| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K211705 |
06/28/2022 |
3M Attest Rapid Readout Biological Indicator, 1295 |
3M Company |
Mary Fretland |
| K220942 |
06/24/2022 |
3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) |
3M Company |
Yumi Wackerfuss |
| K221695 |
06/13/2022 |
3M Filtek Supreme Flowable Restorative |
3M Company ESPE Dental Products |
Regina Feferman-Savvateev |
| K220801 |
06/24/2022 |
ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 |
Abbott Diagnostics Scarborough, Inc. |
Jessica Stahle |
| K203597 |
06/30/2022 |
Cholesterol2 |
Abbott Ireland Diagnostics Division |
Tracy Schmidt |
| K221750 |
06/30/2022 |
CPS AIM Universal II Slittable Inner Catheter |
Abbott Medical |
Indira Verdekel |
| K220634 |
06/30/2022 |
NC TREK NEO Coronary Dilatation Catheter |
Abbott Vascular |
Nishi Singh |
| K221195 |
06/28/2022 |
OsteoProbe |
Active Life Scientific, Inc. |
Alexander Proctor |
| K210766 |
06/21/2022 |
AcQMap 3D Imaging and Mapping Catheter, Model 900009 |
Acutus Medical, Inc. |
Karla Schaffner |
| K211076 |
06/28/2022 |
Patient Specific Marking Guides |
Additive Orthopaedics, LLC |
Greg Kowalczyk |
| K221050 |
06/30/2022 |
ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System |
Aegis Spine, Inc. |
Kihyang Kim |
| K213753 |
06/01/2022 |
Purgo |
AeroClean Technologies, LLC |
Riachard Foster |
| K221314 |
06/03/2022 |
BriefCase |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K213924 |
06/03/2022 |
Gastric Alimetry System |
Alimetry Ltd. |
Yaara Yarmut |
| K220782 |
06/09/2022 |
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 |
| K213114 |
06/24/2022 |
BentrioTM Allergy Blocker |
Altamira Therapeutics, Inc. |
Elena Cavallini |
| K220488 |
06/01/2022 |
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) |
Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. |
Kitty xu |
| K213577 |
06/28/2022 |
VenAir, Sequential Compression System |
Apex Medical Corp. |
Chieh Yang |
| K213971 |
06/03/2022 |
Atrial Fibrillation History Feature |
Apple Inc. |
Luke Olson |
| K213838 |
06/01/2022 |
AneuGuide |
ArteryFlow Technology Co., Ltd. |
Jianping Xiang |
| K211718 |
06/28/2022 |
Venus Cervical Plate System |
ArtFx Medical LLC |
Ozgen Ozfidan |
| K220947 |
06/06/2022 |
Arthrex Knotless AC Repair Devices |
Arthrex Inc. |
Ivette Galmez |
| K220937 |
06/29/2022 |
Arthrex Mini Fragment System |
Arthrex Inc. |
Stacy Valdez |
| K220633 |
06/03/2022 |
MICROLET NEXT lancing device, MICROLET Lancet |
Ascensia Diabetes Care US Inc |
Sangram Yadav |
| K213726 |
06/28/2022 |
PL-1 Skin Treatment System |
Avava, Inc |
Jay Bhawalkar |
| K220856 |
06/21/2022 |
Vial Adapter ╪13mm |
Avenir Performance EuropΘenne Medical (APEM) |
Bruno Bertholet |
| K221511 |
06/23/2022 |
Axial3D Cloud Segmentation Service |
Axial Medical Printing Limited |
Jenna McGarry |
| K220164 |
06/02/2022 |
Rayvolve |
AZmed SAS |
Patricia Massako |
| K220756 |
06/23/2022 |
Introcan Safety 2 IV Catheter |
B.Braun Medical Inc. |
Tracy Larish |
| K213582 |
06/30/2022 |
Epicardial Access System |
Baylis Medical Company Inc. |
May Tsai |
| K213478 |
06/28/2022 |
BD Pen Needle |
Becton, Dickinson and Company |
Karen Immanuel |
| K213222 |
06/06/2022 |
Disposable Polypectomy Snare |
Beijing ZKSK Technology Co.,Ltd |
Ma Li |
| K213239 |
06/02/2022 |
Endoscopic Injection Needle |
Beijing ZKSK Technology Co.,Ltd |
Ma Li |
| K213223 |
06/06/2022 |
Multi-Band Ligator |
Beijing ZKSK Technology Co.,Ltd |
Ma Li |
| K213931 |
06/03/2022 |
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 ╡g/mL) |
bioMerieux, Inc. |
Debra Broyles |
| K212785 |
06/30/2022 |
Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments |
Blue Sky Bio, LLC |
Albert Zickmann |
| K221256 |
06/28/2022 |
Mg OSTEOINJECT |
Bone Solutions, Inc. |
Drew Diaz |
| K220796 |
06/10/2022 |
IntellaMap Orion High Resolution Mapping Catheter |
Boston Scientific Corporation |
Melissa Schneider |
| K220652 |
06/03/2022 |
Knee 3 |
Brainlab AG |
Chiara Cunico |
| K220270 |
06/21/2022 |
Aspirex Thrombectomy System |
C.R. Bard, Inc. |
Aaron Conovaloff |
| K213258 |
06/09/2022 |
Nasogastric Feeding Tubes - ENFit Port - PVC |
Cair Lgl |
Irving L. Wiesen |
| K220413 |
06/22/2022 |
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System |
Canary Medical USA LLC |
Nora C.R. York |
| K221620 |
06/14/2022 |
Digital Radiography CXDI-Elite, Digital Radiography E1 |
Canon Inc. |
Akira Hirai |
| K213504 |
06/16/2022 |
Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A |
Canon Medical Systems Corporation |
Paul Biggins |
| K220300 |
06/24/2022 |
OTOPLAN |
Cascination AG |
Jean-Francois Clemence |
| K213349 |
06/23/2022 |
Catalyst R1 Reverse Shoulder System |
Catalyst OrthoScience, Inc |
Dale Davison |
| K221658 |
06/10/2022 |
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set |
Centers for Disease Control and Prevention |
Julie Villanueva, PhD |
| K221834 |
06/24/2022 |
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set |
Centers For Disease Control And Prevention |
Julie Villanueva, PhD |
| K221188 |
06/23/2022 |
ZEPTO Precision Capsulotomy System |
Centricity Vision, Inc. |
Neal Hartman |
| K221160 |
06/07/2022 |
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System |
Cepheid |
Suzette Chance |
| K220572 |
06/17/2022 |
Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 |
CERAGEM Co, Ltd. |
Hyeonggeun Hwang |
| K220469 |
06/16/2022 |
Disposable Vinyl Examination Glove |
Chifeng Huawei Medical Science&Technology Co.,Ltd. |
Li Xiaohong |
| K220614 |
06/15/2022 |
MEDOJECT fine Pen Needles |
Chirana T. Injecta |
Zdenka Klbeckova |
| K210947 |
06/27/2022 |
Navident |
ClaroNav Inc |
Tal Bresler Stramer |
| K220420 |
06/10/2022 |
Saffron Fixation System |
Coloplast A/S |
Gayatri Ghadge |
| K213185 |
06/08/2022 |
ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits |
Coloplast Corp |
Gayatri Ghadge |
| K221204 |
06/23/2022 |
Excipio SV Thrombectomy Device |
Contego Medical Inc. |
Jim Clossick |
| K221339 |
06/09/2022 |
Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection |
Contego Medical Inc. |
Jim Clossick |
| K213283 |
06/22/2022 |
GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter |
ConvaTec Limited |
Louise Hollywood |
| K220973 |
06/01/2022 |
CoreLink Navigation Instruments |
CoreLink, LLC |
Steven Mounts |
| K213818 |
06/27/2022 |
VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula |
Covidien |
Michael Mach |
| DEN220006 |
06/13/2022 |
ProdiGI |
Covidien LLC |
Liron Bar Yaakov |
| K211099 |
06/17/2022 |
FreezeÆn Clear Skin Clinic Warts & Tags |
CryoConcepts LP |
Sam Niedbala |
| K214123 |
06/24/2022 |
T-FIX« 3DSI Joint Fusion System |
Cutting Edge Spine, LLC |
Kyle Kuntz |
| K213467 |
06/14/2022 |
EVA NEXUS Ophthalmic Surgical System |
D.O.R.C. Dutch Ophthalmic Research Center (International) |
Linda van Leeuwen |
| K220834 |
06/29/2022 |
Powder Free Nitrile Examination Glove |
DAXWELL, LLC |
Frank Zhang |
| K220440 |
06/16/2022 |
Dentis s-Clean Abutment Mini |
Dentis Co., Ltd. |
Gyu Ri Kim |
| K201348 |
06/16/2022 |
DePuy 3D Additive TriFlange Acetabular Cup |
DePuy International, Ltd |
Erin Combs |
| K212933 |
06/08/2022 |
INHANCETM Hybrid Anatomic Glenoid Implant |
Depuy Ireland UC |
Yayoi Fujimaki |
| K220804 |
06/15/2022 |
Dia-X Bond Universal |
Diadent Group International |
Kab Sun Lee |
| K213037 |
06/17/2022 |
IDx-DR v2.3 |
Digital Diagnostics Inc. |
Ashley Miller |
| K213201 |
06/01/2022 |
DeltaFil, DeltaFil Conditioner |
DMG Chemisch-Pharmazeutische Fabrik GmbH |
Stephan Schaefer |
| K220017 |
06/29/2022 |
Coloring Liquid |
Dongguan Xiangtong Co., Ltd. |
Charles Shen |
| K212426 |
06/16/2022 |
Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) |
DonneVie Medical Technology (Shanghai) Co. Ltd. |
Hannah Hang Yin |
| K203579 |
06/07/2022 |
Infinity Gateway Suite |
Draeger Medical Systems, Inc. |
Eileen M Boyle |
| K221231 |
06/06/2022 |
Drug Relief v1 |
DyAnsys, Inc. |
Srini Nageshwar |
| K213882 |
06/08/2022 |
EarliPoint System |
EarliTec Diagnostics, Inc. |
Thomas Ressemann |
| K221233 |
06/27/2022 |
DT-703 |
ECOTRON Co., Ltd |
Sang Bong Lee |
| K213682 |
06/22/2022 |
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, A |
Edwards Lifesciences, LLC |
Manthan Damani |
| K213794 |
06/29/2022 |
Eko Murmur Analysis Software (EMAS) |
Eko Devices, Inc. |
Sam Huang |
| K220988 |
06/09/2022 |
EksoNR |
Ekso Bionics, Inc. |
Scott Davis |
| K221463 |
06/17/2022 |
ElucidVivo A.3 |
Elucid Bioimaging Inc. |
Doug Shufelt |
| K213228 |
06/20/2022 |
NeuroLine Disposable Cranial Perforator with Hudson end |
EMD Endoszkop Muszer Gyarto es Kereskedelmi Kft. |
Gyula Ujvari |
| K220894 |
06/10/2022 |
SmileGuard |
EnvisionTEC GmbH |
Ruediger Van Bernum |
| K220449 |
06/28/2022 |
DePuy CONDUIT LLIF SQUID Inserter |
Enztec Limited |
Claire Mai |
| K213230 |
06/22/2022 |
T3 Platform Software |
Etiometry, Inc. |
Tim Hanson |
| K220665 |
06/03/2022 |
Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile |
Excellent Medical Technology Group Co., Ltd. |
Kenney Song |
| K221077 |
06/09/2022 |
Auryon Atherectomy System |
Eximo Medical Ltd. |
Yoel Zabar |
| K221362 |
06/10/2022 |
Omni Foot and Ankle Plating System |
Exremity Medical, LLC. |
Mary Hoffman |
| K213220 |
06/21/2022 |
Revaree Plus Vaginal Suppositories |
Farma-Derma S.R.L. |
Mara Calzolari |
| K212741 |
06/24/2022 |
EZYPOR |
FCI (France Chirurgie Instrumentation) SAS |
Thierry Fetick |
| K213949 |
06/30/2022 |
VASSALLO GT 018 Floppy |
Filmecc Co., Ltd. |
Toshiya Osawa |
| K221081 |
06/13/2022 |
iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System |
First Source Inc. |
Ronald Viola |
| K213255 |
06/17/2022 |
CipherOx CRI Tablet |
Flashback Technologies, Inc. |
John Jedziniak |
| K212445 |
06/01/2022 |
freeflex+ Transfer Adapter |
Fresenius Kabi AG |
Keith Dunn |
| K220289 |
06/29/2022 |
FridaMom Anti-Nausea Bands |
FridaBaby LLC |
Jeffrey Davidson |
| K214089 |
06/03/2022 |
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 |
Fujifilm Corporation |
Randy Vader |
| K221264 |
06/01/2022 |
FROG Forceps Valve (VAL1-F1-100) |
FUJIFILM medwork GmbH |
Randy Vader |
| K213117 |
06/07/2022 |
FX V135 Shoulder Prosthesis |
FX Shoulder USA, Inc. |
Kathy Trier |
| K211909 |
06/09/2022 |
Cysto-Gastro-Sets |
G-Flex Europe SPRL |
Thierry Cremer |
| K212871 |
06/17/2022 |
Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode |
Galvanize Therapeutics, Inc. |
Deborah Sheffield |
| K220851 |
06/27/2022 |
Venue |
GE Medical Systems |
Lee Bush |
| K220848 |
06/27/2022 |
Venue Fit |
GE Medical Systems |
Lee Bush |
| K220732 |
06/23/2022 |
Mural Perinatal Surveillance |
GE Medical Systems Information Technologies, Inc. |
Brandon O'Shea |
| K220800 |
06/21/2022 |
Venue Go |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Lee Bush |
| K220358 |
06/06/2022 |
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Bryan Behn |
| K213717 |
06/08/2022 |
AIR Recon DL |
GE Medical Systems,LLC (GE Healthcare) |
Glen Sabin |
| K210107 |
06/01/2022 |
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System |
Genadyne Biotechnologies, Inc. |
Saiken Ho |
| K213087 |
06/07/2022 |
Natural Rubber Latex Ultrasound Transducer Probe Covers |
Global Protection Corp. |
Christina Cataldo |
| K211207 |
06/06/2022 |
Diacare 7000 |
Globus Sport and Health Technologies LLC |
Jorge Millan |
| K221312 |
06/29/2022 |
Diode Laser Hair Removal Device |
Guangzhou CHUANG ZAO MEI Technology Co., Ltd |
Karpov Aleksandr |
| K214063 |
06/03/2022 |
Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle |
Guangzhou Shengwei Medical Devices Co., Ltd |
Xiaojun Cai |
| K211016 |
06/29/2022 |
Powered Breast Pump (Models 7V and 7X) |
Haenim Co., Ltd. |
Dae Won Kim |
| K213739 |
06/22/2022 |
Nitrile Examination Gloves |
Hangzhou Runheng Medical Co., Ltd. |
Yaya Lu |
| K212418 |
06/30/2022 |
hCG One Step Pregnancy Test |
Healstone Biotech Inc. |
Guang Gao |
| K210084 |
06/03/2022 |
SILKRO |
Hironic Co., Ltd |
Ji Yeong Seo |
| K221384 |
06/11/2022 |
Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 |
Hivox Biotek Inc. |
Aaron Huang |
| K220321 |
06/03/2022 |
Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris |
Hologic, Inc. |
Jill Wyland |
| K211173 |
06/23/2022 |
maxmorespine Bipolar Electrodes |
Hoogland Spine Products, GmbH |
Jaap Hoogland |
| K212665 |
06/22/2022 |
Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911) |
Huizhou Xiaoou Technology Co., Ltd. |
Xia Wang |
| K221393 |
06/10/2022 |
Swoop Portable MR Imaging System |
Hyperfine, Inc. |
Christine Kupchick |
| K213250 |
06/24/2022 |
Secret Duo |
Ilooda Co Ltd |
Moon Mason |
| K211000 |
06/09/2022 |
ACUTRON |
ILOODA Co., Ltd |
Yun-Jung Ha |
| K213338 |
06/23/2022 |
CORE-CLIP |
Incore Co., Ltd. |
Jae-Hun Lee |
| K211148 |
06/21/2022 |
CORE-Trocar |
Incore CO., LTD. |
Jae-Hun Lee |
| K221571 |
06/30/2022 |
InMode Multi-system |
InMode Ltd. |
Amit Goren |
| K220612 |
06/06/2022 |
PrimeLOC Attachment System |
Innovative Product Brands, Inc. |
Chris Gervais |
| K221387 |
06/14/2022 |
BEL-GEN Cold Storage Solution |
Institut Georges Lopez |
Matthieu Porteau |
| K221386 |
06/14/2022 |
PERF-GEN Pulsatile Perfusion Solution |
Institut Georges Lopez |
Matthieu Prouteau |
| K220751 |
06/02/2022 |
Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA |
Institut Straumann AG |
Viviana Horhoiu |
| K220878 |
06/16/2022 |
Straumann TLX Variobase C |
Institut Straumann AG |
Gordon Dodds |
| K220299 |
06/16/2022 |
Ion Endoluminal System (IF1000) |
Intuitive Surgical, Inc. |
Jyoti Singh |
| K221714 |
06/29/2022 |
Flat Panel Detector |
iRay Technology Taicang Ltd. |
Guo Wu |
| K221345 |
06/16/2022 |
Wireless Digital Flat Panel Detector |
iRay Technology Taicang Ltd. |
Junjie Qian |
| K210804 |
06/07/2022 |
Adhese Universal DC, Cention Primer |
Ivoclar Vivadent, AG |
Sandra Cakebread |
| K220060 |
06/10/2022 |
Pre-filled Syringe with Saline |
Jiangsu Caina Medical Co., Ltd. |
Jianwei Pan |
| K201788 |
06/23/2022 |
EDEN Spinal Fixation System |
JMT Co., Ltd |
Sang-Ok Nam |
| K212288 |
06/02/2022 |
Minjie Catheter System |
Kai Medtech, LLC |
Stephanie Rallis |
| K213194 |
06/23/2022 |
HD Mediastinoscope |
Karl Storz Endoscopy America, Inc. |
Alita McElroy |
| K212450 |
06/06/2022 |
Keos Anterior Cervical Interbody Fusion Device System |
Keos |
Scott Peterson |
| K213231 |
06/29/2022 |
Kerecis Silicone |
Kerecis Limited |
Gudmundur Fertram Sigurjonsson |
| K210741 |
06/03/2022 |
KLS Martin Neuro Rongeurs |
KLS-MARTIN L.P. |
Jennifer Damato |
| K220993 |
06/23/2022 |
Ultrasound System SONIMAGE MX1 |
Konica Minolta, INC. |
Tsutomu Fukui |
| K221226 |
06/16/2022 |
1st Glove Blue Nitrile Examination Gloves Powder Free |
Koove Iot Pvt. Ltd. |
Sudarsan Mohapatra |
| K212663 |
06/09/2022 |
HELIOS IV 785 |
Laseroptek Co., Ltd. |
Hong Chu |
| K214049 |
06/02/2022 |
Leaseir MHR Xcell |
Leaseir Technologies S.L.U. |
Pablo Boto |
| K220259 |
06/09/2022 |
ALLY Adaptive Cataract Treatment System |
Lensar, Inc. |
Keith Peck |
| K221061 |
06/03/2022 |
21HQ613D |
LG Electronics Inc. |
Jinhwan Jun |
| K220377 |
06/24/2022 |
Procedure Mask |
Little Rapids Corporation |
Tom Diedrich |
| K211979 |
06/21/2022 |
Lumenis Y&R Laser System |
Lumenis Inc. |
Karen Smith |
| K220729 |
06/09/2022 |
The Luminance RED Acne Device |
Luminance Medical Ventures, Inc. |
Troy Stites |
| K213439 |
06/24/2022 |
FlexBoardTM, EagleBoardTM, BreastBoard SXTM |
MacroMedics BV |
Elizabeth Hajos |
| K220670 |
06/28/2022 |
Magnum |
Magnum Health And Safety Pvt Ltd |
Rakesh Bhagat |
| K220930 |
06/02/2022 |
Restoris Multi-Compartmental Knee System |
Mako Surgical Corp. |
Emily DiMambro |
| K220550 |
06/14/2022 |
Disposable Surgical Face Mask (M663BE, M663BT) |
MAKRITE INDUSTRIES, INC. |
Bob Wen |
| K220632 |
06/02/2022 |
Boss Crossing Support Catheter |
Marvao Medical Devices Ltd |
Chris Davey |
| K213684 |
06/15/2022 |
SurgiCase Viewer |
Materialise NV |
Aya Nishikawa |
| K221389 |
06/08/2022 |
FairFix AM Adjustable Button FairFix PSP Adjustable Button |
Medacta International S.A. |
Stefano Baj |
| K210758 |
06/02/2022 |
Q Patch |
Medicalgorithmics S.A. |
Maciej Gamrot |
| K221087 |
06/10/2022 |
Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 |
Medtronic Navigation, Inc. |
Silver Wirth |
| K220494 |
06/23/2022 |
BreathID Hp Lab System, BreathID Smart System |
Meridian Bioscience Israel Ltd. |
Raffi Werner |
| K220514 |
06/23/2022 |
bite away neo |
MibeTec, GmbH |
Oliver Grunert |
| K220157 |
06/13/2022 |
Disposable Hemostatic Closure Clip Device |
Micro-Tech (Nanjing) Co., Ltd. |
Sally He |
| K212024 |
06/10/2022 |
PAL System |
MicroAire Surgical Instruments, LLC |
Glenn Gerstenfeld |
| K213173 |
06/08/2022 |
TrabEx Pro |
MicroSurgical Technologies Inc |
Angela Mallery |
| K221524 |
06/24/2022 |
Sugita AVM Microclip Applier |
Mizuho America, Inc. |
Richard Chadwick |
| K203791 |
06/21/2022 |
Stainless Turbine |
NAKANISHI INC. |
Masaaki Kikuchi |
| K221376 |
06/10/2022 |
Nalu Neurostimulation System |
Nalu Medical, Inc. |
Chelsea Gutierrez |
| K220410 |
06/29/2022 |
Ebony HP PTA OTW 0.035 Catheter |
Natec Medical Ltd. |
Roy Devassy Pallippatt |
| K213261 |
06/02/2022 |
EpilME |
Neauvia North America |
Joy Willard |
| K211466 |
06/14/2022 |
Yomi Robotic System with YomiPlan Go |
Neocis Inc. |
William Tapia |
| K213786 |
06/27/2022 |
CiRX Single use electrosurgical pencil with non-coated and coated electrode |
Ningbo Shun Ye Medical Company, Ltd. |
Ding Feng Yu |
| K210852 |
06/24/2022 |
Noris Medical Dental Implants System - Cortical |
Noris Medical Ltd |
Simha Sibony |
| K220478 |
06/21/2022 |
NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System |
NuVasive, Incorporated |
Krunal Shah |
| K220541 |
06/02/2022 |
PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves |
O&M Halyard, Inc. |
Angela L. Bunn |
| K220547 |
06/02/2022 |
PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves |
O&M Halyard, Inc. |
Angela L. Bunn |
| K213988 |
06/03/2022 |
SOFT PLUG Extended Duration 180 Tapered Canalicular Plug |
Oasis Medical, Inc |
James Christensen |
| K220431 |
06/17/2022 |
Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile |
One Glove Industrial Sdn Bhd |
Marcus Low |
| K220482 |
06/21/2022 |
Sherlock |
Open Implants, LLC |
Gregg Gellman |
| K213626 |
06/15/2022 |
VITROS AFP |
Ortho Clinical Diagnostics |
Declan Hynes |
| K220761 |
06/03/2022 |
CIRCUL8 Connect DVT Prevention Device |
Ortho8, Inc. |
Jeff Culhane |
| K213587 |
06/09/2022 |
MyCRO Band |
Otto Bock Healthcare LP |
Caleb Beck |
| K220399 |
06/16/2022 |
WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System |
OTU Medical Inc. |
Geping Liu |
| K213097 |
06/10/2022 |
Armory Motion |
Pain Management Technologies, Inc. |
Joshua A. Lefkovitz |
| K213332 |
06/03/2022 |
Multifrax Laser System |
Paradigm Medical Corporation |
Nikolai Tankovich |
| K221465 |
06/17/2022 |
Baby Gorilla/Gorilla Plating System |
Paragon 28, Inc. |
Haylie Hertz |
| K213345 |
06/22/2022 |
Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE |
Path Medical GmbH |
Johann Oswald |
| K220960 |
06/29/2022 |
BruxZir Opaque Coloring Liquid |
Prismatik Dentalcraft, Inc. |
So Hyun Park |
| K213765 |
06/22/2022 |
Glidewell 3DP Denture Base Resin |
Prismatik Dentalcraft, Inc. |
Jiahe Li |
| K221368 |
06/09/2022 |
Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K221371 |
06/08/2022 |
Promisemed Heel Blood Lancet |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K220106 |
06/15/2022 |
QardioArm 2 |
Qardio Inc |
Rosario Iannella |
| K213862 |
06/08/2022 |
HD60 Series Ultrasound Diagnostic System |
Qingdao Hisense Medical Equipment Co., Ltd |
Yalan Wu |
| K210371 |
06/03/2022 |
Portable Oxygen Concentrator, model: P2-E6 |
Qingdao Kingon Medical Science and Technology Co., Ltd. |
Zhang Benrong |
| K213274 |
06/22/2022 |
Qlicksmart BladeFlask UNIVERSAL |
Qlicksmart Pty Ltd. |
Michael Sinnott |
| K213846 |
06/05/2022 |
Q2 Blood Administration Sets |
Quest Medical, Inc. |
Tosan Eweka |
| K213588 |
06/02/2022 |
Q2 IV Administration Sets |
Quest Medical, Inc. |
Tosan Eweka |
| K220544 |
06/29/2022 |
DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) |
Ra Medical Systems, Inc. |
Jami Miller |
| K220717 |
06/09/2022 |
RedPoint Medical's Better Bunion System |
Redpoint Medical, LLC |
James Spitler |
| K213913 |
06/30/2022 |
leva Pelvic Health System |
Renovia Inc. |
Jim O'Connor |
| K220455 |
06/07/2022 |
Lap-Band System Calibration Tube |
ReShape Lifesciences |
Michelle Ravert |
| K220523 |
06/17/2022 |
restor3d TiDAL Lumbar Interbody Fusion Device |
Restor3d |
Shyam Patel |
| K212808 |
06/14/2022 |
Logic Hd camera head green, System green |
Richard Wolf Medical Instruments Corporation |
Michael Loiterman |
| K220205 |
06/03/2022 |
3D Anatomic Models |
Ricoh USA, Inc. |
Gary Turner |
| K220672 |
06/03/2022 |
Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim |
Riverstone Resources Sdn Bhd |
Suresh Kumar |
| K203757 |
06/10/2022 |
Elecsys AMH |
Roche Diagnostics |
Edie Eads |
| K200715 |
06/24/2022 |
RoughRider Aurora Manual Wheelchair |
RoughRider America LLC |
Marc Krizack |
| K213519 |
06/10/2022 |
Rune Labs Tremor Transducer System |
Rune Labs, Inc. |
Brian Pepin |
| K211981 |
06/09/2022 |
KHEIRON« Spinal Fixation System |
S.M.A.I.O. |
Jean-Charles Roussouly |
| K212043 |
06/24/2022 |
TRAUS ENDO |
Saeshin Precision Co., Ltd. |
Nam-Gung San |
| K221117 |
06/17/2022 |
RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Jee Young Ju |
| K220975 |
06/29/2022 |
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Jee Young Ju |
| K212788 |
06/16/2022 |
Seer Home |
Seer Medical Pty Ltd |
David Mitchell |
| K221192 |
06/22/2022 |
Disposable Nitrile Powder-Free Examination Gloves |
Shandong Maida Medical Technology Co.,Ltd. |
Kitty Xu |
| K221272 |
06/28/2022 |
Medical Face Mask |
Shandong Xingyu Gloves Co., Ltd. |
Carrie Li |
| K221008 |
06/22/2022 |
HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) |
Shanghai Handy Medical Equipment Co., Ltd |
Marcia Qiu |
| K221222 |
06/06/2022 |
Surgical Face Mask (HNFM0304) |
Shanghai Hua En Industrial CO LTD |
Lisa Zhao |
| K221569 |
06/30/2022 |
Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K |
Shenzhen Fansizhe Science And Technology Co., Ltd |
Endang Cheng |
| K220651 |
06/30/2022 |
Wrist Type Blood Pressure Monitor |
Shenzhen Jamr Medical Technology Co., Ltd |
Luo Fusheng |
| K220309 |
06/27/2022 |
Wearable Breast Pump (Model S10) |
Shenzhen Lutejiacheng Technology Co., Ltd. |
Johnny Dai |
| K220447 |
06/28/2022 |
Med-link Disposable ECG Cable and Leadwires |
Shenzhen Med-link Electronics Tech Co., Ltd. |
Yi Liu |
| K220058 |
06/01/2022 |
BeneVision Central Monitoring System |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
Li Lei |
| K220927 |
06/02/2022 |
IPL Hair Removal |
Shenzhen Qiaochengli Technology Co., Ltd. |
Guoming Zhou |
| K221002 |
06/01/2022 |
IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C |
Shenzhen Ulike Smart Electronics Co.,Ltd |
Xiaoming Lin |
| K213667 |
06/10/2022 |
iFuse-TORQ« Implant System |
SI-BONE, Inc. |
Meirav Harsat |
| K213665 |
06/21/2022 |
Syngo Carbon Space VA20A |
Siemens Healthcare GmbH |
Vijay Ramadas |
| K221500 |
06/14/2022 |
ACUSON Sequoia Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc |
Sulgue Choi |
| K220432 |
06/29/2022 |
ARTIS icono (VE21) System |
Siemens Medical Solutions USA, Inc. |
Patricia D. Jones |
| K220409 |
06/29/2022 |
ARTIS pheno (VE21) System |
Siemens Medical Solutions USA, Inc. |
Patricia D. Jones |
| K220575 |
06/24/2022 |
MAGNETOM Free.Max, MAGNETOM Free.Star |
Siemens Medical Solutions USA, Inc. |
Alina Goodman |
| K213233 |
06/23/2022 |
EZYPRO ECG Recorder (Model: UG02) |
Sigknow Biomedical Co.,Ltd. |
Hsiao-Fan Liu |
| K221065 |
06/10/2022 |
MediLab |
Sigma Scientific Services LLC |
Jorge Millan |
| K212870 |
06/16/2022 |
TLC Unicompartmental Knee System |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K213088 |
06/15/2022 |
ZQuiet Advance |
Sleeping Well, LLC |
Daniel Webster |
| K220497 |
06/23/2022 |
CoLumbo |
Smart Soft Healthcare AD |
Yoana Ivanova |
| K213442 |
06/10/2022 |
Extroducer Infusion Catheter System |
Smartwise Sweden AB |
Maria Nordlinder |
| K220586 |
06/22/2022 |
Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh |
Sofradim Production |
Paula Paz |
| K203233 |
06/01/2022 |
4CIS Chiron Spinal Fixation System |
Solco Biomedical Co., Ltd. |
Hee-Hoon Kim |
| K212325 |
06/15/2022 |
EEG-acp |
SOMNOmedics GmbH |
Sabrina Forster |
| K220378 |
06/30/2022 |
Sparta 3-Ply Surgical Disposable Face Mask |
Sparta East, LLC |
Ricardo Samayoa |
| K220861 |
06/02/2022 |
M6-C Artificial Cervical Disc Instruments AS |
Spinal Kinetics LLC |
Joyce Zhong |
| K213448 |
06/06/2022 |
Powder Free Nitrile Gloves |
St Future International Limited |
Ivan Tan |
| K221335 |
06/07/2022 |
D▓RS and D▓RS 9090 |
Stephanix |
Sandie Perret |
| K221611 |
06/29/2022 |
780 nm L11 LED Light Source with AIM |
Stryker |
Michelle Hughes |
| K221217 |
06/17/2022 |
SPY Laparoscope |
Stryker |
Christie Samsa |
| K220319 |
06/10/2022 |
Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System |
Stryker GmbH |
Danielle Jannuzzi Madureira |
| K210582 |
06/10/2022 |
EasyClip« and EasyClip« Xpress |
Stryker GmbH |
Danielle Jannuzzi Madureira |
| K221071 |
06/09/2022 |
Niti-S Biliary Slim M Stent |
Taewoong Medical Co., Ltd |
Jangsoo Lee |
| K221482 |
06/22/2022 |
Esophageal TTS Stent |
Taewoong Medical Co., Ltd. |
Jangsoo Lee |
| K201037 |
06/16/2022 |
FORA ADVANCED GD40 Glucose, ▀-Ketone and Cholesterol Monitoring System |
TaiDoc Technology Corporation |
Jacky Chou |
| K203208 |
06/12/2022 |
Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System |
Taiwan Aulisa Medical Devices Technologies, Inc. |
Paul Liu |
| K220934 |
06/29/2022 |
RADIFOCUS Torque Device |
Terumo Medical Products (Hangzhou) Co., Ltd. |
Qing Liu |
| K220693 |
06/07/2022 |
Zoupure Nitrile Powder Free Examination glove |
Thai Rayong Product Glove Zoupure Co., Ltd |
Rattiya Pitutacha |
| K221186 |
06/16/2022 |
TC Gloves |
Thanh Cong Pharmaceutical and Trading Company Limited |
Nguyen Thi Tu Anh |
| K221185 |
06/22/2022 |
TC Gloves |
Thanh Cong Pharmaceutical and Trading Company Limited |
Nguyen Thi Tu Anh |
| K220813 |
06/17/2022 |
ART-PLAN |
TheraPanacea |
Edwin Lindsay |
| K213197 |
06/17/2022 |
MyOnyx System |
Thought Technology Ltd. |
Suresh Sugirtharaja |
| K211877 |
06/22/2022 |
Klassic Knee System |
Total Joint Orthopedics, Inc. |
Chris Weaber |
| K220650 |
06/01/2022 |
TriMed Ripcord Device |
TriMed, Inc. |
David Medoff |
| K221448 |
06/15/2022 |
ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) |
Varian Medical Systems, Inc |
Peter J. Coronado |
| K221408 |
06/17/2022 |
ARIA Radiation Therapy Management (v16.1 MR3) |
Varian Medical Systems, Inc |
Peter J. Coronado |
| K213977 |
06/03/2022 |
TrueBeam, TrueBeam STx, Edge, VitalBeam |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K221470 |
06/17/2022 |
Langston dual lumen catheter |
Vascular Solutions LLC |
Becky Astrup |
| K213612 |
06/23/2022 |
SYLFIRM X |
VIOL Co., Ltd. |
Chai Kyoung Woo |
| K211046 |
06/03/2022 |
eCareManager 4.5 |
Visicu, Inc. |
Janine Treter |
| K221286 |
06/29/2022 |
CLAROX |
VSI Co., Ltd. |
Jake Yu |
| K200754 |
06/02/2022 |
Hemosure Accu-Reader A100 |
W.H.P.M., Inc |
Farokh Etemedieh |
| K211567 |
06/03/2022 |
BiMobile Instruments (for BiMobile Dual Mobility System) |
Waldemar Link GmbH & Co. KG |
Stefanie Fuchs |
| K213515 |
06/10/2022 |
WesperO2 |
Wesper Inc. |
Amir Reuveny |
| K221438 |
06/07/2022 |
WHILL Model F |
Whill, Inc. |
Tsuyoshi Iriyama |
| K221366 |
06/06/2022 |
Smart Correction System Rings and Compatible HA-Coated Half Pins |
WishBone Medical, Inc. |
Ramakrishna Bajaj |
| K220528 |
06/10/2022 |
Surgical Isolation Cover Gown |
Wuhan Dymex Healthcare Co., Ltd. |
Lynn Wu |
| K221273 |
06/28/2022 |
Medical Face Mask (M001) |
Xingyu Medical Tech Co., Ltd |
Carrie Li |
| K220210 |
06/17/2022 |
Disposable Endoscopy Adapter Set |
Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
Tina Han |
| K220790 |
06/27/2022 |
Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare |
Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
Tina Han |
| K213789 |
06/24/2022 |
Intelligence LaserComb |
Yibin Yingtong Intelligent Technology Co.,Ltd. |
Pengcheng Pan |
| K220581 |
06/02/2022 |
Zavation eZspand Interbody System |
Zavation Medical Products, LLC |
Matt Jones |
| K203624 |
06/16/2022 |
Custom-made Invisible Aligners |
Zhejiang Yinchili Medical Technology Co., Ltd. |
Hangli Chen |
| K220008 |
06/02/2022 |
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ |
ZOLL Circulation, Inc |
Elizabeth Haines |
| K220004 |
06/14/2022 |
Zsquare ENT-Flex Endoscope |
Zsquare, Ltd |
Asaf Shahmoon |
| DEN210004 |
06/17/2022 |
Zuno Smart Sterilization Container |
Zuno Medical, Inc. |
Allan McNichol |
