| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K212803 |
05/23/2022 |
DailyMate Orthodontic Aligner System |
3D Global Biotech Inc |
Keng-Liang Ou |
| K221000 |
05/23/2022 |
ON3D |
3D ONS, Inc. |
Jeong Rae Cho |
| K220564 |
05/23/2022 |
3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355 |
3M Company |
Yumi Wackerfuss |
| K220507 |
05/23/2022 |
3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large |
3M Company |
Hilary Hovde |
| K212527 |
05/17/2022 |
Cervical Spine Truss System Plating Solution (CSTS-PS) |
4WEB Medical, Inc. |
Lewis Harrison |
| K220463 |
05/18/2022 |
Osteotomy Truss System (OTS) |
4WEB Medical, Inc. |
Lewis Harrison |
| K220522 |
05/20/2022 |
7D Surgical System - Percutaneous Application (7D Flash Frame) |
7D Surgical |
Daniel Ziskind |
| K213001 |
05/11/2022 |
Procedure Mask, Surgical Mask |
A Plus International, Inc. |
Solomon Chen |
| K213996 |
05/26/2022 |
FreeStyle Libre 3 Continuous Glucose Monitoring System |
Abbott Diabetes Care Inc. |
Rodney Huang |
| K212132 |
05/26/2022 |
FreeStyle Libre 3 Continuous Glucose Monitoring System |
Abbott Diabetes Care Inc. |
Naveen Thuramalla |
| K210633 |
05/26/2022 |
Amylase2 |
Abbott Ireland Diagnostics Division |
Magdalena Suszko |
| K203771 |
05/31/2022 |
Urea Nitrogen2 |
Abbott Ireland Diagnostics Division |
Tiffini Jenkins |
| K210596 |
05/19/2022 |
ARCHITECT Toxo IgG |
Abbott Laboratories |
Linda Sohn |
| K202525 |
05/19/2022 |
Alinity i STAT High Sensitivity Troponin-I |
Abbott Laboratories Diagnostics Division |
Judi Wallach |
| K221057 |
05/05/2022 |
Viatrac 14 Plus Peripheral Dilatation Catheter |
Abbott Vascular |
Jiyoung Dang |
| K213550 |
05/04/2022 |
HydroPICC 5F Dual Lumen Catheter |
Access Vascular Inc |
Brian Hanley |
| K221044 |
05/05/2022 |
AcQGuide« VUE Steerable Sheath |
Acutus Medical, Inc. |
Sarah Clay |
| K211878 |
05/23/2022 |
LiquiBand XL |
Advanced Medical Solutions Limited |
Martin Mitchell |
| K220404 |
05/16/2022 |
STERRAD NX with ALLClear Technology |
Advanced Sterilization Products, Inc. |
Katy Nennig |
| K221240 |
05/17/2022 |
BriefCase |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K220416 |
05/25/2022 |
SwiftMR |
AIRS Medical Inc. |
Jihyeon Seo |
| DEN200063 |
05/02/2022 |
Kerasave |
AL.CHI.MI.A. S.r.l |
Mauro Beccaro |
| K221215 |
05/24/2022 |
e-motion M25 |
Alber GmbH |
Christoph Hauschel |
| K212257 |
05/04/2022 |
Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311 |
Alicn Medical Shenzhen, Inc. |
Fang Meisong |
| K210937 |
05/12/2022 |
Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 |
Alicn Medical Shenzhen, Inc. |
Fang Meisong |
| K210565 |
05/05/2022 |
Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711 |
Alicn Medical Shenzhen,Inc |
Fang Meisong |
| K220350 |
05/25/2022 |
KardiaMobile 6L |
AliveCor, Inc. |
Susan Noriega |
| K220311 |
05/03/2022 |
Cardiovascular Angiography System |
Allengers Medical Systems Limited |
Sanjeev K. Marjara |
| K212597 |
05/28/2022 |
Amazing+ Latex Examination Powder Free Gloves |
Amazing Rubber Products Pvt Ltd |
Jayasankar S |
| K212584 |
05/28/2022 |
Blue Nitrile Examination Gloves Powder Free |
Amazing Rubber Products Pvt Ltd |
Jayasankar S |
| K220516 |
05/17/2022 |
CATALYS Precision Laser system |
AMO Manufacturing USA, LLC |
Alex Etlin |
| DEN200062 |
05/24/2022 |
Parsortix PC1 Device |
ANGLE Europe Ltd. |
Andrew Newland |
| K220083 |
05/25/2022 |
LDV((Low Dead Volume )Syringe |
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. |
Bingyi Xiang |
| K212092 |
05/06/2022 |
Portable Folding Electric Wheelchair (Model: DC01) |
Anhui JBH Medical Apparatus Co., Ltd |
Yang Dandan |
| K211652 |
05/25/2022 |
Renuvion Dermal Handpiece, Renuvion Dermal System |
Apyx Medical Corporation (formerly Bovie Medical Corporation |
Topaz Kirlew |
| K200788 |
05/23/2022 |
Assure Titanium Blood Glucose Monitoring System |
Arkray, Inc. |
Yosiharu Uehata |
| K221099 |
05/13/2022 |
Arthrex Self-Punching PushLock Suture Anchor |
Arthrex Inc. |
Kelsey Roberts |
| K213837 |
05/02/2022 |
Arthrx Fracture Plates |
Arthrex Inc. |
Stacy Valdez |
| K221232 |
05/19/2022 |
Univers Revers Humeral Cup Implant |
Arthrex Inc. |
Ivette Galmez |
| K213800 |
05/19/2022 |
Artiglass NRFitTM Tip L.O.R. Glass Syringes |
Artiglass Srl |
Sabrina Baccarin |
| K220889 |
05/27/2022 |
Senhance Surgical System |
Asensus Surgical, Inc. |
Casey Hinckley |
| K220610 |
05/27/2022 |
SOLO-L |
Aurora Spine Inc |
Laszlo Garamszegi |
| K220626 |
05/14/2022 |
Introcan Safety IV Catheter |
B.Braun Medical Inc. |
Tracy Larish |
| K221440 |
05/31/2022 |
LivertyÖ TIPS Access Set |
Bard Peripheral Vascular, Inc |
Scott Johnson |
| K213191 |
05/24/2022 |
S-Line |
Barkey GmbH & Co. KG |
Thomas Barkey |
| K220414 |
05/09/2022 |
VersaCross Connect Transseptal Dilator |
Baylis Medical Company Inc. |
May Tsai |
| K210585 |
05/10/2022 |
BD CTGCTV2 |
Becton Dickinson and Company |
Sue Werner |
| K210983 |
05/19/2022 |
BD Epilor Syringe |
Becton Dickinson and Company |
Huwien Yang |
| K220381 |
05/20/2022 |
Diode Laser Therapy Systems |
Beijing LaserTell Medical Co., Ltd. |
Zeng Xun |
| K213811 |
05/12/2022 |
Sterile Hypodermic Syringes for Single Use |
Berpu Medical Technology Co., Ltd. |
Buxin Yu |
| K212761 |
05/17/2022 |
Biocore9 Acetabular Cup System |
Biocore9, LLC. |
Stan Matlak |
| K220653 |
05/06/2022 |
Astroglide Glycerin & Paraben Free |
BioFilm Inc. |
Kevin Jamil |
| K220355 |
05/26/2022 |
Astroglide Ultra Gentle Gel |
BioFilm Inc. |
Kevin Jamil |
| K212729 |
05/31/2022 |
Bone Cement-Normal Viscosity |
Biomecanica Industria e Comerciode Produtos Ortopedicos LTDA |
Thais Busquim |
| K212782 |
05/17/2022 |
SternaLock Sternal Closure System |
Biomet Microfixation |
Mark Wladkowski |
| K211707 |
05/04/2022 |
BioTeke Sterile Disposable Virus Sampling Kit |
BioTeke Corporation (WuXi) Co., Ltd |
Zhitu Zhou |
| K213877 |
05/02/2022 |
ExactechGPS« System |
Blue Ortho |
Matthieu Coic |
| DEN210044 |
05/17/2022 |
CERAMENT G |
BoneSupport AB |
Blerta Shuka |
| K212582 |
05/06/2022 |
SpyGlass Discover Balloon Dilation Catheter |
Boston Scientific Corporation |
Laura Kuroski |
| K220578 |
05/25/2022 |
Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) |
Bozhou Rongjian Medical Appliance Co.,Ltd. |
Wu Zhifang |
| K213203 |
05/13/2022 |
Provena(TM) Midline Catheter |
C. R. Bard, Inc. |
Jeremy Kuyakana |
| K212588 |
05/04/2022 |
Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter |
C.R. Bard, Inc |
Arieona Boyle |
| K220704 |
05/04/2022 |
Serranator PTA Serration Balloon Catheter |
Cagent Vascular, LLC |
Carol Burns |
| K213174 |
05/19/2022 |
Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection |
Cardinal Health |
Nivedita Namjoshi |
| K213137 |
05/13/2022 |
INTDose |
Carina Medical LLC |
Xue Feng |
| K220306 |
05/03/2022 |
ECGenius System |
CathVision ApS |
Mads Matthiesen |
| K213022 |
05/09/2022 |
CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED |
CEFLA S.C. |
Lorenzo Bortolotti |
| K220664 |
05/06/2022 |
NewTom 7G |
CEFLA S.C. |
Lorenzo Bortolotti |
| K210548 |
05/17/2022 |
Medline Integrated Arterial Catheter |
Centurion Medical Products |
Amy Ganton |
| K203429 |
05/09/2022 |
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System |
Cepheid |
Yi-Ping Lin |
| K211779 |
05/26/2022 |
ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. |
Chip Ideas Electronics S.L. |
Bernardo Plaza Trillo |
| K213341 |
05/31/2022 |
Fibrillar Collagen Wound Dressing |
Collagen Matrix, Inc. |
Peggy Hansen |
| K221059 |
05/10/2022 |
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) |
Conformis Inc. |
Kara Johnson |
| K220757 |
05/13/2022 |
Argo Knotless SP Anchor |
CONMED Corporation |
Dionne Sanders |
| K220186 |
05/13/2022 |
Zone Specific AIM |
CONMED Corporation |
Orjada Dervishleri |
| K213946 |
05/09/2022 |
Compass BDS Biliary Stent |
Cook Ireland LTD |
Kieran Casey |
| K220468 |
05/18/2022 |
BENCOX Mirabo Cup System |
Corentec Co.,Ltd. |
Yoorim Bae |
| K210614 |
05/24/2022 |
BENCOX Mirabo Z Cup Cortinium |
Corentec Co.,Ltd. |
Yoorim Bae |
| K221013 |
05/05/2022 |
GIA Auto Suture Stapler with DST Series Technology |
Covidien |
Robert Zott |
| K212555 |
05/06/2022 |
Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC |
Covidien llc |
Anushka Jayaraman |
| K203661 |
05/25/2022 |
CRYO Arctic, CRYO Penguin |
CryoScience North America, Inc. |
Greg Nehrlich |
| K220766 |
05/31/2022 |
eMurmur Heart AI |
CSD Labs GmbH |
Andreas Reinisch |
| K213491 |
05/12/2022 |
Universal Pilot Guidance Instrument System |
CTL Medical Corporation |
Sean Suh |
| K220738 |
05/12/2022 |
Motive Knee Wrap |
CyMedica Orthopedics, Inc. |
Kereshmeh Shahriari |
| K220105 |
05/12/2022 |
Saige-Dx |
DeepHealth, Inc. |
B. Nathan Hunt |
| K220557 |
05/27/2022 |
MoistureMeterD Compact, LymphScanner |
Delfin Technologies Ltd |
Jouni Nuutinen |
| K220791 |
05/03/2022 |
Surgical and Prosthetic Trays |
Dentsply Sirona |
Courtney Clark |
| K213788 |
05/06/2022 |
TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) |
Dongguan Bohuikang Technology Co.,Ltd |
Rihua Meng |
| K220397 |
05/12/2022 |
ANSiStim-PP |
DyAnsys, Inc. |
Srini Nageshwar |
| K212629 |
05/26/2022 |
PP Care Nitrile Examination Gloves |
EG Group Product and Services CO., Ltd |
Aristotle Nafpliotis |
| K221136 |
05/10/2022 |
RadiForce MX243W |
EIZO Corporation |
Hiroaki Hashimoto |
| K213787 |
05/17/2022 |
Monaco RTP System |
Elekta Solutions AB |
Anju Kurian |
| K213594 |
05/03/2022 |
ECHOLASER X4 |
ELESTA SPA |
Fabio Andreola |
| K220867 |
05/23/2022 |
Tapestry Biointegrative Implant |
Embody, Inc. |
Brianna Schehr |
| K220609 |
05/27/2022 |
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 |
| K213731 |
05/31/2022 |
EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows |
Ever Fortune.AI Co., Ltd. |
Cheng Ming-Fong |
| K213302 |
05/03/2022 |
exoplan |
exocad GmbH |
Tobias Turba |
| K221115 |
05/13/2022 |
Flow-Nail |
Flow-FX, LLC |
Patrick J. Sweeney |
| K212268 |
05/27/2022 |
FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT |
FMD Co., Ltd. |
Takashi Higashikubo |
| K211036 |
05/04/2022 |
Plus Medical Chemotherapy Gown |
Foshan Nanhai Plus Medical CO LTD |
Eric Li |
| K213177 |
05/11/2022 |
Plus Medical Cover Gown |
Foshan Nanhai Plus Medical CO LTD |
Eric Li |
| K212620 |
05/12/2022 |
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K212873 |
05/27/2022 |
Aspire Cristalle |
FUJIFILM Corporation |
Randy Vader |
| K213829 |
05/23/2022 |
SCENARIA View |
FUJIFILM Healthcare Corporation |
Randy Vader |
| DEN200072 |
05/04/2022 |
Lumipulse G ▀-Amyloid Ratio (1-42/1-40) |
Fujirebio Diagnostics, Inc. |
Stacey Dolan |
| K211180 |
05/02/2022 |
Liver Suite |
GE Medical Systems SCS |
Peter Uhlir |
| K220446 |
05/11/2022 |
Versana Balance |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K220423 |
05/19/2022 |
PAPAYA & PAPAYA Plus |
GENORAY Co., Ltd. |
Jiyeon Lee |
| K220392 |
05/19/2022 |
PAPAYA 3D & PAPAYA 3D Plus |
GENORAY Co., Ltd. |
Jiyeon Lee |
| K220249 |
05/26/2022 |
Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue) |
Grand Work Plastic Products Co., Ltd |
Wu Yuli |
| K220250 |
05/11/2022 |
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs |
Grand Work Plastic Products Co., Ltd |
Wu Yuli |
| K220917 |
05/18/2022 |
gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler |
GRI-Alleset, Inc. |
Marty D Paugh |
| K212564 |
05/06/2022 |
Electric Breast Pump |
Guangdong Horigen Mother & Baby Products Co., Ltd. |
Changxin Chen |
| K213065 |
05/31/2022 |
Distal Access Catheter |
Guangzhou Easycess Medical Co., Ltd |
Xingcheng Liu |
| K220491 |
05/14/2022 |
Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs |
Hainan Asther Medical Equipment Co., Ltd |
Viki Ye |
| K214074 |
05/26/2022 |
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs |
Hartalega NGC SDN. BHD. |
Kuan Mun Leong |
| K211665 |
05/16/2022 |
SONON Ultrasound Imaging System, Model: SONON300C |
HEALCERION CO., LTD. |
Lee Sooyeol |
| K220211 |
05/18/2022 |
Nitrile Powder Free Examination Gloves |
Hebei kangxida Medical Technology Development Co., Ltd. |
Xiaomin Liu |
| K210411 |
05/05/2022 |
PosiSep EAR Fragmentable Ear Dressing |
Hemostasis LLC |
Lakshmi Ganesh Bollina |
| K220545 |
05/26/2022 |
Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs |
HL Rubber Industries Sdn bhd |
Noorzaliza Ahmad |
| K220283 |
05/02/2022 |
TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) |
Hong Qiangxing (Shen Zhen) Electronics Limited |
Xu Jianhua |
| K220838 |
05/20/2022 |
Artisan Bone Plug, Universal Cement Restrictor |
Howmedica Osteonics, dba Stryker Orthopaedics |
Margaret Klippel |
| K213832 |
05/16/2022 |
AAMI3 Isolation Gown |
Hubei Xinxin Non-woven Co., Ltd. |
Nicole Jin |
| K220824 |
05/19/2022 |
Medical Surgical Mask (Planar type) |
Hunan Chopard Medical Devices Co., Ltd |
Hongwei Wei |
| K212413 |
05/26/2022 |
I-Motion |
I-Motion Group Global Iberica S.L. |
Jose Luis Soto Belloso |
| K220807 |
05/17/2022 |
Imperative Care Radial 088 Access System |
Imperative Care Inc. |
Kristin Elis |
| K213698 |
05/27/2022 |
CoLink PCR Plating System |
In2Bones USA, LLC |
Christine Scifert |
| K213402 |
05/23/2022 |
Triever24, Triever20 |
Inari Medical |
Kit Cariquitan |
| K220727 |
05/10/2022 |
inHEART MODELS |
inHEART, SAS |
Audrey LabΦque |
| K213119 |
05/13/2022 |
Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens |
Innova Vision Inc. |
Kari Huang |
| K210655 |
05/25/2022 |
Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter |
Innovative Health, LLC. |
Rick Ferreira |
| K220793 |
05/25/2022 |
InnoVoyce Laser Fiber |
InnoVoyce LLC |
Kent Johnson |
| K210987 |
05/31/2022 |
IRRIGO Wound Wash Jet System |
Inopro Inc |
Alain Lefebvre |
| K220760 |
05/13/2022 |
Pre-Formed Penile Silicone Block |
International Medical Devices, Inc. |
James Elist |
| K212644 |
05/26/2022 |
Aura Storm |
Invictus Lighting |
Neeraj Lal |
| K221248 |
05/31/2022 |
Rapid LVO |
iSchemaView Inc. |
James Rosa |
| K220499 |
05/17/2022 |
Rapid PE Triage and Notification (PETN) |
iSchemaView Inc. |
James Rosa |
| K211953 |
05/25/2022 |
Disposable Sterilized Latex Surgical Gloves |
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd |
Jenny Huang |
| K220191 |
05/24/2022 |
Disposable Face Mask |
Jiujiang Taixin Technology Co., Ltd. |
Li Xiaojie |
| K220902 |
05/27/2022 |
Navagio Lumbar Cage |
Kalitec Medical, LLC |
Scott Winn |
| K213027 |
05/26/2022 |
Laser Hair Growth Comb |
Kam Yuen Plastic Products Ltd |
Anna Dan |
| K213025 |
05/12/2022 |
Laser hair growth helmet |
Kam Yuen Plastic Products Ltd. |
Anna Dan |
| K221174 |
05/13/2022 |
Telepack + |
KARL STORZ Endoscopy America, Inc |
Mario Trujillo |
| K220118 |
05/12/2022 |
Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves |
KL-Kepong Rubber Products SDN. BHD. |
Cheng Phooi Yann |
| K220559 |
05/05/2022 |
17HQ901G-B |
LG Electronics Inc. |
Jinhwan Jun |
| K213039 |
05/25/2022 |
Micro-current facial cold and hot service (model: TPML-100) |
Li-Tek Electronics Technology C0., Ltd |
Barry Yuan |
| K220341 |
05/02/2022 |
ARx Modular Spinal System |
Life Spine, Inc. |
Angela Batker |
| K213785 |
05/13/2022 |
SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid |
LimaCorporate |
Roberto Gabetta |
| K220792 |
05/19/2022 |
SMR Reverse Liner |
LimaCorporate S.p.A. |
Michela Zanotto |
| K212064 |
05/03/2022 |
Orchid Safety Release Valve(TM) |
Linear Health Sciences, LLC |
Daniel Clark |
| K211534 |
05/19/2022 |
RevoLix HTL |
LISA Laser Products GmbH |
Ralf Balkenhol |
| K201302 |
05/04/2022 |
LiveOne |
LiveMetric (Medical) S.A. |
Chen Botvin Moshe |
| K203527 |
05/09/2022 |
Immunalysis Tapentadol Urine HEIA |
lmmunalysis Corporation |
Elina Arroyo |
| K220467 |
05/18/2022 |
The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories |
Lumenis Be, Ltd. |
Shlomit Segman |
| K212680 |
05/31/2022 |
LuxCreo Clear Aligner System |
Luxcreo Inc |
Mike Yang |
| K212909 |
05/11/2022 |
VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips |
MacroMedics BV |
Elizabeth Hajos |
| K213526 |
05/04/2022 |
Aurora-RT |
MagnetTx Oncology Solutions Ltd. |
Michael Cook |
| K214120 |
05/18/2022 |
GSS610N21 Series Steam Sterilizer |
Maquet GmbH |
Holger Ullrich |
| K210545 |
05/20/2022 |
Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine |
Marci Beauty Inc |
Shaul Rappaport |
| K214072 |
05/06/2022 |
Masimo O3 Regional Oximeter System |
Masimo Corporation |
Kertana Shankar |
| K212699 |
05/31/2022 |
Disposable Powder Free Polyethylene Examination Gloves |
Mastermax Plastic (Huizhou) LTD |
Benson Xu |
| K212327 |
05/24/2022 |
M-Vizion Monobloc |
Medacta International S.A. |
Stefano Baj |
| K220705 |
05/04/2022 |
MyKnee R Pin Positioners |
Medacta International S.A. |
Stefano Baj |
| K220888 |
05/24/2022 |
MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides |
Medacta International S.A. |
Stefano Baj |
| K213004 |
05/10/2022 |
Needle Free Connector |
Medcaptain Life Science Co., Ltd. |
David Xia |
| K213659 |
05/24/2022 |
LigaPASSÖ 2.0 Ligament Augmentation System |
Medicrea International S. A. |
Teal Bjoraker |
| K213171 |
05/26/2022 |
Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) |
Meditrina, Inc. |
Csaba Truckai |
| K214108 |
05/06/2022 |
Medline Orbis Chemo Surgical Gown |
Medline Industries LP |
Adam Ostrower |
| K213481 |
05/24/2022 |
Medline General Surgery Tray |
Medline Industries, Inc. |
Stephanie Augsburg |
| K220333 |
05/18/2022 |
Medline Orbis LVL 3 Surgical Gown |
Medline Industries, LP. |
Adam Ostrower |
| K212756 |
05/05/2022 |
Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set |
MEDOS International SARL |
Nicole Aeschbacher |
| K214065 |
05/04/2022 |
ROSA ONE Brain application |
Medtech S.A.S |
Paul Hardy |
| K221244 |
05/25/2022 |
CD HorizonÖ Spinal System |
Medtronic |
Justin O'Connor |
| K221180 |
05/25/2022 |
Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments |
Medtronic Sofamor Danek USA, INC |
Elizabeth Hamilton |
| K211966 |
05/06/2022 |
Segment 3DPrint |
Medviso AB |
Einar Heiberg |
| K211021 |
05/06/2022 |
Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible |
Micro-Tech (Nanjing) Co., Ltd. |
Cecilia Sun |
| K212434 |
05/05/2022 |
Neuromuscular Transmission Monitor TOF3D |
MIPM Mammendorfer Institut fⁿr Physik und Medizin GmbH |
Jennifer Rosenheimer |
| K220115 |
05/13/2022 |
ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System |
MiRus, LLC |
Jordan Bauman |
| K213840 |
05/18/2022 |
MolecuLight I:X |
MolecuLight, Inc. |
Jordan John |
| K220155 |
05/23/2022 |
Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs |
Motex Healthcare (Anhui) Co., Ltd. |
Jen Ke-Min |
| K212915 |
05/03/2022 |
MVision AI Segmentation |
MVision AI |
Kalpana Jha |
| K220952 |
05/24/2022 |
MY01 Continuous Compartmental Pressure Monitor |
MY01 Inc. |
Charles Allen |
| K211529 |
05/05/2022 |
NAVIRFA Scope |
NaviFUS Corporation |
Arthur Lung |
| K211396 |
05/17/2022 |
Neoss Individual Prosthetics |
Neoss Ltd |
Stellan Sundstrom |
| K210575 |
05/13/2022 |
HDF Assist Mudule, HDF Infusion Set and Substitution Filter |
Nephros |
Vashone R Thomas |
| DEN210046 |
05/18/2022 |
Quell-FM |
NeuroMetrix, Inc. |
Shai Gozani |
| K212289 |
05/06/2022 |
NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar |
Neuronetics, Inc |
Cory Anderson |
| K212979 |
05/20/2022 |
CalcShiftÖ Displacement Calcaneal Osteotomy System |
Nextremity Solutions, Inc. |
Elise Fox |
| K220146 |
05/27/2022 |
VisAR |
Novarad Corporation |
Doug Merrill |
| K221046 |
05/06/2022 |
Invu by Nuvo |
Nuvo- Group Ltd. |
Chen Rubinstein |
| K220587 |
05/11/2022 |
Evis Exera III Duodenovideoscope Olympus TJF-Q190V |
Olympus Medical Systems Corp. |
Toshio Nakamura |
| K220428 |
05/10/2022 |
Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile |
One Glove Industrial SDN BHD |
Marcus Low |
| K220429 |
05/13/2022 |
Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile |
One Glove Industrial SDN BHD |
Marcus Low |
| K220427 |
05/10/2022 |
White Nitrile Powder-Free Patient Examination Glove, Non Sterile |
One Glove Industrial SDN BHD |
Marcus Low |
| K212988 |
05/23/2022 |
ONO Retrieval Device |
Onocor Vascular LLC |
Tiffini Wittwer |
| K211869 |
05/19/2022 |
OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement |
Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi Ve |
Kenan Kara |
| K213935 |
05/06/2022 |
PISCES-SA Standalone ALIF Interbody System |
Osseus Fusion Systems |
Jonathan Rosen |
| K212519 |
05/10/2022 |
Overjet Caries Assist |
Overjet, Inc. |
Wardah Inam |
| K202920 |
05/25/2022 |
OptiComp |
Pac-Dent, Inc. |
Jiahe Li |
| K220656 |
05/20/2022 |
iovera System |
Pacira Biosciences, Inc. |
Danny Rivera |
| K220641 |
05/26/2022 |
Barrigel Injectable Gel |
Palette Life Sciences |
David Goodnough |
| K220200 |
05/25/2022 |
Paltop Conical Implant System |
Paltop Advanced Dental Solutions, Ltd |
Zina Gurgov |
| K221135 |
05/19/2022 |
X-Twist PEEK Suture Anchor |
Parcus Medical LLC |
Calen Souther |
| K213299 |
05/11/2022 |
Wireless EEG System |
Pascall Systems Inc |
Tuan Le Mau |
| K212838 |
05/27/2022 |
Benchmark Intracranial Access System |
Penumbra, Inc. |
Buu Buu Ly |
| K212565 |
05/19/2022 |
CoverScan v1 |
Perspectum Ltd. |
Ioan Wigley |
| K213583 |
05/16/2022 |
Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems |
Philips Medical Systems Nederland B.V. |
Jan Van De Kerkhof |
| K221270 |
05/31/2022 |
EchoNavigator R4.0 |
Philips Medical Systems Nederland B.V. |
Supriya A. Dalvi |
| K212875 |
05/13/2022 |
Spectral CT on Rails |
Philips Medical Systems Nederland B.V. |
Maya Tolchinsky |
| K212376 |
05/16/2022 |
Caas Qardia |
Pie Medical Imaging B.V. |
Annemiek Bouts |
| K220662 |
05/11/2022 |
Disposable Barrier Sleeves |
Premium Plus (Dongguan) Limited |
Jessica Mao |
| K212563 |
05/23/2022 |
CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid |
Prevest Denpro Limited |
Atul Modi |
| K212475 |
05/13/2022 |
Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) |
Prevest Denpro Limited |
Atul Modi |
| K212408 |
05/18/2022 |
Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid) |
Pt. Maja Agung Latexindo |
Sivaprakash S |
| K211810 |
05/23/2022 |
Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) |
PT. Shamrock Manufacturing Corpora |
Jeni Chuason |
| K220597 |
05/26/2022 |
Disposable Surgical Face Mask (FM-34EE,FM-44EE) |
Qingdao Bestex Rubber & Plastic Products Co.,Ltd. |
Lucy Wang |
| K220685 |
05/05/2022 |
HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx |
Qingdao HIGHTOP Biotech Co., Ltd. |
Ray Li |
| K220430 |
05/12/2022 |
Capsulo |
Quantel Medical |
Bruno Pages |
| K221106 |
05/13/2022 |
Quantib Prostate |
Quantib BV |
Arnault Massink |
| K220110 |
05/06/2022 |
Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger |
Qura S.r.l. |
Raffaella Tommasini |
| K213540 |
05/20/2022 |
Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set |
Qura S.r.l. |
Raffaella Tommasini |
| K221144 |
05/13/2022 |
PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG |
Radisen Co., Ltd |
John Lim |
| K220689 |
05/06/2022 |
Vatech Clismile |
Rayence Co.,Ltd |
Kevin Kim |
| K211152 |
05/11/2022 |
Durex Condom with Benzocaine |
RB Health (US) LLC |
Kyle Prince |
| K214096 |
05/31/2022 |
Respire Clear |
Respire Medical, LLC |
David Walton |
| K201393 |
05/25/2022 |
restor3d MTP Implant |
Restor3d, Inc. |
Nathan Evans |
| K203711 |
05/06/2022 |
IWL2020 Blood Glucose Monitoring System |
Roche Diabetes Care Inc. |
Kelly Brennan |
| K220849 |
05/19/2022 |
Accu-Chek Safe-T-Pro Plus Lancing Device |
Roche Diabetes Care, Inc. |
Jason Lee |
| K211685 |
05/06/2022 |
Elecsys Testosterone II |
Roche Diagnostics |
Adennis N Cora |
| K211840 |
05/09/2022 |
Sight OLO |
S.D. Sight Diagnostics Ltd. |
Sarah Levy |
| K213975 |
05/06/2022 |
KEOPS Balance Analyzer 3D |
S.M.A.I.O |
Jean-Charles Roussouly |
| K221134 |
05/19/2022 |
Procedure Mask with Ear Loops and Surgical Mask with Ties |
SafeSource Direct, LLC |
Robbie Wicks |
| K220269 |
05/06/2022 |
HM70 EVO Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Ju Jee Young |
| K220013 |
05/03/2022 |
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application |
Scopio Labs Ltd. |
Shahar Karny |
| K220711 |
05/10/2022 |
SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System |
SeaSpine Orthopedics Corporation |
Kavita Chandrashekar |
| K213420 |
05/04/2022 |
WaveForm L System, WaveForm TO System, WaveForm TA System |
SeaSpine Orthopedics Corporation |
Aly Alvarez |
| K220691 |
05/05/2022 |
LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension |
Seigla Medical, Inc. |
Chad J. Kugler |
| K220470 |
05/23/2022 |
Smart Wireless Stethoscope |
Shanghai Hulu Devices Co., Ltd |
Junfeng Zhao |
| K213141 |
05/28/2022 |
Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution |
Shen Wei USA Inc. |
Cheryl Reep |
| K213485 |
05/25/2022 |
Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E |
Shenzhen AOJ Medical Technology Co., Ltd. |
Queena Chen |
| K221001 |
05/12/2022 |
IPL Home Use Hair Removal Device |
Shenzhen Beauty Every Moment intelligent electric Co.,Ltd. |
Luo Huajun |
| K213884 |
05/06/2022 |
Disposable EEG cable |
Shenzhen Changke Connect Electronics Co., Ltd. |
Yahui Zhou |
| K220113 |
05/31/2022 |
Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112) |
Shenzhen Finicare Co., Ltd. |
Chao Li |
| K220669 |
05/16/2022 |
IPL HAIR REMOVAL HANDSET, Model: IPL-666 |
Shenzhen Junbobeauty Technology Co., Ltd. |
Jian Zhan |
| K220168 |
05/17/2022 |
Skin Care Beauty Mask (Model: MJ-06) |
Shenzhen Kaiyan Medical Co Ltd |
Alain Dijkstra |
| K212752 |
05/20/2022 |
Med-link Pulse Oximeter |
Shenzhen Med-link Electronics Tech Co., Ltd. |
Jialing Zhang |
| K212346 |
05/05/2022 |
Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618 |
Shenzhen Pango Medical Electronics Co., Ltd. |
Youjian Xie |
| K214008 |
05/10/2022 |
Dental diode laser |
Shenzhen Soga Technology Co., Ltd. |
Tse Adrian |
| K220596 |
05/26/2022 |
Wearable Breast Pump (Model S9) |
Shenzhen TPH Technology Co., Ltd. |
Peter Chen |
| K220195 |
05/26/2022 |
iFuse Bedrock GraniteÖ Implant System |
SI-BONE, Inc. |
Meirav Harsat |
| K220589 |
05/13/2022 |
MAGNETOM Skyra Fit |
Siemens Medical Solutions USA, Inc. |
Karthik Pillai |
| K220919 |
05/17/2022 |
MULTIX Impact E |
Siemens Medical Solutions USA, Inc. |
Denise Adams |
| K220832 |
05/20/2022 |
syngo Dynamics (Version VA40E) |
Siemens Medical Solutions USA, Inc. |
Abhineet Johri |
| K221219 |
05/17/2022 |
syngo.CT CaScoring |
Siemens Medical Solutions USA, Inc. |
Monsuru Bello |
| K220723 |
05/12/2022 |
Hand Trauma Screw System |
Skeletal Dynamics, Inc. |
Alexandra Rodriguez |
| K220716 |
05/05/2022 |
Spartan SC 069 |
Spartan Micro, Inc. |
Gary Avedovech |
| K212657 |
05/06/2022 |
Quantum Heater-Cooler |
Spectrum Medical Ltd. |
Colleen Powell |
| K214046 |
05/25/2022 |
780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable |
Stryker |
Michelle Hughes |
| K220593 |
05/27/2022 |
Spine Guidance Software, Stryker Q Guidance System |
Stryker Leibinger GmbH & Co. KG |
Andrea Wallen-Gerding |
| K220481 |
05/25/2022 |
Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) |
Stryker Sustainability Solutions |
Scott English |
| K220411 |
05/13/2022 |
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) |
Stryker Sustainability Solutions |
Scott English |
| K220285 |
05/19/2022 |
PINE Pedicle Screw System |
TDM Co. Ltd. |
Choi Jung Wook |
| K220485 |
05/19/2022 |
Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) |
The Anspach Effort, Inc. |
Marie Ferrier |
| K210615 |
05/13/2022 |
Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) |
Thompson Surgical Instruments Inc. |
Tiffany Irwin |
| K220442 |
05/12/2022 |
Synguard Nitrile Exam Glove |
Tianjin Aoshang Outdoor Equipment Co., Ltd. |
Xiaoning Zhang |
| K220372 |
05/17/2022 |
Heel Stick Safety Lancet (HHZ-II, HHZ-III) |
Tianjin Huahong Technology Co., Ltd. |
Yuan Ying |
| K220370 |
05/19/2022 |
Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) |
Tianjin Huahong Technology Co., Ltd. |
Yuan Ying |
| K220218 |
05/18/2022 |
Siren SGT |
Tools for Surgery, LLC |
Arnold R. Leiboff |
| K220749 |
05/13/2022 |
Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP |
Unimax Medical Products Co., Ltd. |
Haibo Ning |
| K212348 |
05/02/2022 |
ALPHALOKÖ Plating System |
Vilex LLC |
Louis Monaco |
| K221010 |
05/03/2022 |
Intra.Ox 2.0 Handheld Tissue Oximeter |
ViOptix, Inc. |
Scott Coleridge |
| K220030 |
05/04/2022 |
Vista Ophthalmics Vitrectomy Probe |
Vista Ophthalmics LLC |
Don Knowles |
| K220041 |
05/05/2022 |
HandPICO |
Vydence Medical Industria E Comercio Ltda |
Kathy Maynor |
| K210748 |
05/25/2022 |
Well-life TM Pen Needles, Well-life TM Safety Pen Needles |
W. L. Med Co., Ltd. |
Ha Tae Joo |
| K213221 |
05/26/2022 |
AMADEO, M-UK1015 (incl. attachments and accessories) |
W&H Dentalwerk Buermoss GmbH |
Weidler Gerhard |
| K220628 |
05/03/2022 |
LINK Endo-Model EVO Knee System |
Waldemar Link GmbH & Co. KG |
Stefanie Fuchs |
| K213900 |
05/06/2022 |
WAVi SCAN EEG System and Accessories |
WAVi Co. |
David Oakley |
| K212416 |
05/18/2022 |
WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203 |
Wenzhou Xikang Medical Instruments Co., Ltd |
Wang Tiance |
| K220194 |
05/17/2022 |
Procedure mask/Surgical mask/Face mask |
Winner Medical Co., Ltd. |
Mingni Liu |
| K221016 |
05/05/2022 |
Steriking Packaging for Medical Devices |
Wipak OY |
Hanna Marttila |
| K211256 |
05/20/2022 |
Disposable Sampler Viral Transport Media |
Wuxi Nest Biotechnology Co., Ltd. |
Cheng Zhiwei |
| K221116 |
05/13/2022 |
XACT ACE Robotic System |
XACT Robotics Ltd. |
Chen Levin |
| K220532 |
05/23/2022 |
Disposable surgical mask |
Xiamen Blue Star Enterprise Co., Ltd. |
Jincong Zhang |
| K220700 |
05/04/2022 |
Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine |
Yian Medical Technology (Haining) Co., Ltd |
Zhiqin Yu |
| K210516 |
05/16/2022 |
Clicky Cross |
Yomura Technologies Inc. |
David Lee |
| K212669 |
05/27/2022 |
Single Use Hemoclip |
Zhejiang Chuangxiang Medical Technology Co., LTD. |
Lucius Long |
| K220065 |
05/25/2022 |
Single Use Ureteral Access Sheath |
Zhejiang Chuangxiang Medical Technology Co., Ltd. |
Lucius Long |
| K220747 |
05/12/2022 |
Power Wheelchair (N5515B) |
Zhejiang Innuovo Rehabilitation Devices Co., Ltd. |
Leo Zheng |
| K220740 |
05/12/2022 |
Power Wheelchair, W5907 (Q50 R Carbon) |
Zhejiang Innuovo Rehabilitation Devices Co., Ltd. |
Leo Zheng |
| K213535 |
05/13/2022 |
Sterile Safety Hypodermic Needles for Single Use |
Zhejiang Kangkang Medical-Devices CO., Ltd. |
Chun Guo |
| K211571 |
05/31/2022 |
Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit |
Zhejiang Longterm Medical Technology Co., LTD |
Claudia Zsang |
