| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K211244 |
11/10/2021 |
VSP« Orthopedics System |
3D Systems |
Ben Johnson |
| K212237 |
11/29/2021 |
3D-Cut |
3D-Side SA |
Laurent Paul |
| K210943 |
11/22/2021 |
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) |
Abbott Diabetes Care Inc. |
Ono Bacani |
| K203248 |
11/23/2021 |
Albumin BCG2 |
Abbott Ireland Diagnostics Division |
Suzanne Cheang |
| K213364 |
11/11/2021 |
EnSite X EP System |
Abbott Medical |
Tabitha Payne |
| K212275 |
11/18/2021 |
Dermalux Flex MD |
Aesthetic Technology Ltd. |
Dale Needham |
| K212659 |
11/10/2021 |
More-Cell-System |
Agency for Medical Innovations GmbH |
Martin Hohlrieder |
| K213469 |
11/18/2021 |
VALORY |
Agfa N.V. |
Wim Govaerts |
| K211668 |
11/30/2021 |
KardiaMobile Card |
AliveCor, Inc. |
Saket Bhatt |
| K210499 |
11/01/2021 |
Alpha Dent Implants Dental Implants System |
Alpha Dent Implants GmbH |
Simha Sibony |
| DEN210006 |
11/13/2021 |
Hemolung Respiratory Assist System |
ALung Technologies, Inc. |
Joe Argyros |
| K211983 |
11/24/2021 |
AMRA Profiler |
AMRA Medical AB |
Eric Converse |
| K211696 |
11/30/2021 |
Disposable Surgical Face Mask |
Anhui Cleanpro Pharmpack Co., Ltd. |
Chong Xiuming |
| K212551 |
11/05/2021 |
Nitrile Examination Gloves |
Anhui Fine Glove Medical Technology Co., Ltd |
Guanghao Liu |
| K211956 |
11/23/2021 |
039 Surgical Face Mask |
AOK Tooling Limited |
Francis Nithyananthan |
| DEN210014 |
11/16/2021 |
EaseVRx |
AppliedVR, Inc. |
Jafar Shenasa |
| K212415 |
11/17/2021 |
Arthrex Modular Glenoid System-Titanium Glenosphere |
Arthrex Inc. |
David L. Rogers |
| K213213 |
11/19/2021 |
Arthrex Vortex Threaded Bone Marrow Recovery Needle |
Arthrex Inc. |
Nick Moore |
| K212047 |
11/16/2021 |
Pantheris System |
Avinger, Inc. |
Thomas Lawson |
| K211538 |
11/17/2021 |
Protect X Level 3 Isolation Gown |
AZAC Group |
Yen Ping Shan |
| K210350 |
11/18/2021 |
Gemini 2 810+980 Soft Tissue Laser |
Azena Medical, LLC |
Lindsay Tilton |
| K212912 |
11/04/2021 |
OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System |
b-ONE ORTHO, Corp |
Allison Gecik |
| K211649 |
11/23/2021 |
PCEA Syringe Set |
Baxter Healthcare Corporation |
Jeffrey E Thompson |
| K212015 |
11/19/2021 |
BD Nano 2nd Gen Pen Needle |
Becton Dickinson and Company |
Charlton Foo |
| K191964 |
11/03/2021 |
BD Kiestra IdentifA |
Becton, Dickinson and Company |
Janine Spafford |
| K211754 |
11/15/2021 |
Vital Signs Monitor |
Beijing Choice Electronic Technology Co., Ltd. |
Haiying Zhao |
| K202371 |
11/08/2021 |
Highspeed Airturbine Handpiece |
Beijing Dongbo Dental Handpiece Co., Ltd. |
Chao Hao |
| K212978 |
11/10/2021 |
Diode laser therapy system |
BEIJING UNT Technology Co., Ltd |
Qianwen Sheng |
| K202326 |
11/09/2021 |
BESPA Charcot System |
Bespa Global, LLC |
Lisa Viele |
| K210253 |
11/05/2021 |
Best Glove-Latex Powder Free Examination Glove |
Bestsafe Glove CO., LTD. |
Piyawat Chirasakulkarun |
| K211079 |
11/01/2021 |
BioFire COVID-19 Test 2 |
BioFire Defense, LLC |
Cynthia Phillips |
| K210757 |
11/12/2021 |
ETEST Fosfomycin (FO) (0.032-512 ╡g/mL) |
bioMerieux SA |
Marine Taravant |
| K211729 |
11/04/2021 |
Comprehensive« Convertible Glenoid - Vivacit-E Liner |
Biomet Manufacturing Corp. |
Patricia Sandborn Beres |
| K212068 |
11/08/2021 |
Biotech Dental Kits |
Biotech Dental, SAS |
Delphine Mercier |
| K212765 |
11/15/2021 |
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank |
Bloomden Bioceramics (HuNan) Co., Ltd |
Shengyong Liao |
| K212537 |
11/03/2021 |
REAL INTELLIGENCE CORI (CORI) |
Blue Belt Technologies, Inc. |
Sarah Plittman |
| K211080 |
11/19/2021 |
EkoSonic Endovascular Device |
Boston Scientific |
Joshua Kim |
| K211960 |
11/22/2021 |
Agile Esophageal OTW Stent System |
Boston Scientific Corporation |
Inderdeep Tiwana |
| K210989 |
11/12/2021 |
Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System |
Brainlab AG |
Chiara Cunico |
| K211544 |
11/03/2021 |
Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization |
Brainlab AG |
Chiara Cunico |
| K210598 |
11/02/2021 |
Pediatric Nasogastric Feeding Tubes - Single ENFit Port |
CAIR LGL |
Irving L. Wiesen |
| K211975 |
11/10/2021 |
Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System |
Caldera Medical, Inc. |
Vicki Gail |
| K211765 |
11/23/2021 |
Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown |
Cardinal Health LLC |
Brenda Gerena |
| K212112 |
11/18/2021 |
Cardiologs Holter Platform |
Cardiologs Technologies |
Arezou Azar |
| K210009 |
11/24/2021 |
Guiding Catheter |
CenterPoint Systems LLC |
Marybeth Gamber |
| K211326 |
11/19/2021 |
EndoScreener |
Chengdu Wision Medical Device Co., LTD. |
JingJia Liu |
| K212013 |
11/10/2021 |
eKuore Pro 4T - REF EP0098 |
Chip Ideas Electronics S.L. |
Bernardo Plaza Trillo |
| K210785 |
11/13/2021 |
Disposable Surgical Gowns |
Chongqing Litai Fashion Group Limited Company |
David Ni |
| K213436 |
11/15/2021 |
Clarius Ultrasound Scanner |
Clarius Mobile Health Corp. |
Agatha Szeliga |
| K212444 |
11/17/2021 |
Qora Stool Management Kit |
CM Technologies, Inc. |
Nishith Chasmawala |
| K213389 |
11/10/2021 |
Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System |
Conformis Inc. |
Kara Johnson |
| K213455 |
11/24/2021 |
ControlRad Select Model Z |
ControlRad, Inc. |
Chris Fair |
| K211517 |
11/09/2021 |
Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1 |
Convergent Laser Technologies |
Jennifer Mok |
| K210831 |
11/19/2021 |
OnQ Neuro |
CorTechs Labs, Inc |
Kora Marinkovic |
| K212301 |
11/15/2021 |
Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device |
Covidien, LLC |
Celso Duran |
| K212532 |
11/11/2021 |
Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) |
CRDLight Optoelectronic Technology Co., Ltd |
Fishy Liang |
| K212510 |
11/04/2021 |
7 Series Phototherapy Device |
Daavlin Distributing Co. |
Michele Thiel |
| K210384 |
11/04/2021 |
CARESCAPE R860 |
Datex-Ohmeda, Inc. |
Trishia Mercier |
| K211289 |
11/09/2021 |
RMU-2000 Automated Chest Compression System |
Defibtech, LLC |
Allison Bohren |
| K213449 |
11/15/2021 |
DS Implants abutments provided with the EV connection |
Dentsply Sirona |
Courtney Clark |
| K212529 |
11/23/2021 |
Hypotension Decision Assist Model HDA-OR2 |
Directed Systems Ltd |
Mark S. Leaning |
| K211894 |
11/24/2021 |
Trachealator |
DISA Medinotec |
Michelle Nieuwoudt |
| K202087 |
11/18/2021 |
DIXI Medical Microdeep Micro-Macro Depth Electrodes |
Dixi Medical |
Lucie Petegnief |
| DEN200040 |
11/03/2021 |
OMNIgene GUT Dx |
DNA Genotek Inc. |
Austin Udocor |
| K212171 |
11/01/2021 |
Electronic Blood Pressure Monitor |
Dongguan Kangweile Electronic Technology Co., Ltd. |
Zhixin Gao |
| K211967 |
11/09/2021 |
Sensual Massage, Ultra Pure |
Dreambrands, Inc. |
Cecile Kehoe |
| K213326 |
11/02/2021 |
VisionX 3.0 |
Durr Dental SE |
Oliver Lange |
| K211971 |
11/05/2021 |
Drug Relief v1 |
DyAnsys, Inc. |
Srini Nageshwar |
| K212558 |
11/24/2021 |
MicroPen EVO |
Eclipse Medcorp LLC |
Julie Summerville |
| K212306 |
11/02/2021 |
Tapestry Biointegrative Implant |
Embody, Inc. |
Brianna Schehr |
| K212853 |
11/05/2021 |
Cervical Stand-Alone System |
Eminent Spine, LLC |
Stephen Courtney |
| K212823 |
11/01/2021 |
DePuy CONDUIT LLIF Angled Inserters |
Enztec Limited |
Claire Mai |
| K212595 |
11/12/2021 |
Erchonia FX-405 |
Erchonia Corporation |
Steven Shanks |
| K211871 |
11/18/2021 |
FAICO Dental Implant System and CAD/CAM Abutments |
Faico Medical LLC |
Hernan Dario Fernandez |
| K202024 |
11/30/2021 |
ARROW Short Stem Humeral System |
FH Industrie |
Patricia Donnard |
| K212762 |
11/29/2021 |
geko W-2 |
Firstkind Limited |
Neil Buckley |
| K212169 |
11/23/2021 |
Air compression therapy system FO3002 |
Foshan Hongfeng Co., Ltd. |
Dongfeng Cheng |
| K212104 |
11/18/2021 |
Water-soluble Personal Lubricant |
Foshan PingChuang Medical Technology Co., Ltd. |
Huang Zhiyue |
| K212485 |
11/05/2021 |
Disposable Nitrile Examination gloves |
Fujian Yuanxin Safety Protection Technology Co., Ltd. |
Alan Wu |
| K212956 |
11/08/2021 |
FDR Cross (DR-XD 3000) |
FUJIFILM Corporation |
Randy Vader |
| K213041 |
11/18/2021 |
IPL Hair Removal, Model: OBT-02 |
Glan Electronics Co., Ltd. |
Lisa Pan |
| K211998 |
11/18/2021 |
Desnuda Reflect |
Good Clean Love, Inc. |
Wendy Strgar |
| K212000 |
11/18/2021 |
Medley |
Good Clean Love, Inc. |
Wendy Strgar |
| K212506 |
11/07/2021 |
Medical Examination Gloves (Tested for Use with Chemotherapy) |
GUANGDONG GYMDA MEDICAL TECHNOLOGY CO.,LTD |
Olivia Chen |
| K210222 |
11/02/2021 |
Disposable Medical Mask |
Guangdong Lide Medical Technology Co., Ltd. |
Zhuang Shenglin |
| K202110 |
11/05/2021 |
MStim Drop Model: LGT-233 |
Guangzhou Longest Science & Technology CO., Ltd. |
Xiaobing Luo |
| K202671 |
11/12/2021 |
DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) |
Guangzhou Xinbo Electronic Co., Ltd. |
Sammy Li |
| K212948 |
11/01/2021 |
Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I) |
Guangzhou Xinbo Electronic Co., Ltd. |
Sammy Li |
| K212460 |
11/05/2021 |
Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm╫9.5cm)) |
Guangzhou ZhengKang Medical Equipment Co.,Ltd |
Mike Wu |
| K213497 |
11/15/2021 |
ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) |
H&abyz Co., Ltd. |
Hyunook (David) Han |
| K212471 |
11/04/2021 |
Medical Face Mask |
Haian Medigauze Co., Ltd |
Weihua Xu |
| K211744 |
11/24/2021 |
Non-Contact Infrared Thermometer, model HL710H |
Health & Life Co., Ltd |
Simon Lee |
| K211817 |
11/05/2021 |
Anterion |
Heidelberg Engineering GmbH |
Arianna Schoess Vargas |
| K202842 |
11/26/2021 |
Medical surgical mask |
Henan Huibo Medical Co.,Ltd. |
Hui Lu |
| K210383 |
11/12/2021 |
Wrap Accessory Electrodes |
Hi-Dow International Inc. |
Eric Chen |
| K212575 |
11/14/2021 |
Surgical Face Mask |
Hubei Huanfu Plastic Products Co., Ltd |
Yan Zhao |
| K211165 |
11/09/2021 |
Medical Face Masks, Model Name:MY020003 |
Huizhou Jie Bai Purification Co.,Ltd. |
Terrance Huang |
| K212550 |
11/08/2021 |
Hura CTP v1.0 |
Hura Imaging, Inc. |
Danny Wang |
| K212456 |
11/17/2021 |
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System |
Hyperfine, Inc. |
Christine Kupchick |
| K202445 |
11/23/2021 |
Hystero-V Hysteroscope |
Hysterovue, Inc. |
Thomas Lawson |
| K212523 |
11/05/2021 |
VFSS Pro Mobile Digital Imaging System |
IMAGExRAY, LLC |
Gary Korkola |
| K210473 |
11/02/2021 |
Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) |
Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. |
Hⁿsamettin Sonmez |
| K203748 |
11/29/2021 |
SeptiCyte RAPID |
Immunexpress, Inc |
LaKesha Hunt-Dickens |
| K212046 |
11/18/2021 |
Impertech Surgical Face Mask |
Impertech Industries Ltd. |
Mohamad Khweis |
| K210543 |
11/03/2021 |
IM007 |
Implicity, Inc. |
David Perlmutter |
| K212487 |
11/18/2021 |
CoLink Vallux Plating System |
In2Bones USA, LLC |
Christine Scifert |
| K212467 |
11/04/2021 |
Disposable Nitrile Examination Glove |
Inner Mongolia Boming Medical Supplies Co., Ltd. |
Guo Hua |
| K212661 |
11/19/2021 |
Disposable Nitrile Examination Glove |
Inner Mongolia Cureguard Medical Technology Co.,Ltd. |
Guo Hua |
| K211662 |
11/18/2021 |
Reprocessed IntellaMap Orion High Resolution Mapping Catheter |
Innovative Health, LLC. |
Rick Ferreira |
| K212150 |
11/23/2021 |
Exablate Prostate System |
Insightec, Inc |
Nadir Alikacem |
| K212107 |
11/10/2021 |
Reverso |
Intelis Instruments Ltd. |
Amit Goren |
| K211876 |
11/12/2021 |
Intellijoint VIEW |
Intellijoint Surgical Inc. |
Katarina Jugovic |
| K212101 |
11/23/2021 |
da Vinci SP Firefly Imaging System |
Intuitive Surgical, Inc. |
Connor McCarty |
| K213089 |
11/10/2021 |
Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector |
Ivenix, Inc. |
John Sokolowski |
| K212497 |
11/11/2021 |
Nitrile Examination Glove (Powder free, Blue) |
Jiangsu Jinlian Medical Technology Co., Ltd |
Wu Min |
| K211329 |
11/15/2021 |
Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle |
Jiangsu Kangbao Medical Equipment Co., Ltd |
Rujun Tang |
| K212019 |
11/04/2021 |
Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Colle |
Jiangsu Micsafe Medical Technology Co., Ltd |
Tony Yang |
| K211937 |
11/18/2021 |
SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System |
Jiangsu Synecoun Medical Technology Co., Ltd. |
Zhheng Li |
| K210930 |
11/29/2021 |
ACUVUE« OASYS MAX 1-DAY Contact Lenses (senofilcon A) |
Johnson & Johnson Vision Care, Inc. |
Jamie Frenz-Ross |
| K212695 |
11/15/2021 |
KARL STORZ ICG Imaging System |
KARL STORZ Endoscopy America |
Mario Trujillo |
| K210854 |
11/16/2021 |
Enteral Feeding Set |
KB Medical (Group) Inc. |
Chunsheng Sheng |
| K212504 |
11/07/2021 |
Isolation Gown AAMI Level 3 |
Kenpax International Limited |
Solomon Chen |
| K211741 |
11/22/2021 |
Pre-Formed Extra Support Guidewire |
Lake Region Medical |
Deko Hussein |
| K212984 |
11/12/2021 |
MiPACS HTML5 Web Viewer |
LEAD Technologies Inc. |
William Little |
| K210432 |
11/03/2021 |
LELTEK Ultrasound Imaging System (Model: LU700 Series) |
Leltek Inc |
Jessie Wang |
| K212003 |
11/10/2021 |
ESSENZ Patient Monitor |
LivaNova Deutschland GmbH |
Florian Goetz |
| K211733 |
11/10/2021 |
Lunit INSIGHT CXR Triage |
Lunit Inc. |
Seulhee Jung |
| K211678 |
11/17/2021 |
Lunit INSIGHT MMG |
Lunit Inc. |
Joohee Lee |
| K212607 |
11/15/2021 |
Darwin |
Luvo Medical Technologies, Inc |
Gregory Berzak |
| K211586 |
11/01/2021 |
Nitrile Examination Gloves (Blue, Violet) |
Lyncmed Medical Technology (Beijing) Co., Ltd. |
Jiali Zhou |
| K213251 |
11/18/2021 |
HANAROSTENT Esophagus Asymmetric (CCC) |
M.I.Tech Co., Ltd. |
Sunyoung Jo |
| K213090 |
11/19/2021 |
Frontier Series Power Wheelchairs |
Magic Mobility |
Jill Mckechnie |
| K213070 |
11/18/2021 |
MD-320W Ultrasound Biomicroscope |
Meda Co., LTD |
Linda Zhang |
| K213071 |
11/16/2021 |
MOTOTM Partial Knee & MOTO PFJ Systems Extension |
Medacta International S.A. |
Stefano Baj |
| K210859 |
11/05/2021 |
NextARÖ Spine Platform |
Medacta International, SA |
Stefano Baj |
| K213454 |
11/23/2021 |
Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm |
Medtronic Powered Surgical Solutions |
Carrie Eddings |
| K212653 |
11/19/2021 |
Catalyft LS Expandable Interbody System |
Medtronic Sofamor Danek USA, Inc. |
Madhuvanthi Soundirarajan |
| K212839 |
11/16/2021 |
Opulent TiNbN Coated Knee |
Meril Healthcare Pvt. Ltd. |
Neelam Desai |
| K212199 |
11/03/2021 |
ASAP Aspiration Catheter, ASAPLP Aspiration Catheter |
Merit Medical Systems, Inc. |
Kirk McIntosh |
| K211463 |
11/24/2021 |
Regulora |
metaMe Health, Inc. |
Tim Rudolphi |
| K211288 |
11/04/2021 |
Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B |
Microlife Intellectual Property GmbH |
Gerhard Firck |
| K211356 |
11/08/2021 |
GIQuant |
Motilent Ltd |
Ian Knott |
| K210969 |
11/03/2021 |
Nulife |
MRK Healthcare Pvt Ltd |
Anil R Dave |
| K213184 |
11/23/2021 |
MZ Skin LightMAX Supercharged LED Mask 2.0 |
Mz Skin |
Maryam Zamani |
| K211295 |
11/24/2021 |
Surgical Mask (sterile) |
Nanjing 3H Medical Products Co., Ltd. |
Chun Yang |
| K212264 |
11/13/2021 |
Surgical Face mask |
Nantong Taiweishi Medical Technology Co., Ltd. |
Zhang Xuewen |
| K213214 |
11/24/2021 |
Xpert Wrist |
Newclip Technics |
Gregoire Larche |
| K212640 |
11/18/2021 |
Stratum« Ankle Fusion Plating System |
Nextremity Solutions, Inc. |
Elise Fox |
| K212446 |
11/03/2021 |
NuVasive Anterior Cervical Plate Systems |
NuVasive, Incorporated |
Priscila Saraiva |
| K211650 |
11/24/2021 |
The Radian MIS Bunion System |
Nvision Biomedical Technologies, Inc |
Diana Langham |
| K213421 |
11/19/2021 |
Vector« Hammertoe Correction System |
Nvision Biomedical Technologies, Inc |
Diana Langham |
| K211063 |
11/19/2021 |
HALYARD Flexaprene Green Powder-Free Exam Glove |
O & M Halyard, Inc. |
Steven Dowdley |
| K212336 |
11/17/2021 |
Soteria.AI |
Omega Medical Imaging, LLC |
John Newman |
| K212664 |
11/30/2021 |
Sherlock |
Open Implants, LLC |
Gregg Gellman |
| K212496 |
11/04/2021 |
Ortho Aligner System |
Ortho Lab Services, LLC |
Zuzana Huelsbusch |
| K212731 |
11/15/2021 |
Circul8 Pro |
Ortho8 Inc. |
Nordeen Taylor |
| K212044 |
11/05/2021 |
TrueLok Evo |
Orthofix SRL |
Gianluca Ricadona |
| K210921 |
11/02/2021 |
TaiChiB |
Our United Corporation |
Qi Liu |
| K210782 |
11/26/2021 |
Tablo Cartridge |
Outset Medical, Inc. |
Jennifer Mascioli-Tudor |
| K211286 |
11/16/2021 |
Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger |
Pall Corporation |
Brian Goetz |
| K210117 |
11/30/2021 |
Paltop Narrow Implant |
Paltop Advanced Dental Solutions, Ltd |
Zina Gurgov |
| K211315 |
11/09/2021 |
Comby EEG Caps |
Pamel d.o.o |
Marko Pavic |
| K212895 |
11/08/2021 |
Paragon 28 External Ring Fixation System |
Paragon 28, Inc |
Haylie Hertz |
| K212814 |
11/29/2021 |
C2 CryoBalloon Ablation System |
PENTAX of America, Inc. |
William Goeller |
| K211345 |
11/24/2021 |
C-30 Crown Kit |
Perfect Fit Crowns, LLC |
Steve Ziskind |
| K211432 |
11/23/2021 |
Myomics Q |
Phantomics Inc. |
Sangmin Cho |
| K211168 |
11/22/2021 |
Philips Incisive CT on Trailer |
Philips Healthcare (Suzhou) Co., Ltd. |
Shiguang An |
| K212673 |
11/19/2021 |
MR 5300 |
Philips Medical Systems Nederland B.V. |
Jan van de Kerkhof |
| K212937 |
11/04/2021 |
Dakota ALIF Plate System |
Precision Spine, Inc. |
Michael Dawson |
| K210344 |
11/10/2021 |
inVisionOS |
PrecisionOS Technology Inc. |
Danny Goel |
| K213425 |
11/17/2021 |
BruxZir Esthetic |
Prismatik Dentalcraft, Inc. |
So Hyun Park |
| K211890 |
11/17/2021 |
Promisemed Sharps container |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K203074 |
11/19/2021 |
Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) |
PT. Universal Gloves |
Li I-Feng |
| K213254 |
11/15/2021 |
Axialis Ophthalmic Ultrasound System |
Quantel Medical |
Bruno Pages |
| K211342 |
11/23/2021 |
Sofia 2 Campylobacter FIA |
Quidel Corporation |
Michelle Bodien |
| K203067 |
11/08/2021 |
Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F |
Qura S.r.l. |
Raffaella Tommasini |
| K201320 |
11/03/2021 |
Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor |
Qura S.r.l. |
Raffaella Tommasini |
| K213226 |
11/29/2021 |
RCT700 |
RAY Co., Ltd |
Youna Im |
| K202537 |
11/26/2021 |
ALTMS Magnetic Stimulation Therapy System |
REMED Co., Ltd |
Yonsoo Nam |
| K211206 |
11/09/2021 |
FreedomEdge(R) Syringe Infusion System |
Repro-Medical System, Inc., dba Koru Medical Systems |
Brian Schiller |
| K212331 |
11/09/2021 |
BodySculp |
Rohrer Aesthetics, LLC |
Mark Rohrer |
| K210990 |
11/22/2021 |
Non-sterile Powder Free Nitrile Examination Gloves |
Rubberex Alliance Sdn Bhd |
Sabri Abd Hamid |
| K212404 |
11/03/2021 |
S.I.N. Instrument Kits |
S.I.N. - Sistema de Implante Nacional S.A. |
Denise Domiciano |
| K211139 |
11/26/2021 |
CUBE Air Purifier |
Samsung Electronics Co., Ltd. |
Hana Jung |
| K203184 |
11/12/2021 |
HYDRASHIFT 2/4 isatuximab |
Sebia |
Karen Anderson |
| K212887 |
11/10/2021 |
RTapp |
SegAna, Inc. |
Jennifer Bosley |
| K212488 |
11/26/2021 |
Synthetic Nitrile Examination Gloves |
Shandong Hongxin Chemicals Co., Ltd. |
Ping Wang |
| K210777 |
11/02/2021 |
Powder Free Nitrile Patient Examination Gloves, Blue Color |
Shandong Jieshi Medical Products Co.,Ltd |
Li Biao |
| K210779 |
11/10/2021 |
Powder Free Nitrile Patient Examination Gloves, Blue Color |
Shandong Shangwei Medical Products Co.,Ltd |
Li Hua |
| K211169 |
11/24/2021 |
Bronchoscope System |
Shanghai AnQing Medical Instrument CO., Ltd. |
Shuwen Fan |
| K211103 |
11/04/2021 |
Powder Free Vinyl Examination Gloves |
Shanghai Shengda Medical Applications Co., Ltd |
Ying Su |
| K211562 |
11/23/2021 |
Virtue RF |
ShenB Co Ltd |
Sunny Kang |
| K212897 |
11/04/2021 |
IPL Hair Removal Device, model: AI01 |
Shenzhen Century Dongyuan Technology Co Ltd. |
He Wang |
| K211055 |
11/05/2021 |
Microcurrent device (Model: HBR2-1) |
Shenzhen DJ Medical Equipment Co., Ltd. |
Jet Li |
| K212697 |
11/19/2021 |
Leaf Smooth |
Shenzhen Leaflife Technology Co., Ltd |
Cheng Qiang |
| K212084 |
11/03/2021 |
Fetal Doppler |
Shenzhen Mericonn Technology Co., Ltd. |
Jiang Chuanyuan |
| K212900 |
11/05/2021 |
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., LTD. |
Shi Jufang |
| K212265 |
11/16/2021 |
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co.,LTD |
Hao Yixuan |
| K212989 |
11/22/2021 |
Low-frequency Stimulator (Model: AST-645, AST-646) |
Shenzhen OSTO Technology Co., Ltd. |
Li Yang |
| K203746 |
11/10/2021 |
Venen-trainer (Model: FM150, SFM90) |
Shenzhen Pango Electronic CO., LTD |
Guojun Zeng |
| K212223 |
11/24/2021 |
Atellica CH Enzymatic Creatinine_3 (ECre3) |
Siemens Healthcare Diagnostics Inc. |
Ian Thompson |
| K211726 |
11/05/2021 |
Acuson SC2000 Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
Christine Dunbar |
| K212621 |
11/12/2021 |
MAMMOVISTA B.smart |
Siemens Medical Solutions USA, Inc. |
Martin Rajchel |
| K210833 |
11/26/2021 |
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula |
Smiths Medical ASD, Inc. |
Nancy DeAngelo |
| K202288 |
11/19/2021 |
Finebeam |
SNJ Co., Ltd. |
Hyang-Kee Lee |
| K211483 |
11/15/2021 |
SofWave System |
Sofwave Medical Ltd. |
Ruthie Amir |
| K202732 |
11/03/2021 |
SOL-CARE IV Bag Safety Connector |
Sol-Millennium Medical Group |
Jim Barley |
| K212502 |
11/05/2021 |
Resonic Rapid Acoustic Pulse Device |
Soliton Inc. |
Leslie Honda |
| K211387 |
11/23/2021 |
Breathe Easy Mobile Respiratory Monitor (MRM) |
Sound Life Sciences, Inc. |
Kamal Shah |
| K211845 |
11/16/2021 |
Deploy Expandable Interbody System |
Southern Spine LLC |
Calder Clay |
| K211651 |
11/22/2021 |
Eclipse PRO |
Spacelabs Healthcare Ltd. |
Roger Moldon |
| K213451 |
11/22/2021 |
Spartan MC 0165 |
Spartan Micro |
Gary Avedovech |
| K212109 |
11/14/2021 |
Spin Care Disposable Protective Mask Level 3 |
SpinTech LLC |
Jim Jean |
| K212448 |
11/12/2021 |
NightGuard Flex |
SprintRay Inc |
Sara Moghtadernejad |
| K212515 |
11/03/2021 |
MOVIX DReamy |
Stephanix |
Sandie Perret |
| K212338 |
11/01/2021 |
SterileRight sterilization pouch and roll |
SterileRight Packaging Mfg., Inc. |
Thomas Chou |
| K211347 |
11/23/2021 |
Uretero1 Ureteroscope System |
STERIS Corporation |
Caroll Martin |
| K212633 |
11/24/2021 |
Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue |
String King Lacrosse, LLC |
Thomas Frasca |
| K212511 |
11/04/2021 |
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110) |
Stryker |
Marlene Fraga |
| K212455 |
11/16/2021 |
InZone Detachment System |
Stryker Neurovascular |
Breskella Halteh |
| K211594 |
11/26/2021 |
Trevo Trak 21 Microcatheter |
Stryker Neurovascular |
Shivani H Patel |
| K210836 |
11/30/2021 |
InstruSafe Instrument Protection System |
Summitt Medical LLC |
Debra Kridner |
| K212600 |
11/18/2021 |
Disposable Medical Nitrile Examination Gloves (Non-sterile) |
Suqian Linglian Medical Technology Co., Ltd |
Eric Li |
| K212526 |
11/09/2021 |
Surgical Face Mask |
Suzhou JaneE Medical Technology Co., Ltd. |
Chen Ke |
| K212284 |
11/10/2021 |
Disposable Automatic Core Biopsy Instrument |
Suzhou Leapmed Healthcare Corporation |
Yu Zhu |
| K210042 |
11/17/2021 |
Disposable Surgical Mask |
Suzhou Letian Protective Products Co., Ltd. |
Huang Qizhi |
| K203372 |
11/03/2021 |
SyMRI |
SyntheticMR AB |
Lisa Warnroth |
| K212029 |
11/16/2021 |
Disposable Medical Nitrile Examination Gloves (non-sterile) |
Taizhou Kangjian Medical Equipments Co., Ltd. |
Hua Cong |
| K200091 |
11/18/2021 |
Capiox iCP Centrifugal Pump |
Terumo Cardiovascular Systems Corporation |
John Chesney |
| K213406 |
11/18/2021 |
Savvy Mask - Level 3 Surgical Face Mask |
Texas MedPlast LLC |
Diego Olmos |
| K210095 |
11/23/2021 |
Playboy Premium Silicone Lubricant |
Thai Nippon Rubber Industry Public Company Limited |
Ryosuke Takamiya |
| K212151 |
11/03/2021 |
FLUME catheter |
The Flume Catheter Company, Ltd. |
Roger Holmes |
| K211541 |
11/26/2021 |
MammoScreen 2.0 |
Therapixel |
Quentin De Snoeck |
| K210628 |
11/04/2021 |
X-FLO Fluid Management System |
Thermedx, LLC |
Daniel Marijian |
| K202319 |
11/12/2021 |
Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) |
Tianjin Huahong Technology Co., Ltd. |
Yan Li |
| K211359 |
11/12/2021 |
Tornier PerformÖ Patient-Matched Primary Reversed Glenoid and BLUEPRINTÖ Patient Specific Instrumentation |
Tornier, Inc. |
Lisa Stahl |
| K211199 |
11/08/2021 |
ST AIA-PACK BNP Assay |
Tosoh Bioscience, Inc. |
Louise Musante |
| K210573 |
11/19/2021 |
Velofix SA Cervical Cage |
U&I Corporation |
Jee-Ae Bang |
| K211577 |
11/05/2021 |
SoftFix Balloon Trocar |
Unimax Medical Systems Inc. |
Monoj Mon Kalita |
| K211032 |
11/19/2021 |
Urinary Catheter 12 Fr, Urinary Catheter 16 Fr |
UroGen Pharma Ltd |
James G. Otinger |
| K211546 |
11/09/2021 |
Vektor Computational ECG Mapping System (vMap) |
Vektor Medical, Inc. |
Mike Monko |
| K211947 |
11/03/2021 |
GlideScope BFlex 2.8 Single-Use Bronchoscope |
Verathon Medical (Canada) ULC |
Teresa Davidson |
| DEN210012 |
11/23/2021 |
vPatch |
Virility Medical |
Bosmat Friedman |
| K212896 |
11/05/2021 |
Visible Patient Suite |
Visible Patient, SAS |
Emeline Degivry |
| K212583 |
11/10/2021 |
AlignRT Plus |
Vision RT Ltd |
Jade Dunphy |
| K210265 |
11/22/2021 |
VS3 Iridium Sytem |
Visionsense Ltd. |
Nancy Sauer |
| K211854 |
11/22/2021 |
VITA Akzent LC |
VITA Zahnfabrik GmbH H Rauter & Co |
Bernd Walker |
| K201082 |
11/10/2021 |
LTV2 Series Ventilators |
Vyaire Medical Inc |
Colleen Watson |
| K212992 |
11/18/2021 |
LINK« Embrace Shoulder System - Reverse Configuration |
Waldemar Link GmbH & Co. KG |
Stefanie Fuchs |
| K211697 |
11/16/2021 |
Esperance Aspiration Catheter System |
Wallaby Medical |
Nathaniel Knock |
| K213000 |
11/15/2021 |
Air Compression Massager (Model LF-FT003) |
Wenzhou Lingfeng Electronic Technology Co., Ltd |
Xiaoqun Ye |
| K213383 |
11/09/2021 |
WHILL Model C2 |
Whill, Inc. |
Tsuyoshi Iriyama |
| K212996 |
11/16/2021 |
Sterile PHALINX Hammertoe System |
Wright Medical Technology, Inc. |
Michael Mullins |
| K212787 |
11/08/2021 |
GT5 conductive & abrasive gel |
Wuhan Greentek Pty Ltd. |
Yarong Liu |
| K212722 |
11/26/2021 |
Nitrile Examination Gloves |
Wuhan Huirui Technology Co., Ltd |
Jing Li |
| K212344 |
11/16/2021 |
Surgical Mask |
Xiantao Dingcheng Non-woven Product Co., Ltd |
Cheng Qin |
| K212707 |
11/05/2021 |
CoolSculpting Elite System |
Zeltiq Aesthetics, Inc. |
Vicky Chai |
| K202676 |
11/05/2021 |
Disposable Medical Face Mask |
Zhejiang Senhong Medical&Instrument Co., Ltd. |
Eric Jian |
| K212259 |
11/12/2021 |
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank |
Zirdent New Material Co., Ltd |
Jia Li |
