| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K191534 |
06/10/2019 |
ID NOW Influenza A & B 2 |
Abbott Diagnostics Scarborough, Inc. |
Angela Drysdale |
| K191595 |
06/17/2019 |
ARCHITECT STAT High Sensitivity Troponin-I |
Abbott Laboratories Diagnostics Division |
Judi Wallach |
| K191514 |
06/07/2019 |
CareStart Flu A&B Plus |
Access Bio, Inc. |
Sang Joon Han |
| K191734 |
06/28/2019 |
MatriStem UBM Pericardial Patch |
Acell, Inc. |
Michelle Huettner |
| K191479 |
06/04/2019 |
Velocity Alpha Highspeed Surgical Drill System |
adeor Medical AG |
Viktor Rundel |
| DEN190031 |
06/24/2019 |
NP Screen |
Advance Sentry Corporation |
Leo Chui |
| K191598 |
06/17/2019 |
AOS ES Retrograde Femoral Nail |
Advanced Orthopaedic Solutions, Inc. |
Elaine Nguyen |
| K191623 |
06/18/2019 |
ScanX Touch/ScanX Duo Touch |
Air Techniques, Inc. |
Samir Ghevariya |
| K191650 |
06/20/2019 |
LEGION System |
Alcon Research, LLC |
Nickerson Hill |
| K191739 |
06/28/2019 |
Sterile LeadConfirm |
Alpha Omega Engineering Ltd. |
Maysana Mousa |
| K191723 |
06/27/2019 |
ATEC IOM Accessory Instruments |
Alphatec Spine, Inc. |
Ruby Zheng |
| K191644 |
06/19/2019 |
TK Safety Needle |
Anhui Tiankang Medical Technology Co., Ltd. |
Bai Baodong |
| K191643 |
06/19/2019 |
TK Sterile Hypodermic Needle |
Anhui Tiankang Medical Technology CO.,Ltd |
Bai Baodong |
| K191639 |
06/19/2019 |
TK Insulin Syringe with/without Saftey Retractable Device |
Anhui Tiankang Medical Technology Co.,Ltd. |
Bai Baodong |
| K191640 |
06/19/2019 |
TK Intravascular Administration Set |
Anhui Tiankang Medical Technology Co.,Ltd. |
Bai Baodong |
| K191642 |
06/19/2019 |
TK Sterile Piston Syringe without Needle |
Anhui Tiankang Medical Technology Co.,Ltd. |
Bai Baodong |
| K191460 |
06/03/2019 |
PWD Platform Wound Dressing 3ö x 5ö Oblong |
Applied Tissue Technologies LLC |
Michael Broomhead |
| K191484 |
06/04/2019 |
Renuvion/J-Plasma Precise Handpiece |
Apyx Medical Corporation(formerly Bovie Medical Corporation) |
Topaz Kirlew |
| K191563 |
06/13/2019 |
FILTRAY 2G Disposable Water Filters |
aqua-tools |
Virginie S. Grondin |
| K191651 |
06/20/2019 |
Arthrex Nano SwiveLock Suture Anchor |
Arthrex Inc. |
Rebecca R. Homan |
| K191714 |
06/26/2019 |
ASAHI Neurovascular Guide Wire CHIKAI X 014 soft |
Asahi Intecc Co., Ltd. |
Yasuyuki Kawahara |
| K191464 |
06/03/2019 |
Asahi PTCA Guide Wire Asahi SION Series |
Asahi Intecc Co., LTD. |
Yasuyuki Kawahara |
| K191566 |
06/13/2019 |
Avinent Surgical Tray |
AVINENT Implant System, S.L.U. |
Anna Cortina |
| K191658 |
06/21/2019 |
IV Sets not made with PVC |
B. Braun Medical Inc. |
Angela J. Caravella |
| K191537 |
06/10/2019 |
eCarbon IBDs |
Back 2 Basics Direct, LLC |
Scot Miller |
| K191471 |
06/03/2019 |
Carnation Ambulatory Monitor |
Bardy Diagnostics, Inc |
Brit Baird |
| K191654 |
06/20/2019 |
SILICONE Personal Lubricant |
Bath Concept Cosmetics (Dongguan) Co., Ltd |
Jack Yin |
| K191494 |
06/05/2019 |
FacilisÖ Spinal System |
Baui Biotech Co., Ltd. |
Herman Jhan |
| K191513 |
06/07/2019 |
Altapore Shape |
Baxter Healthcare Corporation |
Phillip Romei |
| K191546 |
06/12/2019 |
Epicardial Access System |
Baylis Medical Company Inc. |
May Tsai |
| K191556 |
06/12/2019 |
Red Dot |
Behold.AI Technologies Limited |
Simon Rasalingham |
| K191614 |
06/18/2019 |
BioSticker System |
BioIntelliSense Inc. |
Henry Leung |
| K191657 |
06/21/2019 |
Bioland Blood Glucose Monitoring System |
Bioland Technology Ltd. |
Ke-Min Jen |
| K191459 |
06/03/2019 |
JuggerStitch Meniscal Repair Device |
Biomet Inc. |
Kyle Ponce |
| K191587 |
06/14/2019 |
L360 Thigh System |
Bioness Inc. |
Mercedes Bayani |
| K191660 |
06/21/2019 |
CARTO 3 EP Navigation System, Version 7.1 and Accessories |
Biosense Webster, Inc. |
Phuong Chau |
| K191469 |
06/03/2019 |
Biotronik Stylets |
Biotronik, Inc |
Jon Brumbaugh |
| K191700 |
06/25/2019 |
EyeStat |
Blinktbi Inc. |
Ryan Fiorini |
| K191538 |
06/10/2019 |
Resectr Tissue Resection Device |
Boston Scientific Corporation |
Brooke Cuddy |
| K191609 |
06/17/2019 |
Tria Soft Ureteral Stent |
Boston Scientific Corporation |
Justin Kapitan |
| K191542 |
06/11/2019 |
Apyx Plasma/RF Handpiece |
Bovie Medical Corporation dba Apyx Medical Corporation |
Topaz Kirlew |
| K191728 |
06/27/2019 |
ULTepap Expiratory Positive Airway Pressure (EPAP) Device |
Bryggs Medical, LLC |
Geoffrey Sleeper |
| K191718 |
06/26/2019 |
Buhlmann fCAL turbo and CALEX Cap |
BUHLMANN Laboratories AG |
Laura Zurbrugg |
| K191532 |
06/10/2019 |
The Caterpillar and Caterpillar Micro Arterial Embolization Devices |
C. R. Bard, Inc. |
Melanie Hadlock |
| K191584 |
06/14/2019 |
FORTICO Anterior Cervical Fixation System |
Camber Spine Technologies LLC |
Rami Hamzey |
| K191685 |
06/24/2019 |
PicoWay Laser System |
Candela Corporation |
Brenda Geary |
| K191663 |
06/21/2019 |
Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 |
Canon Medical Systems Corporation |
Paul Biggins |
| K191467 |
06/03/2019 |
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 |
Canon Medical Systems Corporation |
Paul Biggins |
| K191582 |
06/14/2019 |
Cartesion Prime |
Canon Medical Systems Corporation |
Paul Biggins |
| K191662 |
06/21/2019 |
Vantage Orian 1.5T, MRT-1550, V4.5 |
Canon Medical Systems Corporation |
Paul Biggins |
| K191672 |
06/24/2019 |
NuFACE Mini Device |
Carol Cole Company dba NuFACE |
Nadia Vazirzadeh Miller |
| K191461 |
06/03/2019 |
Exofin Fusion Skin Closure System |
Chemence Medical, Inc. |
Kenneth N Broadley |
| K191621 |
06/18/2019 |
ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octan |
ChoiceSpine, LLC |
Kim Finch |
| K191470 |
06/03/2019 |
C-CAT Anaesthesia Catheter kit |
Cimpax ApS |
Patrick Busch-Madsen |
| K191733 |
06/28/2019 |
The ZIP Accessory Shuttle for PleuraFlow System |
ClearFlow, Inc. |
Dov Gal |
| K191536 |
06/10/2019 |
Biatain Silicone Ag |
Coloplast A/S |
Kimberly Tokach |
| K191668 |
06/21/2019 |
Infrared Forehead Thermometer (Model IR-FT) |
Comper Chuangxiang (Beijing) Technology Co., Ltd. |
Han Du |
| K191696 |
06/25/2019 |
Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft |
Cook Biotech Incorporated |
Perry W. Guinn |
| K191498 |
06/05/2019 |
Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc |
Cook Incorporated |
Carly Powell |
| K191485 |
06/04/2019 |
Deflectable Brush Biopsy Set |
Cook Incorporated |
Irasema Rivera |
| K191601 |
06/17/2019 |
Valleylab FT10 Electrosurgical Platform |
Covidien |
Jennie van Diemen |
| K191719 |
06/26/2019 |
X-MIND Trium |
de Gotzen S.R.L |
Dario Bandiera |
| K191634 |
06/19/2019 |
Scan Abutments and Comfort Caps |
Dentium Co., Ltd. |
Byung-sun Kim |
| K191616 |
06/18/2019 |
Orthophos S |
Dentsply Sirona |
Karl Nittinger |
| DEN190029 |
06/03/2019 |
Acumen Assisted Fluid Management (AFM) Software Feature |
Edwards Lifesciences |
Lisa Gilman |
| K191564 |
06/13/2019 |
Progenikine Concentrating System 25 mL System |
Emcyte Corporation |
Patrick Pennie |
| K191612 |
06/17/2019 |
Encision AEM Monopolar Laparoscopic Instruments and Accessories |
Encision Incorporated |
Denise Baker |
| K191590 |
06/14/2019 |
AA temp temporary restoration 3D printing photoreactive resin |
Enlighten Materials Co., Ltd |
Jiun Ming Su |
| K191591 |
06/14/2019 |
BB Base 3D printing resin for denture base |
Enlighten Materials Co., Ltd |
Jiun Ming Su |
| K191555 |
06/12/2019 |
HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length |
Ethicon Endo-Surgery, LLC |
Nathan Anderson |
| K191589 |
06/14/2019 |
Calprest, EasyCal |
Eurospital S.p.A. |
Chiara Pelillo |
| K191592 |
06/14/2019 |
CalprestNG, EasyCal |
Eurospital S.p.A. |
Chiara Pelillo |
| K191561 |
06/13/2019 |
Exactech Equinoxe Humeral Augmented Trays |
Exactech, Inc |
Shing Jen Tai |
| K191545 |
06/11/2019 |
Exogenesis Hernia Mesh |
Exogenesis Corporation |
Joseph Khoury |
| K191577 |
06/14/2019 |
Willow Wearable Breast Pump 2.0 |
Exploramed NC7, Inc. |
Steve Holmes |
| K191525 |
06/10/2019 |
KinematX Total Wrist Arthroplasty System |
Extremity Medical, LLC. |
Brian Smekal |
| K191673 |
06/24/2019 |
Upper Arm Blood Pressure Monitor |
Famidoc Technology Company Limited |
Leon Cao |
| K191624 |
06/18/2019 |
F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version |
Fisher & Paykel Healthcare Limited |
Nicholas Yap |
| K191550 |
06/12/2019 |
Broncholab |
Fluidda Inc. |
Anjali Nair |
| K191554 |
06/12/2019 |
LightWalker Laser System Family |
Fotona d.o.o. |
Lina Rupnik |
| K191474 |
06/04/2019 |
NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton) |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K191495 |
06/05/2019 |
Biopsy Positioner |
FUJIFILM Corporation |
Randy Vader |
| K191544 |
06/11/2019 |
Synapse 3D Blood Flow Analysis |
Fujifilm Corporation |
Randy Vader |
| K191698 |
06/25/2019 |
TiN Coated Humeral Head |
FX Shoulder USA, Inc. |
Kathy Trier |
| K191699 |
06/25/2019 |
Discovery XR656 HD with VolumeRad |
GE Hualun Medical Systems Co., Ltd |
Chris Paulik |
| K191489 |
06/04/2019 |
Genesys Spine 3DP Cervical Interbody System |
Genesys Spine |
Benjamin V. Keller |
| K191593 |
06/14/2019 |
Digital Automatic Blood Pressure Monitor MD36 Series |
Grandway Technology (Shenzhen) Limited |
Patrick Chow |
| K191570 |
06/13/2019 |
Infrared Thermometer Model MD-H30 |
Guangzhou Berrcom Medical Device Co., Ltd. |
Zhigang Du |
| K191512 |
06/07/2019 |
LotusCatheter (Lotus No Balloon Catheter) |
Hakki Medical Technologies, Inc. |
Shereen Said Hakky |
| K191552 |
06/12/2019 |
GM501 Mineral Oil |
Hamilton Thorne Inc. |
Donald Fournier |
| K191667 |
06/21/2019 |
Electronic Stethoscope |
Hefei Mintti Medical Technology Co., Ltd. China |
Shengsheng Cai |
| K191502 |
06/06/2019 |
Heraeus Peripheral Guidewire |
Heraeus Medical Components, LLC |
Chelsea Pioske |
| K191633 |
06/19/2019 |
Infyna Chic |
Hollister Incorporated |
Michelle Schiltz-Taing |
| K191562 |
06/13/2019 |
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor |
HORIBA ABX SAS |
Caroline Ferrer |
| K191477 |
06/04/2019 |
AEON-C Stand Alone System |
Huvexel Co., Ltd |
Sung Kyu Hur |
| K191615 |
06/18/2019 |
Huvitz Imaging System |
Huvitz Co., Ltd. |
Hyung Min Heo |
| K191510 |
06/06/2019 |
Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae |
Hycor Biomedical |
Kaitlyn Weinkauf |
| K191709 |
06/26/2019 |
V-STRUT Vertebral Implant |
Hyprevention SAS |
Cecile Vienney |
| K191530 |
06/10/2019 |
StoneChecker |
Imaging Biometrics, LLC |
Timothy Dondlinger |
| K191692 |
06/25/2019 |
KardioScreen |
iMedrix Inc. (formerly Piitech Inc.) |
Srikanth Jadcherla |
| K191569 |
06/13/2019 |
Implantcast ic-Bipolar Head System |
Implantcast, GmbH |
Juliiane Hoppner |
| K191535 |
06/10/2019 |
CoLink« Mini Plating System |
In2Bones USA, LLC |
Christine Scifert |
| K191710 |
06/26/2019 |
FlowTriever Retrieval/Aspiration System |
Inari Medical |
Eben Gordon |
| K191641 |
06/19/2019 |
AFFINITY û Variable Angle Distal Radius System, AFFINITY û Variable Angle Distal Radius Plates, AFFINITY û Variable Angle Distal Radius Screws |
Industrias Medicas Sampedro S.A.S |
Liliana Zuluaga-Idarraga |
| K191522 |
06/10/2019 |
Straumann Modular Cassette |
Institut Straumann AG |
Jenni Vescovo |
| DEN190032 |
06/25/2019 |
HemosIL Liquid Anti-Xa |
Instrumentation Laboratory Co. |
Carol Marble |
| K191659 |
06/21/2019 |
Instylla Delivery Kit |
Instylla, Inc. |
Amita Smith |
| K191731 |
06/28/2019 |
Instylla Microcatheter |
Instylla, Inc. |
Amita Shah |
| K191679 |
06/24/2019 |
Omnipod DASH Insulin Management System with interoperable technology |
Insulet Corporation |
Julie Perkins |
| K191684 |
06/24/2019 |
MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System |
Integra Lifesciences Corporation |
Omayra Ramirez |
| K191594 |
06/17/2019 |
Nuvis Battery Arthroscope |
Integrated Endoscopy, Inc. |
Albert Rego |
| K191507 |
06/06/2019 |
Intellijoint« Navigation System |
Intellijoint Surgical Inc. |
Breanne Cuddington |
| K191736 |
06/28/2019 |
da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 |
Intuitive Surgical |
Vishal Kanani |
| K191529 |
06/10/2019 |
da Vinci Xi Surgical System, da Vinci X Surgical System |
Intuitive Surgical |
Brandon Hansen |
| K191583 |
06/14/2019 |
PhotonBlade with Smoke Evacuation |
Invuity Inc. |
Dione Fuller |
| K191629 |
06/19/2019 |
faceLITE |
iSMART Marketing Svcs Ltd |
Susan D'Arcy |
| K191490 |
06/05/2019 |
Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe |
Jiangsu Caina Medical Co., Ltd. |
Xinyan Ruan |
| K191548 |
06/12/2019 |
Nexus Universal Self-Cure |
Kerr Corporation |
Ardrena Jackson |
| K191527 |
06/10/2019 |
Visalys CemCore, Visalys Cem Core Try In Paste |
Kettenbach GmbH & Co. KG |
Katja Simon |
| K191523 |
06/10/2019 |
Visalys Restorative Primer |
Kettenbach GmbH & Co. KG |
Katja Simon |
| K191524 |
06/10/2019 |
Visalys Tooth Primer |
Kettenbach GmbH & Co. KG |
Katja Simon |
| K191558 |
06/12/2019 |
Konan Specular Microscope XVII |
Konan Medical, Inc. |
Tatsuya Kasahara |
| K191645 |
06/19/2019 |
SKR 4000 |
Konica Minolta, Inc. |
Tsutomu Fukui |
| K191501 |
06/06/2019 |
PALLAS 308/311 Solid-State UV Laser System |
Laseroptek Co., Ltd. |
Hong Chu |
| K191575 |
06/14/2019 |
ARx Spinal System |
Life Spine Inc. |
Angela Batker |
| K191622 |
06/18/2019 |
Delta Multihole TT Pro Acetabular System |
Limacorporate S.p.A. |
Roberto Gabetta |
| K191670 |
06/21/2019 |
CureOs TCP |
Linacol Muh Dan Kim Cev Tek Med Ith Ihr San Ve Tic |
Mehmet Ali Cengiz |
| K191720 |
06/27/2019 |
BRUIS Software Suite |
Mechanodontics, Inc. |
Mehdi Roein-Peikar |
| K191677 |
06/24/2019 |
MectaTap TI Suture Anchor |
Medacta International SA |
Stefano Baj |
| K191636 |
06/19/2019 |
APTUS Foot System |
Medartis AG |
Andrea Schweizer |
| K191653 |
06/20/2019 |
Freestyle Flex |
Medela AG |
Judith Bernardo |
| K191483 |
06/04/2019 |
HEALIX ADVANCE Anchor with DYNA+TAPE Sutures |
Medos International SARL |
Ashley Goncalo |
| K191638 |
06/19/2019 |
Pointe Scientific Cocaine Metabolite Enzyme Immunoassay |
MedTest Dx |
William Cripps |
| K191597 |
06/17/2019 |
Stealth Autoguide System, Midas Rex Legend Depth Stop System |
Medtronic Navigation, Inc. |
Jason Woehrle |
| K191526 |
06/10/2019 |
Cardioblate CryoFlex Surgical Ablation System |
Medtronic, Inc. |
Choua Thao |
| K191491 |
06/05/2019 |
EZ-Cover |
MedXPress.Pro |
Katherine Hughey |
| K191596 |
06/17/2019 |
Arcadia Balloon Catheter |
Merit Medical Systems, Inc. |
Shamsa Karimi |
| K191608 |
06/17/2019 |
Impress Angiographic Catheter |
Merit Medical Systems, Inc. |
Luke Meidell |
| K191496 |
06/05/2019 |
TDS Standard Solution |
Mesa Laboratories, Inc. |
Jamie Louie |
| K191462 |
06/03/2019 |
Proov Test |
MFB Fertility, Inc. |
Amy Beckley |
| K191618 |
06/18/2019 |
SleepTight Mouthpiece STZ |
Michael D Williams DDS PA |
Michael Williams |
| K191632 |
06/19/2019 |
PROFEMUR TL2 Stems |
MicroPort Orthopedics Inc. |
Sneh Pingle |
| K191680 |
06/24/2019 |
AZUR Vascular Plug |
MicroVention Inc. |
Ganesh Balachander |
| K191689 |
06/25/2019 |
EleGARD Patient Positioning System |
Minnesota Resuscitation Solutions, d.b.d AdvancedCPR Solutio |
Philip Tetzlaff |
| K191701 |
06/25/2019 |
Arcus Head Fixation Frame |
MRI Interventions, Inc. |
Pete Piferi |
| K191605 |
06/17/2019 |
Neocis Guidance System (NGS) |
Neocis Inc. |
Thomas E. Claiborne |
| K191492 |
06/05/2019 |
Maxxi Position Sensor |
Neurovirtual USA, INC. |
Eduardo Faria |
| K191599 |
06/17/2019 |
NICO Myriad NOVUS |
NICO Corporation |
Sean Spence |
| K191475 |
06/04/2019 |
Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate |
Nobel Biocare AB |
Charlemagne Chua |
| K191626 |
06/18/2019 |
Stat Profile Prime ES Comp Plus Analyzer System |
Nova Biomedical Corporation |
Cesidio Tempesta |
| K191553 |
06/12/2019 |
NuVaisve« Reline« Cervical System |
NuVasive, Incorporated |
Michelle Cheung |
| K191500 |
06/06/2019 |
NuVasive« ACP System |
NuVasive, Incorporated |
Jessica Silverman |
| K191505 |
06/06/2019 |
Rezum System |
NxThera (A Boston Scientific Company) |
Justin Kapitan |
| K191713 |
06/26/2019 |
CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShieldÖ (ROI Assembly) |
Omega Medical Imaging, LLC |
John Newman |
| K191666 |
06/21/2019 |
Unscented W long plastic and cardboard applicator tampons |
ONTEX BVBA |
Henri Lesage |
| K191716 |
06/26/2019 |
Somryst |
Pear Therapeutics, Inc. |
David Amor |
| K191687 |
06/24/2019 |
pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire |
phenox Limited |
Gary Brogan |
| K191647 |
06/20/2019 |
QLAB Advanced Quantification Software |
Philips Healthcare |
Eri Gremi |
| K191738 |
06/28/2019 |
PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph |
Philips Medical Systems |
Hong Zhu |
| K191503 |
06/06/2019 |
MobileRay Pulse SE Digital Imaging System |
Portavision Medical LLC |
Terry Ancar |
| K191521 |
06/07/2019 |
Radiance 330 Proton Beam Therapy System |
ProTom International Holding Corporation |
Stephen L. Spotts |
| K191646 |
06/20/2019 |
Beamscan MR |
PTW-Freiburg Physikalisch-Technische-Werkstaetten |
Sandor-Csaba Ats |
| K191737 |
06/28/2019 |
The Graft Bone Substitute |
Purgo Biologics Inc. |
Eun Ho Kim |
| K191664 |
06/21/2019 |
SelectFlex 072 Neurovascular Access System |
Q'Apel Medical |
Ken Peartree |
| K191504 |
06/06/2019 |
PowerDR |
Radiology Information Systems, Inc. |
Chen-Tai Ma |
| K191516 |
06/07/2019 |
Ali Interbody Fusion System |
Raed M. Ali, MD., Inc. |
Raed Ali |
| K191539 |
06/10/2019 |
1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support |
Rapid Biomedical GmbH |
Christian Zimmermann |
| K191547 |
06/12/2019 |
ReliefBand |
ReliefBand Technologies LLC |
Barbara Whitman |
| K191606 |
06/17/2019 |
RenovoCath |
RenovoRx, Inc. |
Kamran Najmabadi |
| K191693 |
06/25/2019 |
BC-5 |
Reveallux, Corp |
Justin D Linn |
| K191551 |
06/12/2019 |
RIST Cath Radial Access Long Sheath |
RIST Neurovascular, Inc. |
Marianne Grumwaldt |
| K191729 |
06/27/2019 |
Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System |
Roche Molecular Systems, Inc. |
Kaitlyn Hameister |
| K191717 |
06/26/2019 |
Route 92 Medical Sheath System |
Route 92 Medical Inc. |
Kathy Tansey |
| K191574 |
06/14/2019 |
OxSAT 100 |
S.L.P. Ltd. |
Avi Yosef |
| K191488 |
06/04/2019 |
SAM IO Intraosseous Access System |
SAM« Medical Products, Inc. |
Jeff Lipps |
| K191656 |
06/21/2019 |
Zipbond |
SDI Limited |
Ray Cahill |
| K191648 |
06/20/2019 |
Mariner MIS Pedicle Screw System; SeaSpine Navigation System |
SeaSpine Orthopedics Corporation |
Alicia McArthur |
| K191610 |
06/17/2019 |
RTapp |
SegAna, LLC |
Rodney Bosley |
| K191655 |
06/21/2019 |
MEGAFIX« Pedicle Screw Spinal System |
SeohanCare Co., Ltd |
Chae Lynn Song |
| K191518 |
06/07/2019 |
CO2 Laser System |
Shenzhen GSD Tech Co., Ltd |
Jiancheng Zhang |
| K191499 |
06/06/2019 |
MAGLUMI 2000 25-OH Vitamin D |
Shenzhen New Industries Biomedical Engineering Co., Ltd |
Jie Rao |
| K191531 |
06/10/2019 |
Sure-Fine Insulin Syringes |
Shina Med Corporation |
Park Sung-soon |
| K191533 |
06/10/2019 |
ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG |
Siemens Healthcare Diagnostics Inc. |
Paul DaSilva |
| K191578 |
06/14/2019 |
ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control |
Siemens Healthcare Diagnostics Inc. |
Matthew Gee |
| K191468 |
06/03/2019 |
syngo.CT Dual Energy |
Siemens Medical Solutions, USA, Inc |
Cynthia Busch |
| K191708 |
06/26/2019 |
Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K191678 |
06/24/2019 |
IP Converter |
Sony Electronics Inc. |
Shogo Obuchi |
| K191576 |
06/14/2019 |
Mercury« Spinal System, Overwatch« Spinal System |
Spinal Elements, Inc |
Julie Lamothe |
| K191726 |
06/27/2019 |
mont blanc & mont blanc MIS Spinal Systems |
Spineway SA |
Heloise Macaire |
| K191715 |
06/26/2019 |
Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile |
STERIS Corporation |
Jennifer Nalepka |
| K191466 |
06/03/2019 |
SandShark Injectable Anchor (SIA) System |
Stimwave Technologies Inc. |
Elizabeth Greene |
| K191688 |
06/24/2019 |
SubtleMR |
Subtle Medical, Inc. |
Ajit Shankaranarayanan |
| K191732 |
06/28/2019 |
Sutter RaVoR Bipolar Electrodes |
Sutter Medizintechnik GmbH |
Ulrike Zeissler |
| K191617 |
06/18/2019 |
Syntec Tibial Nail System |
Syntec Scientific Corporation |
Kavin Chu |
| K191463 |
06/03/2019 |
DePuy Synthes Hammertoe Continuous Compression Implant |
Synthes (USA) Products, LLC |
Keith Knapp |
| K191585 |
06/14/2019 |
iNtuition-Structural Heart Module |
TeraRecon Inc. |
Megha Jain |
| K191465 |
06/03/2019 |
Human IgM Kit for use on SPAPlus |
The Binding Site Group Ltd. |
Natasha Verhaak |
| K191635 |
06/19/2019 |
Optilite IgM Kit |
The Binding Site Group Ltd. |
Natasha Verhaak |
| K191705 |
06/26/2019 |
OptikView GUP2103CMI |
The Linden Group Corp |
James Chen |
| K191557 |
06/12/2019 |
CentriMag Acute Circulatory Support System |
Thoratec Corporation (now part of Abbott) |
Lori Dondiego |
| K191565 |
06/13/2019 |
Endoskeleton TCS Interbody Fusion Device |
Titan Spine, Inc |
Kelly McDonnell |
| K191581 |
06/14/2019 |
Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device |
Titan Spine, Inc |
Kelly McDonnell |
| K191711 |
06/26/2019 |
ORTHOLOCÖ SPS Shoulder Plating System |
Tornier Inc. |
Renee Stoffel |
| K191482 |
06/04/2019 |
Senhance Surgical System |
TransEnterix Inc. |
Kaitlyn Alexander |
| K191480 |
06/04/2019 |
Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) |
Trigg Laboratories, Inc. D/B/A Wet International |
Louie Goryoka |
| K191559 |
06/13/2019 |
AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM |
United States Endoscopy Group, Inc |
Carroll Martin |
| K191472 |
06/03/2019 |
Biopsy Needle |
Ushare Medical Inc. |
Yan Wang |
| K191580 |
06/14/2019 |
BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K191560 |
06/13/2019 |
Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter |
Vascular Solutions LLC |
Beka Vite |
| K191541 |
06/11/2019 |
Vave Personal Ultrasound System |
Vave Health, Inc. |
Joseph Ko |
| K191602 |
06/17/2019 |
APA Oxy Blade |
Venner Medical (Singapore) Pte Ltd |
Adrian P. Waterton |
| K191493 |
06/05/2019 |
Ventripoint Medical System Plus (VMS+) 3.0 |
Ventripoint Diagnostics, Ltd. |
Desmond Hirson |
| K191528 |
06/10/2019 |
Venus Legacy Pro Device |
Venus Concept USA Inc. |
Yoni Iger |
| K191497 |
06/05/2019 |
NextDent Denture 3D+ |
Vertex-Dental BV |
Loes Vloet-Emonts |
| K191676 |
06/24/2019 |
Intra.Ox 2.0 Handheld Tissue Oximeter |
ViOptix, Inc. |
Scott Coleridge |
| K191579 |
06/14/2019 |
Voyant System |
Viseon, Inc. |
Cora Sim |
| K191620 |
06/18/2019 |
Vitls Platform |
Vitls Inc. |
Werner Vorster |
| K191611 |
06/17/2019 |
Diode Laser Therapy Systems |
Wingderm Electro-Optics Ltd. |
Juan Zhou |
| K191571 |
06/14/2019 |
UV Radiation Treatment System |
Xuzhou Yongkang Electronic Science Technology Co., Ltd |
Kai Li |
| K191619 |
06/18/2019 |
TurboTemp EZ |
Zest Anchors, LLC |
Marysa E. Loustalot |
| K191568 |
06/13/2019 |
sam 2.0 Long Duration Ultrasound System |
ZetrOZ Systems, LLC |
Sabrina Lewis |
| K191722 |
06/27/2019 |
Vital Navigation System |
Zimmer Biomet Spine, Inc. |
Alex Pawlowski |
| K191735 |
06/28/2019 |
CPT Hip System |
Zimmer Inc |
Caleb Barylski |
| K191625 |
06/18/2019 |
Persona Revision Knee System |
Zimmer Inc. |
Nicole Meredith |
| K191631 |
06/19/2019 |
ZMAXX Dental Zirconia Blanks |
ZMAXX Bioceramics LLC |
Josef Wu |
| K191697 |
06/25/2019 |
Cardiac Monitor 1500 |
Zynex Medical, Inc. |
Thomas Sandgaard |
