |
03/30/2022 |
gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler |
GRI-Alleset, Inc. |
Marty D Paugh |
| K220676 |
03/08/2022 |
Blood Pressure Monitor |
Guangdong Transtek Medical Electronics Co., Ltd. |
Ada Liang |
| K220820 |
03/21/2022 |
Parky App |
H2O Bilisim Yazilim |
Yagmur Selin Gulmus-Kolay |
| K220910 |
03/29/2022 |
Medical image processing software |
Hangzhou Deepwise & league of PHD Technology Co.,Ltd. |
Hailong Xu |
| K220774 |
03/16/2022 |
RobPath« Total Hip Application |
Hangzhou Lancet Robotics Co., Ltd. |
Rennes Zhang |
| K220603 |
03/02/2022 |
Disposable Medical Safety Hypodermic Needle |
Hantech Medical Device Co., Ltd. |
Arnold YANG |
| K220671 |
03/07/2022 |
Manual Wheelchair |
Hebei Ruilangde Medical Equipment Technology Group Co., Ltd |
Liu Zhihao |
| K220883 |
03/25/2022 |
Small Field Applicator |
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha |
Tomoyuki Seino |
| K220667 |
03/07/2022 |
Sleeved IC |
Hollister Incorporated |
Sandra Mullen |
| K220838 |
03/22/2022 |
Artisan Bone Plug, Universal Cement Restrictor |
Howmedica Osteonics, dba Stryker Orthopaedics |
Margaret Klippel |
| K220643 |
03/04/2022 |
DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; |
HTL-Strefa S.A. |
Justyna Zemigala |
| K220777 |
03/17/2022 |
Surgical face mask |
Hubei Qianjiang Kingphar Medical Material Co., Ltd |
Zhao Fusong |
| K220824 |
03/21/2022 |
Medical Surgical Mask (Planar type) |
Hunan Chopard Medical Devices Co., Ltd |
Hongwei Wei |
| K220815 |
03/21/2022 |
BrainInsight |
Hyperfine, Inc. |
Christine Kupchick |
| K220852 |
03/23/2022 |
iCare IC200 |
Icare Finland Oy |
Hannes Hyv÷nen |
| K220807 |
03/18/2022 |
Imperative Care Radial 088 Access System |
Imperative Care Inc. |
Kristin Elis |
| K220600 |
03/02/2022 |
Artix Thrombectomy Device |
Inari Medical |
Ellen Nguyen |
| K220887 |
03/28/2022 |
Mini-ClotTriever Thrombectomy System |
Inari Medical |
Ellen Nguyen |
| K220846 |
03/23/2022 |
CORE-SNARE |
Incore Co., Ltd. |
Jae-Hun Lee |
| K220727 |
03/14/2022 |
inHEART MODELS |
inHEART, SAS |
Audrey LabΦque |
| K220875 |
03/25/2022 |
HAcancellous PEEK-C Porous HA PEEK Cervical IBF System |
Innovasis, Inc. |
Marshall McCarty |
| K220612 |
03/03/2022 |
PrimeLOC Attachment System |
Innovative Product Brands, Inc. |
Chris Gervais |
| K220646 |
03/04/2022 |
Play&Joy InvisiLube Lubricant Capsule |
InnoveMed Bio-tech Co., Ltd. |
David Chien |
| K220793 |
03/18/2022 |
InnoVoyce Laser Fiber |
InnoVoyce LLC |
Kent Johnson |
| K220751 |
03/15/2022 |
Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA |
Institut Straumann AG |
Viviana Horhoiu |
| K220878 |
03/25/2022 |
Straumann TLX Variobase C |
Institut Straumann AG |
Gordon Dodds |
| K220742 |
03/14/2022 |
NxtGen Infant Transport Incubator |
International Biomedical |
Amy Pieper |
| K220760 |
03/15/2022 |
Pre-Formed Penile Silicone Block |
International Medical Devices, Inc. |
James Elist |
| K220681 |
03/08/2022 |
Talee, Talee PostOP |
Invent Medical USA, LLC |
Jiri Rosicky |
| K220668 |
03/07/2022 |
Wireless Digital Flat Panel Detector |
iRay Technology Taicang Ltd. |
Junjie Qian |
| K220935 |
03/31/2022 |
Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App |
iRen-Medical, Ltd |
Hezkiah Tsoory |
| K220726 |
03/14/2022 |
K Clear |
K Line Europe GmbH |
Sherif Kandil |
| K220902 |
03/28/2022 |
Navagio Lumbar Cage |
Kalitec Medical, LLC |
Scott Winn |
| K220637 |
03/04/2022 |
3 Ply Medical Grade Single Use Procedural Disposable Face Mask |
KDI Med Supply |
Yolanda Davis |
| K220605 |
03/02/2022 |
Venus Bulk Flow ONE |
Kulzer, LLC |
Marc Henn |
| K220677 |
03/08/2022 |
Kurin Blood Culture Collection Set with Kurin Lock Technology |
Kurin, Inc, |
Neal Hartman |
| K220697 |
03/09/2022 |
Nitrile Patient Examination Gloves, Powder Free |
Lalan Rubbers (Pvt) Ltd |
Renuka Priyangi |
| K220873 |
03/25/2022 |
Perceptive electric dental motor and control unit |
Lares Research |
Bruce Holderbein |
| K220874 |
03/25/2022 |
Smooth Drive contra angle and straight handpieces |
Lares Research |
Bruce Holderbein |
| K220792 |
03/18/2022 |
SMR Reverse Liner |
LimaCorporate S.p.A. |
Michela Zanotto |
| K220898 |
03/28/2022 |
NOxBOXi Nitric Oxide Delivery System |
Linde Gas & Equipment Inc. |
Dave Loflin |
| K220635 |
03/04/2022 |
Heater-Cooler System 3T |
LivaNova Deutschland GmbH |
Julia E. Leslie |
| K220877 |
03/25/2022 |
Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems |
Lumenis Be, Inc. |
Shlomit Segman |
| K220729 |
03/14/2022 |
The Luminance RED Acne Device |
Luminance Medical Ventures, Inc. |
Troy Stites |
| K220670 |
03/07/2022 |
Magnum |
Magnum Health And Safety Pvt Ltd |
Rakesh Bhagat |
| K220930 |
03/31/2022 |
Restoris Multi-Compartmental Knee System |
Mako Surgical Corp. |
Emily DiMambro |
| K220632 |
03/04/2022 |
Boss Crossing Support Catheter |
Marvao Medical Devices Ltd |
Chris Davey |
| K220705 |
03/10/2022 |
MyKnee R Pin Positioners |
Medacta International S.A. |
Stefano Baj |
| K220706 |
03/10/2022 |
MyPAO Guides |
Medacta International S.A. |
Stefano Baj |
| K220888 |
03/28/2022 |
MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides |
Medacta International S.A. |
Stefano Baj |
| K220828 |
03/22/2022 |
SQA-iO Sperm Quality Analyzer |
Medical Electronic Systems LTD |
Marcia Deutsch |
| K220724 |
03/14/2022 |
CD HorizonÖ Spinal System and PASS LPÖ Spinal System |
Medicrea International |
Karine Trogneux |
| K220810 |
03/21/2022 |
InfinityÖ OCT System and PASS OCT Spinal System |
Medicrea International |
Karine Trogneux |
| K220812 |
03/21/2022 |
DynaClip« Bone Staple |
MedShape, Inc. |
Courtney Kline |
| K220773 |
03/16/2022 |
Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque |
Medtronic Vascular |
Nikita Ciandra Vaz |
| K220929 |
03/31/2022 |
Excelsior |
Merit CRO, Inc. |
Yijuan Huang |
| K220779 |
03/17/2022 |
XD |
Mirada Medical Ltd |
Adam Taylor |
| DEN220017 |
03/04/2022 |
BioXmark |
Nanovi A/S |
Hsiao-Qing Chow |
| K220595 |
03/01/2022 |
NeoNavia Biopsy System |
NeoDynamics AB |
Anna Forsberg |
| K220631 |
03/04/2022 |
NomadAir PMU810 |
Neurotronics, Inc. |
James "Cody" Smith |
| K220891 |
03/28/2022 |
Kahook Dual Blade Glide (KDB Glide) |
New World Medical, Inc. |
Victor Arellano |
| K220843 |
03/23/2022 |
OAKTREE Anterior Lumbar Plate and Screw System |
Oak Tree Engineering, LLC. |
Douglas W. Neary |
| K220587 |
03/01/2022 |
Evis Exera III Duodenovideoscope Olympus TJF-Q190V |
Olympus Medical Systems Corp. |
Toshio Nakamura |
| K220761 |
03/15/2022 |
CIRCUL8 Connect DVT Prevention Device |
Ortho8, Inc. |
Jeff Culhane |
| K220809 |
03/21/2022 |
Drive Rail System |
OrthoPediatrics Corp. |
Yan Li |
| K220679 |
03/08/2022 |
Pediatric Nailing Platform Femur |
OrthoPediatrics Corp. |
Yan Li |
| K220733 |
03/14/2022 |
OptiVu ROSA MxR |
Orthosoft, Inc. (d/b/a Zimmer CAS) |
Paul Hardy |
| K220684 |
03/08/2022 |
Oryx Cloud Imaging |
Oryx Dental Software INC |
Rania Saleh |
| K220928 |
03/31/2022 |
Overjet Calculus Assist |
Overjet Inc. |
Adam Odeh |
| K220899 |
03/28/2022 |
Oxehealth Vital Signs |
Oxehealth Limited |
Iain Charlton |
| K220656 |
03/07/2022 |
iovera System |
Pacira Biosciences, Inc. |
Danny Rivera |
| K220897 |
03/28/2022 |
Disposable Brain Biopsy Needle 2.0 |
PAJUNK GmbH Medizintechnologie |
Christian G. H. Quass |
| K220641 |
03/04/2022 |
Barrigel Injectable Gel |
Palette Life Sciences |
David Goodnough |
| K220698 |
03/09/2022 |
Bambino 3, S3 and S3 Swing, U3 and U3 Light, X |
Panthera AB |
Fredrik Stantz |
| K220683 |
03/08/2022 |
INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) |
Penumbra, Inc. |
Sindokht (Sisi) Soltanzadeh |
| K220944 |
03/31/2022 |
PointCore Surgical Mask |
PointCore, Inc. |
William Christiansen |
| K220823 |
03/21/2022 |
Preat Abutments |
Preat Corporation |
Chris Bormes |
| K220862 |
03/24/2022 |
E-GPS Navigated Instruments |
Precision Spine, Inc. |
Michael Dawson |
| K220735 |
03/14/2022 |
Avologi Gel Primer (Model: Av25) |
Premier North America Inc. |
Ellis Tamari |
| K220662 |
03/07/2022 |
Disposable Barrier Sleeves |
Premium Plus (Dongguan) Limited |
Jessica Mao |
| K220816 |
03/21/2022 |
BruxZir NOW |
Prismatik Dentalcraft, Inc. |
So Hyun Park |
| K220597 |
03/01/2022 |
Disposable Surgical Face Mask (FM-34EE,FM-44EE) |
Qingdao Bestex Rubber & Plastic Products Co.,Ltd. |
Lucy Wang |
| K220673 |
03/07/2022 |
Sterile Silver Alginate Wound Dressing |
Qingdao Bright Moon Biomedical Materials Co., Ltd. |
Deng Yunlong |
| K220685 |
03/08/2022 |
HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx |
Qingdao HIGHTOP Biotech Co., Ltd. |
Ray Li |
| K220933 |
03/31/2022 |
QT Scanner 2000 Model A |
QT Imaging, Inc. |
John Klock |
| K220795 |
03/18/2022 |
QT ECG |
QT Medical, Inc. |
Jackal Chen |
| K220842 |
03/23/2022 |
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors |
Qura S.r.l. |
Raffaella Tommasini |
| K220598 |
03/02/2022 |
AutoContour Model RADAC V2 |
Radformation, Inc. |
Kurt Sysock |
| K220582 |
03/01/2022 |
ClearCalc Model RADCA V2 |
Radformation, Inc. |
Kurt Sysock |
| K220583 |
03/01/2022 |
ClearCheck Model RADCC V2 |
Radformation, Inc. |
Kurt Sysock |
| K220808 |
03/18/2022 |
Tigertriever 13 Revascularization Device |
Rapid Medical Ltd. |
Orit Yaniv |
| K220689 |
03/09/2022 |
Vatech Clismile |
Rayence Co.,Ltd |
Kevin Kim |
| K220649 |
03/07/2022 |
Elucis |
Realize Medical Inc. |
Dan La Russa |
| K220674 |
03/08/2022 |
TargetCool |
RecensMedical Inc. |
Yeonui Lee |
| K220717 |
03/11/2022 |
RedPoint Medical's Better Bunion System |
Redpoint Medical, LLC |
James Spitler |
| K220625 |
03/03/2022 |
ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System |
REMED Co., Ltd |
Yuna Cho |
| K220786 |
03/17/2022 |
STAR Apollo Mapping System |
Rhythm Al, Ltd |
Linda D'Abate |
| K220765 |
03/16/2022 |
HS Fiber Cerclage |
Riverpoint Medical, LLC |
Edwin Anderson |
| K220672 |
03/07/2022 |
Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim |
Riverstone Resources Sdn Bhd |
Suresh Kumar |
| K220608 |
03/02/2022 |
Accu-Chek FastClix Blood Lancing System |
Roche Diabetes Care, Inc |
Thomas Kristen |
| K220849 |
03/23/2022 |
Accu-Chek Safe-T-Pro Plus Lancing Device |
Roche Diabetes Care, Inc. |
Jason Lee |
| K220911 |
03/29/2022 |
Elecsys CMV IgG |
Roche Diagnostics |
Bin Sun |
| K220923 |
03/31/2022 |
Elecsys HSV-1 IgG (08948844160) |
Roche Diagnostics |
Cynthia Aker |
| K220924 |
03/31/2022 |
Elecsys HSV-2 IgG (08948887160) |
Roche Diagnostics |
Cynthia Aker |
| K220618 |
03/03/2022 |
SaliPen |
Saliwell Ltd. |
Ben Beiski |
| K220799 |
03/18/2022 |
K-SHIELD Zen |
SB-Kawasumi Laboratories, Inc. |
Shiro Agehama |
| K220711 |
03/11/2022 |
SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System |
SeaSpine Orthopedics Corporation |
Kavita Chandrashekar |
| K220691 |
03/09/2022 |
LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension |
Seigla Medical, Inc. |
Chad J. Kugler |
| K220680 |
03/08/2022 |
Denture Base Polymers |
Shandong Huge Dental Material Corporation |
Maggie Zheng |
| K220651 |
03/07/2022 |
Wrist Type Blood Pressure Monitor |
Shenzhen Jamr Medical Technology Co., Ltd |
Luo Fusheng |
| K220886 |
03/28/2022 |
Upper Arm Type Blood Pressure Monitor |
Shenzhen Jamr Technology Co.,Ltd |
Luo Fusheng |
| K220669 |
03/07/2022 |
IPL HAIR REMOVAL HANDSET, Model: IPL-666 |
Shenzhen Junbobeauty Technology Co., Ltd. |
Jian Zhan |
| K220645 |
03/04/2022 |
Hand-held IPL device (JOVS Hair Removal Device) |
Shenzhen Qianyu Technology Co., Ltd. |
Kunming Lin |
| K220927 |
03/31/2022 |
IPL Hair Removal |
Shenzhen Qiaochengli Technology Co., Ltd. |
Guoming Zhou |
| K220920 |
03/30/2022 |
Matreneu Percutaneous Balloon Compression Kit |
Shenzhen Shineyard Medical Device Co. Ltd. |
Yan Ping |
| K220596 |
03/01/2022 |
Wearable Breast Pump (Model S9) |
Shenzhen TPH Technology Co., Ltd. |
Peter Chen |
| K220688 |
03/08/2022 |
SilentZPro 2.0 |
Shinrin-Yoku Traders LLC |
Ryan Bruss |
| K220728 |
03/14/2022 |
vWF Ag |
Siemens Healthcare Diagnostics Products GmbH |
Petra Dissmann |
| K220939 |
03/31/2022 |
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A |
Siemens Medical Solutions USA Inc. |
Alina Goodman |
| K220783 |
03/17/2022 |
syngo.via RT Image Suite |
Siemens Medical Solutions USA Inc. |
Clayton Ginn |
| K220589 |
03/01/2022 |
MAGNETOM Skyra Fit |
Siemens Medical Solutions USA, Inc. |
Karthik Pillai |
| K220919 |
03/30/2022 |
MULTIX Impact E |
Siemens Medical Solutions USA, Inc. |
Denise Adams |
| K220814 |
03/21/2022 |
NAEOTOM Alpha, Scan&GO Software |
Siemens Medical Solutions USA, Inc. |
Tabitha Estes |
| K220832 |
03/22/2022 |
syngo Dynamics (Version VA40E) |
Siemens Medical Solutions USA, Inc. |
Abhineet Johri |
| K220737 |
03/14/2022 |
World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC) |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K220658 |
03/07/2022 |
COSY Cervicothoracic Occipital Rod-Screw System |
SIGNUS Medizintechnik GmbH |
Holger Noss |
| K220723 |
03/14/2022 |
Hand Trauma Screw System |
Skeletal Dynamics, Inc. |
Alexandra Rodriguez |
| K220847 |
03/23/2022 |
AETOS Shoulder System |
Smith & Nephew, Inc. |
Cassidy Lemkau |
| K220896 |
03/28/2022 |
Legion Inserts with JRNY Lock |
Smith & Nephew, Inc. |
Madison Padgett |
| K220884 |
03/28/2022 |
Disposable Endoscope Valve Sets |
SML Med-Tech Solutions Limited |
Mark Ko |
| K220586 |
03/01/2022 |
Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh |
Sofradim Production |
Paula Paz |
| K220713 |
03/11/2022 |
Sol-Guard Auto-disable Syringe |
Sol-Millennium Medical Inc. |
Ying Zhao |
| K220907 |
03/29/2022 |
The iNAP One Sleep Therapy System |
Somnics Inc. |
Chung-Chu Chen |
| K220716 |
03/11/2022 |
Spartan SC 069 |
Spartan Micro, Inc. |
Gary Avedovech |
| K220861 |
03/24/2022 |
M6-C Artificial Cervical Disc Instruments AS |
Spinal Kinetics LLC |
Joyce Zhong |
| K220893 |
03/28/2022 |
Strados Remote Electronic Stethoscope Platform (RESP) |
Strados Labs, Inc. |
Nicholas Delmonico |
| K220771 |
03/16/2022 |
Stratasys TrueDent |
Stratasys Ltd |
Melanie Glennon |
| K220895 |
03/28/2022 |
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) |
Stryker |
Marlene Fraga |
| K220731 |
03/14/2022 |
Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem |
Stryker |
Gregg Ritter |
| K220593 |
03/01/2022 |
Spine Guidance Software, Stryker Q Guidance System |
Stryker Leibinger GmbH & Co. KG |
Andrea Wallen-Gerding |
| K220901 |
03/28/2022 |
S-Core Implant System |
Subchondral Solutions, Inc. |
Michael Kolber |
| K220794 |
03/18/2022 |
10PL |
Tentech Co. Ltd. |
Lee Dong Gun |
| K220934 |
03/31/2022 |
RADIFOCUS Torque Device |
Terumo Medical Products (Hangzhou) Co., Ltd. |
Qing Liu |
| K220693 |
03/09/2022 |
Zoupure Nitrile Powder Free Examination glove |
Thai Rayong Product Glove Zoupure Co., Ltd |
Rattiya Pitutacha |
| K220813 |
03/21/2022 |
ART-PLAN |
TheraPanacea |
Edwin Lindsay |
| K220830 |
03/22/2022 |
TrueBalanceÖ Surgical System |
These Three Medical, LLC |
Moj Eram |
| K220881 |
03/25/2022 |
INOUE BALLOON A |
Toray Industries, Inc. |
Satoshi Kakuyama |
| K220914 |
03/30/2022 |
Tornier Perform Humeral System û Fracture |
Tornier, Inc. |
Renee Stoffel |
| K220650 |
03/07/2022 |
TriMed Ripcord Device |
TriMed, Inc. |
David Medoff |
| K220778 |
03/17/2022 |
Chemical Indicator for Steam |
True Indicating LLC |
Thomas Riha |
| K220696 |
03/09/2022 |
uCerv Flux-C 3D Porous Titanium Cervical Interbody |
Ulrich Medical USA |
Hans Stover |
| K220749 |
03/14/2022 |
Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP |
Unimax Medical Products Co., Ltd. |
Haibo Ning |
| K220611 |
03/03/2022 |
SUREcore Plus Biopsy Instrument |
Uro-1, Inc. |
Thomas Lawson |
| K220926 |
03/31/2022 |
Spectra Wearable |
Uzinmedicare Co., Ltd. |
Jisun Lee |
| K220869 |
03/25/2022 |
Vapotherm Aerosol Adapter AAA-2 |
Vapotherm Inc. |
Michael J. Webb |
| K220647 |
03/07/2022 |
GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273) |
Vascular Solutions LLC |
Steph Pahl |
| K220592 |
03/01/2022 |
Venus BlissMAX |
Venus Concept USA Inc. |
William H. McGrail |
| K220648 |
03/07/2022 |
OMF ASP System |
VHA DEAN |
Beth Ripley |
| K220640 |
03/04/2022 |
Bifix Hybrid Abutment Cement |
VOCO GmbH |
M. Th. Plaumann |
| K220743 |
03/14/2022 |
CediTEC |
VOCO GmbH |
M. Th. Plaumann |
| K220630 |
03/04/2022 |
TorchTM Software |
Voximetry, Incorporated |
Sue Wallace |
| K220628 |
03/04/2022 |
LINK Endo-Model EVO Knee System |
Waldemar Link GmbH & Co. KG |
Stefanie Fuchs |
| K220722 |
03/14/2022 |
PVC Hydrophilic Urethral Catheter |
Well Lead Medical Co., Ltd. |
Jenny Zhu |
| K220872 |
03/25/2022 |
Saberscope5 Laparoscope |
Xenocor, Inc |
Evan Kelso |
| K220906 |
03/29/2022 |
SECURE-LOCK |
Xiros Ltd |
Steve Curran |
| K220785 |
03/17/2022 |
Clean Connecting Tube |
Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
Tina Han |
| K220790 |
03/17/2022 |
Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare |
Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
Tina Han |
| K220700 |
03/10/2022 |
Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine |
Yian Medical Technology (Haining) Co., Ltd |
Zhiqin Yu |
| K220644 |
03/04/2022 |
Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy« Nitrile Examination Glove, Tested for use with Chemotherapy Drugs |
YTY Industry (Manjung) Sdn Bhd |
Punitha Samy |
| K220581 |
03/01/2022 |
Zavation eZspand Interbody System |
Zavation Medical Products, LLC |
Matt Jones |
| K220739 |
03/14/2022 |
Disposable Urine Collection Tube |
Zhejiang Gongdong Medical Technology Co., Ltd. |
Handson Wei |
| K220747 |
03/14/2022 |
Power Wheelchair (N5515B) |
Zhejiang Innuovo Rehabilitation Devices Co., Ltd. |
Leo Zheng |
| K220740 |
03/14/2022 |
Power Wheelchair, W5907 (Q50 R Carbon) |
Zhejiang Innuovo Rehabilitation Devices Co., Ltd. |
Leo Zheng |
| K220657 |
03/07/2022 |
Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001) |
Zhejiang Rongsheng Industrial Co., Ltd. |
Wu Bentuan |
| K220601 |
03/02/2022 |
CoolTone |
Zimmer MedizinSysteme GmbH |
Julia Kredler |
