| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K192550 |
06/05/2020 |
3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H |
3M Company |
Hilary B Hovde |
| K200536 |
06/01/2020 |
3MTM AttestTM Rapid 5 Steam-Plus Test Pack |
3M Complany |
Mary Fretland |
| K200721 |
06/03/2020 |
Agilis HisPro Steerable Catheter With Electrodes |
Abbott (St. Jude Medical) |
Winnie Yik |
| K193371 |
06/12/2020 |
FreeStyle Libre 2 Flash Glucose Monitoring System |
Abbott Diabetes Care Inc. |
Naveen Thuramalla |
| K201148 |
06/26/2020 |
EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License |
Abbott Medical |
Alyssa Timmers |
| K201181 |
06/26/2020 |
EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System |
Abbott Medical |
Charlie Pickrell |
| K201116 |
06/15/2020 |
Abiomed 23 Fr Sheath |
Abiomed Inc. |
Sandy Fowler |
| K201220 |
06/17/2020 |
Aerus Medical Guardian,model F170A |
Aerus Medical LLC |
Andrew Eide |
| K193298 |
06/19/2020 |
BriefCase |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| DEN200026 |
06/15/2020 |
EndeavorRx |
Akili Interactive Labs Inc. |
Scott Kellogg |
| K200322 |
06/02/2020 |
Altus Spine Pedicle Screw System |
Altus Partners, LLC |
Mark Melton |
| K200532 |
06/02/2020 |
StarPore |
Anatomics Pty, Ltd. |
Christine Scifert |
| K192864 |
06/01/2020 |
UNI*FUSE Infusion System with Cooper Wire |
Angiodynamics, Inc. |
Brandon M. Brackett |
| K200671 |
06/19/2020 |
Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for |
Ansell Healthcare Products LLC |
Donald Cronk |
| K201212 |
06/05/2020 |
Voyant Open Fusion Device |
Applied Medical Resources Corp. |
Sherif Nakhla |
| K200268 |
06/03/2020 |
HaloÖ Single-Loop Snare Kit |
Argon Medical Devices, Inc. |
Ana Jimenez-Hughes |
| K200068 |
06/29/2020 |
Arthrex DynaNite K-Wire |
Arthrex Inc. |
Rebecca R Homan |
| K200057 |
06/04/2020 |
bioli lOL Delivery System |
AST Products, Inc. |
William Lee |
| K192003 |
06/10/2020 |
Auxein Nailing System |
Auxein Medical Private Limited |
Rahul Luthra |
| K200855 |
06/24/2020 |
CINA |
AVICENNA.AI |
Cyril Di Grandi |
| K201313 |
06/15/2020 |
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) |
Aziyo Biologics, Inc. |
Wendy Perreault |
| K200528 |
06/02/2020 |
Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism |
Bausch + Lomb, Incorporated |
Barbara Klube-Falso |
| K201464 |
06/30/2020 |
Altapore MIS |
Baxter Healthcare Corporation |
Phillip Romei |
| K201288 |
06/12/2020 |
ExpanSure Large Access Transseptal Dilator |
Baylis Medical Company Inc. |
May Tsai |
| K201423 |
06/29/2020 |
MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 ╡g/mL) |
Beckman Coulter, Inc. |
Elaine Duncan |
| K201668 |
06/23/2020 |
VarseoSmile Crown plus |
BEGO Bremer GoldschlΣgerei Wilh. Herbst GmbH & Co. KG |
Tanja Goetz |
| K193477 |
06/24/2020 |
Nd: YAG Laser Therapy Systems |
Beijing Kes Biology Technology Co., Ltd. |
Wei Meng Meng |
| K200042 |
06/09/2020 |
CO2 Laser System |
Beijing Superlaser Technology Co., Ltd. |
Shi Shuang |
| K200582 |
06/25/2020 |
Bendit2.7 Steerable Microcatheter |
Bend It Technologies Ltd. |
Simona Beilin-Nissan |
| K192033 |
06/09/2020 |
Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip |
Bennett Jacoby, DDS, MS, Inc. |
Bennett Jacoby |
| K192274 |
06/18/2020 |
BV Dental Implant System |
Bio Concept Co., Ltd |
Xiaodong Dai |
| K193632 |
06/30/2020 |
LassoStar Circular Mapping Catheter |
Biosense Webster, Inc. |
Michelle Wheeler |
| K193513 |
06/18/2020 |
SIGNAFUSE Bioactive Bone Graft |
Bioventus |
Kim Patterson Kelly |
| K201022 |
06/12/2020 |
REAL INTELLIGENCE CORI (CORI) |
Blue Belt Technologies, Inc. |
Corrine Herlinger |
| K193473 |
06/26/2020 |
LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US |
Boston Scientific Corporation |
Melissa Klamerus |
| K193307 |
06/02/2020 |
HIP7 |
Brainlab AG |
Cherita James |
| K200980 |
06/11/2020 |
Auto 3D Bladder Volume Tool |
Butterfly Network, Inc. |
Brian Sawin |
| K192549 |
06/22/2020 |
Byteflies Kit |
Byteflies NV |
Benjamin Vandendriessche |
| K200627 |
06/22/2020 |
GlidePath 10F Long-Term Dialysis Catheter |
C R Bard, Inc |
Joan Bergstrom |
| K193021 |
06/03/2020 |
Vantage Orian 1.5T, MRT-1550, V6.0 |
Canon Medical Systems Corporation |
Paul Biggins |
| K200883 |
06/04/2020 |
CarboClear« Cervical Plate System |
Carbofix Orthopedics Ltd. |
Yael Rubin |
| K201373 |
06/26/2020 |
DRX-Compass |
Carestream Health, Inc |
Duane Gutowski |
| K193376 |
06/15/2020 |
Visalis V500, Visalis S500 |
Carl Zeiss Meditec AG |
Katrin Faber |
| K200602 |
06/03/2020 |
Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant |
CC Wellness LLC |
Marlent Perez |
| K191276 |
06/30/2020 |
Dental Electrical Motor iRoot Pro |
ChangZhou BoMedent Medical Technology Co., Ltd. |
Chen YuLong |
| K200506 |
06/03/2020 |
DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader |
Chembio Diagnostic Systems |
Louise Muscat Sigismondi |
| K191461 |
06/05/2020 |
Exofin Fusion Skin Closure System |
Chemence Medical, Inc. |
Kenneth N Broadley |
| K200445 |
06/24/2020 |
The C100 Contactless Breathing Monitor |
Circadia Technologies Ltd. |
Michal Maslik |
| K201007 |
06/11/2020 |
In-Ka Ureteral Balloon Dilatation Catheter |
Coloplast Corp |
Cori Ragan |
| K192954 |
06/19/2020 |
Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl |
Comfort Rubber Gloves Industries Sdn. Bhd. |
Ng Kok Howe |
| K201337 |
06/18/2020 |
InPen System |
Companion Medical, Inc. |
Jasper Benke |
| K201023 |
06/16/2020 |
iTotal« Identity Posterior Stabilized Knee Replacement System |
Conformis, Inc. |
Nancy Giezen |
| K200540 |
06/01/2020 |
BRAINSTREAM Disposable Deep Cup EEG Electrodes |
CONMED Corporation |
Tessa Hopsicker |
| K200663 |
06/24/2020 |
ControlRad Trace Model 9 |
ControlRad, Inc. |
Chris Fair |
| K200087 |
06/15/2020 |
F3D Cervical Stand-Alone Interbody Fusion System |
CoreLink, LLC |
Steven Mounts |
| K200888 |
06/27/2020 |
OMNIBotics Knee System |
Corin Ltd. |
Christina Rovaldi |
| K193042 |
06/26/2020 |
Optimized Positioning System (OPS) ReView |
Corin USA |
Lucinda Gerber |
| K193077 |
06/01/2020 |
Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff |
Covidien |
Stacy Barton |
| K201063 |
06/09/2020 |
DANNIK Disposable Monopolar Laparoscopic Instrument |
Dannik |
Olga Haberlad |
| K201247 |
06/10/2020 |
Intraoral Sensor |
Dentium Co., Ltd (ICT Branch) |
Sangwoo Lee |
| K201140 |
06/22/2020 |
Axeos |
Dentsply Sirona |
Karl J. Nittinger |
| K201347 |
06/18/2020 |
DePuy ATTUNEÖáTotal Knee System |
DePuy Orthopaedics, Inc. |
Karen Mahoney |
| K193540 |
06/16/2020 |
TRUMATCH Personalized Solutions |
DePuy Orthopaedics, Inc. |
Erin Combs |
| K200232 |
06/23/2020 |
LVivo Software Application |
DiA Imaging Analysis Ltd |
Michal Yaacobi |
| K200175 |
06/25/2020 |
DIA-ROOT BIO Sealer |
Diadent Group International |
Kab Sun Lee |
| K192337 |
06/22/2020 |
Zeroveno |
Dimedi Co., Ltd. |
Nam Youn |
| K200616 |
06/11/2020 |
E>EyeC |
E-SWIN |
Emeric OBIN |
| K193379 |
06/12/2020 |
Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe |
Edwards Lifesciences, LLC |
Wendy Vera Gonzalez |
| K200909 |
06/12/2020 |
Hemo Control (optional Add Pack Hemo Control DM) |
EKF-diagnostic GmbH |
Andrew J. Rutter |
| K200574 |
06/19/2020 |
EksoNR |
Ekso Bionics, Inc. |
Jack Peurach |
| K193226 |
06/03/2020 |
AltiVate Anatomic Canal-Sparing (CS) Shoulder |
Encore Medical, L.P |
Teffany Hutto |
| K193600 |
06/26/2020 |
EndoGI Biliary Stent System |
EndoGI Medical, Ltd. |
Omri Naveh |
| K200107 |
06/05/2020 |
epoc Blood Analysis System |
Epocal Inc. |
Amanda Barriage |
| K200420 |
06/29/2020 |
Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green |
Ethicon Endo-Surgery, LLC |
Nathan Anderson |
| K193555 |
06/04/2020 |
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate |
Ever Global (Vietnam) Enterprise Corp |
Jerry Lin |
| K201430 |
06/20/2020 |
InFrameÖ Cannulated Fixation System |
ExsoMed, Corp. |
Jung Chang |
| K190637 |
06/19/2020 |
Fit & Brilliant Dental Implant System |
F&B Technology Co., Ltd. |
J H An |
| K200089 |
06/02/2020 |
F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Med |
Fisher & Paykel Healthcare Ltd. |
Reena Daken |
| K200698 |
06/29/2020 |
Somnera System |
FRESCA Medical Inc. |
Mary Lou Mooney |
| K200481 |
06/18/2020 |
Andorate Biopsy Valve, Andorate Biopsy Irrigator |
GA Health Company Limited |
Cindy Ye |
| K200495 |
06/24/2020 |
Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve |
GA Health Company Limited |
Cindy Ye |
| K200998 |
06/11/2020 |
Versana Active |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Tracey Ortiz |
| K191923 |
06/20/2020 |
EverLift Submucosal Lifting Agent |
GI Supply |
Erika Parry |
| K201107 |
06/22/2020 |
Opera Lebody (Gold), Opera Lebody (Zafiro) |
GTG Wellness Co., Ltd. |
Sang Won Jun |
| K192201 |
06/12/2020 |
Electrical Stimulator System |
Gymmax Technology Shenzen Co., Ltd. |
Benson Wang |
| K200134 |
06/01/2020 |
Jimushi Sterile Urethral Catheter for single use |
Hangzhou Jimushi Meditech Co., Ltd. |
Fenlong Wu |
| K200897 |
06/01/2020 |
Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) |
Hartalega SDN. BHD. |
Kuan Kam Hon |
| K200521 |
06/12/2020 |
Full Automatic(NIBP) Blood Pressure Monitor |
Health & Life Co., Ltd |
Simon Lee |
| K192028 |
06/25/2020 |
Yumizen C1200 CRP |
Horiba ABX SAS |
Caroline Ferrer |
| K193525 |
06/26/2020 |
Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M |
Horiba ABX SAS |
Caroline Ferrer |
| K200975 |
06/24/2020 |
Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum |
Huntleigh Healthcare Limited |
Steve Monks |
| K200825 |
06/26/2020 |
NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense |
Hycor Biomedical |
Irene M. Guzman |
| K200736 |
06/26/2020 |
Stardust Med |
I.T.S. Group S.R.L. |
Claudio Bellina |
| K200295 |
06/25/2020 |
IlluminOss Bone Stabilization System |
IlluminOss Medical, Inc. |
Robert Rabiner |
| K181813 |
06/09/2020 |
ImmersiveView Surgical Plan (IVSP«) |
ImmersiveTouch |
P. Pat Banerjee |
| K201311 |
06/18/2020 |
PF4 IgG assay |
Immucor GTI Diagnostics, Inc. |
Allison Stray |
| K192221 |
06/25/2020 |
Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts |
Implant Direct Sybron Manufacturing, LLC |
Reina Choi |
| K200265 |
06/30/2020 |
Surgical Drills |
Implant Direct Sybron Manufacturing, LLC |
Reina Choi |
| K200424 |
06/18/2020 |
Giotto Class (Models - 3000X-YY and 4000X-YY) |
IMS GIOTTO S.p.A. |
Antonella Rossi |
| K200753 |
06/09/2020 |
IBS Implant System II |
InnoBioSurg Co., Ltd. |
Bo-Yeon Lim |
| K200874 |
06/30/2020 |
TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End |
Innovasis, Inc. |
Marshall McCarty |
| K201507 |
06/29/2020 |
Cadence Total Ankle System |
Integra Lifesciences Corporation |
Cassidy Lemkau |
| K200774 |
06/23/2020 |
CUSA Clarity Ultrasonic Surgical Aspirator System |
Integra LifeSciences Corporation |
Alexandra Wells |
| K201146 |
06/26/2020 |
Ion Endoluminal System |
Intuitive Surgical, Inc. |
Jennifer Siu |
| K200760 |
06/26/2020 |
Rapid ASPECTS |
iSchemaView Inc. |
Jim Rosa |
| K182081 |
06/26/2020 |
JDentalCare Implant System JDIcon |
J Dental Care S.r.l. |
Giacomo Grandi |
| K193234 |
06/18/2020 |
NUVO IF Implant System |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Luiza Vaccari Toppel |
| K201096 |
06/23/2020 |
CO2mbiLED |
Karl Storz Endoscopy America, Inc. |
Winkie Wong |
| K192963 |
06/19/2020 |
Kogent Torus Ultrasonic Aspirator |
Katalyst Surgical, LLC |
Meryl Koch Wilhelm |
| K192778 |
06/30/2020 |
Kinos Axiom Total Ankle System |
Kinos Medical |
Brian Garvey |
| K193288 |
06/16/2020 |
Koya Ripple |
Koya, Inc. |
Andy Doraiswamy |
| K200756 |
06/12/2020 |
Kubtec Mozart Supra |
KUB Technologies, Inc. |
Chester Lowe |
| K200907 |
06/03/2020 |
Thales 3D Mr Scanner |
LAP GmbH Laser Applikationen |
Martin Pfabel |
| K200614 |
06/25/2020 |
FiteBac Antimicrobial Cavity Cleanser |
Largent Health, LLC |
Kirk Kimmerling |
| K201223 |
06/04/2020 |
LZI Tramadol Enzyme Immunoassay |
Lin-Zhi International, Inc. |
Bernice Lin |
| K200277 |
06/04/2020 |
Livongo Blood Glucose Monitoring System (BG1000) |
Livongo Health, Inc. |
Jacob Gendler |
| K200875 |
06/17/2020 |
ArtiSential Laparoscopic Instruments - Electrodes |
LivsMed Inc. |
Dong Wook Lee |
| K200389 |
06/17/2020 |
INOmax DSIR Plus |
Mallinckrodt Manufacturing LLC |
David Trueblood |
| K192604 |
06/18/2020 |
Servo-air 4.0 Ventilator System |
Maquet Critica Care AB |
David Ardanius |
| K200834 |
06/25/2020 |
Lever Action Plate System |
McGinley Orthpaedic Innovations, LLC |
Adam M. Johnson |
| K200508 |
06/15/2020 |
Pump In Style |
Medela LLC |
PJ Pasia |
| K191443 |
06/26/2020 |
MSDI Dental Implants System |
Medical Systems and Devices International Ltd. |
Iman Khorshid |
| K201319 |
06/17/2020 |
Medline UNITE Jones Fracture Screw System |
Medline Industires, Inc. |
Jennifer Mason |
| K200356 |
06/11/2020 |
MEDO ARIA |
Medo.ai |
Dornoosh Zonoobi |
| K200949 |
06/04/2020 |
HEALIX ADVANCE Anchor with DYNATAPE Suture |
Medos International SARL |
Elizabeth Messana |
| K200514 |
06/03/2020 |
Cardioblate Gemini-s Surgical Ablation Device |
Medtronic |
Rahul Shah |
| K201327 |
06/18/2020 |
NavLock Trackers |
Medtronic Navigation |
Taylor Gold West |
| K201175 |
06/03/2020 |
StealthStation Cranial Software v1.3.0 |
Medtronic Navigation Inc. |
Amelia Striegel |
| K200723 |
06/26/2020 |
StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) |
Medtronic Navigation Inc. |
Carey Brenner |
| K191491 |
06/05/2020 |
EZ-Cover |
MedXPress.Pro |
Katherine Hughey |
| K200283 |
06/18/2020 |
Medussa-PL Cage |
Medyssey USA, Inc. |
Shawn Kim |
| K200250 |
06/26/2020 |
Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor |
Megadyne Medical Products, Inc. |
Sharon Sussex |
| K193399 |
06/17/2020 |
Miru 1day UpSide (midafilcon A) |
Menicon Co., Ltd. |
Li Haosheng |
| K200967 |
06/06/2020 |
mCare(R) Powder Free Nitrile Orange Examination Gloves |
Mercator Medical (Thailand) LTD. |
Dariusz Jan Krezymon |
| K200297 |
06/18/2020 |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor |
Microlife Intellectual Property GmbH |
Gerhard Frick |
| K200685 |
06/11/2020 |
RIGEL 3DR Anterior Cervical Interbody Fusion System |
MiRus, LLC |
Jordan Bauman |
| K192542 |
06/16/2020 |
Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde |
Modern Medical Equipment Manufacturing, LTD. |
Jerry Cheung |
| K201414 |
06/25/2020 |
Rotium Bioresorbable Wick |
Nanofiber Solutions, LLC |
Jason Chakroff |
| K201117 |
06/11/2020 |
Gold Anchor |
Naslund Medical AB |
Tomas Naslund |
| K193094 |
06/10/2020 |
Naviswiss Hip Navigation System |
Naviswiss AG |
Jan Stifter |
| K201101 |
06/02/2020 |
1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil |
NeoCoil, LLC |
Katie Gonzalez |
| K200441 |
06/05/2020 |
UroLift Advanced Tissue Control (ATC) System |
NeoTract, Inc. |
Brian Gall |
| K200840 |
06/26/2020 |
DuoHex CH Cannulated Hammertoe System |
Nextremity Solutions, Inc. |
Elise Fox |
| K200471 |
06/19/2020 |
Infrared Thermometer Model Number RN-60A,RN-60B |
Ningbo Ranor Medical Science & Technology Co., Ltd. |
Emma Hu |
| K192900 |
06/29/2020 |
H500 Multi-Sensing Oximetry System |
Nonin Medical, Inc. |
Kim E Aves |
| K200195 |
06/22/2020 |
NES Reprocessed Visions PV .014P RX Digital IVUS Catheter |
Northeast Scientific, Inc. |
Matthew Farley |
| K201151 |
06/22/2020 |
O-Mec 690 Series Laparoscopes |
OMEC Medical, Inc. |
Claire Nippress |
| K193620 |
06/18/2020 |
OptoMonitor 3 |
Opsens Inc. |
Marc Chaunet |
| K200815 |
06/25/2020 |
VitriGuard |
ORIGIO a/s |
Christine Kupchick |
| K200892 |
06/18/2020 |
Harvey(R) Surgical Assistant |
OrthAlign Inc |
Karyl Haskell |
| K201481 |
06/15/2020 |
Centurion POCT System |
Orthofix Inc. |
Jacki Koch |
| K200615 |
06/05/2020 |
Signature ONE System |
Orthosoft Inc. (d/b/a Zimmer CAS) |
Sankalp Dere |
| K201503 |
06/29/2020 |
Edge Air(1417) Digital Flat Panel X-ray Detector |
Osko, Inc. |
Richard Jeon |
| K192310 |
06/03/2020 |
Flap Fixator, Burr Hole Cover |
Ossaware Biotech Co., Ltd. |
Meng Feng Huang |
| K200684 |
06/02/2020 |
gastroduodenal FTRD Set |
Ovesco Endoscopy AG |
Marc O. Schurr |
| K192710 |
06/24/2020 |
The Simple Locking Intramedullary (Slim) System |
Pega Medical Inc. |
Ariel R. Dujovne |
| K201271 |
06/11/2020 |
Benchmark BMX96 Access System |
Penumbra, Inc. |
Matthew Benenati |
| K200911 |
06/02/2020 |
MIRA Adapter |
Phakos |
Olivier Aumaitre |
| K200974 |
06/03/2020 |
QLAB Advanced Quantification Software |
Philips Healthcare |
Travis Catania |
| K193415 |
06/11/2020 |
physIQ Heart Rhythm and Respiration Module |
physIQ, Inc |
George Allen Hides |
| K200095 |
06/26/2020 |
Streamline Navigated Instruments |
Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. |
Kurtis Hunsberger |
| K201339 |
06/19/2020 |
The NOxBOXi Nitric Oxide Delivery System |
Praxair, Inc. |
Dave Loflin |
| K200952 |
06/05/2020 |
Hummingbird Tympanostomy Tube System |
Preceptis Medical, Inc |
Steve Anderson |
| K200131 |
06/10/2020 |
BruxZir Steel |
Prismatik Dentalcraft, Inc. |
So Hyun Park |
| K193438 |
06/02/2020 |
DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) |
Pro Med Instruments GmbH |
Muhammad Zubair |
| K193361 |
06/01/2020 |
ProCell Surgical Sponge-Blood Recovery Unit |
ProCell Surgical, Inc. |
Robert Krensky |
| K200459 |
06/03/2020 |
pREBOA-PRO Catheter |
Prytime Medical Devices, Inc. |
Brian Young |
| K201455 |
06/30/2020 |
Litho 150, Cyber Ho 150 |
Quanta System Spa |
Francesco Dell'Antonio |
| K200899 |
06/15/2020 |
Quantib AI Node |
Quantib BV |
Floor van Leeuwen |
| K200889 |
06/02/2020 |
iMac 27 & PL 4.0 |
Quantum-Spectra LLC |
Marc Leppla |
| K200438 |
06/19/2020 |
MPS 3 Myocardial Protection System |
Quest Medical, Inc. |
Tosan Onosode |
| K200921 |
06/17/2020 |
qER |
Qure.ai Technologies |
Pooja Rao |
| K201119 |
06/26/2020 |
ChartCheck |
Radformation, Inc. |
Kurt Sysock |
| K200104 |
06/04/2020 |
Oxylight |
RAJA Trading Company, Inc. |
Robert J Adipietro |
| K200487 |
06/10/2020 |
RayCare 3.1 |
RaySearch Laboratories AB (publ) |
Viktoria Hammarstedt |
| K192747 |
06/17/2020 |
Yxoss CBR« |
ReOss GmbH |
Michael Peetz |
| K192779 |
06/02/2020 |
Bunny Wax Personal Lubricant |
Reoxcyn, LLC |
Ellie Hartz |
| K200226 |
06/26/2020 |
RetroFix |
Retrofix Screws, LLC |
Keith A Barritt |
| K200617 |
06/23/2020 |
Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 |
Richard Wolf Medical Instruments Corporation |
Michael Loiterman |
| K192910 |
06/19/2020 |
STATClave G4 Chamber Autoclave |
SciCan Ltd. |
Teresa Boyce |
| K200879 |
06/10/2020 |
SeaSpine Meridian System, SeaSpine Regatta Lateral System |
SeaSpine Orthopedics Corporation |
Aly Alvarez |
| K190408 |
06/16/2020 |
Spinal Fixation System |
Shangdong Kangsheng Medical Devices Co., Ltd. |
Wenxing Dong |
| K192601 |
06/01/2020 |
uWS-MR |
Shanghai United Imaging Healthcare Co., Ltd |
Xin Gao |
| K192630 |
06/11/2020 |
uWS-MI |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K200976 |
06/10/2020 |
SR-8230, SR-8230S Portable X-ray Unit |
Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) |
Flower Cai |
| K200727 |
06/18/2020 |
TENS and Muscle Stimulator |
Shenzhen As Tec Technology Co., Ltd |
Connie Li |
| K193253 |
06/17/2020 |
Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 |
Shenzhen Changkun Technology Co., Ltd. |
Steve Li |
| K192404 |
06/22/2020 |
Patient Monitoring Cable (SpO2 Extension Cable) |
Shenzhen Coreray Technology., Ltd |
Simon Fan |
| K193354 |
06/08/2020 |
Air Compression Therapy Device |
Shenzhen Dongjilian Electronics Co.,Ltd. |
Zhang Hong |
| K200354 |
06/29/2020 |
Electronic stimulator |
Shenzhen Dongjilian Electronics Co.,Ltd. |
Zhang Hong |
| K200437 |
06/25/2020 |
Blood Pressure Monitor |
Shenzhen Jamr Technology Co., Ltd. |
Luo Fusheng |
| K192466 |
06/22/2020 |
Air Compression Therapy System |
Shenzhen Lifotronic Technology Co., Ltd. |
Xiang Lei |
| K200015 |
06/08/2020 |
ePM Series Patient monitors |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
Yanhong Bai |
| K193348 |
06/25/2020 |
Blood Pressure Monitor |
Shenzhen Viatom Technology Co., Ltd. |
Zhou Saixin |
| K201156 |
06/29/2020 |
ARTIS pheno (VE2) |
Siemens Medical Solution USA, Inc. |
Patricia D. Jones |
| K201462 |
06/24/2020 |
ACUSON Sequoia Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc |
Sulgue Choi |
| K193290 |
06/17/2020 |
AI-Rad Companion Brain MR |
Siemens Medical Solutions USA, Inc. |
Lauren Bentley |
| K193166 |
06/12/2020 |
MAMMOMAT Revelation |
Siemens Medical Solutions USA, Inc. |
Martin Rajchel |
| K201202 |
06/02/2020 |
MI View&GO |
Siemens Medical Solutions USA, Inc. |
Clayton Ginn |
| K192024 |
06/19/2020 |
Cemented TSI Hip Stem |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K193075 |
06/09/2020 |
Osteo3 ZP Putty |
Sirakoss Ltd. |
Jordan Conway |
| K200538 |
06/01/2020 |
Skeletal Dynamics Forearm Plating System |
Skeletal Dynamics, Inc. |
Diana Taylor |
| K200227 |
06/04/2020 |
Journey II XR Knee Instrument |
Smith & Nephew, Inc |
Meenakshi Gupta |
| K193003 |
06/05/2020 |
NemoCast |
Software Nemotec S.L. |
Carlos Arias |
| K200683 |
06/12/2020 |
INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoi |
Sorin Group Italia S.R.L. |
Luigi Vecchi |
| K201029 |
06/17/2020 |
Sapphire« Spinal System, Sapphire X Anterior Cervical Plate Spinal System |
Spinal Elements, Inc. |
Julie Lamothe |
| K193106 |
06/19/2020 |
SpineFrontier Lumbar Interbody Fusion Device System |
SpineFrontier, Inc. |
Vito Lore |
| K192952 |
06/05/2020 |
Spire Health Remote Patient Monitoring System |
Spire, Inc. d/b/a Spire Health |
Joanne Hollenbach |
| K193577 |
06/01/2020 |
SleepRight ProRx Custom Dental Guard |
Splintek, Inc. |
Thomas W Brown |
| K201370 |
06/19/2020 |
Multiflex Tinnitus Technology |
Starkey Laboratories, Inc. |
Ka Zoua Xiong |
| K200446 |
06/13/2020 |
STERIS Patient Warming System |
STERIS Corporation |
Gregory Land |
| K200398 |
06/05/2020 |
AxSOS 3 AF System and AxSOS 3 Ti System |
Stryker GmbH |
Paul Nelson |
| K200467 |
06/16/2020 |
Control-IQ Technology |
Tandem Diabetes Care, Inc. |
Michael Sarrasin |
| K201214 |
06/04/2020 |
t:slim X2 Insulin Pump with Interoperable Technology |
Tandem Diabetes Care, Inc. |
Ashley Reynolds |
| K200272 |
06/30/2020 |
Terragene Chemdye |
Terragene SA |
Maria Victoria Rocha |
| K201255 |
06/10/2020 |
TSolution« One Total Knee Application |
THINK Surgical, Inc. |
Meliha Mulalic |
| K193150 |
06/05/2020 |
Latex Examination Powder Free Glove, Aloe Vera |
Top Glove SDN BHD |
Noor Akilah BT Saidin |
| K191913 |
06/19/2020 |
TruAbutment DS |
TruAbutment Inc. |
Kiyoon Nam |
| K200772 |
06/23/2020 |
ULab Systems uDesign Software |
ULab Systems, Inc. |
Charlie Wen |
| K200720 |
06/26/2020 |
D-Stat Radial Topical Hemostat |
Vascular Solutions LLC |
Iroquois Ledbeter |
| K193119 |
06/29/2020 |
Twin-Pass Dual Access Catheter |
Vascular Solutions LLC |
Iroquois Ledbeter |
| K193319 |
06/01/2020 |
XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System |
Vasoptic Medical Inc. |
Abhishek Rege |
| K200786 |
06/09/2020 |
Venus Epileve |
Venus Concept USA Inc. |
Yoni Iger |
| K201164 |
06/26/2020 |
Venus Viva MD Device |
Venus Concept USA Inc. |
Yoni Iger |
| K191620 |
06/01/2020 |
Vitls Platform |
Vitls Inc. |
Werner Vorster |
| K192957 |
06/05/2020 |
VivaChek Blood Glucose and B-Ketone Monitoring System |
Vivachek Biotech (Hangzhou) Co., Ltd |
Mark Qian |
| K201340 |
06/19/2020 |
AQUILA 320 D / AQUILA 320 S |
VMI Tecnologias LTDA |
Siele Santos |
| K201322 |
06/17/2020 |
Entuit Nasal Jejunal Feeding Tube |
Wilson-Cook Medical, Inc |
Tiffanny A Thomas |
| K200972 |
06/10/2020 |
Hemospray Endoscopic Hemostat |
Wilson-Cook Medical, Inc |
Marge Walls-Walker |
| K193067 |
06/08/2020 |
The INBONEÖ Total Ankle System, the INFINITYÖ Total Ankle System and the INVISIONÖ Total Ankle Revision System |
Wright Medical Technology, Inc. |
Antonio Ayala |
| K200929 |
06/03/2020 |
Hair Growth System |
Xuzhou Kernel Medical Equipment Co., Ltd. |
Wang Jing |
| K192478 |
06/17/2020 |
LT Antibacterial Alginate with Silver Dressing |
Zhejiang Longterm Medical Technology Co., Ltd. |
Claudia Zsang |
