| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K212527 |
08/11/2021 |
Cervical Spine Truss System Plating Solution (CSTS-PS) |
4WEB Medical, Inc. |
Lewis Harrison |
| K212738 |
08/30/2021 |
Amplatzer Talisman Delivery Sheath |
Abbott Medical |
Daniel Gapp |
| K212421 |
08/04/2021 |
ADAS 3D |
Adas3D Medical S.L |
Antonio Riu |
| K212766 |
08/31/2021 |
Maxiocel Chitosan Wound Dressing |
Advamedica Inc. |
Leo Mavely |
| K212525 |
08/11/2021 |
Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices |
Advcare Medical |
Meng T. Tan |
| K212659 |
08/23/2021 |
More-Cell-System |
Agency for Medical Innovations GmbH |
Martin Hohlrieder |
| K212409 |
08/03/2021 |
Ulspira TS Nitric Oxide Therapy System |
Airgas Therapeutics |
Steven Miller |
| K212662 |
08/23/2021 |
AliveCor QT Service |
AliveCor, Inc. |
Susan Noriega |
| K212757 |
08/31/2021 |
Jada System |
Alydia Health |
Colby Holtshouse |
| K212586 |
08/16/2021 |
Amazing+ |
Amazing Rubber Products Pvt Ltd |
Jayasankar S |
| K212597 |
08/16/2021 |
Amazing+ Latex Examination Powder Free Gloves |
Amazing Rubber Products Pvt Ltd |
Jayasankar S |
| K212584 |
08/16/2021 |
Blue Nitrile Examination Gloves Powder Free |
Amazing Rubber Products Pvt Ltd |
Jayasankar S |
| K212596 |
08/16/2021 |
Sterile Latex Surgical Gloves Powder Free |
Amazing Rubber Products Pvt Ltd |
Jayasankar S |
| K212382 |
08/02/2021 |
Ambu« aScopeÖ Gastro, Ambu« aBoxÖ2 |
Ambu A/S |
Mette Anderson |
| K212598 |
08/16/2021 |
iHealth infrared Ear thermometer PT5 |
Andon Health Co., Ltd. |
Liu Yi |
| K212386 |
08/02/2021 |
AngioVac F18 85 |
AngioDynamics, Inc. |
Kasey E. Newcomb |
| K212551 |
08/13/2021 |
Nitrile Examination Gloves |
Anhui Fine Glove Medical Technology Co., Ltd |
Guanghao Liu |
| K212516 |
08/10/2021 |
IRNF App |
Apple Inc. |
Dachan Kwon |
| K212773 |
08/31/2021 |
ARDO Alyssa |
ARDO Medical AG |
Thomas Schlieper |
| K212415 |
08/03/2021 |
Arthrex Modular Glenoid System-Titanium Glenosphere |
Arthrex Inc. |
David L. Rogers |
| K212645 |
08/20/2021 |
AT |
AT Glove Engineering SDN. BHD |
L. A. Choong |
| K212468 |
08/06/2021 |
Tigereye CTO-Crossing Catheter |
Avinger, Inc. |
Thomas Lawson |
| K212499 |
08/09/2021 |
BD Insulin Syringe (0.3mL) |
Becton, Dickinson and Company |
Mark William |
| K212724 |
08/27/2021 |
BD Vacutainer UltraTouch Push Button Blood Collection Set |
Becton, Dickinson and Company |
Katherine Kenner Lemus |
| K212611 |
08/17/2021 |
CO2 Laser Equipment |
Beijing Globalipl Development Co., Ltd. |
Liu Jun |
| K212733 |
08/30/2021 |
Diode laser therapy device |
Beijing Star New Tech Co., Ltd. |
Liang ZhongDong |
| K212478 |
08/09/2021 |
Dermatological diode laser system |
Beijing Stelle Laser Technology Co., Ltd. |
Zhao Changcheng |
| K212514 |
08/10/2021 |
Safety Pen Needle for Single Use, Insulin Pen Needles |
Berpu Medical Technology Co., Ltd. |
Buxin Yu |
| K212423 |
08/04/2021 |
EndoDrill« Model X |
Bibbinstruments AB |
Marie Grey |
| K212721 |
08/27/2021 |
Genex Bone Graft Substitute |
Biocomposites Ltd |
Simon Fitzer |
| K212761 |
08/31/2021 |
Biocore9 Acetabular Cup System |
Biocore9, LLC. |
Stan Matlak |
| K212727 |
08/27/2021 |
FilmArray Pneumonia Panel |
BioFire Diagnostics, LLC |
Kevin Bourzac |
| K212729 |
08/27/2021 |
Bone Cement-Normal Viscosity |
Biomecanica Industria e Comerciode Produtos Ortopedicos LTDA |
Thais Busquim |
| K212461 |
08/06/2021 |
VITEK MS PRIME |
bioMerieux, Inc. |
Nathan Hardesty |
| K212730 |
08/30/2021 |
BellaTek Encode Emergence Healing Abutments |
Biomet 3i LLC |
Krupal Patel |
| K212435 |
08/04/2021 |
Comprehensive Humeral Fracture Positioning Sleeves |
Biomet Inc. |
Aishwarya Pandey |
| K212608 |
08/17/2021 |
RibFix Blu Thoracic Fixation System |
Biomet Microfixation |
Lauren Jasper |
| K212431 |
08/04/2021 |
Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve |
Biomet, Inc. |
Gregory Foster |
| K212593 |
08/16/2021 |
ViaCath, AcQRate Dx Steerable Catheter |
Biotronick, Inc. |
Jon Brumbaugh |
| K212765 |
08/31/2021 |
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank |
Bloomden Bioceramics (HuNan) Co., Ltd |
Shengyong Liao |
| K212537 |
08/12/2021 |
REAL INTELLIGENCE CORI (CORI) |
Blue Belt Technologies, Inc. |
Sarah Plittman |
| K212430 |
08/04/2021 |
BONREE Nelaton Catheter |
Bonree Medical Co., Ltd |
He Hongbo |
| K212490 |
08/09/2021 |
AVVIGO Guidance System II |
Boston Scientific Corporation |
Margaret Batchelder |
| K212582 |
08/16/2021 |
SpyGlass Discover Balloon Dilation Catheter |
Boston Scientific Corporation |
Laura Kuroski |
| K212420 |
08/04/2021 |
Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio |
Brainlab AG |
Chiara Cunico |
| K212723 |
08/27/2021 |
BTL-995-rTMS |
BTL Industries Inc. |
David Chmel |
| K212588 |
08/16/2021 |
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 |
| K212708 |
08/26/2021 |
Halo One Thin-Walled Guiding Sheath |
C.R.Bard, Inc |
Annmarie Fitzgerald |
| K212492 |
08/09/2021 |
Frax 1940 for Nordlys and Frax Pro |
Candela Corporation |
Rina Ordonez |
| K212553 |
08/13/2021 |
DIGITAL RADIOGRAPHY CXDI-Pro, D1 |
Canon Inc. |
Akira Hirai |
| K212725 |
08/27/2021 |
ViperCross Support Catheters |
Cardiovascular Systems, Inc. |
Erika Huffman |
| K212711 |
08/26/2021 |
SteriTite Container System with MediTray Products |
Case Medical, Inc. |
Michael Polozani |
| K212705 |
08/26/2021 |
Actively Trying Personal Lubricant Unfragrance |
CC Wellness LLC |
Marlent Perez |
| K212758 |
08/31/2021 |
Autoplaque |
Cedars-Sinai Medical Center: AIM |
Damini Dey |
| K212528 |
08/11/2021 |
Change Healthcare Cardiology |
Change Healthcare Israel Ltd. |
Chester McCoy |
| K212567 |
08/16/2021 |
PVC Hydrophilic Urethral Catheter |
Chengdu Daxan Innovative Medical Tech. Co., Ltd |
Kevin Huang |
| K212716 |
08/27/2021 |
Dermoaroma Disposable Nitrile Examination Glove |
ChuZhou Harmony Gloves Medical Technology Co.,Ltd |
WeiHong Ou |
| K212562 |
08/13/2021 |
Idys-C ZP 3DTi |
Clariance, SA |
MΘlody La Porte |
| K212470 |
08/06/2021 |
iRAD |
Claritas HealthTech Pte Ltd |
Devika Dutt |
| K212658 |
08/23/2021 |
CloudCath Peritoneal Dialysis Drain Set Monitoring System |
CloudCath |
Brian Fisher |
| K212444 |
08/05/2021 |
Qora Stool Management Kit |
CM Technologies, Inc. |
Nishith Chasmawala |
| K212411 |
08/03/2021 |
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) |
Conformis Inc. |
Kara Johnson |
| K212631 |
08/19/2021 |
Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses |
Contamac Ltd. |
Rob McGregor |
| K212479 |
08/09/2021 |
Cohitech Reusable Tampon Applicator |
Cotton High Tech S.L. |
Anna Garcia |
| K212555 |
08/13/2021 |
Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC |
Covidien llc |
Anushka Jayaraman |
| K212532 |
08/11/2021 |
Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) |
CRDLight Optoelectronic Technology Co., Ltd |
Fishy Liang |
| K212422 |
08/04/2021 |
Disposable Surgical Isolation Gown |
Crown Name Disposable Hygiene Products Fty.Ltd. |
Ying Fang |
| K212442 |
08/04/2021 |
Cydar EV (Series B) and Cydar EV Maps |
Cydar Ltd. |
Vanisha Mistry |
| K212510 |
08/10/2021 |
7 Series Phototherapy Device |
Daavlin Distributing Co. |
Michele Thiel |
| K212751 |
08/30/2021 |
Powder Free Nitrile Examination Glove |
Dainam Glove Joint Stock Company |
Damon Nguyen |
| K212509 |
08/09/2021 |
OSSIX Breeze |
Datum Dental Ltd. |
Arie Goldlust |
| K212541 |
08/12/2021 |
3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix |
DeltaMed GmbH |
Michael Zimmermann |
| K212548 |
08/13/2021 |
LUXEN CL Dental Liquid |
DENTALMAX Co., Ltd. |
Park Seung Bum |
| K212683 |
08/24/2021 |
GLOBAL ICON Stemless Shoulder System |
DePuy (Ireland) |
Kathy Harris |
| K212746 |
08/30/2021 |
ATTUNE Revision Cones |
Depuy Ireland UC |
Erin Combs |
| K212710 |
08/26/2021 |
GLOBAL UNITEÖ Platform Shoulder System |
DePuy Ireland UC |
Yayoi Fujimaki |
| K212737 |
08/30/2021 |
INHANCEÖ Reverse Shoulder System |
Depuy Ireland UC |
Yayoi Fujimaki |
| K212466 |
08/06/2021 |
LVivo Seamless |
DiA Imaging Analysis Ltd |
Michal Yaacobi |
| K212491 |
08/09/2021 |
Air Relax Pro Model AR-4.0 |
Diode Art Engineering doing business as Air Relax |
Beomjoon Lee |
| K212529 |
08/11/2021 |
Hypotension Decision Assist Model HDA-OR2 |
Directed Systems Ltd |
Mark S. Leaning |
| K212745 |
08/30/2021 |
ORAcollect«òDx |
DNA Genotek Inc |
Austin Udocor |
| K212426 |
08/04/2021 |
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 |
| K212606 |
08/17/2021 |
BeamSite |
DoseOptics LLC |
Venkat Krishnaswamy |
| K212464 |
08/06/2021 |
Dukal Corporation AAMI Level 4 Open-Back Protective Gown |
Dukal Corporation |
Megan Quevedo |
| K212769 |
08/31/2021 |
DYNEX SmartPLEX MMRV IgG Assay Kit |
Dynex Technologies Inc. |
Jeff Fisher |
| K212558 |
08/13/2021 |
MicroPen EVO |
Eclipse Medcorp LLC |
Julie Summerville |
| K212629 |
08/19/2021 |
PP Care Nitrile Examination Gloves |
EG Group Product and Services CO., Ltd |
Aristotle Nafpliotis |
| K212630 |
08/19/2021 |
Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo |
Ellex Medical Pty Ltd |
Rashmi Pillay |
| K212701 |
08/25/2021 |
Eminent Spine 3D Cervical Interbody Fusion System |
Eminent Spine |
Stephen Courtney |
| K212595 |
08/16/2021 |
Erchonia FX-405 |
Erchonia Corporation |
Steven Shanks |
| K212419 |
08/04/2021 |
Magnifico Open, Magnifico MSK |
Esaote S.p.A. |
Alberto Carcagni |
| K212380 |
08/02/2021 |
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture |
Ethicon, Inc. |
Marife Sevek |
| K212624 |
08/18/2021 |
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System |
Ever Fortune. AI Co., Ltd. |
Chen Ming-Fong |
| K212405 |
08/02/2021 |
EMERGEÖ Anterior Cervical Plate System |
Evolution Spine |
Todd Wallenstein |
| K212425 |
08/04/2021 |
MicroTrend System |
ExoStat Medical, Inc. |
Irvin Pierskalla |
| K212618 |
08/18/2021 |
iRelieve Microcurrent Pain Relief System |
Fast Track Technologies, Inc. |
Geoffrey Pfeifer |
| K212741 |
08/30/2021 |
EZYPOR |
FCI (France Chirurgie Instrumentation) SAS |
Thierry Fetick |
| K212762 |
08/31/2021 |
geko W-2 |
Firstkind Limited |
Neil Buckley |
| K212615 |
08/18/2021 |
EpiFaith CV |
Flat Medical Co., Ltd. |
Tseng Shao Wei |
| K212698 |
08/25/2021 |
Plus Medical Isolation Gown Level 3 |
Foshan Nanhai Plus Medical Co Ltd |
Eric Li |
| K212610 |
08/17/2021 |
Surgical Face Mask |
Foshan Nanhai Plus Medical CO LTD |
Suyi Li |
| K212445 |
08/05/2021 |
freeflex+ Transfer Adapter |
Fresenius Kabi AG |
Keith Dunn |
| K212620 |
08/18/2021 |
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K212522 |
08/11/2021 |
Lilliput APD System |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K212485 |
08/09/2021 |
Disposable Nitrile Examination gloves |
Fujian Yuanxin Safety Protection Technology Co., Ltd. |
Alan Wu |
| K212463 |
08/06/2021 |
Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack |
Geistlich Pharma AG |
Marco Steiner |
| K212652 |
08/23/2021 |
Sterile Syringe with Fixed Safety Needle for Single Use |
Gemtier Medical (Shanghai) Inc. |
Lenny Cao |
| DEN210034 |
08/26/2021 |
ONE Male Condom |
Global Protection Corp. |
Davin Wedel |
| K212433 |
08/04/2021 |
Anthem Fracture System |
Globus Medical Inc. |
Jennifer Antonacci |
| K212506 |
08/09/2021 |
Medical Examination Gloves (Tested for Use with Chemotherapy) |
GUANGDONG GYMDA MEDICAL TECHNOLOGY CO.,LTD |
Olivia Chen |
| K212564 |
08/13/2021 |
Electric Breast Pump |
Guangdong Horigen Mother & Baby Products Co., Ltd. |
Changxin Chen |
| K212460 |
08/05/2021 |
Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm╫9.5cm)) |
Guangzhou ZhengKang Medical Equipment Co.,Ltd |
Mike Wu |
| K212702 |
08/26/2021 |
IM/ST Fixture System |
Guilin FiTeeth Medical Instrument Co., Ltd. |
Jun Zhou |
| K212650 |
08/23/2021 |
Celeris, Disposable Sinus Debrider |
Gyrus ACMI, Inc. |
Dolan Mills |
| K212471 |
08/06/2021 |
Medical Face Mask |
Haian Medigauze Co., Ltd |
Weihua Xu |
| K212447 |
08/05/2021 |
SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream |
Hangzhou Sejoy Electronics & Instruments Co., Ltd. |
Yanyan Zhang |
| K212400 |
08/02/2021 |
SONON Ultrasound Imaging System, Model: SONON 500L |
Healcerion Co., Ltd |
Sooyeol Lee |
| K212623 |
08/18/2021 |
Healgen Strep A Rapid Test Strip (Throat Swab) |
Healgen Scientific, LLC |
Jianqiu Fang |
| K212418 |
08/03/2021 |
hCG One Step Pregnancy Test |
Healstone Biotech Inc. |
Guang Gao |
| DEN210035 |
08/27/2021 |
ôGeniusÖ Digital Diagnostics System with the GeniusÖ Cervical AI algorithmö |
Hologic Inc. |
Bryce Dzialo |
| K212575 |
08/16/2021 |
Surgical Face Mask |
Hubei Huanfu Plastic Products Co., Ltd |
Yan Zhao |
| K212726 |
08/27/2021 |
Disposable Medical Surgical Mask |
Hubei Huaqiang High-Tech Co., Ltd. |
Jing Yang |
| K212398 |
08/02/2021 |
Surgical Face Mask (Non-sterile) |
Hubei Kimsoul Industrial Co., Ltd |
Faming Zhang |
| K212665 |
08/23/2021 |
Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911) |
Huizhou Xiaoou Technology Co., Ltd. |
Xia Wang |
| K212550 |
08/13/2021 |
Hura CTP v1.0 |
Hura Imaging, Inc. |
Danny Wang |
| K212635 |
08/19/2021 |
Sofjec |
Hwajin Medical Co.,Ltd. |
Jeon Sung Hun |
| K212456 |
08/05/2021 |
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System |
Hyperfine, Inc. |
Christine Kupchick |
| K212413 |
08/03/2021 |
I-Motion |
I-Motion Group Global Iberica S.L. |
Jose Luis Soto Belloso |
| K212561 |
08/13/2021 |
MTX-C1 |
ILOODA Co., Ltd |
Yun-Jung Ha |
| K212523 |
08/11/2021 |
VFSS Pro Mobile Digital Imaging System |
IMAGExRAY, LLC |
Gary Korkola |
| K212394 |
08/02/2021 |
Implant-One Multi-Unit Abutment |
Implant Logistics, Inc. |
Thomas Arendt |
| K212676 |
08/24/2021 |
Osteon Precision Milled Suprastructure |
Implant Solutions PTY LTD (Osteon Medical) |
Andrea Del Ciotto |
| K212487 |
08/09/2021 |
CoLink Vallux Plating System |
In2Bones USA, LLC |
Christine Scifert |
| K212632 |
08/19/2021 |
ClotTriever Thrombectomy System |
Inari Medical, Inc. |
Larry Boucher |
| K212392 |
08/02/2021 |
Intri24 Sheath |
Inari Medical, Inc. |
Kit Cariquitan |
| K212467 |
08/06/2021 |
Disposable Nitrile Examination Glove |
Inner Mongolia Boming Medical Supplies Co., Ltd. |
Guo Hua |
| K212401 |
08/02/2021 |
Disposable Nitrile Examination Glove |
Inner Mongolia Cureguard Medical Technology Co.,Ltd. |
Guo Hua |
| K212661 |
08/23/2021 |
Disposable Nitrile Examination Glove |
Inner Mongolia Cureguard Medical Technology Co.,Ltd. |
Guo Hua |
| K212517 |
08/10/2021 |
Magicore System |
InnoBioSurg Co., Ltd. |
JongHyuk Seo |
| K212547 |
08/13/2021 |
Quick-Start Screws |
Innovate Orthopaedics Limited |
Alex Gutteridge |
| K212627 |
08/19/2021 |
True Tulip, True M.I.S. |
Innovative Surgical Designs, Inc. |
Jon Rinehart |
| K212533 |
08/11/2021 |
BLX WB ╪5.0 (L18), ╪5.5 and ╪6.5 mm (L14 and L16) Implants |
Institut Straumann AG |
Corinne Arimatea |
| K212389 |
08/02/2021 |
Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF |
Intelivation LLC |
Amit Sinha |
| K212747 |
08/30/2021 |
Da Vinci SP Surgical System |
Intuitive Surgical, Inc. |
Connor McCarty |
| K212644 |
08/20/2021 |
Aura Storm |
Invictus Lighting |
Neeraj Lal |
| K212518 |
08/10/2021 |
Jeesung Safety Syringe and Single Use Needles |
JeeSung Medical Co., Ltd. |
Choi Yong Hyun |
| K212497 |
08/09/2021 |
Nitrile Examination Glove (Powder free, Blue) |
Jiangsu Jinlian Medical Technology Co., Ltd |
Wu Min |
| K212639 |
08/20/2021 |
Disposable Medical Nitrile Examination Gloves (Non sterile) |
Jiangsu Nanfang Medical Co., Ltd |
Xia Li |
| K212385 |
08/02/2021 |
YUWELL Finger Pulse Oximeter |
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. |
Yuzhuo Wang |
| K212656 |
08/23/2021 |
Flexible Intubation Video Endoscope û Sterile (FIVE-S) |
KARL STORZ Endoscopy America |
Mario Trujillo |
| K212458 |
08/05/2021 |
Flexible Video-Uretero-Renoscope SSU System |
KARL STORZ Endoscopy America |
Mario Trujillo |
| K212695 |
08/25/2021 |
KARL STORZ ICG Imaging System |
KARL STORZ Endoscopy America |
Mario Trujillo |
| K212476 |
08/06/2021 |
KARL STORZ Flexible HD Cysto-Urethroscope System |
KARL STORZ Endoscopy America, Inc. |
Winkie Wong |
| K212609 |
08/17/2021 |
BHA100 Series Braun Clear Hearing Aid |
Kaz USA, Inc., a Helen of Troy Company |
Matt J. Baun |
| K212504 |
08/09/2021 |
Isolation Gown AAMI Level 3 |
Kenpax International Limited |
Solomon Chen |
| K212450 |
08/05/2021 |
Keos Anterior Cervical Interbody Fusion Device System |
Keos |
Scott Peterson |
| K212521 |
08/10/2021 |
Field Shield Wound Dressing |
Kericure Inc. |
Kerriann Greenhalgh |
| K212616 |
08/18/2021 |
Koios DS |
Koios Medical, Inc. |
Patricia Setti-Laperch |
| K212685 |
08/24/2021 |
KONICAMINOLTA DI-X1 |
Konica Minolta, Inc. |
Tsutomu Fukui |
| K212613 |
08/18/2021 |
Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue) |
Koon Seng Sdn Bhd |
Jennifer Yeo |
| K212503 |
08/09/2021 |
HP458E Electrically Powered Wheelchair |
Kunshan Hi-Fortune Health Products Co., Ltd. |
Jianjiang Fan |
| K212663 |
08/23/2021 |
HELIOS IV 785 |
Laseroptek Co., Ltd. |
Hong Chu |
| K212573 |
08/16/2021 |
PicoLO Premium |
Laseroptek Co., Ltd. |
Hong Chu |
| K212771 |
08/31/2021 |
LightStim Elipsa |
LED Intellectual Properties LLC |
Chase Marchese |
| K212520 |
08/10/2021 |
ProLift Micro Expandable Spacer System |
Life Spine, Inc. |
Angela Batker |
| K212500 |
08/09/2021 |
ArtiSential Trocar |
LivsMed Inc. |
Dong Wook Lee |
| K212703 |
08/26/2021 |
AcuPulse CO2 Laser System, Delivery Devices and Accessories |
Lumenis, Ltd. |
Shlomit Segman |
| K212607 |
08/17/2021 |
Darwin |
Luvo Medical Technologies, Inc |
Gregory Berzak |
| K212680 |
08/24/2021 |
LuxCreo Clear Aligner System |
Luxcreo Inc |
Mike Yang |
| K212649 |
08/23/2021 |
Disposable Surgical Face Mask |
Lyncmed Medical Technology (Beijing) Co., Ltd. |
Naomi Zhou |
| K212535 |
08/11/2021 |
Nitrile Powder Free Blue Examination Gloves, Non-Sterile |
Mah Sing Healthcare Sdn Bhd |
Azlan Hashim |
| K212699 |
08/25/2021 |
Disposable Powder Free Polyethylene Examination Gloves |
Mastermax Plastic (Huizhou) LTD |
Benson Xu |
| K212569 |
08/16/2021 |
Materialise Shoulder SystemÖ, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner |
Materialise NV |
Simona Beri |
| K212391 |
08/02/2021 |
MCI-Neuro Fixation System |
MCI Medical Concept Innovation Inc. |
Carlos Lacerda |
| K212684 |
08/24/2021 |
BrainView QEEG Software |
Medeia, Inc. |
Slav Danev |
| K212412 |
08/03/2021 |
IRIS-XP |
Medicore Co., Ltd. |
Kyo-bum Kim |
| K212756 |
08/31/2021 |
Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set |
MEDOS International SARL |
Nicole Aeschbacher |
| K212743 |
08/30/2021 |
MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System |
MedSchenker, Inc. |
Joseph Kim |
| K212397 |
08/02/2021 |
StealthStation S8 Cranial v2.0 |
Medtronic Navigation |
Carey Brenner |
| K212641 |
08/20/2021 |
StrataMR II Valves and Shunts |
Medtronic Neurosurgery |
Swara Vashi |
| K212428 |
08/04/2021 |
Centerpiece Plate Fixation System |
Medtronic Sofamor Danek |
Diamond Wallace |
| K212524 |
08/11/2021 |
Anteralign Spinal System with Titan nanoLOCK Surface Technology |
Medtronic Sofamor Danek USA, INC. |
Elizabeth Hamilton |
| K212653 |
08/23/2021 |
Catalyft LS Expandable Interbody System |
Medtronic Sofamor Danek USA, Inc. |
Madhuvanthi Soundirarajan |
| K212764 |
08/31/2021 |
Medwell Technology Ltd Syringes, various sizes |
Medwell Technology Ltd |
Andy Song |
| K212675 |
08/24/2021 |
Aspira Peritoneal Drainage System |
Merit Medical Systems, Inc. |
Jennifer Webb |
| K212696 |
08/25/2021 |
Aspira Pleural Drainage System |
Merit Medical Systems, Inc. |
Jennifer Webb |
| K212748 |
08/30/2021 |
Disposable Dual Action Tissue Clip |
Micro-Tech (Nanjing) Co., Ltd. |
Cecilia Sun |
| K212403 |
08/02/2021 |
Tracheal Stent System (Y-Shaped) |
Micro-Tech (Nanjing) Co., Ltd. |
Sally He |
| K212434 |
08/04/2021 |
Neuromuscular Transmission Monitor TOF3D |
MIPM Mammendorfer Institut fⁿr Physik und Medizin GmbH |
Jennifer Rosenheimer |
| K212402 |
08/02/2021 |
MIVI Q Distal Access Catheter |
MIVI Neuroscience, Inc. |
Janel Hurtado |
| K212407 |
08/03/2021 |
Gastric Lightguide (GLG) |
Naser Dib Gabinet Lekarksi Nasmed |
Naser Dib |
| K212399 |
08/02/2021 |
Aveli |
NC8, Inc. |
Mellissa Viotti |
| K212489 |
08/09/2021 |
BonOs Inject Bone Cement; NEO Pedicle Screw System |
Neo Medical SA |
Jonas Larsson |
| K212545 |
08/12/2021 |
FlexitSystem Knee osteotomy system |
Neosteo |
JD Webb |
| K212396 |
08/02/2021 |
UroLift System Rigid Retrieval Kit Sterilization Tray |
NeoTract, Inc. |
Brian Gall |
| K212666 |
08/23/2021 |
Neuromark System |
Neurent Medical |
Kenny Walsh |
| DEN210033 |
08/18/2021 |
Lenire Tinnitus Treatment Device |
Neuromod Devices Limited |
Fran Coogan |
| K212640 |
08/20/2021 |
Stratum« Ankle Fusion Plating System |
Nextremity Solutions, Inc. |
Elise Fox |
| K212498 |
08/09/2021 |
Stable-L Standalone Lumbar Interbody System |
Nexus Spine, LLC |
Jared Crocker |
| K212377 |
08/02/2021 |
Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 |
Ningbo MedKinetic Medical Device Co., Ltd. |
Zhang Wei |
| K212677 |
08/24/2021 |
aboNT SYRINGE |
Nipro Medical Corporation |
Jessica Oswald-McLeod |
| K212720 |
08/27/2021 |
nordicDSC |
NordicNeurolab AS |
Chandana Gurung Bhandari |
| K212446 |
08/05/2021 |
NuVasive Anterior Cervical Plate Systems |
NuVasive, Incorporated |
Priscila Saraiva |
| K212477 |
08/09/2021 |
EARP Interbody System |
Nvision Biomedical Technologies, Inc. |
Diana Langham |
| K212544 |
08/12/2021 |
MiniLoad Syringe |
OcuJect, LLC |
Rebecca K Pine |
| K212667 |
08/23/2021 |
Single Use Guide Sheath Kit-401, K-402 |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K212643 |
08/20/2021 |
POWERSEAL Curved Jaw Sealer and Divider, Double Action |
Olympus Surgical Technologies America |
Christina Flores |
| K212612 |
08/17/2021 |
Omnia Medical TiBrid-SC |
Omnia Medical, LLC |
Morgan Hill |
| K212530 |
08/11/2021 |
IVX Fluid Transfer Set |
Omnicell, Inc. |
David Vanella |
| K212664 |
08/23/2021 |
Sherlock |
Open Implants, LLC |
Gregg Gellman |
| K212579 |
08/16/2021 |
FortiShield (Biosynthetic Wound Matrix) |
Organogenesis Inc. |
Christina Nichols |
| K212648 |
08/23/2021 |
VITROS Immunodiagnostic Products CK-MB Reagent Pack |
Ortho Clinical Diagnostics |
Declan Hynes |
| K212496 |
08/09/2021 |
Ortho Aligner System |
Ortho Lab Services, LLC |
Zuzana Huelsbusch |
| K212381 |
08/02/2021 |
VersaTap, VersaLat, DueLock, VersaTi, MiniTi |
Ortho-Design (Pty) Ltd |
Dian Peach |
| K212731 |
08/30/2021 |
Circul8 Pro |
Ortho8 Inc. |
Nordeen Taylor |
| K212601 |
08/17/2021 |
DRPx Locking Distal Radius Plate System |
Orthopaedic Implant Company |
Douglas Fulton |
| K212560 |
08/13/2021 |
SignatureÖ ONE System |
Orthosoft Inc. (d/b/a Zimmer CAS) |
Sankalp Dere |
| K212414 |
08/03/2021 |
OSSDSIGN Cranial PSI |
OssDsign AB |
Ulrik Birgersson |
| K212594 |
08/16/2021 |
OSSIOfiber« Staple |
OSSIO Ltd. |
Taly Linder |
| K212570 |
08/16/2021 |
OsteoPlan System |
OsteoMed LLC |
Diane Rutherford |
| K212519 |
08/10/2021 |
Overjet Caries Assist |
Overjet, Inc. |
Wardah Inam |
| K212654 |
08/23/2021 |
Micro C Medical Imaging System, M01 |
OXOS Medical, Inc. |
Evan Ruff |
| K212717 |
08/27/2021 |
Paneffort AAMI Level 3 Isolation Gown |
Paneffort, LLC |
Harry Harry |
| K212739 |
08/30/2021 |
ActiFlip |
Parcus Medical LLC. |
Calen Souther |
| K212655 |
08/23/2021 |
Flyte |
Pelvital USA, Inc. |
Dale Wahlstrom |
| K212565 |
08/13/2021 |
CoverScan v1 |
Perspectum Ltd. |
Ioan Wigley |
| K212441 |
08/04/2021 |
Philips Incisive CT |
Philips Healthcare (Suzhou) Co., Ltd. |
Shiguang An |
| K212704 |
08/26/2021 |
Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System |
Philips Medical Systems |
Brenna Loufek |
| K212673 |
08/24/2021 |
MR 5300 |
Philips Medical Systems Nederland B.V. |
Jan van de Kerkhof |
| K212493 |
08/09/2021 |
KODEX û EPDÖ System 1.5.0 |
Philips Medical Systems Nederland, B.V. (PMSN) |
Betina Schepers |
| K212557 |
08/13/2021 |
Virtual C DRF-NEO Digital Imaging System |
Portavision Medical LLC |
Terry Ancar |
| K212772 |
08/31/2021 |
Precision Align |
Precision Align LLC. |
Chris Freeman |
| K212563 |
08/13/2021 |
CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid |
Prevest Denpro Limited |
Atul Modi |
| K212475 |
08/06/2021 |
Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) |
Prevest Denpro Limited |
Atul Modi |
| K212592 |
08/16/2021 |
Gas-Chex Indicator |
Propper Manufacturing Co., Inc. |
Andrew Sharavara |
| K212636 |
08/19/2021 |
CORUS Spinal System-X |
Providence Medical Technology, Inc. |
Edward Liou |
| K212408 |
08/03/2021 |
Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid) |
Pt. Maja Agung Latexindo |
Sivaprakash S |
| K212494 |
08/09/2021 |
Lung Image Analysis |
Pulmonx Corporation |
Terry Solomon |
| K212740 |
08/30/2021 |
Puravita Medical Fold Flat Surgical Mask |
Puravita M, LLC |
Jefferson Nemelka |
| K212688 |
08/25/2021 |
Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger |
Qura S.r.l. |
Raffaella Tommasini |
| K212690 |
08/25/2021 |
qXR-BT |
Qure.ai Technologies |
Bunty Kundnani |
| K212587 |
08/16/2021 |
3D-RD-S |
Radiopharmaceutical Imaging and Dosimetry, LLC |
Nadine Bonds |
| K212753 |
08/31/2021 |
0909FCB, 1212FCA |
Rayence Co., Ltd |
Kevin Kim |
| K212451 |
08/05/2021 |
Surgical Mask |
ReMade USA LLC |
David Durst |
| K212495 |
08/09/2021 |
Leva Pelvic Health System |
Renovia Inc. |
Jim O'Connor |
| K212427 |
08/04/2021 |
cobas Cdiff nucleic acid test for use on the cobas Liat System |
Roche Molecular Systems, Inc. |
Kaitlyn Hameister |
| DEN210032 |
08/09/2021 |
AccuMeasure System |
RQMIS Inc. |
Barry Sands |
| K212404 |
08/02/2021 |
S.I.N. Instrument Kits |
S.I.N. - Sistema de Implante Nacional S.A. |
Denise Domiciano |
| K212709 |
08/26/2021 |
VoqX Electronic Stethoscope |
Sanolla Ltd. |
Doron Adler |
| K212540 |
08/12/2021 |
Explorer TO System |
SeaSpine Orthopedics Corporation |
Aly Alvarez |
| K212692 |
08/25/2021 |
Mariner Pedicle Screw System |
SeaSpine Orthopedics Corporation |
Jesse Albright |
| K212603 |
08/17/2021 |
Non Absorbable Surgical Nylon Suture |
Shandong Haidike Medical Product Co., Ltd. |
Lili Xu |
| K212488 |
08/09/2021 |
Synthetic Nitrile Examination Gloves |
Shandong Hongxin Chemicals Co., Ltd. |
Ping Wang |
| K212436 |
08/04/2021 |
NBR Synthetic Nitrile Examination Gloves |
Shandong Langtai International Trade Co., Ltd. |
Ping Wang |
| K212626 |
08/18/2021 |
PathBuilder Transseptal Guiding Introducer |
Shanghai MicroPort EP MedTech Co., Ltd. |
Tian Xia |
| K212625 |
08/18/2021 |
PathBuilder Transseptal Needle |
Shanghai MicroPort EP MedTech Co., Ltd. |
Tian Xia |
| K212395 |
08/02/2021 |
Nebulizer |
Shenzhen Homed Medical Device Co., Ltd. |
Shi Shengming |
| K212697 |
08/25/2021 |
Leaf Smooth |
Shenzhen Leaflife Technology Co., Ltd |
Cheng Qiang |
| K212752 |
08/30/2021 |
Med-link Pulse Oximeter |
Shenzhen Med-link Electronics Tech Co., Ltd. |
Jialing Zhang |
| K212410 |
08/03/2021 |
VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium |
Shenzhen VitaVitro Biotech Co.,Ltd. |
Donghai Pan |
| K212559 |
08/13/2021 |
CardioPhase« hsCRP |
Siemens Healthcare Diagnostics Products GmbH |
Martina Pfeiff |
| K212379 |
08/02/2021 |
N Latex FLC kappa, N Latex FLC lambda |
Siemens Healthcare Diagnostics Products GmbH |
Martina Pfeiff |
| K212621 |
08/18/2021 |
MAMMOVISTA B.smart |
Siemens Medical Solutions USA, Inc. |
Martin Rajchel |
| K212604 |
08/17/2021 |
Symbia VA10A Family |
Siemens Medical Solutions USA, Inc. |
Tabitha Estes |
| K212755 |
08/31/2021 |
SIGNUS SACRONAIL« Transsacral Stabilization System |
SIGNUS Medizintechnik GmbH |
Holger Noss |
| K212393 |
08/02/2021 |
OPN NC PTCA Dilatation Catheter |
SIS Medical AG |
Sergej Kammerzell |
| K212750 |
08/30/2021 |
Ultrasonic Surgical Aspirator System, Model: XD880B |
SMTP Technology Co., Ltd. |
Songtao Zhan |
| K212660 |
08/23/2021 |
Smylio Invisible Clear Aligners |
Smylio, Inc |
Ren Menon |
| K212770 |
08/31/2021 |
Vision |
SoftSmile, Inc. |
Khamzat Asabaev |
| K212502 |
08/09/2021 |
Resonic Rapid Acoustic Pulse Device |
Soliton Inc. |
Leslie Honda |
| K212657 |
08/23/2021 |
Quantum Heater-Cooler |
Spectrum Medical Ltd. |
Colleen Powell |
| K212706 |
08/26/2021 |
SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard |
Splintek, Inc. |
Thomas W. Brown |
| K212767 |
08/31/2021 |
SleepRight Select-Comfort Dental Guard |
Splintek, Inc. |
Thomas W. Brown |
| K212448 |
08/05/2021 |
NightGuard Flex |
SprintRay Inc |
Sara Moghtadernejad |
| K212482 |
08/09/2021 |
Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White |
Sri Trang Gloves (Thailand) Public Company Limited |
Jarinya Jirokjul |
| K212728 |
08/27/2021 |
Standard Bougie, 38 Fr. and Hand Pump |
Standard Bariatrics |
Michelle Schnell |
| K212554 |
08/13/2021 |
Bonvadis Topical Cream |
StemCyte Inc. |
Angel Hsieh |
| K212515 |
08/10/2021 |
MOVIX DReamy |
Stephanix |
Sandie Perret |
| K212424 |
08/04/2021 |
AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers |
STERIS Corporation |
Anthony Piotrkowski |
| K212576 |
08/16/2021 |
MDx-Chex for BCID2 |
Streck, Inc |
Deborah S. Kipp |
| K212633 |
08/19/2021 |
Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue |
String King Lacrosse, LLC |
Thomas Frasca |
| K212511 |
08/10/2021 |
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 |
| K212581 |
08/16/2021 |
VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System |
Stryker GmbH |
Keith Neligan |
| K212455 |
08/05/2021 |
InZone Detachment System |
Stryker Neurovascular |
Breskella Halteh |
| K212600 |
08/17/2021 |
Disposable Medical Nitrile Examination Gloves (Non-sterile) |
Suqian Linglian Medical Technology Co., Ltd |
Eric Li |
| K212614 |
08/18/2021 |
Ultrasonic Scalpel System |
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. |
Guofang Ma |
| K212719 |
08/27/2021 |
Micro Catheter and Guidewire System |
Suzhou Hengrui Hongyuan Medical Co., Ltd |
Wang Peipei |
| K212591 |
08/16/2021 |
Disposable Surgical Gown |
Suzhou JaneE Medical Technology Co., Ltd |
Chen Ke |
| K212526 |
08/11/2021 |
Surgical Face Mask |
Suzhou JaneE Medical Technology Co., Ltd. |
Chen Ke |
| K212700 |
08/25/2021 |
Dyflex-II |
Taeyeon Medical Co., Ltd. |
Sin-Ae Kang |
| K212538 |
08/12/2021 |
DESS Dental Implants |
Terrats Medical SL |
Roger Terrats |
| K212577 |
08/16/2021 |
DESS Dental Smart Solutions |
Terrats Medical SL |
Roger Terrats |
| K212628 |
08/19/2021 |
DESS Dental Smart Solutions |
Terrats Medical SL |
Roger Terrats |
| K212438 |
08/04/2021 |
Comfortpro |
Thai Rubber Industry Company Limited |
Chawalit Tiyadechachai |
| K212505 |
08/09/2021 |
DUMI ManipulatOR |
The O R Company Pty Ltd |
Amesha Silva |
| K212383 |
08/02/2021 |
EndoNaut |
Therenva SAS |
Audrey Gallois |
| K212734 |
08/30/2021 |
Diode laser therapy device |
TRIANGEL RSD LIMITED |
Zhao Fengdan |
| K212556 |
08/13/2021 |
mi-eye 3 needlescope with cannula, mi-tablet 3 |
Trice Medical, Inc. |
David Vancelette |
| K212378 |
08/02/2021 |
Arsenal Ankle Plating System |
Trilliant Surgical |
Sofia Middleton |
| K212472 |
08/06/2021 |
AgeJet |
Triworks Group SRL |
Elio Piero Berchicci |
| K212736 |
08/30/2021 |
Canady Flex RoboWrist |
US Medical Innovations, LLC |
Jerome Canady |
| K212552 |
08/13/2021 |
Correx Software |
Vilex LLC |
Louis Monaco |
| K212583 |
08/16/2021 |
AlignRT Plus |
Vision RT Ltd |
Jade Dunphy |
| K212763 |
08/31/2021 |
UniVit HE, UniVit UHS |
VisionCare Devices, LLC. |
Rick Morgan |
| K212678 |
08/24/2021 |
Viveve System, Viveve 2.0 System |
Viveve Medical, Inc. |
Kevin Robison |
| K212715 |
08/26/2021 |
Vy Spine ClariVy Cervical IBF System |
Vy Spine, LLC |
Jordan Hendrickson |
| K212742 |
08/30/2021 |
GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating |
Waldemar Link GmbH & Co. KG |
Lydia Ditter |
| K212473 |
08/06/2021 |
Welch Allyn Connex Central Station |
Welch Allyn, Inc. |
Megan Pellenz |
| K212416 |
08/03/2021 |
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 |
| K212722 |
08/27/2021 |
Nitrile Examination Gloves |
Wuhan Huirui Technology Co., Ltd |
Jing Li |
| K212713 |
08/26/2021 |
Air compression leg massager HY-1117A |
Xiamen High Top Electronic Technology Co., Ltd. |
Liangsan Zhao |
| K212574 |
08/16/2021 |
Surgical Face Mask |
Xiantao Deming Healthcare products Co., Ltd |
Gan Jing |
| K212718 |
08/27/2021 |
Surgical gowns |
Xiantao Dingcheng Non-Woven Product Co., Ltd |
Cheng Qin |
| K212578 |
08/16/2021 |
Nitrile disposable examination gloves |
Xingyu Medical Tech Co., Ltd. |
Cathrine Luan |
| K212735 |
08/30/2021 |
Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) |
Xingyu Medical Tech Co., Ltd. |
Cathrine Luan |
| K212707 |
08/26/2021 |
CoolSculpting Elite System |
Zeltiq Aesthetics, Inc. |
Vicky Chai |
| K212668 |
08/23/2021 |
Sclerotherapy Needle |
Zhejiang Chuangxiang Medical Technology Co., LTD. |
Lucius Long |
| K212669 |
08/23/2021 |
Single Use Hemoclip |
Zhejiang Chuangxiang Medical Technology Co., LTD. |
Lucius Long |
| K212512 |
08/10/2021 |
G7« Vivacit-E« Freedom« Constrained Liner |
Zimmer, Inc. |
Romil Sheth |
| K212622 |
08/18/2021 |
Zyter RPM |
Zyter, Inc. |
Lakshmi Narayana Babu |
