| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K193599 |
09/03/2020 |
BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair |
21st Century Scientific, Inc. |
RD Davidson |
| K200835 |
09/04/2020 |
3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad |
3M Company |
Hilary B. Hovde |
| K202256 |
09/09/2020 |
3Shape Implant Studio |
3Shape Medical A/S |
Jenny Axel |
| K201966 |
09/03/2020 |
7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array |
7D Surgical Inc. |
Daniel Zisind |
| K192665 |
09/15/2020 |
Accelerate Pheno System, Accelerate PhenoTest BC Kit |
Accelerate Diagnostics, Inc. |
Carrene Plummer |
| K193583 |
09/25/2020 |
Restrata« |
Acera Surgical, Inc. |
Lily Jeng |
| K201948 |
09/09/2020 |
AcroDTI Visualizer |
AcroViz Inc. |
Yung-Chin Hsu |
| K201194 |
09/08/2020 |
Acuity 200Ö (fluoroxyfocon A) Rigid Gas Permeable Contact Lens |
Acuity Polymers, Inc. |
James A. Bonafini |
| K201341 |
09/15/2020 |
AcQMap 3D Imaging and Mapping Catheter |
Acutus Medical, Inc. |
Karla Schaffner |
| K201494 |
09/17/2020 |
ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card |
Advin Biotech, Inc. |
Daniel Hsu |
| K202124 |
09/02/2020 |
Aesculap PAS-Port Proximal Anastomosis System |
Aesculap Inc. |
Sierra Mertz |
| K201631 |
09/14/2020 |
VersaWrap Nerve Protector |
Alafair Biosciences Inc |
Angela Mallery |
| K202448 |
09/22/2020 |
DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal |
Alcon Laboratories, Inc. |
Sherri Lakota |
| K193401 |
09/29/2020 |
Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants |
Altatec GmbH |
Reto Pusterla |
| K200051 |
09/25/2020 |
PUGGLE Enteral Feeding Pump and Feeding Set |
Amsino International Inc. |
Jane Gao |
| K201203 |
09/03/2020 |
Cliq Aspirator |
Anest Iwata Sparmax Co., Ltd. |
Lika Lo |
| K202347 |
09/15/2020 |
UNIFUSE Infusion System with Cooper Wire |
AngioDynamics, Inc. |
Brandon M. Brackett |
| K191639 |
09/11/2020 |
TK Insulin Syringe with/without Saftey Retractable Device |
Anhui Tiankang Medical Technology Co.,Ltd. |
Bai Baodong |
| K201517 |
09/04/2020 |
Plain Surgical Mask |
AOK Tooling Limited |
Francis Nithyananthan |
| K201552 |
09/02/2020 |
ApolloVue S100 Image System |
Apollo Medical Optics, Ltd. |
Chi-Hua Wu |
| K200123 |
09/22/2020 |
Accessories for the SixFix« Hexapod Fixator |
Arrowhead DE, LLC |
Thomas J. Twardzik |
| K201677 |
09/02/2020 |
Arthrex Mesh Plates |
Arthrex Inc. |
Rebecca R Homan |
| K201522 |
09/03/2020 |
Arthrex Syndesmosis TightRope XP Buttress Plate Implant System |
Arthrex Inc. |
Rebecca R. Homan |
| K201134 |
09/04/2020 |
Arthrex NanoScope System |
Arthrex, Inc. |
Heli F Chambi Infantas |
| K202252 |
09/08/2020 |
ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N), |
Asahi Intecc Co., Ltd. |
Yasuyuki Kawahara |
| K200641 |
09/03/2020 |
HaloGUARD Protective Disc with CHG |
ATTWILL Medical Solutions |
Attilio Di Fiore |
| K201779 |
09/11/2020 |
HotDog Temperature Management Controller |
Augustine Temperature Management |
Temi Ogunse |
| K201330 |
09/10/2020 |
Tigereye CTO-Crossing Catheter |
Avinger, Inc. |
Thomas Lawson |
| K200987 |
09/22/2020 |
LTJ Screws and Washer |
AzurMeds inc. |
Jean-Marie Berger |
| K201532 |
09/19/2020 |
B&J DVT Calf/Thigh Garments, Models 801/830 Series |
B & J Manufacturing Ltd. |
Billy Yu |
| K201539 |
09/09/2020 |
Keeogo Dermoskeleton System |
B-Temia Inc. |
Alexandre Jokic |
| K192452 |
09/03/2020 |
Lyograft |
B. Bruan Surgical, SA |
Pau Turon Dols |
| K201547 |
09/18/2020 |
B&J DVT Foot Garments, Models 820 Series |
B&J Manufacturing Ltd. |
Billy Yu |
| K200416 |
09/23/2020 |
Boston One Step Liquid Enzymatic Cleaner |
Bausch & Lomb Incorporated |
Pinal Shah |
| K201717 |
09/22/2020 |
BD Cathena Safety IV Catheter |
Becton Dickinson Infusion Therapy Systems Inc. |
Paul Holman |
| K201814 |
09/28/2020 |
BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, |
Becton, Dickinson and Company |
Niya Su |
| K193131 |
09/29/2020 |
BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle |
Becton, Dickinson and Company |
Murtaza Rana |
| K192538 |
09/04/2020 |
BD Syringe NRFit Lok and BD Syringe NRFit Slip |
Becton, Dickinson and Company |
Murtaza Rana |
| K202446 |
09/25/2020 |
BD Preset Syringe & BD A-Line Syringe |
Becton, Dickinson, and Company |
Avital Merl |
| K200462 |
09/02/2020 |
EtchPro Etching Gel |
Belport Company, Inc., Gingi-Pak |
Daniel Wang |
| K202008 |
09/10/2020 |
Disposable Vinyl Glove |
Best Care Trading Co., LTD |
Chongfeng Zhao |
| K201350 |
09/20/2020 |
CORVUS |
Best Nomos |
Vineet Gupta |
| K202566 |
09/30/2020 |
Wiygul Catheter |
Big Blue Biotech, Inc. |
Russ Olsen |
| K201467 |
09/21/2020 |
Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B |
Bioland Technology Ltd. |
Yiqing Feng |
| K193299 |
09/28/2020 |
VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 ╡g/mL) |
BioMerieux, Inc. |
Cherece L. Jones |
| K193546 |
09/25/2020 |
Distal Centralizers |
Biomet Inc. |
Jessica Andreshak |
| K192730 |
09/09/2020 |
CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV |
BioSystems S.A. |
Noelia Gil |
| K193618 |
09/02/2020 |
ExactechGPS System |
Blue Ortho |
Matthieu Coic |
| K201170 |
09/15/2020 |
Athletis PTA Balloon Dilatation Catheter |
Boston Scientific Corporation |
Jennifer Mrkvicka |
| K193424 |
09/01/2020 |
Resolution 360Ö ULTRA Clip |
Boston Scientific Corporation |
Elena Hennessey |
| K202406 |
09/16/2020 |
Butterfly iQ Ultrasound System |
Butterfly Network, Inc. |
Brian Sawin |
| K201819 |
09/29/2020 |
Cadwell Apollo System |
Cadwell Industries, Inc. |
Brad Weeks |
| K192822 |
09/09/2020 |
Benesta Hysteroscope |
Caldera Medical, Inc. |
Vicki Gail |
| K201273 |
09/25/2020 |
ImageSPECTRUM |
Canon Inc. |
Akira Hirai |
| K202210 |
09/22/2020 |
Vantage Orian 1.5T, MRT-1550, V6.0 |
Canon Medical Systems Corporation |
Paul Biggins |
| K201992 |
09/18/2020 |
Caption Guidance |
Caption Health |
Sam Surette |
| K201738 |
09/10/2020 |
SubNovii Advanced Plasma Technology |
Cartessa Aesthetics |
Gabe Lubin |
| K200313 |
09/14/2020 |
VIVO |
Catheter Precision, Inc. |
Steve Adler |
| K201895 |
09/29/2020 |
Cefaly Dual |
CEFALY Technology |
Rufus Kay Moberly |
| K201642 |
09/18/2020 |
Paragon Adult Maxi PMP Oxygenator with Tubing Pack |
Chalice Medical Ltd |
Stephen Horan |
| K201188 |
09/30/2020 |
Clear Guide SCENERGY |
Clear Guide Medical |
Jack Kent |
| K202235 |
09/03/2020 |
ArtPIX DRF |
CMT Medical Technologies Ltd |
Dror Wertman |
| K201859 |
09/11/2020 |
Porcine Mineral Collagen Composite Moldable |
Collagen Matrix, Inc. |
Gloria Zuclich |
| K202484 |
09/24/2020 |
Cordera Hip System |
Conformis, Inc. |
Nancy Giezen |
| K201849 |
09/17/2020 |
eNAT molecular collection and preservation medium |
Copan Italia S.p.A. |
Elena Simeonato |
| K201333 |
09/11/2020 |
SABER .035 PTA Dilatation Catheter |
Cordis Corporation |
Kyungyoon Kang |
| K192051 |
09/30/2020 |
THINQ |
CorticoMetrics LLC |
Nick Schmansky |
| K190561 |
09/04/2020 |
NICU V'02 |
COSMED Nordic ApS |
Peter Clemensen |
| K200916 |
09/01/2020 |
Patient Administration Set |
Cyclomedica Australia Pty Ltd |
Niamh Mc Aree |
| K193341 |
09/04/2020 |
iCTmotor (WL-1) |
Dentium Co., Ltd |
Sangwoo Lee |
| K200102 |
09/03/2020 |
MIS Dental Implant System |
Dentsply Sirona |
Karl Nittinger |
| K193405 |
09/02/2020 |
Simplant Digital Guide |
Dentsply Sirona |
Karl Nittinger |
| K200854 |
09/11/2020 |
DePuy PINNACLE Dual Mobility Liner |
DePuy Ireland UC |
Erin Combs |
| K201959 |
09/11/2020 |
DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System |
DePuy Synthes |
Stacey Bonnell |
| K202546 |
09/29/2020 |
LVivo Seamless |
DiA Imaging Analysis Ltd |
Michal Yaacobi |
| K200174 |
09/18/2020 |
DIA-ROOT BIO MTA |
Diadent Group International |
Kab Sun Lee |
| K202499 |
09/03/2020 |
Diamond Digital Sleep Orthotic (DDSO) |
Diamond Orthotic Laboratory |
Matt Rago |
| K202335 |
09/04/2020 |
Ambra ProViewer |
Dicom Grid, Inc, dba Ambra Health |
Patrice Nedelec |
| K192830 |
09/02/2020 |
Bright Temporary C&B |
DMP Dental Industry S.A. |
Dimitris Prantsidis |
| K201074 |
09/03/2020 |
Delta III Lithotripter |
Dornier MedTech America, Inc. |
John Hoffer |
| K202156 |
09/10/2020 |
DIAMOND-5A/6A/8A |
DRGEM Corporation |
Ki-Nam Yang |
| K202572 |
09/24/2020 |
GXR-Series Diagnostic X-Ray System |
DRGEM Corporation |
Ki-Nam Yang |
| K193212 |
09/10/2020 |
DSM Biomedical Dental Bone Graft Plus |
DSM Biomedical |
Susan Pileggi |
| K202477 |
09/24/2020 |
EndoGI S-Path Biliary Stent System |
Endo GI Medical |
Omri Naveh |
| K202685 |
09/28/2020 |
Eon Aligner |
Eon Dental Jordan LLC |
Fadi Samawi |
| K202394 |
09/16/2020 |
EOSedge |
EOS imaging |
Bernard Ismael |
| K201686 |
09/17/2020 |
GYNECARE TVTÖ System, GYNECARE TVTÖ with Abdominal Guides System, GYNECARE TVTÖ Introducer and Catheter Guide, GYNECARE TVT EXACTÖ Continence System and Trocar, GYNECARE TVTÖ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVOÖ Continence |
Ethicon Inc. |
Ariell Joiner |
| K193115 |
09/17/2020 |
EUROIMMUN Anti-BP230-CF ELISA (IgG) |
Euroimmun US, Inc. |
Kruti Shah |
| K201145 |
09/10/2020 |
X-Pac Expandable Lumbar Cage System |
Expanding Innovations, Inc. |
Mbithi Muthini |
| K182906 |
09/27/2020 |
Portable Mesh Nebulizer |
FeelLife Health Inc. |
Owen Zhang |
| K201928 |
09/30/2020 |
e-Ortho Shoulder Software |
FH Industrie |
Oscar Ramirez |
| K200948 |
09/11/2020 |
Fitbit ECG App |
Fitbit, Inc. |
Shruti Rajagopalan |
| K200530 |
09/11/2020 |
AMICUS Separator System |
Fresenius Kabi AG |
Kim Forch |
| K201207 |
09/18/2020 |
CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K192707 |
09/21/2020 |
Optiflux F180NR Dialyzer |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K202160 |
09/01/2020 |
Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System |
FUJIFILM SonoSite Inc. |
Anoush Frankian |
| K192524 |
09/04/2020 |
Lumipulse G CA15-3 |
Fujirebio Diagnostics, Inc. |
Kristin Maddaloni |
| K201103 |
09/25/2020 |
Xeleris V Processing and Review Systems |
GE Healthcare |
Alexandra Lifshits |
| K202238 |
09/04/2020 |
SIGNA Artist |
GE Healthcare (Tianjin) Company Limited |
Qiang Ding |
| K200708 |
09/09/2020 |
Vivid iq |
GE Medical Systems Ultrasound and |
Tracey Ortiz |
| K200852 |
09/18/2020 |
EchoPAC Software Only, EchoPAC Plug-In |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Tracey Ortiz |
| K200851 |
09/09/2020 |
Vivid T8, Vivid T9 |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Tracey Ortiz |
| K200469 |
09/16/2020 |
PAPAYA 3D Premium & PAPAYA 3D Premium Plus |
Genoray Co.,Ltd |
Hyunju Hwang |
| K202376 |
09/30/2020 |
EverLift Submucosal Lifting Agent |
Gi Supply, Inc. |
Erika Parry |
| K200343 |
09/14/2020 |
FusionFrame Ring Lock System |
GLW Medical Innovation |
Elijah Wreh |
| K193449 |
09/11/2020 |
Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) |
Guangdong Horigen Mother & Baby Products Co., Ltd |
Jun Deng |
| K182020 |
09/17/2020 |
Portable Electro-Stimulation Therapy Device |
Guangzhou Longest Science & Technology Co., Ltd. |
Xiaobing Luo |
| K202567 |
09/25/2020 |
Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx |
Guangzhou Wondfo Biotech Co., Ltd. |
Yi Mei |
| K192423 |
09/09/2020 |
MINT Product Family |
Hans Biomed Corporation |
Lucy Choi |
| K201252 |
09/09/2020 |
Spectralis HRA+OCT and variants |
Heidelberg Engineering GmbH |
Christoph Schoess |
| K193664 |
09/09/2020 |
SubQKath Catheter and Needle Set |
HK Surgical |
Gary Mocnik |
| DEN190039 |
09/17/2020 |
ToothWaveÖ |
Home Skinovations Ltd. |
Amit Goren |
| K192704 |
09/02/2020 |
Endofresh Digestive Endoscopy System |
HuiZhou Xzing Technology Co., Ltd. |
Yonglin Ni |
| K202354 |
09/08/2020 |
Surgical Mask-Model Number CW01 |
Hunan Heng Chang Pharmaceutical Co., Ltd. |
Tao Jingfeng |
| K201551 |
09/09/2020 |
KetoSens BT Blood B-Ketone Monitoring System |
i-SENS, Inc. |
Joon Ho Jung |
| K201570 |
09/11/2020 |
PF4 Enhanced assay |
Immucor GTI Diagnostics, Inc. |
Allison Stray |
| K200475 |
09/30/2020 |
IDS-iSYS Ostase BAP |
Immunodiagnostic Systems Ltd. |
Mick Henderson |
| K202182 |
09/02/2020 |
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing |
Imperative Care Inc. |
Jake Wolenberg |
| K193462 |
09/09/2020 |
ClotTriever Thrombectomy System |
Inari Medical |
Eben Gordon |
| K202479 |
09/23/2020 |
IBS Implant System |
InnoBioSurg Co., Ltd. |
Bo-Yeon Lim |
| K200212 |
09/03/2020 |
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled |
Innovative Health, LLC. |
Rick Ferreira |
| K201051 |
09/24/2020 |
Straumann BoneCeramic |
Institut Straumann AG |
Christelle Gerspach-Gasser |
| DEN190032 |
09/17/2020 |
HemosIL Liquid Anti-Xa |
Instrumentation Laboratory Co. |
Carol Marble |
| K201367 |
09/23/2020 |
FlareHawk TiHawk9 Interbody Fusion System |
Integrity Implants Inc. |
Lauren Kamer |
| K193409 |
09/09/2020 |
Vista Rinse, Vista Rinse Plus |
Inter-Med/Vista Dental Products |
Alex Johnson |
| K200503 |
09/02/2020 |
ATL Anchors |
International Life Sciences |
Tiffini Wittwer |
| K192717 |
09/28/2020 |
da Vinci SP Surgical System |
Intuitive Surgical Inc. |
Brandon Hansen |
| K200827 |
09/02/2020 |
LOCATOR R-Tx |
Ivory Super Holdco, Incp. |
Marysa Loustalot |
| K201656 |
09/15/2020 |
ARIX Elbow System |
Jeil Medical Corporation |
Sejin Ryu |
| K200027 |
09/09/2020 |
Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter |
Jiangsu Caina Medical Co., Ltd. |
Jianwei Pan |
| K200557 |
09/28/2020 |
Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) |
Jiangsu Shenli Medical Production Co., Ltd |
Tina Cai |
| K202277 |
09/25/2020 |
Surgical Face Mask |
Jiangxi 3L Medical Products Group Co., Ltd |
Ge Zhang |
| K201225 |
09/04/2020 |
Neodent Implant System - GM Helix Implants 7.0 |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Mariana Soares Hartmann |
| K201470 |
09/08/2020 |
Disposable Medical Face Mask |
JKH USA, LLC |
Bill Quanqin Dai |
| K201645 |
09/15/2020 |
Massage Compression Boots |
JKH USA, LLC |
Bill Quanqin Dai |
| K201591 |
09/03/2020 |
Flat Panel Detector |
KA Imaging Inc. |
Samuel To |
| K201135 |
09/01/2020 |
Image1 S CCU, Image1 S 4U Camera Head |
Karl Storz Endoscopy-America, Inc. |
Alita McElroy |
| K201538 |
09/18/2020 |
Life Spine SIMPACT Sacroiliac Joint Fixation System |
Life Spine Inc. |
Angela Batker |
| K201721 |
09/04/2020 |
TruLift Expandable Spacer System |
Life Spine Inc. |
Angela Batker |
| K202007 |
09/17/2020 |
LZI Oxycodone III Enzyme Immunoassay |
Lin-Zhi International, Inc. |
Bernice Lin |
| K201208 |
09/23/2020 |
Halo AF Detection System |
LIVMOR |
Ken Persen |
| K201770 |
09/24/2020 |
Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor |
Masimo Corporation |
Katelynn Kirby |
| K193439 |
09/04/2020 |
MEBO Wound Dressing |
MEBO Life Science Inc. |
Sidney Hong |
| K202022 |
09/18/2020 |
GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE) |
Medacta International SA |
Stefano Baj |
| K201673 |
09/18/2020 |
SMS Cementless Stem |
Medacta International SA |
Stefano Baj |
| K202176 |
09/03/2020 |
Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes |
Medical Components Inc. (Dba Medcomp) |
Courtney Nix |
| K202039 |
09/25/2020 |
Honorst Implant System |
Medimecca Co., Ltd. |
Seung Yoon Lee |
| K201506 |
09/11/2020 |
Talos«-C Cervical Intervertebral Body Fusion System, Talos«-C (HA) Cervical Intervertebral Body Fusion System |
Meditech Spine, LLC |
Bruce Dunaway |
| K201390 |
09/18/2020 |
Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) |
Medline Industires, Inc. |
Adam Ostrower |
| K201290 |
09/21/2020 |
Medline DeNovo 4Pro Electrical Stimulation Device |
Medline Industries Inc |
Leontyne Banks |
| K201829 |
09/09/2020 |
SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs) |
Medline Industries, Inc. |
Jennifer Mason |
| K201661 |
09/16/2020 |
Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set |
Medos International, SARL |
Nicole Aeschbacher |
| K201224 |
09/18/2020 |
Electrosurgical Generator and Accessories |
Medrange |
Helen Xie |
| K202328 |
09/08/2020 |
CD Horizon Spinal System |
Medtronic Sofamor Danek USA, Inc. |
Venkata Sandeep Manne |
| K201407 |
09/10/2020 |
CD HorizonÖ Spinal System |
Medtronic Sofamor Danek USA, INC. |
Usman Rashid |
| K201765 |
09/02/2020 |
SmartHDM-510 System |
Mesa Laboratories, Inc. |
Jamie Louie |
| K202318 |
09/14/2020 |
Marathon Flow Directed Micro Catheter |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Elizabeth Campion |
| K193340 |
09/11/2020 |
GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System |
MicroTech Medical, Inc. |
Dore Mark |
| K202297 |
09/11/2020 |
Aline Ablation Intelligence |
Mirada Medical Ltd |
David Clafton |
| K201854 |
09/01/2020 |
CAPOGEN Laser Cap |
Nature Incredible Inc |
John Lee |
| K201769 |
09/03/2020 |
Cavetto [MAX] Cervical Cage System |
NeuroStructures, Inc. |
Moti Altarac |
| K200115 |
09/24/2020 |
Cavetto-SA Cervical Cage System |
NeuroStructures, Inc. |
Moti Altarac |
| K201221 |
09/28/2020 |
Electrosurgical Generator |
New Deantronics Taiwan Ltd |
Jane Liu |
| K202192 |
09/17/2020 |
STRUXXURE«-L and STRUXXURE«-A Plate System |
Nexxt Spine LLC |
Andy Elsbury |
| K200430 |
09/16/2020 |
Precice« Ankle Salvage System |
NuVasive Specialized Orthopedics, Inc. |
Ivanna Lopez |
| K201820 |
09/25/2020 |
NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody |
NuVasive, Incorporated |
Daniela Mahan |
| K200843 |
09/22/2020 |
Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs |
O&M Halyard, Inc. |
Steven Dowdley |
| K190798 |
09/18/2020 |
LaborViewÖ LV1000 Wireless Electrode System |
OBMedical Company |
Mark A. Samuels |
| K201841 |
09/06/2020 |
EyeBOX |
Oculogica, Inc. |
Rosina Samadani |
| K201920 |
09/01/2020 |
Endoscope Reprocessor OER-Elite |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K201013 |
09/18/2020 |
Optixon 1-Day |
Optixon Inc. |
Oh Jeong Ju |
| K200516 |
09/02/2020 |
OCT-Camera ID 21101A3 |
OptoMedical Technologies GmbH |
Julia Behrens |
| K201664 |
09/15/2020 |
FIREBIRD SI Fusion System |
Orthofix Inc. |
Jacki Koch |
| K192653 |
09/09/2020 |
Perseus |
Orthokey Italia S.r.l. |
Cristiano Paggetti |
| K200812 |
09/02/2020 |
VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter |
Philips Image Guided Therapy Corporation |
Rand Daoud |
| K191738 |
09/29/2020 |
PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph |
Philips Medical Systems |
Hong Zhu |
| K202564 |
09/30/2020 |
DigitalDiagnost C90 |
Philips Medical Systems DMC GmbH |
Ming Xiao |
| K192137 |
09/11/2020 |
IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 |
Philips Medizin Systeme Boeblingen GmbH |
Stefan Breuer |
| K200603 |
09/20/2020 |
AAA Model |
Philips Ultrasound, Inc |
Hebe Sun |
| K201665 |
09/15/2020 |
Collaboration Live |
Philips Ultrasound, Inc. |
Colin S. Jacob |
| K202216 |
09/02/2020 |
EPIQ Series Diagnostic Ultrasound Systems |
Philips Ultrasound, Inc. |
Colin S. Jacob |
| K202542 |
09/30/2020 |
Allura Vaginal Stent |
PMT Corporation |
Matt Cree |
| K202286 |
09/16/2020 |
Tulsa-Pro System |
Profound Medical Inc |
Goldy Singh |
| K201774 |
09/16/2020 |
Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs |
PT. Medisafe Technologies |
Sajeev Joseph |
| K201691 |
09/17/2020 |
Single-Use Surgical Mask With Ear Loop |
Qiqihar Hengxin Medical Supplies, Ltd. |
Sihui Xiong |
| K202169 |
09/02/2020 |
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 |
Qura S.r.l |
Raffaella Tommasini |
| K201260 |
09/24/2020 |
Dermal Cooling System |
R2 Technologies, Inc. |
Ragan Reppond |
| K202287 |
09/18/2020 |
Ran-Flex-B Bone Marrow Aspiration Needle |
Ranfac Corporation |
Eric Kreuz |
| K200569 |
09/24/2020 |
RayStation |
RaySearch Laboratories AB (publ) |
Viktoria Hammarstedt |
| K201746 |
09/18/2020 |
Tempus Pro Patient Monitor |
Remote Diagnostic Technologies Limited |
Timothy Bubb |
| K201439 |
09/25/2020 |
Ventilator, Non-continuous (Respirator) |
Respironics, Inc. |
Jennifer Richardson |
| K202569 |
09/23/2020 |
Responsive Arthroscopy Interference Screw System |
Responsive Arthroscopy LLC |
Douglas Kohrs |
| K202153 |
09/09/2020 |
Responsive Arthroscopy Suture Anchor System |
Responsive Arthroscopy LLC |
Douglas Korhs |
| K200135 |
09/10/2020 |
RGK Daily Range Wheelchairs |
RGK Wheelchairs, Ltd. |
Devin McElroy |
| K201682 |
09/28/2020 |
RIST Radial Access Catheter |
RIST Neurovascular, Inc. |
Marianne Grumwaldt |
| K202399 |
09/18/2020 |
OrthoButton FL |
Riverpoint Medical |
Amanda Cole |
| K202242 |
09/10/2020 |
HS Fiber |
Riverpoint Medical, LLC |
Edwin Anderson |
| K201790 |
09/29/2020 |
Dual Cure Resin Cement |
Rizhao HuGe Biomaterials Company, Ltd. |
Maggie Zheng |
| K201787 |
09/25/2020 |
Light Cure Dental Adhesive |
Rizhao HuGe Biomaterials Company, Ltd. |
Maggie Zheng |
| K202215 |
09/02/2020 |
cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit |
Roche Molecular Systems, Inc. |
Rita Hoady |
| K201909 |
09/10/2020 |
RxSight Contact Lens |
RxSight, Inc. |
Maureen O'Connell |
| K201073 |
09/18/2020 |
Seaspine WaveForm C Interbody System |
SeaSpine Orthopedics Corporation |
Aly Alvarez |
| K201646 |
09/14/2020 |
Shoreline ACS (Anterior Cervical System) |
SeaSpine Orthopedics Corporation |
Alicia McArthur |
| K201369 |
09/16/2020 |
AVA (Augmented Vascular Analysis) |
See-Mode Technologies Pte. Ltd. |
Sadaf Monajemi |
| K193655 |
09/04/2020 |
MSLS6QF TENS/PMS Device |
Self Doctor Care, LLC |
Wei Wei |
| K192890 |
09/18/2020 |
SentEP |
SentiAR, Inc |
Berk Tas |
| K201684 |
09/24/2020 |
A-Silicone for Bite Registration |
Shandong Huge Dental Material Corporation |
Maggie Zheng |
| K201537 |
09/04/2020 |
Protective Face Mask for Medical Use |
Shandong Shengquan New Material Co., Ltd. |
Xiumei Zhang |
| K201731 |
09/10/2020 |
Diode Laser Body Sculpture System |
Shanghai Apolo Medical Technology Co., Ltd. |
Felix Li |
| K200414 |
09/23/2020 |
Pulse Oximeter |
Shenzhen Aeon Technology Co., Ltd. |
Xie Hua |
| K201211 |
09/03/2020 |
3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+ |
Shenzhen Beacon Display Technology Co., Ltd. |
Fu Ailing |
| K191982 |
09/25/2020 |
Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) |
Shenzhen Kentro Medical Electronics Co., Ltd |
Zewu Zhang |
| K193276 |
09/23/2020 |
Nerve and Muscle Stimulator |
Shenzhen XFT Medical Limited |
Julia Ye |
| K193657 |
09/12/2020 |
Disposable Enteral Feeding Syringe with Enfit Connector |
Shinva Ande Healthcare Apparatus Co., Ltd. |
Xiaolei Tian |
| K202014 |
09/08/2020 |
Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit |
Siemens Medical Solutions USA, Inc. |
Andrew Turner |
| K201278 |
09/21/2020 |
World Hip Stem, World Cup, World Liner |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K192375 |
09/18/2020 |
Intellifuse Administration and Intellifuse Blood Administration Sets |
Smiths Medical ASD, Inc. |
Wendy Hills |
| K200862 |
09/14/2020 |
Feelix Stethoscope |
Sonavi Labs, Inc. |
Ian McLane |
| DEN200010 |
09/18/2020 |
Spineology Interbody Fusion System |
Spineology, Inc. |
Andrew Adams |
| K202197 |
09/04/2020 |
Astopad Patient Warming System |
Stihler Electronic GmbH |
Jens- Peter Weege |
| K201450 |
09/10/2020 |
Straight T Clear Dental Aligner |
Straight T, Inc. |
Minh Trinh |
| K202522 |
09/25/2020 |
Synchro SELECT Guidewire |
STRYKER NEUROVASCULAR |
Hailey Hinkle |
| K201756 |
09/25/2020 |
Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent |
Stryker Sustainability Solutions |
Scott English |
| K201900 |
09/03/2020 |
3D GraftRasp System |
SurGenTec |
Andrew Shoup |
| K192814 |
09/21/2020 |
Pounce Thrombus Retrieval System |
Surmodics, Inc. |
Amy Yanta |
| K192702 |
09/18/2020 |
DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional |
Synthes (USA) Products LLC |
Jeffrey Krawiec |
| K201944 |
09/10/2020 |
DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) |
Synthes (USA) Products, LLC |
Prem Pisupati |
| K201346 |
09/23/2020 |
DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm |
Synthes (USA) Products, LLC |
Keith Knapp |
| K201336 |
09/03/2020 |
DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm |
Synthes (USA) Products, LLC |
Pol Fort Grebol |
| K201578 |
09/09/2020 |
DePuy Synthes Variable Angle Locking Patella Plating System |
Synthes (USA) Products, LLC |
Enrico Gindro |
| DEN200002 |
09/24/2020 |
Tangible Boost |
Tangible Science, Inc. |
Kelly Mabry |
| K200724 |
09/01/2020 |
VICTUS Femtosecond Laser Platform |
Technolas Perfect Vision GmbH |
Friedrich Moritz |
| K200076 |
09/25/2020 |
Breezing Med |
TF Health Co. |
Erik Herrmann |
| K201277 |
09/02/2020 |
Oral-B Dry Mouth Oral Rinse |
The Procter & Gamble Company |
Michael A Kaminski |
| K192111 |
09/03/2020 |
Biodegradable Nitrile Examination Powder Free Glove, Green |
Top Glove SDN BHD |
Noor Akilah Saidin |
| K201315 |
09/11/2020 |
PERFORM Humeral System û Stem |
Tornier, Inc. |
Renee Stoffel |
| K202227 |
09/14/2020 |
ArtusÖ cervical plate system |
Ulrich GmbH & Co. KG |
Christoph Ulrich |
| K200845 |
09/10/2020 |
Navigation Module of the Momentum System |
ulrich medical USA |
Hans Stover |
| K201795 |
09/28/2020 |
Transcend |
Ultradent Product, Inc. |
Karen Kakunes |
| K202463 |
09/18/2020 |
Disposable Surgical Mask |
Unisources Group LLC |
Henry Shen |
| K202187 |
09/11/2020 |
FLEX Vessel Prep System |
VentureMed Group, Inc. |
Jill Schweiger |
| K202143 |
09/11/2020 |
Dynex Micro |
Vilex, LLC |
Joyce Thacker |
| K200833 |
09/02/2020 |
RX-1 Rhythm Express Remote Cardiac Monitoring System |
VivaQuant Inc. |
Brian Brockway |
| K201090 |
09/09/2020 |
Structur CAD |
VOCO GmbH |
M. TH. Plaumann |
| K202543 |
09/28/2020 |
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip |
Volcano Corporation |
Patrick Juarez |
| K201298 |
09/16/2020 |
VX1 |
Volta Medical |
ThΘophile Mohr Durdez |
| K192077 |
09/30/2020 |
Tua Face Fitness / Tua Trend Face |
Vupiesse S.R.L |
Marco Paolizzi |
| K193368 |
09/18/2020 |
Smart Correction System |
WishBone Medical, Inc. |
Mary Wentorf |
| K202360 |
09/16/2020 |
Ziehm Vision RFD 3D |
Ziehm Imaging GmbH |
Stefan Fidler |
