| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K221432 |
05/17/2022 |
Customize |
3D-Side SA |
Laurent Paul |
| K221249 |
05/02/2022 |
L1P-1F (TRIOS 5) |
3Shape TRIOS A/S |
Klaus Rudbaek Hoj |
| K221266 |
05/02/2022 |
Cervical Spine Truss System (CSTS) Interbody Fusion Device |
4WEB Medical, Inc. |
Lewis Harrison |
| K221283 |
05/03/2022 |
Hammertoe Truss System (HTS) |
4WEB Medical, Inc. |
Lewis Harrison |
| K221397 |
05/13/2022 |
MitraClip G4 Steerable Guide Catheter |
Abbott Medical |
Cynthia Aguirre |
| K221294 |
05/04/2022 |
preCARDIA Occlusion System |
Abiomed Inc. |
Ken Ryder |
| K221468 |
05/20/2022 |
CitregenÖ Tendon Interference Screw (TIS), CitrelockÖ Tendon Fixation Device, CitresplineÖ and CitrelockÖ ACL Implants |
Acuitive Technologies, Inc. |
Matthew Poggie |
| K221535 |
05/27/2022 |
Align Lumbar Interbody Fusion System |
Acuity Surgical Devices, LLC |
Bryan Cowan |
| K221333 |
05/09/2022 |
Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional |
Acumed LLC |
Saleh Amirriyazi |
| K221314 |
05/05/2022 |
BriefCase |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K221330 |
05/06/2022 |
BriefCase |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K221275 |
05/02/2022 |
Qraycam PRO |
Aiobio Co., Ltd. |
HongCheol Yoon |
| K221570 |
05/31/2022 |
Antibacterial bandage |
Allmed Medical Products Co., Ltd. |
Vince Tian |
| K221491 |
05/23/2022 |
Anivia SG1000 Pump Console |
APMTD, Inc. |
John Sasso |
| K221365 |
05/12/2022 |
LapBox Tissue Containment Removal System |
ARK Surgical, Ltd. |
Stav Tori |
| K221396 |
05/13/2022 |
Arthrex FiberTak Suture Anchor |
Arthrex Inc. |
Lai Saeteurn |
| K221485 |
05/23/2022 |
Arthrex FiberTape and TigerTape Cerclage Sutures |
Arthrex Inc. |
Kelsey N. Roberts |
| K221354 |
05/10/2022 |
Arthrex SutureTape |
Arthrex Inc. |
Lai Saeteurn |
| K221546 |
05/27/2022 |
OneTouch Delica Plus Lancing System |
Asahi Polyslider Co., Ltd. |
Yoshitaka Akagi |
| K221473 |
05/20/2022 |
Flowart |
Asset Medikal Tasarim AS. |
Ebru Sirali |
| K221481 |
05/23/2022 |
NeutrArt |
Asset Medikal Tasarim AS. |
Ebru Sirali |
| K221358 |
05/11/2022 |
Isolator« Linear Pen (MLP1); Isolator« TranspolarÖ Pen (MAX1, MAX5), Coolrail« Linear Pen (MCR1); Isolator« Synergy Surgical Ablation System (EMR2, EML2); Isolator« SynergyÖ EnCompass Clamp (OLH, OSH) and Guide System; Isolator« Synergy Access Clamp (EMT1 |
AtriCure, Inc |
Jonathan McElwee |
| K221499 |
05/23/2022 |
Minimally Invasive Prostate Surgery Navigation System |
Augment Intelligent Medical System (China) Co., Ltd. |
Chen Lihong |
| K221399 |
05/13/2022 |
ZIPÖ MIS Interspinous Fusion System |
Aurora Spine, Inc. |
Laszlo Garamszegi |
| K221268 |
05/02/2022 |
SR-1 Skin Treatment System |
AVAVA, Inc |
Jay Bhawalkar |
| K221511 |
05/24/2022 |
Axial3D Cloud Segmentation Service |
Axial Medical Printing Limited |
Jenna McGarry |
| K221440 |
05/17/2022 |
LivertyÖ TIPS Access Set |
Bard Peripheral Vascular, Inc |
Scott Johnson |
| K221351 |
05/10/2022 |
Mechanical Guidewire |
Baylis Medical Company Inc. |
May Tsai |
| K221504 |
05/23/2022 |
BD SurgiphorÖ Antimicrobial Irrigation System |
BD |
Shelley Wilcox |
| K221493 |
05/23/2022 |
MicroScan Prompt Inoculation System-D |
Beckman Coulter, Inc. |
Sharon Cullen |
| K221269 |
05/02/2022 |
Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Better Care Plastic Technology Co., Ltd. |
Zhu Chunyan |
| K221460 |
05/19/2022 |
BioFire COVID-19 Test 2 |
BioFire Defense, LLC |
Cynthia Phillips |
| K221390 |
05/13/2022 |
BNLE Access Guidewire |
Biomerics NLE |
Jason Albers |
| DEN220030 |
05/04/2022 |
RemeOsÖ Screw LAG Solid |
Bioretec Ltd. |
Mari Ruotsalainen |
| K221361 |
05/11/2022 |
circulÖ pro Ring |
BodiMetrics, LLC |
Mark Goettling |
| K221256 |
05/02/2022 |
Mg OSTEOINJECT |
Bone Solutions, Inc. |
Drew Diaz |
| K221340 |
05/09/2022 |
iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) |
Boston Scientific Corporation |
Inderdeep Tiwana |
| K221515 |
05/25/2022 |
StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring |
Boston Scientific Corporation |
Tanmay Shukla |
| DEN220027 |
05/02/2022 |
B╖R╖A╖H╖M╖S sFlt-1/ PlGF KRYPTOR Test System |
BRAHMS GmbH, Part of Thermo Fisher Scientific |
Anja Jagalla |
| K221564 |
05/31/2022 |
Brainomix 360 e-ASPECTS |
Brainomix Limited |
Gwilym Owen |
| K221542 |
05/27/2022 |
Galileo Vertebral Body Replacement Device |
Bright Spine |
Robert Simonson |
| K221324 |
05/06/2022 |
ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) |
Camber Spine Technologies |
Noel Hetrick |
| K221260 |
05/02/2022 |
CSF-3 |
CardiacSense |
Benita Lanzer |
| K221319 |
05/06/2022 |
BD AlarisÖ Pump Epidural Infusion Set |
CareFusion |
Paulina Davis |
| K221327 |
05/06/2022 |
BD AlarisÖ Pump Infusion Sets |
CareFusion |
Roya Borazjani |
| K221549 |
05/31/2022 |
X-ray Flat Panel Detectors (CareView 1800 RF) |
CareRay Digital Medical Technology Co., Ltd. |
Xu Wei |
| K221492 |
05/23/2022 |
SteriTite Container System with MediTray Parts |
Case Medical, Inc. |
Michael Polozani |
| K221331 |
05/05/2022 |
Disposable Endoscope Valves System |
Changzhou Endoclean Medical Device Co., Ltd. |
Wang Qi |
| K221310 |
05/05/2022 |
Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing |
Changzhou Endoclean Medical Device Co., Ltd. |
Wang Qi |
| K221263 |
05/02/2022 |
Aqua Naina Plus Sterile Saline Solution |
Chemtex USA Inc. |
Haribabu Talasila |
| K221431 |
05/17/2022 |
TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant |
Church & Dwight Co., Inc. |
Supreet Sahota-Bhatti |
| K221401 |
05/16/2022 |
Self-Cath and Self-Cath Plus |
Coloplast |
Preeti Jain |
| K221404 |
05/16/2022 |
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) |
Conformis Inc. |
Mary Kruitwagen |
| K221339 |
05/09/2022 |
Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection |
Contego Medical Inc. |
Jim Clossick |
| K221464 |
05/19/2022 |
CorPath GRX System |
Corindus, Inc. |
Robert Lavado |
| K221400 |
05/16/2022 |
hygh-tec drainage |
Creative Balloons GmbH |
Claudia Falk |
| DEN220028 |
05/02/2022 |
Cue COVID-19 Molecular Test |
Cue Health Inc. |
Roderick Castillo |
| K221407 |
05/16/2022 |
truSculpt iD |
Cutera Inc. |
Amogh Kothare |
| K221556 |
05/31/2022 |
T-Line Hernia Mesh |
Deep Blue Medical Advances, Inc. |
William Perry |
| K221494 |
05/23/2022 |
Quality Mix Blender, Oxymixer |
DEHAS Medical Systems GmbH |
Jens Mittendorf |
| K221429 |
05/16/2022 |
KDF Zirconia Disc |
DENKEN-HIGHDENTAL Co., Ltd. |
Daijiro Goto |
| K221322 |
05/06/2022 |
CUSTMBITE Snoring System |
Dental Choice Holdings LLC |
Danielle M Jackson |
| K221402 |
05/16/2022 |
CEREC Tessera Abutment Block, CEREC Tessera Abutment System |
Dentsply Sirona Inc. |
Courtney Clark |
| K221462 |
05/19/2022 |
DePuy Reclaim Monobloc Revision Femoral Stem |
DePuy Ireland UC |
Jennifer Hill |
| K221467 |
05/20/2022 |
INHANCETM Reverse Glenoid Peripheral Posts |
Depuy Ireland UC |
Yayoi Fujimaki |
| K221391 |
05/13/2022 |
WOLF ThrombectomyÖ SmartClaw Catheter |
DeVoro Medical, Inc |
Vanessa Fowler |
| K221259 |
05/02/2022 |
Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System |
Dexcom, Inc. |
Rachel Ellena |
| K221471 |
05/20/2022 |
E3 and Profile |
Diagnosys LLC |
Jeffrey Farmer |
| K221425 |
05/16/2022 |
Primary Relief |
DyAnsys, Inc. |
Srini Nageshwar |
| K221528 |
05/26/2022 |
Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter |
Edwards Lifesciences, LLC |
Mahvish Iqbal |
| K221463 |
05/19/2022 |
ElucidVivo A.3 |
Elucid Bioimaging Inc. |
Doug Shufelt |
| K221282 |
05/03/2022 |
Empatica Health Monitoring Platform |
Empatica S.r.l. |
Alberto Poli |
| K221513 |
05/25/2022 |
Equashield Closed System Transfer Device |
EQUASHIELD Medical Ltd. |
Michal Levy |
| K221343 |
05/09/2022 |
ECHELON ENDOPATH Staple Line Reinforcement |
Ethicon Endo-Surgery LLC |
Rubina Dosani |
| K221552 |
05/31/2022 |
EFAI ChestSuite XR Pneumothorax Assessment System |
Ever Fortune AI Co., Ltd. |
Joseph Chang |
| K221323 |
05/06/2022 |
Exactech« Alteon« Short Tapered Wedge |
Exactech, Inc |
Valdimir Talley |
| K221362 |
05/11/2022 |
Omni Foot and Ankle Plating System |
Exremity Medical, LLC. |
Mary Hoffman |
| K221433 |
05/17/2022 |
Facet 28G Universal Lancet |
Facet Technologies LLC |
James Bonds |
| K221369 |
05/12/2022 |
FBCC Night Guard |
FBCC Inc |
Pablo Osorio |
| K221547 |
05/27/2022 |
InActiv Blue |
FertiPro NV |
Liesbeth Faes |
| K221338 |
05/09/2022 |
F&P Airvo 3 |
Fisher & Paykel Healthcare |
Reena Daken |
| K221436 |
05/17/2022 |
F&P 950 Accessory Breathing Circuit Kits |
Fisher & Paykel Healthcare Ltd |
Reena Daken |
| K221428 |
05/16/2022 |
PerioStom Dental Dressing |
Forward Science LLC |
Brian Pikkula |
| K221274 |
05/02/2022 |
StarFormer, TightWave |
Fotona d.o.o. |
Tina Bartolic |
| K221551 |
05/31/2022 |
FUJIFILM Endoscope Model EI-740D/S |
FUJIFILM Corporaton |
Randy Vader |
| K221264 |
05/02/2022 |
FROG Forceps Valve (VAL1-F1-100) |
FUJIFILM medwork GmbH |
Randy Vader |
| K221321 |
05/06/2022 |
MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System |
GE Medical Systems Information Technologies, Inc. |
Honghong Yang |
| K221489 |
05/23/2022 |
Artemis Proximal Femoral Nail System |
GLW, Inc. |
Arundhati Radhakrishnan |
| K221419 |
05/16/2022 |
TD-5010 Lancing Device and TD-5084 Sterile Lancets |
GOSTAR Co., Ltd. |
Pei-Fen Yang |
| K221539 |
05/27/2022 |
GammaTile |
GT Medical Technologies |
Jessica Newhard |
| K221312 |
05/05/2022 |
Diode Laser Hair Removal Device |
Guangzhou CHUANG ZAO MEI Technology Co., Ltd |
Karpov Aleksandr |
| K221251 |
05/02/2022 |
Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) |
Guangzhou Hua Kai Electronic Technology Co., Ltd. |
Cao Ke |
| K221454 |
05/19/2022 |
Disposable Medical Nitrile Examination Gloves - Non Sterile |
Guangzhou Kangling Biotechnology Co., Ltd |
Yan Wang |
| K221548 |
05/27/2022 |
Dental Air Polishing Handpiece |
Guilin Woodpecker Medical Instrument Co., Ltd. |
Xunxian Wu |
| K221487 |
05/23/2022 |
NEOVEIL Staple Line Reinforcement |
Gunze Limited |
Hidenori Nishioka |
| K221306 |
05/05/2022 |
SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories |
Gyrus ACMI, Inc. |
Jon Gilber |
| K221374 |
05/12/2022 |
Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) |
Hebei Titans Hongsen Medical Technology Co., Ltd. |
Chai Wu |
| K221384 |
05/13/2022 |
Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 |
Hivox Biotek Inc. |
Aaron Huang |
| K221449 |
05/18/2022 |
Genius AI Detection 2.0 |
Hologic, Inc. |
Deborah Thomas |
| K221278 |
05/03/2022 |
Transducer Probe Cover |
Hony Medical Co., Ltd. |
Zhu Huina |
| K221477 |
05/23/2022 |
AG100s |
Hospitech Respiration Ltd. |
Yoel Bergman |
| K221242 |
05/02/2022 |
Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank |
Hunan Vsmile Biotechnology Co., Ltd |
Xiaomi Tang |
| K221393 |
05/13/2022 |
Swoop Portable MR Imaging System |
Hyperfine, Inc. |
Christine Kupchick |
| K221531 |
05/26/2022 |
ClotTriever Thrombectomy System |
Inari Medical, Inc. |
Amnon Talmor |
| K221483 |
05/23/2022 |
FlowSaver Blood Return System |
Inari Medical, Inc. |
Kaitlyn Weinkauf |
| K221571 |
05/31/2022 |
InMode Multi-system |
InMode Ltd. |
Amit Goren |
| K221387 |
05/13/2022 |
BEL-GEN Cold Storage Solution |
Institut Georges Lopez |
Matthieu Porteau |
| K221386 |
05/13/2022 |
PERF-GEN Pulsatile Perfusion Solution |
Institut Georges Lopez |
Matthieu Prouteau |
| K221359 |
05/11/2022 |
ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-▀2 Glycoprotein-I IgM |
Instrumentation Laboratory Co. |
Nikita Malladi |
| K221517 |
05/25/2022 |
POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens |
Interojo Inc. |
Si-Chul Rho |
| K221345 |
05/09/2022 |
Wireless Digital Flat Panel Detector |
iRay Technology Taicang Ltd. |
Junjie Qian |
| K221456 |
05/19/2022 |
Rapid ICH |
iSchemaView Inc. |
James Rosa |
| K221248 |
05/02/2022 |
Rapid LVO |
iSchemaView Inc. |
James Rosa |
| K221293 |
05/04/2022 |
E-Brik Visualization Assistant |
JDI Surgical, Inc. |
Dwight Lenox |
| K221412 |
05/16/2022 |
ARIX Rib System |
Jeil Medical Corporation |
Sejin Ryu |
| K221406 |
05/16/2022 |
Vented Vial Transfer Pin |
Jiangsu Caina Medical Co., Ltd. |
Jianwei Pan |
| K221247 |
05/02/2022 |
Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle |
Jiangsu Kangbao Medical Equipment Co., Ltd. |
Rujun Tang |
| K221372 |
05/12/2022 |
YUWELL Electronic Blood Pressure Monitor |
Jiangsu Yuyue Medical Equipment & Supply CO.,LTD. |
Yinzhen Zhu |
| K221308 |
05/05/2022 |
Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle |
Jiangxi Maidikang Medical Devices Co., Ltd |
Wu Huansheng |
| K221255 |
05/02/2022 |
SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow |
Kerr Corporation |
Haiyan Wei |
| K221475 |
05/20/2022 |
MyClearALIGN Dental Aligner System |
Key Dental Technologies, LLC |
Larry Moray |
| K221381 |
05/13/2022 |
KDG Abutments |
Keystone Dental Inc. |
Nancy DeAngelo |
| K221568 |
05/31/2022 |
KOLO Evolution XHD Series Ultrasound Diagnostic System |
Kolo Medical (Suzhou) Co., Ltd |
Mike SU |
| K221245 |
05/02/2022 |
PTA Balloon Dilatation Catheter |
Kossel Medtech (Suzhou) Co., Ltd. |
Ron Lv |
| K221430 |
05/17/2022 |
reVive Light Therapy LED Cleansing System |
LED Technologies, Inc. |
Jelena Barbaric |
| K221461 |
05/19/2022 |
10HQ701G-B |
LG Electronics Inc. |
Jinhwan Jun |
| K221394 |
05/13/2022 |
14HQ701G-B |
LG Electronics Inc. |
Jinhwan Jun |
| K221434 |
05/17/2022 |
17HQ701G-B |
LG Electronics Inc. |
Jinhwan Jun |
| K221444 |
05/18/2022 |
LED Eye Perfector, model: EY-36A, EY-36B |
Light Tree Ventures Europe B.V. |
Kim Laurens |
| K221541 |
05/27/2022 |
LimFlow ARC |
LimFlow, Inc. |
Zachary Woodson |
| K221373 |
05/12/2022 |
Essenz HLM |
LivaNova Deutschland GmbH |
Julia E. Leslie |
| K221452 |
05/18/2022 |
DiLumen C1, EZ1 and Tool Mount |
Lumendi, LLC |
Dennis Daniels |
| K221280 |
05/03/2022 |
Vesseal |
Lydus Medical Ltd. |
Jessica Weiss |
| K221253 |
05/02/2022 |
SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control |
Maine Molecular Quality Controls, Inc. |
Joan Gordon |
| K221337 |
05/09/2022 |
Materialise TKA Guide System |
Materialise NV |
Jenny Jones |
| K221389 |
05/13/2022 |
FairFix AM Adjustable Button FairFix PSP Adjustable Button |
Medacta International S.A. |
Stefano Baj |
| K221545 |
05/27/2022 |
MectaLIF Anterior Extension |
Medacta International S.A. |
Stefano Baj |
| K221360 |
05/11/2022 |
Medline UNITE« Medial Malleolus Peg Plate System |
Medline Industries, LP |
Jennifer Mason |
| K221364 |
05/11/2022 |
Mitek TIGHT-N Anchor |
Medos International SARL |
Ashley Aromando (Goncalo) |
| K221325 |
05/06/2022 |
CONDUIT Lateral Switch Plate |
Medos International, SARL |
LiJuan He |
| K221495 |
05/23/2022 |
SOLID CLIPÖ Single Use Clip Applier |
Medscope Biotech Co., Ltd. |
Waine Su |
| K221244 |
05/02/2022 |
CD HorizonÖ Spinal System |
Medtronic |
Justin O'Connor |
| K221498 |
05/23/2022 |
Miha Bodytec II |
Miha Bodytec GmbH |
Felix Schweigert |
| K221524 |
05/26/2022 |
Sugita AVM Microclip Applier |
Mizuho America, Inc. |
Richard Chadwick |
| K221410 |
05/16/2022 |
Maestro Platform |
Moon Surgical |
Anne Osdoit |
| K221376 |
05/12/2022 |
Nalu Neurostimulation System |
Nalu Medical, Inc. |
Chelsea Gutierrez |
| K221250 |
05/02/2022 |
EasyOne Filter |
NDD Medizintechnik AG |
Andreas Senn |
| K221405 |
05/16/2022 |
Neurophet SCALE PET |
NEUROPHET, Inc. |
Boreum Yoo |
| K221563 |
05/31/2022 |
Neurosteer EEG Recorder |
Neurosteer Inc. |
Nathan Intrator |
| K221469 |
05/20/2022 |
PATI (Protector Against Tongue Injury) |
NeuroVice, LLC |
Ashlyn Sanders |
| K221303 |
05/05/2022 |
Neuspera Nuity System |
Neuspera Medical Inc. |
Alexander Yeh |
| K221424 |
05/16/2022 |
Sterile Surgical Powder Free Latex Glove |
New Era Medicare Sdn. Bhd. |
Fatin Nor Irdina binti Ahmad Fauzi |
| K221395 |
05/13/2022 |
Footmotion Plating System |
Newclip Technics |
Gaδlle Lussori |
| K221320 |
05/06/2022 |
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX |
Nidek Co., LTD. |
Tsutomu Sunada |
| K221472 |
05/20/2022 |
Filter and HME/Filter |
Ningbo Huakun Medical Equipment Co., Ltd. |
Lei Xi |
| K221326 |
05/06/2022 |
Nova Allegro HbA1c Assay, Nova Allegro Analyzer |
Nova Biomedical Corporation |
Cesidio Tempesta |
| K221375 |
05/12/2022 |
CureSight-CS100 |
NovaSight Ltd. |
Ran Yam |
| K221518 |
05/25/2022 |
NP Medical nCompass Extension Set with Stabilizing Base |
NP Medical |
Krishna Govindarajan |
| K221388 |
05/13/2022 |
NuVasive Reline Cervical System |
NuVasive, Incorporated |
Sali Gully |
| K221344 |
05/09/2022 |
nView s1 with nav option |
nView medical |
Lisa Last |
| K221426 |
05/16/2022 |
Functional MR V1.0 |
Olea Medical SAS |
Nathalie Palumbo |
| K221557 |
05/31/2022 |
Visera Hysterovideoscope Olympus HYF Type V |
Olympus Medical Systems Corporation |
Toshio Nakamura |
| K221522 |
05/26/2022 |
HF-cables (resusable) |
Olympus Winter & Ibe Gmbh |
Lilly Omland |
| K221527 |
05/26/2022 |
StitchKit |
Origami Surgical Inc . |
John Gillespie |
| K221355 |
05/10/2022 |
VITROS Immuodiagnostic Products CA 125 II Reagent Pack |
Ortho Clinical Diagnostics |
Rebecca Lewis |
| K221332 |
05/09/2022 |
OsteoCentric Spine MIS Pedicle Fastener System |
OsteoCentric Technologies |
Todd Evans |
| K221292 |
05/04/2022 |
Uni Knee Resurfacing System |
Overture Resurfacing Inc. |
Riley Williams |
| K221385 |
05/13/2022 |
LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) |
Ovesco Endoscopy AG |
Marc O. Schurr |
| K221409 |
05/16/2022 |
Paneffort 3-ply Surgical and Procedural Masks |
Paneffort, LLC |
Harry No Last Name Provided |
| K221465 |
05/19/2022 |
Baby Gorilla/Gorilla Plating System |
Paragon 28, Inc. |
Haylie Hertz |
| K221502 |
05/23/2022 |
Parcus Synd-EZ SS |
Parcus Medical, LLC |
Vasavi Vora |
| K221478 |
05/23/2022 |
Dolphin Blue Imaging |
Patterson Dental Supply, Inc. |
Erin Daly |
| K221329 |
05/06/2022 |
Eyer Retinal Camera NM-STD |
Phelcom Technologies |
Flßvio Pascoal Vieira |
| K221279 |
05/03/2022 |
pNOVUS 21 Microcatheter |
phenox Ltd |
Sarah Cregg |
| K221270 |
05/02/2022 |
EchoNavigator R4.0 |
Philips Medical Systems Nederland B.V. |
Supriya A. Dalvi |
| K221348 |
05/09/2022 |
IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470) |
Philips Medizin Systeme B÷blingen GmbH |
Stefan Breuer |
| K221533 |
05/27/2022 |
Plasma Shield |
Plasmatica LTD |
Adam Sagiv |
| K221435 |
05/17/2022 |
SUPERTILT PLUS (STP) |
Power Plus Mobility |
Jason Mohan |
| K221254 |
05/02/2022 |
Hummingbird Tympanostomy Tube System |
Preceptis Medical, Inc. |
Steve Anderson |
| K221525 |
05/26/2022 |
PreXion3D Explorer PRO |
PreXion Corporation |
Hiroaki Takahashi |
| K221474 |
05/20/2022 |
PRIMUS Healthcare Sterilizer (Model PSS11-HC) |
PRIMUS Sterilizer Company, LLC |
Patrick Hansen |
| K221420 |
05/16/2022 |
AlphaIDÖ At Home Genetic Health Risk Service |
Progenika Biopharma S.A., a Grifols company |
Diego Tejedor |
| K221368 |
05/12/2022 |
Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K221371 |
05/12/2022 |
Promisemed Heel Blood Lancet |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K221567 |
05/31/2022 |
LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) |
Qingdao Hisense Medical Equipment Co., Ltd. |
Li Mingcheng |
| K221353 |
05/10/2022 |
Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V |
Qura S.r.l. |
Raffaella Tommasini |
| K221550 |
05/31/2022 |
Evidence MultiSTAT DOA Urine MultiPlex |
Randox Laboratories Limited |
Karena Shaw |
| K221520 |
05/25/2022 |
Miro3D Wound Matrix |
Reprise Biomedical, Inc. |
Herzog Kathy |
| K221336 |
05/09/2022 |
AvΘli |
Revelle Aesthetics, Inc. |
Melissa Viotti |
| K221277 |
05/03/2022 |
Mygen M-3004 RF Generator M-3004 |
RF Medical Co., Ltd |
Kwang S Choi |
| K221450 |
05/18/2022 |
Phosphoric Acid Etching Gel |
Rizhao HuGe Biomaterials Company, Ltd. |
Maggie Zheng |
| K221510 |
05/24/2022 |
TrusFIL-Flow Flowable Composite Restorative |
Rizhao HuGe Biomaterials Company, Ltd. |
Maggie Zheng |
| K221350 |
05/10/2022 |
Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) |
Rubberex Alliance Products Sdn Bhd |
Sabri Bin Abdul Hamid |
| K221453 |
05/19/2022 |
S.I.N. Dental Implant System |
S.I.N. û Sistema de Implante Nacional S.A. |
Denise Domiciano |
| K221534 |
05/27/2022 |
Surgical Face Masks (Ear Loops And Tie-On) |
San-M Package Co., Ltd. |
Akihiko Goto |
| K221508 |
05/24/2022 |
AnemoCheck Home |
Sanguina, Inc. |
Cathryn Cambria |
| K221252 |
05/02/2022 |
Scivita 4KINSIGHT ICG Imaging System |
Scivita Medical Technology Co., Ltd. |
Ruqin Wu |
| K221347 |
05/09/2022 |
Transpara 1.7.2 |
ScreenPoint Medical B.V. |
Robin Barwegen |
| K221302 |
05/05/2022 |
Recon Steerable Sheath |
Serpex Medical, Inc. |
Sasha Schrode |
| K221271 |
05/02/2022 |
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) |
Shandong Maida Medical Technology Co.,Ltd. |
Kitty Xu |
| K221272 |
05/02/2022 |
Medical Face Mask |
Shandong Xingyu Gloves Co., Ltd. |
Carrie Li |
| K221383 |
05/13/2022 |
MedtFine Blood Lancet |
Shanghai Carelife International Trading Co. Ltd. |
Zhang Xiaoying |
| K221416 |
05/16/2022 |
Sterile Safety Syringes for Single Use |
Shanghai Kindly Enterprise Development Group Co., Ltd |
Liu Hualong |
| K221363 |
05/11/2022 |
AF Laser |
ShenB Co Ltd |
Sunny Kang |
| K221466 |
05/19/2022 |
IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17 |
Shenzhen Century Dongyuan Technology Co Ltd. |
He Wang |
| K221569 |
05/31/2022 |
Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K |
Shenzhen Fansizhe Science And Technology Co., Ltd |
Endang Cheng |
| K221451 |
05/18/2022 |
IPL hair removal |
Shenzhen Lizbella Technology Co.,Ltd |
Shiwei Zhang |
| K221496 |
05/23/2022 |
Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System |
Shenzhen Mindray Bio-medical Electronics Co., Ltd |
Zhang Wei |
| K221300 |
05/05/2022 |
Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona O |
Shenzhen Mindray Bio-Medical Electronics Co.,LTD |
Zhang Wei |
| K221267 |
05/02/2022 |
VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor |
Shenzhen Mindray Bio-Meidcal Electronics Co., LTD |
Li Lei |
| K221246 |
05/02/2022 |
IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) |
Shenzhen Semlamp Intelligent Technology Co., Ltd |
Qi Wenjun |
| K221317 |
05/06/2022 |
S-Mono |
Shinhung MST Co., Ltd. |
Sun Ho Lee |
| K221530 |
05/26/2022 |
ANNE Pediatric |
Sibel Inc. |
Sarah Coughlin |
| K221501 |
05/23/2022 |
syngo.via View&GO |
Siemens Healthcare GmBH |
Frederike Jakob |
| K221281 |
05/03/2022 |
Multitom Rax |
Siemens Medical Solutions |
Denise Adams |
| K221500 |
05/23/2022 |
ACUSON Sequoia Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc |
Sulgue Choi |
| K221305 |
05/05/2022 |
AI-Rad Companion Organs RT |
Siemens Medical Solutions USA, Inc |
Kira Kuzmenchuk |
| K221516 |
05/25/2022 |
ARTIS icono (Ceiling Configuration) |
Siemens Medical Solutions USA, Inc. |
Patricia D. Jones |
| K221309 |
05/05/2022 |
AI100 with Shonit |
SigTuple Technologies Pvt. Ltd. |
Tathagato Rai Dastidar |
| K221414 |
05/16/2022 |
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter |
Silk Road Medical, Inc. |
Denise Aycox |
| K221537 |
05/27/2022 |
Nightwear Aligners |
Smylio Inc. |
Ren Menon |
| K221447 |
05/18/2022 |
Southern Anterior Screw Fixated Cage (SASCA) |
Southern Medical (Pty) Ltd |
Dalene Styger |
| K221257 |
05/02/2022 |
SpectraWAVE Imaging System |
SpectraWAVE Inc |
Farzad Parsaie |
| K221307 |
05/05/2022 |
Edge Upper Cervical System |
Spinal Simplicity LLC |
Adam Rogers |
| K221335 |
05/09/2022 |
D▓RS and D▓RS 9090 |
Stephanix |
Sandie Perret |
| K221507 |
05/23/2022 |
Disposable Blood Lancet |
SteriLance Medical (Suzhou) Inc. |
Susan Sun |
| K221521 |
05/25/2022 |
Disposable Safety Lancet |
SteriLance Medical (Suzhou) Inc. |
Susan Sun |
| K221559 |
05/31/2022 |
Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3 |
StringKing |
Thomas Frasca |
| K221346 |
05/09/2022 |
Stryker VariAx 2 MIS Calcaneus |
Stryker GmbH |
Jonathan Schell |
| K221490 |
05/23/2022 |
Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement Syste |
Stryker Spine |
Renee Norby |
| K221243 |
05/02/2022 |
OFNat Lubricant (L15) |
Suretex Limited |
KC Nguyen |
| K221403 |
05/16/2022 |
Cortera Spinal Fixation System |
Surgalign Spine Technologies |
Jessica Jho |
| K221540 |
05/27/2022 |
Synexis Sphere Rx |
Synexis, LLC |
Athena Hansen |
| K221482 |
05/23/2022 |
Esophageal TTS Stent |
Taewoong Medical Co., Ltd. |
Jangsoo Lee |
| K221349 |
05/09/2022 |
XPER Technology PREMIUM Pro Blood Glucose Monitoring System |
TaiDoc Technology Corporation |
Jacky Chou |
| K221378 |
05/12/2022 |
Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile |
Tec Gloves Industry (M) Sdn.Bhd. |
Eunice Arumugam |
| K221301 |
05/05/2022 |
DESS Dental Smart Solutions |
Terrats Medical SL |
Roger Terrats |
| K221411 |
05/16/2022 |
Surflo Winged Infusion Set |
Terumo Medical Products (Hangzhou) Co., Ltd. |
Brian Byrd |
| K221328 |
05/06/2022 |
Bloomi Smooth Water Based Lubricant |
The Bloomi Inc.. |
Rebecca Story |
| K221544 |
05/27/2022 |
MagVenture TMS Atlas Neuro Navigation System |
Tonica Elektronik A/S |
Jan Kjoller |
| K221555 |
05/31/2022 |
Dozee VS |
Turtle Shell Technologies Private Limited |
Gaurav Parchani |
| K221553 |
05/31/2022 |
Diamond Air+ (UI04A, UI04B, UI04C) |
Ulike Co., Ltd |
Lin Xiaoming |
| K221315 |
05/06/2022 |
UNIdental Symphony Implant System |
UNIdental Co., Ltd. |
Nam Kyu Kang |
| K221523 |
05/26/2022 |
Tanning Lamp |
Unilam Co., Ltd. |
Y B Cho |
| K221318 |
05/06/2022 |
HVT 2.0 |
Vapotherm Inc. |
Michael J. Webb |
| K221448 |
05/18/2022 |
ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) |
Varian Medical Systems, Inc |
Peter J. Coronado |
| K221408 |
05/16/2022 |
ARIA Radiation Therapy Management (v16.1 MR3) |
Varian Medical Systems, Inc |
Peter J. Coronado |
| K221470 |
05/20/2022 |
Langston dual lumen catheter |
Vascular Solutions LLC |
Becky Astrup |
| K221512 |
05/24/2022 |
Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) |
Vieworks Co., Ltd. |
Kevin Oh |
| K221558 |
05/31/2022 |
ALPHALOK Plating System |
Vilex LLC |
Brock Johnson |
| K221342 |
05/09/2022 |
REDEMPTION Beaming System |
Vilex, LLC |
Louis Monaco |
| K221286 |
05/03/2022 |
CLAROX |
VSI Co., Ltd. |
Jake Yu |
| K221417 |
05/16/2022 |
CLAROX plus (Model: VX-100) |
VSI Co., Ltd. |
Jake Yu |
| K221356 |
05/10/2022 |
Wee Bell |
wee MEDICAL |
D Preston Smith |
| K221438 |
05/17/2022 |
WHILL Model F |
Whill, Inc. |
Tsuyoshi Iriyama |
| K221311 |
05/05/2022 |
Antibacterial Bandage |
Winner Medical Co., Ltd. |
Yi Fu |
| K221532 |
05/26/2022 |
PHMB Wound Dressing |
Winner Medical Co., Ltd. |
Yi Fu |
| K221377 |
05/12/2022 |
SteriKing LT-Blueline Pouches with Tyvek |
Wipak OY |
Hanna Marttila |
| K221379 |
05/12/2022 |
Steriking LT-Blueline Pouches with Tyvek |
Wipak OY |
Hanna Marttila |
| K221366 |
05/12/2022 |
Smart Correction System Rings and Compatible HA-Coated Half Pins |
WishBone Medical, Inc. |
Ramakrishna Bajaj |
| K221427 |
05/16/2022 |
V-Laser |
WON TECH Co., Ltd. |
Hyun Sik Yoon |
| K221352 |
05/10/2022 |
Surgical Face Mask |
Wuhan Huashida Protective Products Co., Ltd. |
Chen Mei |
| K221476 |
05/20/2022 |
Perifit |
X6 Innovations |
Artem Rodionov |
| K221273 |
05/02/2022 |
Medical Face Mask (M001) |
Xingyu Medical Tech Co., Ltd |
Carrie Li |
| K221443 |
05/18/2022 |
PureLift Pro Plus |
Xtreem Pulse LLC |
Andrew Barile |
| K221486 |
05/23/2022 |
INDEX BPM |
Ya Horng Electronic Co., Ltd. |
Jerry Hsu |
| K221488 |
05/23/2022 |
Z7 Zirconia Implant System |
Z7 LLC |
Gerald Andrew Kaminsky |
| K221479 |
05/23/2022 |
Persona Personalized Knee System |
Zimmer, Inc. |
Gregory Foster |
