| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K190926 |
07/23/2019 |
Hammertoe Truss System (HTS) |
4Web, Inc. |
Jessee Hunt |
| K182455 |
07/15/2019 |
A.B. DENTAL DEVICES Dental Implants System |
A.B. Dental Device Ltd. |
Gabi Krauss |
| K191345 |
07/17/2019 |
Pegasus System |
A.M. Surgical, Inc. |
Vincent Pascale |
| K191534 |
07/11/2019 |
ID NOW Influenza A & B 2 |
Abbott Diagnostics Scarborough, Inc. |
Angela Drysdale |
| K191173 |
07/25/2019 |
Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires |
Abbott Vascular |
Namratha Manthani |
| K183066 |
07/25/2019 |
The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C« with BioGUARDÖ Technology-3 Fr, 4 Fr, and 5 Fr Model |
Access Scientific, LLC |
Martina Nguyen |
| K191060 |
07/18/2019 |
ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit |
ACIST Medical Systems, Inc. |
Matthew D. Stepanek |
| K190924 |
07/05/2019 |
Revitive Medic Plus, Revitive Advanced 2 |
Actegy, Ltd. |
Lawrence Brookfield |
| K191817 |
07/26/2019 |
ActivOrtho Continuous Compression Screw System |
ActivOrtho, Inc. |
Paul Hindrichs |
| K190291 |
07/30/2019 |
Addivation Medical Cervical Interbody System |
Addivation Medical, LLC |
Gregory Stebbins |
| K182820 |
07/17/2019 |
The POD |
Advanced Facialdontics LLC |
Scott Simonetti |
| K190819 |
07/25/2019 |
Silicone PHMB Foam Wound Dressing |
Advanced Medical Solutions Ltd. |
Adam Gregory |
| K191598 |
07/18/2019 |
AOS ES Retrograde Femoral Nail |
Advanced Orthopaedic Solutions, Inc. |
Elaine Nguyen |
| K182414 |
07/05/2019 |
Aesculap« SterilContainer(TM) S2 System |
Aesculap, Inc. |
Sierra Mertz |
| K190174 |
07/05/2019 |
Miethke Shunt System GAV 2.0 and SA 2.0 Valves |
Aesculap, Inc. |
Kathy A. Racosky |
| K183121 |
07/18/2019 |
Qraypen |
AIOBIO Co., Ltd. |
Jongcheol Yoon |
| K190949 |
07/26/2019 |
ScanX Barrier Envelopes |
Air Techniques Inc. |
Samir Ghevariya |
| K191138 |
07/11/2019 |
AeroForm Tissue Expander, Smooth |
AirXpanders, Inc. |
Belinda Pinedo |
| K191795 |
07/31/2019 |
AOCup Lens Case with AODisc |
Alcon Laboratories, Inc. |
Katryna Warren |
| K180968 |
07/03/2019 |
AlphaDent Implants Dental Implants System |
AlphaDent Implants Ltd |
Natalia Kenig |
| K190972 |
07/12/2019 |
Ambu aScope 4 RhinoLaryngo Intervention |
Ambu A/S |
Gurpreet Kaur Rehal |
| K183473 |
07/12/2019 |
AMSafe(R) Pre-Filled Normal Saline Flush Syringe |
Amsino International, Inc. |
Jim Barley |
| K190594 |
07/05/2019 |
AngioVac C20, AngioVac C180 |
AngioDynamics, Inc. |
Kasey Newcomb |
| K191092 |
07/22/2019 |
Powder-Free Vinyl Patient Examination Gloves, Yellow Color |
Anhui Intco Medical Products Co. Ltd |
Jacken Cai |
| K191460 |
07/02/2019 |
PWD Platform Wound Dressing 3ö x 5ö Oblong |
Applied Tissue Technologies LLC |
Michael Broomhead |
| K191484 |
07/30/2019 |
Renuvion/J-Plasma Precise Handpiece |
Apyx Medical Corporation(formerly Bovie Medical Corporation) |
Topaz Kirlew |
| K190343 |
07/18/2019 |
Silverlon Wound Contact, Burn Contact Dressings |
Argentum Medical, LLC |
Aftab Ahmad |
| K183194 |
07/26/2019 |
Arthrex Eclipse Shoulder Prosthesis System |
Arthrex Inc. |
David L Rogers |
| K190645 |
07/05/2019 |
Arthrex NanoScope System |
Arthrex Inc. |
Heli F. Chambi Infantas |
| K191714 |
07/26/2019 |
ASAHI Neurovascular Guide Wire CHIKAI X 014 soft |
Asahi Intecc Co., Ltd. |
Yasuyuki Kawahara |
| K183062 |
07/01/2019 |
ASAHI Silverway |
Asahi Intecc Co., LTD. |
Yasuyuki Kawahara |
| K190524 |
07/01/2019 |
MRopen 0.5 T |
ASG Superconductors S.p.A. |
Luisella De Benedetti |
| K191167 |
07/17/2019 |
Fungitell STAT |
Associates of Cape Cod, Inc |
Alison Skinner |
| K190587 |
07/24/2019 |
Coolrail Linear Pen |
AtriCure, Inc |
Jake Lawson |
| K182971 |
07/19/2019 |
SpaceOAR Vue Hydrogel |
Augmenix, Inc |
Marcus Garcia |
| K191078 |
07/22/2019 |
BAROnova Access Sheath Kit |
BAROnova, Inc. |
Lian Cunningham |
| K190910 |
07/25/2019 |
PrisMax System Version 2 |
Baxter Healthcare Corp |
Chris Scavotto |
| K191252 |
07/09/2019 |
Gem FlowCoupler System |
Baxter/ Synovis Micro Companies Alliance Inc. |
Julie Carlston |
| K190292 |
07/25/2019 |
Passio Pump Drainage System |
Bearpac Medical |
Jay Zimmerman |
| K190905 |
07/01/2019 |
BD Phoenix Automated Microbiology System û GN Ceftaroline (0.0156-4 ╡g/mL) |
Becton, Dickinson and Company |
Laura Stewart |
| K183138 |
07/02/2019 |
Certain BellaTek Express and BellaTek Flex Abutments |
Biomet 3i |
Krupal Patel |
| K191660 |
07/20/2019 |
CARTO 3 EP Navigation System, Version 7.1 and Accessories |
Biosense Webster, Inc. |
Phuong Chau |
| K190548 |
07/05/2019 |
BIOMONITOR III, Remote Assistant III |
Biotronik, Inc. |
Jon Brumbaugh |
| K190996 |
07/28/2019 |
Bonus Therapeutics Mixing and Delivery System |
Bonus Therapeutics Ltd. |
Nir Shtayer |
| K191008 |
07/02/2019 |
iLab Polaris Multi-Modality Guidance System |
Boston Scientific Corporation |
Mugdha Dongre |
| K191789 |
07/25/2019 |
Stonetome Stone Removal Device |
Boston Scientific Corporation |
Laura Kuroski |
| K190550 |
07/01/2019 |
IKON 40 Manual Wheelchair |
Broda Seating (Broda LP) |
Jeremy Ballard |
| K190456 |
07/05/2019 |
BTL 799-2L |
BTL Industries, Inc. |
David Chmel |
| K181446 |
07/08/2019 |
Bard Power-Injectable Implantable Ports (PowerPorts«) |
C.R. Bard, Inc. |
Jeff Peterson |
| K190492 |
07/18/2019 |
Peralta Stone Removal Catheter |
Calcula Technologies, Inc |
Raymond Buzz Bonneau |
| K182942 |
07/24/2019 |
Canon OCT-A1 |
Canon Inc. |
Tatsuya Yamazaki |
| K191467 |
07/19/2019 |
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 |
Canon Medical Systems Corporation |
Paul Biggins |
| K182901 |
07/05/2019 |
Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE |
Canon Medical Systems Corporation |
Paul Biggins |
| K191662 |
07/23/2019 |
Vantage Orian 1.5T, MRT-1550, V4.5 |
Canon Medical Systems Corporation |
Paul Biggins |
| K191797 |
07/29/2019 |
BiomarC Fiducial Marker |
Carbon Medical Technologies |
Eric Furlich |
| K183623 |
07/09/2019 |
LifeSPARC Pump, LifeSPARC Controller |
CardiacAssist Inc |
Greg Johnson |
| K190634 |
07/02/2019 |
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System |
Cardiovascular Systems Inc. |
Kris Miller |
| K183149 |
07/04/2019 |
Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim |
Central Medicare Sdn. Bhd. |
Muhammad Abdul Rahman |
| K182487 |
07/20/2019 |
CerusEndo Microcatheter |
Cerus Endovascular, Inc. |
Theresa Brandner |
| K191367 |
07/05/2019 |
Harrier-SA Lumbar Interbody System |
ChoiceSpine LLC |
Kim Finch |
| K191733 |
07/26/2019 |
The ZIP Accessory Shuttle for PleuraFlow System |
ClearFlow, Inc. |
Dov Gal |
| K190589 |
07/03/2019 |
Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments |
Cochlear Americas |
Laura Blair |
| K190620 |
07/10/2019 |
SpeediCath Flex Coude Pro |
Coloplast |
Delaney McDougal |
| K191204 |
07/03/2019 |
Infinity Fixation System |
ConMed Corporation |
Orjada Dervishleri |
| K190277 |
07/08/2019 |
ProVate Vaginal Support |
ConTIPI Medical Ltd. |
Tsvia Erlich |
| K183051 |
07/16/2019 |
Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set |
Cook Incorporated |
Yan Li |
| K182985 |
07/22/2019 |
Roadrunner PC Wire Guide, Olcott Torque Device |
Cook Incorporated |
Daniel J. Corbin |
| K190834 |
07/22/2019 |
Corin Optimized Position System Functional Hip Analysis (OPS FHA) |
Corin USA |
Lucinda Gerber |
| K191374 |
07/22/2019 |
Revival Modular Hip Stem |
Corin USA Limited |
Rachel King |
| K191601 |
07/12/2019 |
Valleylab FT10 Electrosurgical Platform |
Covidien |
Jennie van Diemen |
| K191272 |
07/12/2019 |
Wearable Device, Wearable Package |
Current Health Ltd. |
Edwin Lindsay |
| K190678 |
07/24/2019 |
TempSure |
Cynosure, Inc |
Michael King |
| K191287 |
07/16/2019 |
OptiFix AT Absorbable Fixation System with Articulating Technology û 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology û 15 Fasteners |
Davol Inc., Subsidiary of C.R. Bard |
Angelica Hutchison |
| K182875 |
07/10/2019 |
DeepCT |
Deep01 Limited |
William Lai |
| K190777 |
07/31/2019 |
DemeTECH DemeFORCE Nonabsorbable Surgical Suture |
DemeTECH Corporation |
Tracy Chadwrick |
| K191616 |
07/16/2019 |
Orthophos S |
Dentsply Sirona |
Karl Nittinger |
| K183079 |
07/10/2019 |
Conometric Abutments |
Dentsply Sirona Inc. |
Karl Nittinger |
| K190569 |
07/29/2019 |
Shaders ZR |
Digital Age Dental Lab |
Tim McKimson |
| K191370 |
07/18/2019 |
DreaMed Advisor Pro |
DreaMed Diabetes Ltd |
Eran Atlas |
| K191325 |
07/16/2019 |
EMPOWR Partial Knee |
Encore Medical, L.P. |
Teffany Hutto |
| K190351 |
07/02/2019 |
Site Seal SV |
Ensite Vascular |
Thomas Reidy |
| K191589 |
07/10/2019 |
Calprest, EasyCal |
Eurospital S.p.A. |
Chiara Pelillo |
| K191592 |
07/10/2019 |
CalprestNG, EasyCal |
Eurospital S.p.A. |
Chiara Pelillo |
| K190150 |
07/16/2019 |
Sage 2-in-1 Personal Lubricant and Moisturizer |
Fairhaven Health, LLC |
Suzanne Munson |
| K190891 |
07/31/2019 |
Fluobeam LX |
Fluoptics |
Odile Allard |
| K191495 |
07/03/2019 |
Biopsy Positioner |
FUJIFILM Corporation |
Randy Vader |
| K183572 |
07/16/2019 |
FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L |
FUJIFILM Corporation |
Randy Vader |
| K182854 |
07/11/2019 |
GC FujiCEM 2 (Improved) |
GC America Inc. |
Mark Heiss |
| K190809 |
07/29/2019 |
Sample Imaging for Senographe Pristina |
GE Healthcare |
Nicole Landreville |
| K191699 |
07/24/2019 |
Discovery XR656 HD with VolumeRad |
GE Hualun Medical Systems Co., Ltd |
Chris Paulik |
| K191777 |
07/26/2019 |
Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition |
GE Medical Systems, LLC |
Laura Turner |
| K191100 |
07/24/2019 |
ExcelsiusGPS Spine 1.1 Interbody Module |
Globus Medical Inc. |
Kelly J. Baker |
| K191593 |
07/22/2019 |
Digital Automatic Blood Pressure Monitor MD36 Series |
Grandway Technology (Shenzhen) Limited |
Patrick Chow |
| K180295 |
07/30/2019 |
Hamilton-G5 |
Hamiton Medical AG |
Frederick Bruhschwein-Mandic |
| K180845 |
07/25/2019 |
Maxima Electric System |
Handpiece Headquarters - HPR Inc. |
Timothy Ropchan |
| K191931 |
07/31/2019 |
HardyDisk AST Imipenem/relebactam 10/25╡g (IMR10/25) |
Hardy Diagnostics |
Anna Klavins |
| K182384 |
07/26/2019 |
ACR LAB Urine Analysis Test System |
Healthy.io Ltd |
Ron Zohar |
| K190617 |
07/02/2019 |
Wrap accessory electrodes |
Hi-Dow International Inc. |
Eric Chen |
| K191633 |
07/19/2019 |
Infyna Chic |
Hollister Incorporated |
Michelle Schiltz-Taing |
| K190694 |
07/11/2019 |
Unifi Workspace v1.0.0 |
Hologic, Inc. |
Meghan Wakeford |
| K191396 |
07/26/2019 |
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe |
Horiba ABX SAS |
Caroline Ferrer |
| K191615 |
07/18/2019 |
Huvitz Imaging System |
Huvitz Co., Ltd. |
Hyung Min Heo |
| K191510 |
07/31/2019 |
Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae |
Hycor Biomedical |
Kaitlyn Weinkauf |
| K183048 |
07/29/2019 |
Quantisal II Oral Fluid Collection Device |
Immunalysis Corporation |
Wenying (Jessica) Zhu |
| K191535 |
07/29/2019 |
CoLink« Mini Plating System |
In2Bones USA, LLC |
Christine Scifert |
| K191764 |
07/31/2019 |
Inion BioRestore |
Inion Oy |
Tiina Tyni |
| K190980 |
07/01/2019 |
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter |
Innovative Health, LLC. |
Amanda Babcock |
| K191594 |
07/11/2019 |
Nuvis Battery Arthroscope |
Integrated Endoscopy, Inc. |
Albert Rego |
| K191372 |
07/15/2019 |
Lyra |
Interacoustics A/S |
Erik Nielsen |
| K180994 |
07/09/2019 |
SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F |
Interrad Medical Inc |
Denise Lenz |
| K191736 |
07/26/2019 |
da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 |
Intuitive Surgical |
Vishal Kanani |
| K190999 |
07/12/2019 |
SureForm 45 Curved Tip, SureForm 45 Gray Reload |
Intuitive Surgical, Inc. |
Nadine Nasr |
| K190272 |
07/03/2019 |
Bluephase PowerCure |
Ivoclar Vivadent, AG |
Sandra Cakebread |
| K190339 |
07/29/2019 |
Helioseal F Plus |
Ivoclar Vivadent, AG |
Sandra Cakebread |
| K190718 |
07/11/2019 |
Zygomatic Implants |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Mariana Soares Hartmann |
| K190886 |
07/29/2019 |
Non-invasive blood pressure measurement systems |
Joytech Healthcare Co., Ltd |
Ren Yunhua |
| K190873 |
07/26/2019 |
Infrared Ear/Forehead Thermometer |
Joytech Healthcare Co., Ltd. |
Ren Yunhua |
| K191137 |
07/02/2019 |
5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 |
JVC Kenwood Corporation |
Hideki Tengeiji |
| K190485 |
07/08/2019 |
Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) |
Kawasumi Laboratories, Inc. |
Katsu Furuya |
| K190528 |
07/10/2019 |
MariGen Wound Extra |
Kerecis Limited |
Gudmundur Fertram Sigurjonsson |
| K182889 |
07/26/2019 |
KLS Martin Individual Patient Solutions (IPS) Planning System |
KLS-Martin L.P. |
Jennifer Damato |
| K190442 |
07/03/2019 |
Koios DS for Breast |
Koios Medical, Inc. |
Lev Barinov |
| K190488 |
07/23/2019 |
ProLift Expandable System |
Life Spine Inc. |
Angela Batker |
| K183173 |
07/01/2019 |
LIGHTMED Ultrasound System |
Lightmed USA, Inc |
Hedy Chiang |
| K190286 |
07/08/2019 |
Materialise Glenoid Positioning System |
Materialise NV |
Mieke Janssen |
| K182794 |
07/18/2019 |
BionicGym Powered Muscle Stimulator |
Medical Currents Ltd |
Louis Crowe |
| K182158 |
07/15/2019 |
UNiD Patient-matched PLIF cage |
MEDICREA INTERNATIONAL S.A. |
David RYAN |
| K190950 |
07/04/2019 |
Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown |
Medline Industries, Inc. |
Pauline Maralit |
| K190895 |
07/18/2019 |
MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System |
Medos International Sarl |
Sheree Geller |
| K190774 |
07/25/2019 |
RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant |
Medos International SARL |
LeeAnn Walosin |
| K183547 |
07/30/2019 |
Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter |
Medtronic |
Matthew Lobeck |
| K190132 |
07/30/2019 |
Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter |
Medtronic |
Matthew Lobeck |
| K183129 |
07/26/2019 |
Medtronic Total Hip Arthroplasty System |
Medtronic Advanced Energy |
Gina Cunsolo |
| K190672 |
07/31/2019 |
StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 |
Medtronic Navigation Inc |
Elizabeth Waite |
| K190959 |
07/03/2019 |
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology |
Medtronic Sofamor Danek USA, Inc |
Emmarie Halteman |
| K191328 |
07/26/2019 |
Megadyne Foot Switch |
Megadyne Medical Products, Inc. |
Sharon Sussex |
| K183532 |
07/18/2019 |
Latitud Hip Replacement System |
Meril Healthcare Pvt. Ltd. |
Gayathri Nair |
| K191608 |
07/16/2019 |
Impress Angiographic Catheter |
Merit Medical Systems, Inc. |
Luke Meidell |
| K190724 |
07/03/2019 |
MD-Temp Plus |
Meta Biomed Co., Ltd |
Suk Song Oh |
| K183663 |
07/16/2019 |
Microlife Digital Infrared Ear Thermometer |
Microlife Intellectual Property GmbH |
Gerhard Frick |
| K190818 |
07/10/2019 |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor |
Microlife Intellectual Property GmbH |
Gerhard Frick |
| K190123 |
07/15/2019 |
MicroPort CoCr Femoral Heads |
MicroPort Orthopedics Inc. |
Tejas Patel |
| K182829 |
07/10/2019 |
Scepter Mini Occlusion Balloon Catheter |
MicroVention Inc. |
Marina Emond |
| K190975 |
07/22/2019 |
Plexus SCD110 Sequential Compression Device Sleeve |
Midway Medical, LLC. |
Jim Tobin |
| K182930 |
07/12/2019 |
PerioLase Nd:YAG Pulsed Dental Laser System |
Millennium Dental Technologies, Inc. |
Robert H. Gregg |
| K191451 |
07/03/2019 |
CMDR 2CW (Multiple models) |
MinXray, Inc |
Keith Kretchmer |
| K191757 |
07/19/2019 |
EUROPA Pedicle Screw System |
MiRus, LLC |
Jordan Bauman |
| K182407 |
07/19/2019 |
Exceed Microneedling device |
Mt. Derm GmbH |
Andreas Pachten |
| K190960 |
07/11/2019 |
Nalu Lead Blank (50cm) |
Nalu Medical, Inc. |
Sunny Gill |
| K191408 |
07/10/2019 |
Nexxt Matrixx System |
Nexxt Spine LLC |
Andy Elsbury |
| K191117 |
07/19/2019 |
NvisionVLE Low-profile Optical Probe |
NinePoint Medical, Inc |
Eman Namati |
| K182940 |
07/19/2019 |
Surdial DX Hemodialysis System |
Nipro Medical Corporation |
Jessica Oswald-McLeod |
| K182714 |
07/12/2019 |
Novidia Bulk Fill Flow Composite |
Nobio Ltd. |
Inbal Beinglass Peled |
| K182580 |
07/03/2019 |
Novidia Flowable Composite |
Nobio Ltd. |
Inbal Beinglass Peled |
| K191365 |
07/19/2019 |
Stat Profile Prime ES Comp Plus Analyzer System |
Nova Biomedical Corporation |
Cesidio Tempesta |
| K181754 |
07/30/2019 |
Blood Collection Accessory (BUCA) |
NSP Tech Pte Ltd |
HC Tan |
| K181743 |
07/30/2019 |
Blood Transfer Accessory (BTA) |
NSP Tech Pte Ltd |
HC Tan |
| K191169 |
07/03/2019 |
NuVasive« Camber Laminoplasty System |
NuVasive, Incorporated |
Thao Huynh |
| K190064 |
07/08/2019 |
nView system 1 |
nView medical, Inc. |
Lisa Last |
| K191183 |
07/31/2019 |
EyeBOX |
Oculogica, Inc. |
Rosina Samadani |
| K190969 |
07/09/2019 |
ENDOSCOPE REPROCESSOR OER-Elite |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K182984 |
07/24/2019 |
MaxiTears Contacts PF |
Omnivision AG |
Joachim Kolter |
| K190732 |
07/31/2019 |
P200TxE |
Optos Plc |
Rachel Reay |
| K191317 |
07/12/2019 |
StitchKit |
Origami Surgical |
John Gillespie |
| K191140 |
07/18/2019 |
MONTAGE-QS Settable, Resorbable Hemostatic Bone |
Orthocon, Inc. |
Howard L. Schrayer |
| K190324 |
07/05/2019 |
OrthoPediatrics Cannulated Screw System |
Orthopediatrics, Corp |
Jen Gregory |
| K182091 |
07/12/2019 |
Osstem Abutment System |
Osstem Implant Co., Ltd. |
Jungmin Yoo |
| K183017 |
07/25/2019 |
Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer |
Osteoremedies LLC |
Chris Hughes |
| K190915 |
07/03/2019 |
OsteoFab Suture Anchors |
Oxford Performance Materials, Inc. |
Andrus Maandi |
| K181457 |
07/11/2019 |
EndoStream(TM) |
Partnership Medical Limited |
Rob Hartley |
| K181418 |
07/11/2019 |
ScopeFlow Pure(TM) |
Partnership Medical Limited |
Rob Hartley |
| K191136 |
07/29/2019 |
Access CT |
Philips Healthcare (Suzhou) Co., Ltd. |
Ray Sun |
| K183322 |
07/10/2019 |
physIQ Heart Rhythm and Respiratory Module |
physIQ, Inc |
George Allen Hides |
| K190498 |
07/05/2019 |
Fortilink« IBF System with TETRAfuse«3D Technology, include the following designs: Fortilink«-TS IBF System, Fortilink«-L I BF System, Fortilink«-C IBF System |
Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. |
Kristina Hall |
| K182089 |
07/30/2019 |
Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs |
Platinum Glove Industries Sdn Bhd |
Foo Khon Pu |
| K183270 |
07/17/2019 |
Silent Nite sl |
Prismatik Dentalcraft, Inc. |
Mythili Reguraman |
| K180992 |
07/16/2019 |
Biotex |
Purgo Biologics Inc. |
Seonghwan Song |
| K190749 |
07/15/2019 |
087 Balloon Guide Catheter System |
Q'Apel |
Ken Peartree |
| K190976 |
07/12/2019 |
Radial Medical Compression System |
Radial Medical, Inc. |
Eric Johnson |
| K182814 |
07/15/2019 |
Rael Tampon |
Rael, Inc. |
Binna Won |
| K191384 |
07/08/2019 |
RayCare 2.3 |
RaySearch Laboratories AB (publ) |
David Hedfors |
| K191315 |
07/12/2019 |
Remington Medical, Inc. Automatic Cutting Needle (NAC) |
Remington Medical, Inc. |
Caitlin Senter |
| K173974 |
07/14/2019 |
DROWZLE |
Resonea, Inc. |
Ruchir Sehra |
| K181166 |
07/18/2019 |
Trilogy Evo |
Respironics Inc. |
Colleen Witt |
| K181170 |
07/18/2019 |
Trilogy Evo Universal |
Respironics Inc. |
Colleen Witt |
| K190801 |
07/10/2019 |
PressOn Electrode Headset |
Rhythmlink International, LLC |
Gabriel Orsinger |
| K191729 |
07/24/2019 |
Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System |
Roche Molecular Systems, Inc. |
Kaitlyn Hameister |
| K191162 |
07/09/2019 |
EpiLaze Multi-wavelength Laser |
Rohrer Aesthetics, LLC |
Mark Rohrer |
| K182780 |
07/03/2019 |
XP Composite |
S&C Polymer Silicon- und Composite Spezialitaeten GmbH |
Christian Boettcher |
| K190062 |
07/26/2019 |
STATCLAVE G4 Chamber Autoclave |
SciCan Ltd. |
Teresa Boyce |
| K191648 |
07/19/2019 |
Mariner MIS Pedicle Screw System; SeaSpine Navigation System |
SeaSpine Orthopedics Corporation |
Alicia McArthur |
| K182163 |
07/09/2019 |
Shear Stress Therapeutics SST 3000 |
Shear Stress Therapeutics, LLC |
John Owen |
| K183058 |
07/03/2019 |
Arm-type Electronic Blood Pressure Monitor |
Shenzhen BSX Technology Electronics Co., Ltd. |
Zhijian Zhao |
| K183288 |
07/30/2019 |
Transcutaneous Electrical Nerve Stimulator |
Shenzhen Kentro Medical Electronics Co., Ltd |
Zewu Zhang |
| K190011 |
07/10/2019 |
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
Yanhong Bai |
| K191578 |
07/17/2019 |
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 |
| K191454 |
07/30/2019 |
Atellica CH Amylase_2 (AMY_2) |
Siemens Healthcare Diagnostics Inc. |
Catherine Daigle |
| K183271 |
07/26/2019 |
AI-Rad Companion (Pulmonary) |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K182904 |
07/05/2019 |
syngo.MR Applications |
Siemens Medical Solutions USA, Inc. |
Cordell L. Fields |
| K191050 |
07/12/2019 |
MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow |
Siemens Medical Solutions, USA Inc. |
Milind Dhamankar |
| K191468 |
07/03/2019 |
syngo.CT Dual Energy |
Siemens Medical Solutions, USA, Inc |
Cynthia Busch |
| K191309 |
07/19/2019 |
syngo.via MI Workflows VB40A, Scenium |
Siemens Medical Soultions USA, Inc. |
Veronica Padharia |
| K190680 |
07/18/2019 |
FAVO S-TLIF |
Silony Medical GmbH |
Melanie Lubjuhn |
| K182659 |
07/25/2019 |
Galilei G6 Lens Professional |
SIS AG, Surgical Instrument Systems |
Frank Ziemer |
| K190533 |
07/26/2019 |
Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented |
Sleepnet Corporation |
Jennifer Kennedy |
| K190254 |
07/05/2019 |
Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask |
Sleepnet Corporation |
Jennifer Kennedy |
| K183280 |
07/26/2019 |
PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs |
Smart Glove Corporation Sdn. Bhd. |
Khon Pu Foo |
| K191211 |
07/25/2019 |
JOURNEY II Unicompartmental Knee System |
Smith & Nephew, Inc. |
Meenakshi Gupta |
| K190471 |
07/24/2019 |
4CIS« Chiron Spinal Fixation System |
Solco Biomedical Co., Ltd. |
Kim Il |
| K190457 |
07/12/2019 |
VERITON CT whole body SPECT/CT system |
Spectrum Dynamics Medical Ltd |
Igor Naroditsky |
| K190050 |
07/19/2019 |
Tech Dots - Adhesive and conductive gel |
Spes Medica S.r.l. |
Giorgio Facco |
| K191045 |
07/10/2019 |
SalvoÖ Spine System |
Spine Wave, Inc. |
Amy Noccioli |
| K190687 |
07/02/2019 |
Twilite Appliance |
Stephen J Harkins, DDS, PC |
Stephen Harkins |
| K190229 |
07/11/2019 |
Stryker PEEK Customized Cranial Implant Kit |
Stryker |
Zainab Amini |
| K191259 |
07/12/2019 |
Stryker CrossFlow Integrated Arthroscopy Pump |
Stryker Corp. |
Justin Florence |
| K191768 |
07/30/2019 |
AXS Vecta Aspiration System |
Stryker Neurovascular |
Shazia Hakim |
| K183249 |
07/25/2019 |
Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage |
STRYKER SPINE |
Deirdre Jayko |
| K183349 |
07/19/2019 |
AeroDVx System |
Sun Scientific Inc |
Allan Alward |
| K190163 |
07/16/2019 |
ALARA Neuro Access Kit |
SurGenTec, LLC |
Travis Greenhalgh |
| K191018 |
07/03/2019 |
Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors |
Surgical Instrument Service and Savings Inc |
Stephanie Boyle Mays |
| K182615 |
07/08/2019 |
Surgikor Dental Implant System |
Surgikor LLC |
Jeremy Barbanell |
| K183153 |
07/08/2019 |
Microwave Ablation System |
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. |
Guofang Ma |
| K180365 |
07/08/2019 |
PRAMA White Implant Systems |
Sweden & Martina S.p.A. |
Alessia Pezzato |
| K183325 |
07/14/2019 |
Modus Nav |
Synaptive Medical Inc. |
Maham Ansari |
| K190963 |
07/23/2019 |
DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional |
Synthes (USA) Products LLC |
Jeffrey Krawiec |
| K182817 |
07/22/2019 |
CottonDay Tampon |
Taebong Co., Ltd |
Ha Neul Jeong |
| K182847 |
07/01/2019 |
Hudson RCI Voldyne Volumetric Exerciser |
Teleflex Medical, Inc |
Sirisha Kommana |
| K191585 |
07/12/2019 |
iNtuition-Structural Heart Module |
TeraRecon Inc. |
Megha Jain |
| K190427 |
07/18/2019 |
Immucise |
Terumo Corporation |
Rudima L Jackson |
| K183545 |
07/19/2019 |
Anspach Helix Dissection Tools |
The Anspach Effort, Inc. |
Tamara J. West |
| K191635 |
07/15/2019 |
Optilite IgM Kit |
The Binding Site Group Ltd. |
Natasha Verhaak |
| K191557 |
07/10/2019 |
CentriMag Acute Circulatory Support System |
Thoratec Corporation (now part of Abbott) |
Lori Dondiego |
| K181957 |
07/09/2019 |
Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted |
Tianchang Jiarui Packaging Material Co., Ltd. |
Zhang Ruiqing |
| K182471 |
07/10/2019 |
Scooter |
Tianjin Kepler Vehicle Industry Co. Ltd. |
ChunXi Zhang |
| K190274 |
07/30/2019 |
Endotracheal Tube |
Tianjin Medis Medical Device Co., Ltd. |
Yongzhi Wu |
| K191711 |
07/17/2019 |
ORTHOLOCÖ SPS Shoulder Plating System |
Tornier Inc. |
Renee Stoffel |
| K191482 |
07/11/2019 |
Senhance Surgical System |
TransEnterix Inc. |
Kaitlyn Alexander |
| K190166 |
07/01/2019 |
TriMed Nitinol Staple System |
TriMed, Inc. |
David Medoff |
| K190260 |
07/19/2019 |
STERIZONE(R) VP4 Sterilizer |
TSO3 Inc |
Sandy Cliche |
| K181456 |
07/08/2019 |
Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves |
Tuttnauer Ltd. |
Aline Peled |
| K183243 |
07/10/2019 |
Velofix TLIF Cage |
U&i Corporation |
Jee Ae Bang |
| K190575 |
07/16/2019 |
iBreastExam |
UE LifeSciences Inc. |
Mihir Shah |
| K182876 |
07/02/2019 |
Uro-N Cystoscope |
UroViu Corporation |
Thomas Lawson |
| K190137 |
07/10/2019 |
Identify |
Varian Medical Systems Inc. |
Peter J. Coronado |
| K191761 |
07/31/2019 |
Mobius3D |
Varian Medical Systems, Inc |
Peter J. Coronado |
| K191580 |
07/08/2019 |
BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K191541 |
07/10/2019 |
Vave Personal Ultrasound System |
Vave Health, Inc. |
Joseph Ko |
| K191289 |
07/29/2019 |
Bone Screw Line Addition |
Vilex in Tennessee, Inc |
Victor Lavi |
| K191579 |
07/11/2019 |
Voyant System |
Viseon, Inc. |
Cora Sim |
| K182798 |
07/19/2019 |
KIDScore D3 |
Vitrolife A/S |
Belinda Dueholm |
| K183486 |
07/26/2019 |
RapidVitÖ Oocyte, RapidWarmÖ Oocyte |
Vitrolife Sweden AB |
Nina Arvidsson |
| K183050 |
07/08/2019 |
GLISSANT Intimate Lubricant |
Vjuvenate, LLC |
Karyn Eilber |
| K191773 |
07/31/2019 |
GORE BIO-A Tissue Reinforcement |
W.L. Gore & Associates, Inc. |
Barbara L. Smith |
| K191755 |
07/18/2019 |
SPAR-K Instruments (for use with Gemini SL Total Knee System) |
Waldemar Link GmbH & Co. KG |
Stefanie Fuchs |
| K190107 |
07/10/2019 |
VeriSplint |
Whip Mix Corporation |
John Waters |
| K191048 |
07/18/2019 |
AcuSnare Polypectomy Snare - Duckbill |
Wilson-Cook Medical, Inc. |
Doris A. Hawks |
| K191611 |
07/31/2019 |
Diode Laser Therapy Systems |
Wingderm Electro-Optics Ltd. |
Juan Zhou |
| K191154 |
07/29/2019 |
Hair Boom 69 |
Wontech |
Gyuri (Erin) Park |
| K191068 |
07/17/2019 |
Powersculp laser lipolysis system |
Wuhan Lotuxs Technology Co., Ltd. |
Na Wu |
| K183041 |
07/10/2019 |
Full Digital Colour Doppler Ultrasonic Diagnostic System |
Wuhan Zoncare Bio-medical Electronics Co., Ltd |
Chenglin Tian |
| K191053 |
07/17/2019 |
Xtreme-Loop |
Xiros Ltd |
Stephen Seed |
| K190685 |
07/26/2019 |
Hair Growth System |
Xuzhou Kernel Medical Equipment Co., Ltd. |
Wang Jing |
| K191398 |
07/29/2019 |
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System |
ZEUS Scientific Inc. |
Mark J. Kopnitsky |
| K191240 |
07/29/2019 |
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System |
ZEUS Scientific Inc. |
Mark J. Kopnitsky |
| K190907 |
07/29/2019 |
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System |
ZEUS Scientific, Inc. |
Mark J. Kopnitsky |
| K182908 |
07/18/2019 |
Ziacom Dental Implant Systems |
Ziacom Medical SL |
Olegario Cuevas |
| K191238 |
07/05/2019 |
Zimmer Guide Wire Devices |
Zimmer, Inc |
Annette Minthorn |
