| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K213552 |
04/01/2022 |
PuraStat-RM |
3-D Matrix, Inc. |
Lisa Spirio |
| K213809 |
04/06/2022 |
3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader |
3M Company |
Hilary Hovde |
| K212022 |
04/20/2022 |
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E |
3M Company |
Mary Fretland |
| K220121 |
04/11/2022 |
Non Sterile Nitrile Powder Free Examination Gloves û Blue,Green, and Black |
AAMedix Glove Sdn Bhd |
Annette Schaps |
| K213494 |
04/01/2022 |
Aveir Retrieval Catheter |
Abbott Medical |
Bijal Jain |
| K220243 |
04/30/2022 |
Ultiri Measurement System |
Abbott Medical |
Kenny M Bello |
| K202977 |
04/29/2022 |
Alinity m STI Assay |
Abbott Molecular, Inc. |
Stacy Ferguson |
| K213886 |
04/26/2022 |
BriefCase |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K220287 |
04/07/2022 |
Invisalign System |
Align Technology, Inc. |
Shweta Daga |
| K212662 |
04/26/2022 |
AliveCor QT Service |
AliveCor, Inc. |
Susan Noriega |
| K214006 |
04/04/2022 |
Invictus« Spinal Fixation System |
Alphatec Spine, Inc. |
Sandy Gill |
| K211837 |
04/19/2022 |
Altus Spine Interbody Standalone Fusion System |
Altus Partners, LLC |
Mark Melton |
| K213296 |
04/12/2022 |
Anprolene SteriTest RRBI |
Andersen Sterilizers, Inc. |
William K Andersen |
| K211713 |
04/28/2022 |
AngioCloud Service |
AngioCloud, LLC |
James Lewis |
| K213388 |
04/04/2022 |
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System |
AngioDynamics, Inc. |
Kasey E. Newcomb |
| K214075 |
04/12/2022 |
Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) |
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. |
Bingyi Xiang |
| K212090 |
04/22/2022 |
Electric Scooter |
Anhui JBH Medical Apparatus Co.,Ltd |
Dandan Yang |
| K202534 |
04/06/2022 |
MTM301 Blood Glucose and Ketone Monitoring System |
Apex Biotechnology Corp. |
Lisa Liu |
| K212773 |
04/15/2022 |
ARDO Alyssa |
ARDO Medical AG |
Thomas Schlieper |
| K213506 |
04/06/2022 |
NB 1 SA Implant System |
Arumdentistry Co., Ltd. |
Hyang Mi Lee |
| K210634 |
04/13/2022 |
MCL 31 Dermablate System |
Asclepion Laser Technologies GmbH |
Dania Di Pietro Paolo |
| K213889 |
04/22/2022 |
PicoStar |
Asclepion Laser Technologies GmbH |
Carolin Kuehling |
| K213334 |
04/29/2022 |
Monarch Platform, Urology |
Auris Health Inc |
Angela Wong |
| K220543 |
04/20/2022 |
Auxo A300, A150 and APod |
Auxo Hair, LLC |
Patricia Schnoor |
| K220588 |
04/22/2022 |
Avanos* CORTRAK* 2 Enteral Access System (EAS) |
Avanos Medical Inc |
Nikin Desai |
| K213775 |
04/24/2022 |
GlovatexÖ White Latex Gloves, GlovanilÖ Blue Nitrile Gloves |
Avecena Gloves Sdn Bhd |
Mohd Aswad bin Ramli |
| K213015 |
04/08/2022 |
DORA Disposable A.V. Fistula Needle Sets |
Bain Medical Equipment (Guangzhou)Co., Ltd. |
Zoe Zeng |
| K220699 |
04/08/2022 |
Prestige Coil System |
Bait USA, LLC |
Michael Peters |
| K212216 |
04/01/2022 |
Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set |
Baxter Healthcare Corporation |
Fortunato (Tito) Aldape |
| K220417 |
04/29/2022 |
Spectrum IQ Infusion System with Dose IQ Safety Software |
Baxter Healthcare Corporation |
Jennifer Hoogheem |
| K220767 |
04/14/2022 |
TeleScan |
BB Imaging |
Blanca Lesmes |
| K203842 |
04/13/2022 |
Bendit21 Microcatheter |
Bend It Technologies Ltd |
Simona Beilin-Nissan |
| K212514 |
04/29/2022 |
Safety Pen Needle for Single Use, Insulin Pen Needles |
Berpu Medical Technology Co., Ltd. |
Buxin Yu |
| DEN200066 |
04/29/2022 |
BioFire Joint Infection (JI) Panel |
BioFire Diagnostics, LLC |
Kevin Bourzac |
| K213011 |
04/05/2022 |
Infrared Thermometer (model: E201) |
Bioland Technology Ltd |
Wenjuan Xia |
| K210183 |
04/21/2022 |
Waterlase iPLus |
Biolase, Inc. |
Katy Nennig |
| K214023 |
04/14/2022 |
VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 ╡g/mL) |
bioMerieux, Inc |
Kyle J Olney |
| K212608 |
04/22/2022 |
RibFix Blu Thoracic Fixation System |
Biomet Microfixation |
Lauren Jasper |
| K210419 |
04/13/2022 |
BIOTEQ Drainage Catheter BT-PDS-series |
Bioteque Corporation |
Stella Hsu |
| K211350 |
04/29/2022 |
Bindex BI-2 |
Bone Index Finland Ltd. |
Janne Karjalainen |
| K212430 |
04/29/2022 |
BONREE Nelaton Catheter |
Bonree Medical Co., Ltd |
He Hongbo |
| K220866 |
04/20/2022 |
EKOS+ Endovascular Device |
Boston Scientific |
Daniel Root |
| K213398 |
04/12/2022 |
EMBOLD Fibered Detachable Coil System |
Boston Scientific Corporation |
Heidi Shearer |
| K213930 |
04/19/2022 |
Brainlab Elements Guide XT, Guide 3.0 |
Brainlab AG |
Chiara Cunico |
| K220338 |
04/29/2022 |
ExacTrac Dynamic |
Brainlab AG |
Sadwini Suresh |
| K212245 |
04/13/2022 |
Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning S |
Brainlab AG |
Chiara Cunico |
| K212928 |
04/22/2022 |
Lorals |
Brazen Goods Inc. dba Lorals |
Melanie Cristol |
| K202106 |
04/06/2022 |
Plasmage System |
Brera Medical Inc |
Felix Feldchtein |
| K220038 |
04/29/2022 |
Camber Spine Navigation System |
Camber Spine Technologies |
Noel Hetrick |
| K220335 |
04/05/2022 |
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR |
Canon Medical Systems Corporation |
Paul Biggins |
| K220192 |
04/08/2022 |
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR |
Canon Medical Systems Corporation |
Paul Biggins |
| K213861 |
04/25/2022 |
CER-S |
CardioCalm Srl |
Fabio Badilini |
| K220568 |
04/27/2022 |
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series |
Cardiovascualr Systems Inc. |
Kris Miller |
| K212274 |
04/08/2022 |
INT Contour |
Carina Medical LLC |
Xue Feng |
| K212241 |
04/19/2022 |
QUATERA 700 |
Carl Zeiss Meditec AG |
Hans-Joachim Miesner |
| K212947 |
04/02/2022 |
Trinity Plus Wrinkle Reducer |
Carol Cole Company dba NuFACE |
David Reece |
| K212711 |
04/29/2022 |
SteriTite Container System with MediTray Products |
Case Medical, Inc. |
Michael Polozani |
| K213437 |
04/11/2022 |
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 |
Fatin Nor Irdina Bt Ahmad Fauzi |
| K212184 |
04/01/2022 |
TENS and EMS Stimulation (OTC) |
Changsha Yuwen Medical Equipment Co.,Ltd. |
Dahui Chen |
| K203783 |
04/06/2022 |
ClariPulmo |
ClariPi Inc. |
Hyun-Sook Park |
| K214040 |
04/12/2022 |
ClearPoint Array System (version 1.1) |
ClearPoint Neuro, Inc. |
Pete Piferi |
| K212126 |
04/04/2022 |
MediExpand Cervical Expandable VBR System |
CMF Medicon Surgical Inc. |
Matthias Alber |
| K213808 |
04/05/2022 |
Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream |
Co-Innovation Biotech Co.,Ltd. |
Hong Feng |
| K212163 |
04/14/2022 |
Coala Heart Monitor |
Coala Life AB |
Dan Pitulia |
| K210250 |
04/26/2022 |
SpeedCath Compact Male |
Coloplast |
Delaney McDougal |
| K203855 |
04/22/2022 |
CoNextions TR Tendon Repair System |
CoNextions Medical |
Matthew Swift |
| K220654 |
04/06/2022 |
ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire |
Cordis Corporation |
Dunia Bram |
| K212069 |
04/07/2022 |
Corin MetaFixÖ Hip Stem |
Corin USA Limited |
Janet Grannells |
| K221005 |
04/29/2022 |
EEA Circular Stapler with Tri-Staple Technology |
Covidien |
Leo Chen |
| K221006 |
04/29/2022 |
GIA Stapler with Tri-Staple Technology |
Covidien |
Yanjun Jiao |
| K213518 |
04/12/2022 |
CARESCAPE CO2 Microstream parameter |
Covidien llc |
Inna Reznikov |
| K202691 |
04/28/2022 |
Ortholock Anchorage Devices |
Craniofacial Technologies, Inc. |
Kevin Kaveh |
| K220797 |
04/15/2022 |
FootHold System |
CrossRoads Extremity Systems, LLC |
Kim Strohkirch |
| K212422 |
04/29/2022 |
Disposable Surgical Isolation Gown |
Crown Name Disposable Hygiene Products Fty.Ltd. |
Ying Fang |
| K220604 |
04/27/2022 |
EXTesia Introducer Sheath Set |
Curatia Medical Co. |
Jessica Chiu |
| K213482 |
04/29/2022 |
TIA Tip, Cariosity, Transillumination Accessory Tip |
D4D Technologies, LLC |
Eddie Anderson |
| K220840 |
04/22/2022 |
1 Series Phototherapy Equipment |
Daavlin Distributing Co. |
Michele Thiel |
| K220556 |
04/13/2022 |
OpenSensorX Series |
DentiMax, Inc |
David Arnett |
| K213432 |
04/01/2022 |
MIS Angulated multi-unit abutments |
Dentsply Sirona |
Courtney Clark |
| K212737 |
04/21/2022 |
INHANCEÖ Reverse Shoulder System |
Depuy Ireland UC |
Yayoi Fujimaki |
| K212158 |
04/21/2022 |
HydroMARK Breast Biopsy Site Marker |
Devicor Medical Products, Inc. |
Diane Sung |
| K220574 |
04/22/2022 |
HYBRID S70 |
Digimed Co., LTD. |
Youngbae Kwon |
| K212277 |
04/21/2022 |
Tempo Tampon |
Dong-A Pharmaceutical Co., Ltd. |
Hyunjeong Jang |
| K220871 |
04/18/2022 |
Nautilus |
Dornier MedTech America, Inc |
John Hoffer |
| K220946 |
04/15/2022 |
SURGIVISIO Device |
Ecential Robotics |
Mathilde Saulpic |
| K212278 |
04/07/2022 |
Electrocardiograph |
Edan Instruments, Inc. |
Ying Dai |
| K210109 |
04/08/2022 |
visor2 system |
Eemagine Medical Imaging Solutions GmbH |
Maarten Van De Velde |
| K220695 |
04/29/2022 |
Elite Biomedical Solutions Dose Request Cord |
Elite Biomedical Solutions |
Brenda Compliment |
| K213958 |
04/08/2022 |
Bioabsorbable Anchor |
Embody, Inc. |
Brianna Schehr |
| K213793 |
04/01/2022 |
EMPOWR Revision Knee |
Encore Medical, L.P. |
Michael Siano |
| K213282 |
04/04/2022 |
ERI Handheld Dental X-ray System (Model AG100) |
Energy Resources International Co., Ltd. Hsinchu Branch |
Nancy Liu |
| K220027 |
04/12/2022 |
Audion ET dilation system |
Entellus Medical, Inc. |
Katie Wilson |
| K213783 |
04/05/2022 |
Apyx |
Escala Medical |
Edit Goldberg |
| K213633 |
04/08/2022 |
ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler |
Ethicon Endo-Surgery, LLC |
Nathan Anderson |
| K212624 |
04/04/2022 |
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System |
Ever Fortune. AI Co., Ltd. |
Chen Ming-Fong |
| K220264 |
04/28/2022 |
EFAI RTSuite CT HN-Segmentation System |
Ever Fortune.AI Co., Ltd. |
Joseph Chang |
| K220590 |
04/29/2022 |
aPROMISE X |
EXINI Diagnostics AB |
Aseem Anand |
| K220892 |
04/27/2022 |
ExsoMed INnate NanoTM Lag Screw System |
ExsoMed Corp. |
Reinhold Toerek |
| K212031 |
04/22/2022 |
F&P 850 AirSpiral Adult NIV and NHF Circuit Kit |
Fisher & Paykel Healthcare Ltd |
Reena Daken |
| K212372 |
04/08/2022 |
Fitbit Irregular Rhythm Notifications |
Fitbit Inc |
Randy Parry |
| K210148 |
04/13/2022 |
Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinfor |
Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti. |
Alaattin Saz |
| K220512 |
04/25/2022 |
Disposable Surgical Face Mask (M01, M02) |
Fomed Industries Inc. |
He Xing |
| K202389 |
04/08/2022 |
Oxygen Concentrator |
Foshan MIC Medical Technology Co., LTD |
Wu Huahong |
| K212522 |
04/15/2022 |
Lilliput APD System |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K220295 |
04/29/2022 |
ARIETTA 50 |
FUJIFILM Healthcare Corporation |
Randy Vader |
| K213363 |
04/13/2022 |
CARESCAPE B450, E-musb |
GE Healthcare Finland Oy |
Joel Kent |
| K213181 |
04/13/2022 |
CARESCAPE B650, E-musb |
GE Healthcare Finland Oy |
Joel Kent |
| K213336 |
04/13/2022 |
Carescape B850, E-musb |
GE Healthcare Finland OY |
Joel Kent |
| K213234 |
04/12/2022 |
CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201 |
GE Medical Systems Information Technologies, Inc. |
Joel Kent |
| K213490 |
04/01/2022 |
Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P |
GE Medical Systems Information Technologies, Inc. |
Joel Kent |
| K212463 |
04/05/2022 |
Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack |
Geistlich Pharma AG |
Marco Steiner |
| K213607 |
04/28/2022 |
Geistlich Wound Matrix PLUS |
Geistlich Pharma AG |
Erik Wirth |
| K213236 |
04/27/2022 |
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel |
GenMark Diagnostics, Incorporated |
Alan Maderazo |
| K211203 |
04/07/2022 |
Green OR Reprocessed Aquamantys Bipolar Sealer |
Green OR, LLC. |
John Zehren |
| K210860 |
04/07/2022 |
Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 |
GRI-Alleset, Inc |
Martin Paugh |
| K213040 |
04/27/2022 |
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs |
Guang Dong Kingfa Sci. & Tech.Co., Ltd. |
Xiaoge Yu |
| K213450 |
04/05/2022 |
Medical surgical mask (Black mask, Level 1 and Level 3) |
Guangdong Kingfa Sci.&Tech. Co., Ltd. |
Yu Xiaoge |
| K213746 |
04/05/2022 |
Digital thermometer, Model DT101, DT102 |
Guangzhou Berrcom Medical Device Co., Ltd. |
Zhigang Du |
| K213578 |
04/06/2022 |
Balloon Dilatation Catheter |
Hangzhou AGS MedTech Co., Ltd. |
Jiayuan Zhang |
| K212400 |
04/22/2022 |
SONON Ultrasound Imaging System, Model: SONON 500L |
Healcerion Co., Ltd |
Sooyeol Lee |
| K192931 |
04/19/2022 |
V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control |
Helena Laboratories, Corp. |
Justin Padia |
| K220152 |
04/19/2022 |
TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) |
Hong Qiangxing (Shen Zhen) Electronics Limited |
Xu jianhua |
| K220487 |
04/26/2022 |
Disposable Medical Face Mask |
Hubei Mediunion Medical Products Co., Ltd. |
Jason Sheen |
| K214085 |
04/06/2022 |
Disposable Medical Mask |
Hubei Wanli Protective Products Co. Ltd |
Andy Wen |
| K211123 |
04/22/2022 |
LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel |
Huizhou Foryou Medical Devices CO., Ltd. |
Huiqi Huang |
| K220066 |
04/03/2022 |
Medical Nitrile Examination Gloves |
Hunan Zhenheyikang Medical Instrument Co., Ltd |
Yilin Yin |
| K220490 |
04/08/2022 |
ImaCor Zura Handheld ZHH-010 |
ImaCor Inc |
Richard Lanzillotto |
| K212392 |
04/01/2022 |
Intri24 Sheath |
Inari Medical, Inc. |
Kit Cariquitan |
| K220510 |
04/14/2022 |
Yushan X-Ray Flat Panel Detector with DROC |
InnoCare Optoelectronics Corp. |
Yumei Cheng |
| K213063 |
04/08/2022 |
TLX SRAs and TLX Gold Abutments |
Institut Straumann AG |
Gina Chang |
| K220536 |
04/28/2022 |
Digital flat panel detector |
iRay Technology Taicang Ltd. |
Guo Wu |
| K220668 |
04/01/2022 |
Wireless Digital Flat Panel Detector |
iRay Technology Taicang Ltd. |
Junjie Qian |
| K213620 |
04/22/2022 |
ATUSAÖ Automated 3D Breast Ultrasound System |
iSono Health, Inc. |
Shadi Saberi |
| K213681 |
04/21/2022 |
Ivory Glove Powder-Free Nitrile Examination Gloves |
Ivory Gloves SDN. BHD. |
Arasi No Last Name Provided |
| K211090 |
04/13/2022 |
ZENEX Implant System |
Izenimplant Co., Ltd. |
Mi-Kyung Kwon |
| K213484 |
04/20/2022 |
SmoothCool HR System |
Jeisys Medical Inc |
Sang Hoon Hwang |
| K220382 |
04/21/2022 |
Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple |
Jiangsu Bytech Medical Supplies Co.,Ltd. |
Shen Hongxing |
| K214051 |
04/13/2022 |
Neodent Implant System-Helix NGM Compact Surgical Kit Cases |
JJGC Ind·stria e ComΘrcio de Materiais Dentßrios S.A. |
Thais Barboza |
| K213657 |
04/01/2022 |
DEEPVESSEL FFR |
KeyaMed NA Inc. |
Xiaoxiao Liu |
| K220209 |
04/11/2022 |
Powder Free Nitrile Examination Glove, Non-sterile (Blue) |
KSG MEDICARE Sdn. Bhd. |
Jennifer Yeo |
| K220605 |
04/21/2022 |
Venus Bulk Flow ONE |
Kulzer, LLC |
Marc Henn |
| K213959 |
04/14/2022 |
MagnetOs Flex Matrix |
Kuros Biosciences BV |
Sonja van der Meer |
| K220898 |
04/27/2022 |
NOxBOXi Nitric Oxide Delivery System |
Linde Gas & Equipment Inc. |
Dave Loflin |
| K220459 |
04/15/2022 |
Mako Total Knee Application |
Mako Surgical Corp. |
Emily DiMambro |
| K210284 |
04/26/2022 |
ManaSport |
ManaMed, Inc. |
Trevor Theriot |
| K220477 |
04/11/2022 |
Cellvizio 100 series system with confocal Miniprobes |
Mauna Kea Technologies |
Aline Criton |
| K220405 |
04/12/2022 |
Amis K Long |
Medacta International S .A. |
Stefano Baj |
| K220570 |
04/26/2022 |
M.U.S.T. MINI Posterior Cervical Screws System Extension |
Medacta International S.A. |
Stefano Baj |
| K220724 |
04/08/2022 |
CD HorizonÖ Spinal System and PASS LPÖ Spinal System |
Medicrea International |
Karine Trogneux |
| K220810 |
04/19/2022 |
InfinityÖ OCT System and PASS OCT Spinal System |
Medicrea International |
Karine Trogneux |
| K213408 |
04/17/2022 |
BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free |
Meditech Gloves SDN BHD |
Effendi Tenang |
| K220219 |
04/26/2022 |
PERMALOOP Suture, PERMATAPE Suture |
Medos International SARL |
Ashley Aromando (Goncalo) |
| K214025 |
04/12/2022 |
PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter |
Medos International Sarl |
Ivenette Guzman |
| K210714 |
04/06/2022 |
Extended Reservoir |
Medtronic MiniMed, Inc. |
Prerna Singh |
| K214010 |
04/12/2022 |
Anteralign Spinal System with Titan nanoLOCK Surface Technology |
Medtronic Sofamor Danek USA |
Elizabeth Hamilton |
| K220773 |
04/13/2022 |
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 |
| K214053 |
04/14/2022 |
Amputee Garment for use with Lympha Press Optimal Plus |
Mego Afek AC Ltd. |
Ilan Sharon |
| K212882 |
04/08/2022 |
SCOUT BX Delivery System |
Merit Medical Systems, Inc. |
Sari Stevens |
| K213730 |
04/21/2022 |
MESI mTABLET TBI diagnostic system, MESI mTABLET TBI |
Mesi, Development of Medical Devices, Ltd.; Mesi d.o.o. |
Jakob Susteric |
| K220779 |
04/15/2022 |
XD |
Mirada Medical Ltd |
Adam Taylor |
| K212981 |
04/22/2022 |
MirrorMe3D Modeling System |
MirrorMe3D, LLC |
Jordan Mills |
| K213925 |
04/25/2022 |
MyoCycle MC-2 (Home / Home + / Pro / Pro +) |
Myolyn, LLC |
Matthew Bellman |
| K220561 |
04/14/2022 |
Disposable Medical Nitrile Examination Gloves |
Nanjing universal medical equipment Co., Ltd |
Jerry Gao |
| K220271 |
04/29/2022 |
Hand Diagnostic Radiography Imaging System |
NanoRay Biotech Co., Ltd |
Alice Chen |
| K213944 |
04/22/2022 |
HealthOST |
NanoxAI Ltd. |
Shlomit Cymbalista |
| K220343 |
04/02/2022 |
Nitrile Examination Gloves |
NB Medical Co., LTD |
Kecheng Zhou |
| K213649 |
04/29/2022 |
BodyTom 64 |
NeuroLogica Corporation, |
Ninad Gujar |
| K212377 |
04/15/2022 |
Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 |
Ningbo MedKinetic Medical Device Co., Ltd. |
Zhang Wei |
| K212677 |
04/15/2022 |
aboNT SYRINGE |
Nipro Medical Corporation |
Jessica Oswald-McLeod |
| K220144 |
04/08/2022 |
Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T |
NORAS MRI Products GmbH |
Manuel Noras |
| K212477 |
04/28/2022 |
EARP Interbody System |
Nvision Biomedical Technologies, Inc. |
Diana Langham |
| K220383 |
04/29/2022 |
LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) |
Okami Medical |
Jill Delsman |
| K220189 |
04/29/2022 |
LISA Laser Surgical Fibers |
Omni-Guide Holdings, Inc. |
Carlos O Acosta |
| K212530 |
04/24/2022 |
IVX Fluid Transfer Set |
Omnicell, Inc. |
David Vanella |
| K210593 |
04/06/2022 |
Onera Sleep Test System (Onera STS) |
Onera B.V. |
Ruben de Francisco Martin |
| K213133 |
04/13/2022 |
Keffort (MC-100, MC-100A) |
Oriental Inspiration Limited |
Francis Ko |
| K212962 |
04/11/2022 |
TRELLISÖ SI Joint Fusion System |
OrthoFundamentals, LLC |
Matthew Palmer |
| K212601 |
04/05/2022 |
DRPx Locking Distal Radius Plate System |
Orthopaedic Implant Company |
Douglas Fulton |
| K220809 |
04/08/2022 |
Drive Rail System |
OrthoPediatrics Corp. |
Yan Li |
| K210146 |
04/13/2022 |
Cannulated Compression Device System |
Orthopedic Designs North America, Inc. |
Robin Wilson |
| K213708 |
04/22/2022 |
ROSA« Knee System |
Orthosoft, Inc (d/b/a Zimmer CAS) |
Paul Hardy |
| K220684 |
04/29/2022 |
Oryx Cloud Imaging |
Oryx Dental Software INC |
Rania Saleh |
| K212202 |
04/13/2022 |
WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System |
OTU Medical INC. |
Geping Liu |
| K220899 |
04/29/2022 |
Oxehealth Vital Signs |
Oxehealth Limited |
Iain Charlton |
| K212441 |
04/27/2022 |
Philips Incisive CT |
Philips Healthcare (Suzhou) Co., Ltd. |
Shiguang An |
| K214081 |
04/05/2022 |
MRCAT Head & Neck |
Philips Oy |
Janne Marvola |
| K220244 |
04/28/2022 |
DVR« Crosslock Wrist Spanning Plate (131849181) |
Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech |
Jaclyn Holli |
| K213278 |
04/28/2022 |
Planmed Verity |
Planmed Oy |
Niina Vuorikallas |
| K213118 |
04/01/2022 |
Dakota ALIF System |
Precision Spine, Inc. |
Michael Dawson |
| K212017 |
04/08/2022 |
Thermeo System |
Pro3dure Medical GmbH |
Frank Gischer |
| K213683 |
04/22/2022 |
Promisemed Fine Biopsy Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K213560 |
04/05/2022 |
Verifine Safety Syringe with Fixed Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K213604 |
04/03/2022 |
ELAZ Nitrile Powder Free Examination Glove |
Protect Gloves Co., Ltd. |
Nathaphon Wachakorn |
| K212952 |
04/18/2022 |
Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair |
Psychemedics Corporation |
Neil Stowe |
| K220141 |
04/15/2022 |
RayStation 11B |
RaySearch Laboratories AB (publ) |
David Hedfors |
| K220625 |
04/06/2022 |
ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System |
REMED Co., Ltd |
Yuna Cho |
| K214045 |
04/29/2022 |
FreedomEdge Syringe Infusion System |
Repro-Medical System, Inc., dba Koru Medical Systems |
Christopher Pazdan |
| K211715 |
04/28/2022 |
RetinAI Discovery |
RetinAI Medical AG |
Enisa Dresevic |
| K220401 |
04/09/2022 |
Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim |
Riverstone Resources Sdn Bhd |
Suresh Kumar |
| K220608 |
04/29/2022 |
Accu-Chek FastClix Blood Lancing System |
Roche Diabetes Care, Inc |
Thomas Kristen |
| K220364 |
04/05/2022 |
Accu-Chek Safe-T-Pro Uno Lancing Device |
Roche Diabetes Care, Inc. |
Julia Best |
| K220175 |
04/21/2022 |
GM85 |
Samsung Electronics Co. Ltd. |
Jaesang Noh |
| K213452 |
04/21/2022 |
GEMS-H |
Samsung Electronics Co., Ltd. |
Minhyung Lee |
| K220043 |
04/05/2022 |
HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System |
Samsung Medison Co., LTD |
Jee Young Ju |
| K210052 |
04/01/2022 |
Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band |
Saneso Inc. |
Nitesh Ratnakar |
| K213350 |
04/15/2022 |
mJOULE System and Accessories |
Sciton, Inc |
Jay Patel |
| K213509 |
04/08/2022 |
Latex Examination Gloves, Powder Free |
Shandong Intco Medical Products Co, Ltd. |
Haisheng Yu |
| K212881 |
04/11/2022 |
Intense Pulsed Light (IPL) System |
Shenzhen Fansizhe Science And Technology Co., Ltd |
Cheng Endang |
| K220103 |
04/12/2022 |
LED Therapy Device (Planar LED/Planar LED mini) |
Shenzhen Leaflife Technology Co., Ltd |
Cheng Qiang |
| K220645 |
04/27/2022 |
Hand-held IPL device (JOVS Hair Removal Device) |
Shenzhen Qianyu Technology Co., Ltd. |
Kunming Lin |
| K220005 |
04/01/2022 |
TENS & PMS Unit |
Shenzhen Yuehua Xinsen Technology Co., Ltd. |
Evin Li |
| K220222 |
04/26/2022 |
IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4 |
Shenzhen Yuwei Electronic Technology Co., Ltd. |
Liu Xuemeng |
| K221041 |
04/25/2022 |
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System |
Shockwave Medical, Inc. |
Soraya L Hori |
| K213559 |
04/21/2022 |
FEMTO LDV Z8 Femtosecond Surgical Laser |
SIE AG, Surgical Instrument Engineering |
Frank Ziemer |
| K213706 |
04/15/2022 |
AI-Rad Companion Brain MR |
Siemens Healthcare GmBh |
Kira Kuzmenchuk |
| K220939 |
04/29/2022 |
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A |
Siemens Medical Solutions USA Inc. |
Alina Goodman |
| K220151 |
04/01/2022 |
MAGNETOM Avanto Fit |
Siemens Medical Solutions USA, Inc. |
Karthik Pillai |
| K220737 |
04/11/2022 |
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 |
| K220518 |
04/01/2022 |
SKANRAD 400 |
Skanray Technologies Limited |
Vasundhara R |
| K220158 |
04/11/2022 |
G-EYE System |
Smart Medical Systems Ltd. |
Adva Yoselzon |
| K220896 |
04/26/2022 |
Legion Inserts with JRNY Lock |
Smith & Nephew, Inc. |
Madison Padgett |
| K213557 |
04/12/2022 |
Finexel |
SNJ Co., Ltd |
Taehi Chang |
| K211882 |
04/01/2022 |
HD-550 Video Endoscope System |
Sonoscape Medical Corp |
Toki Wu |
| K220075 |
04/19/2022 |
Spartan Center Wire |
Spartan Micro, Inc. |
Gary Avedovech |
| K212309 |
04/08/2022 |
Non-sterile, Powder-Free Latex Examination Glove |
Sri Trang Gloves (Thailand) Public Company Limited |
Jarinya Jirojkul |
| K220893 |
04/27/2022 |
Strados Remote Electronic Stethoscope Platform (RESP) |
Strados Labs, Inc. |
Nicholas Delmonico |
| K220895 |
04/22/2022 |
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) |
Stryker |
Marlene Fraga |
| K220373 |
04/13/2022 |
Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Aci |
Summit Glove, Inc |
James Hull |
| K220375 |
04/13/2022 |
Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) |
Summit Glove, Inc |
James Hull |
| K213921 |
04/28/2022 |
Microthin Natural Rubber Latex Condom |
Suretex Limited |
KC Nguyen |
| K212719 |
04/11/2022 |
Micro Catheter and Guidewire System |
Suzhou Hengrui Hongyuan Medical Co., Ltd |
Wang Peipei |
| K213974 |
04/20/2022 |
GEM FLOW COUPLER Monitor (GEM1020M-2) |
Synovis Micro Companies Alliance, Inc. |
Russell Pagano |
| K200946 |
04/05/2022 |
Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241) |
TaiDoc Technology Corporation |
Jacky Chou |
| K212203 |
04/07/2022 |
Dong Hai Xiang Surgical Mask |
Taizhou Donghaixiang Protective Equipment Co., Ltd |
Hong Wei |
| K220131 |
04/18/2022 |
KYPHON VuE Bone Cement |
Tecres S.p.A. |
Massio Grazioli |
| K210558 |
04/01/2022 |
LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber |
Thayer Medical Corporation |
Christine Woeppel |
| K213265 |
04/27/2022 |
Tomey Cornea/Anterior Segment OCT CASIA2 |
Tomey Corporation |
Yuko Matsushita |
| K214107 |
04/11/2022 |
XO CROSS CORONARY Support Catheter |
Transit Scientific, LLC |
Jennifer Arnold |
| K220022 |
04/04/2022 |
TRATE Dental Implant System |
Trate AG |
Vladlena Shulezhko |
| K214114 |
04/06/2022 |
Prodigy Thrombectomy System |
Truvic Medical Inc. |
Micheal Buck |
| K220231 |
04/27/2022 |
GyroStim |
UltraThera Technologies, Inc. |
Kevin Maher |
| K213650 |
04/12/2022 |
ThermPix Thermovisual Camera |
USA Therm, Inc. |
Ariel Soffer |
| K212260 |
04/13/2022 |
Sensuva Premium Silicone Personal Lubricant |
Valencia Naturals, Inc |
Anthony Santoro |
| K220592 |
04/27/2022 |
Venus BlissMAX |
Venus Concept USA Inc. |
William H. McGrail |
| K213795 |
04/21/2022 |
Videa Caries Assist |
VideaHealth, Inc |
Florian Hillen |
| K213675 |
04/11/2022 |
MP Reconstruction System |
Waldemar Link GmbH & Co.KG |
Lydia Ditter |
| K220503 |
04/23/2022 |
TENS device-EmeTerm 2, Model: YF-ZTY-E2 |
WAT Medical Technology Inc. |
Joe Xu |
| K212929 |
04/09/2022 |
Nitrile Examination Gloves |
Watchtower PPE Supplies Inc. |
Riva Zheng |
| K214088 |
04/12/2022 |
Disposable Surgical Gown |
Weihai Hongyu Nonwoven Fabric Products Co., Ltd. |
Bin Dong |
| K213483 |
04/26/2022 |
SnapLoc Wire Lock |
Wilson Cook Medical |
Paul Meyer |
| K220872 |
04/20/2022 |
Saberscope5 Laparoscope |
Xenocor, Inc |
Evan Kelso |
| K220149 |
04/19/2022 |
General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) |
XERA Medical Systems & Technology Ltd. |
Zeynep Oruc |
| K212811 |
04/12/2022 |
Ti3Z Lumbar Interbody System |
Zavation Medical Products, LLC |
Katie Motley |
| K220252 |
04/14/2022 |
High Retention Attachment System |
Zest Anchors, LLC |
Richard Hines |
| K201956 |
04/29/2022 |
Zeus IFA ANA HEp-2 Test System, Zeus dIFine |
Zeus Scientific, Inc. |
Mark J. Kopnitsky |
| K213077 |
04/27/2022 |
Automatically Retractable Safety Syringe |
Zhejiang Lingyang Medical Apparatus Co., Ltd. |
Wang Minjun |
| K220601 |
04/01/2022 |
CoolTone |
Zimmer MedizinSysteme GmbH |
Julia Kredler |
| K212512 |
04/28/2022 |
G7« Vivacit-E« Freedom« Constrained Liner |
Zimmer, Inc. |
Romil Sheth |
