| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K191236 |
05/08/2019 |
3MÖ AttestÖ Steam Chemical Integrators |
3M Company |
Mary Fretland |
| K191355 |
05/21/2019 |
3MÖ High Fluid-Resistant Surgical Mask and 3MÖ High Fluid-Resistant Procedure Mask |
3M Health Care |
Angie Draper |
| K191362 |
05/22/2019 |
LifeFlow Blood System |
410 Medical, Inc. |
Galen Robertson |
| K191345 |
05/20/2019 |
Pegasus System |
A.M. Surgical, Inc. |
Vincent Pascale |
| K191298 |
05/14/2019 |
i-STAT CHEM8+ cartridge with the i-STAT 1 System |
Abbott Point of Care Inc. |
Susan Tibedo |
| K191360 |
05/21/2019 |
i-STAT CHEM8+ cartridge with the i-STAT 1 System |
Abbott Point of Care, Inc. |
Susan Tibedo |
| K191173 |
05/01/2019 |
Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires |
Abbott Vascular |
Namratha Manthani |
| K191175 |
05/01/2019 |
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System |
ACIST Medical Systems, Inc. |
Angela Johnson |
| K191392 |
05/24/2019 |
AcQMap High Resolution Imaging and Mapping System |
Acutus Medical, Inc. |
Karla Schaffner |
| K191186 |
05/03/2019 |
Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode |
Ad-Tech Medical Instrument Corporation |
Lisa Theama |
| K191431 |
05/29/2019 |
Interlude Rolled Tampons in Plastic Applicator |
ALBAAD fem |
Shlomo Helvits |
| K191379 |
05/23/2019 |
RELiZORB |
Alcresta Therapeutics, Inc. |
Eric First |
| K191406 |
05/28/2019 |
KardiaMobile, KardiaStation |
AliveCor, Inc. |
Saket Bhatt |
| K191185 |
05/03/2019 |
Solanas« Posterior OCT Fixation System |
Alphatec Spine |
Ruby Zheng |
| K191311 |
05/15/2019 |
ATEC Lateral Interbody System |
Alphatec Spine, Inc. |
Cynthia Adams |
| K191290 |
05/13/2019 |
Ancora Nerve Block Catheter Set |
Ancora Medical Technology |
Chunyuan Qiu |
| K191292 |
05/14/2019 |
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Anhui Powerguard Technology Co.,Ltd |
Nike Dai |
| K191439 |
05/30/2019 |
OverStitch 2-0 Polypropylene Suture |
Apollo Endosurgery |
Maritza Ward |
| K191294 |
05/14/2019 |
Transvaginal Access Platform |
Applied Medical Resources Corp. |
Corinne Yestrepsky |
| K191326 |
05/16/2019 |
Arthrex Mini Comprehensive Fixation System û 1.4mm & 1.6mm Module |
Arthrex Inc. |
Rebecca R. Homan |
| K191344 |
05/20/2019 |
Arthrex Mini Comprehensive Fixation System û 2.0mm & 2.4mm Module |
Arthrex Inc. |
Rebecca R. Homan R. Homan |
| K191226 |
05/07/2019 |
Arthrex SwiveLock Suture Anchor |
Arthrex Inc. |
David L. Rogers |
| K191426 |
05/29/2019 |
FiberTak Button |
Arthrex Inc. |
Ivette Galmez |
| K191286 |
05/13/2019 |
CONTOUR« NEXT Blood Glucose Monitoring System, CONTOUR« NEXT USB Blood Glucose Monitoring System, CONTOUR« NEXT ONE Blood Glucose Monitoring System, CONTOUR« NEXT EZ Blood Glucose Monitoring System, CONTOUR« NEXT LINK Wireless Blood Glucose Monitoring Sys |
Ascensia Diabetes Care |
Stacie Geffner-Atiya |
| K191167 |
05/01/2019 |
Fungitell STAT |
Associates of Cape Cod, Inc |
Alison Skinner |
| K191413 |
05/28/2019 |
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip |
AtriCure, Inc |
Jim Taufen |
| K191340 |
05/20/2019 |
CORTRAK* 2 Equilateral Enteral Access System |
Avanos Medical, Inc. |
Monica King |
| K191353 |
05/21/2019 |
COMET Lumbar Interbody Fusion Cage |
BAUI Biotech Co., Ltd. |
Jessy Lin |
| K191252 |
05/09/2019 |
Gem FlowCoupler System |
Baxter/ Synovis Micro Companies Alliance Inc. |
Julie Carlston |
| K191417 |
05/28/2019 |
Belun Ring |
Belun Technology Company Limited |
Leung Lap Wai Lydia |
| K191304 |
05/14/2019 |
EthanZir Zirconia |
Besorah Dental Solutions NZ Limited |
Jobin Jose |
| K191352 |
05/20/2019 |
binx health io CT/NG Assay |
binx health, Inc. |
Sarah Kalil |
| K191411 |
05/28/2019 |
Ah!Yes Ob Coco Personal Lubricant |
Bio-Tech Lubricants Ltd |
Sarah Brooks |
| K191346 |
05/20/2019 |
Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) |
Blackrock Microsystems |
Rachelle Frischknecht |
| K191223 |
05/07/2019 |
NAVIO |
Blue Belt Technologies, Inc. |
Amy Winegarden |
| K191330 |
05/16/2019 |
Arc Enterocuff |
Boddingtons Plastics Ltd |
Shimaa Elsawy |
| K191150 |
05/01/2019 |
Bodycad Unicompartmental Knee System |
Bodycad Laboratories, Inc. |
Guy Sevigny |
| K191274 |
05/13/2019 |
BonAlive Granules |
BonAlive Biomaterials Ltd. |
Jimmy Lucchesi |
| K191446 |
05/31/2019 |
Ureteral Stent Systems, Biliary Drainage Catheters |
Boston Scientific Corporation |
Jois Zuniga Gamboa |
| K191285 |
05/13/2019 |
Spine & Trauma Navigation |
Brainlab AG |
Julia Mehltretter |
| K191331 |
05/16/2019 |
Life Sensor Cardiac Monitor |
BraveHeart Wireless, Inc. |
Balaji Sudabattula |
| K191232 |
05/08/2019 |
AccuCath Ace Intravascular Catheter |
C.R. Bard, Inc |
Mona Shahrebani |
| K191416 |
05/28/2019 |
Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack |
Caldera Medical, Inc. |
Vicki Gail |
| K191202 |
05/06/2019 |
CAPENERGY - C100, C200, C300, C400, C50 |
Capenergy Medical SL |
Pilar Sanchez |
| K191194 |
05/03/2019 |
CLARUS |
Carl Zeiss Meditec, Inc |
Saurabh Jamkhindikar |
| K191301 |
05/14/2019 |
Ceribell Pocket EEG Device |
Ceribell, Inc. |
Josef Parvizi |
| K191246 |
05/09/2019 |
Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) |
Chalice Medical Ltd |
Carol Middleton |
| K191276 |
05/13/2019 |
Dental Electrical Motor iRoot Pro |
ChangZhou BoMedent Medical Technology Co., Ltd. |
Chen YuLong |
| K191174 |
05/01/2019 |
Mercy babyTAPE |
Children's Mercy Hospital |
Susan Abdel-Rahman |
| K191367 |
05/22/2019 |
Harrier-SA Lumbar Interbody System |
ChoiceSpine LLC |
Kim Finch |
| K191314 |
05/15/2019 |
Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q |
Chongqing Sunkingdom Medical Instrument Co., Ltd |
Shulin Guo |
| K191324 |
05/16/2019 |
CivaDerm |
CivaTech Oncology Inc. |
Suzanne Babcock |
| K191263 |
05/10/2019 |
Idys ALIF TiVac |
Clariance SAS |
Fadwa Bahr |
| K191237 |
05/08/2019 |
CERENOVUS Large Bore Catheter |
Codman & Shurtleff, Inc. |
Kirsten Franco |
| K191385 |
05/23/2019 |
BRILLIANT COMPONEER |
Coltene/Whaledent AG |
Wolfgang Dorner |
| K191204 |
05/06/2019 |
Infinity Fixation System |
ConMed Corporation |
Orjada Dervishleri |
| K191163 |
05/01/2019 |
Lumax Guiding Catheter |
Cook Incorporated |
David Lehr |
| K191291 |
05/14/2019 |
Wallace Dual Lumen Oocyte Recovery System |
CooperSurgical, Inc. |
Christine Kupchick |
| K191374 |
05/23/2019 |
Revival Modular Hip Stem |
Corin USA Limited |
Rachel King |
| K191335 |
05/17/2019 |
Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags |
Corinth MedTech, Inc. |
Sandeep Saboo |
| K191341 |
05/20/2019 |
Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags |
Corinth MedTech, Inc. |
Sandeep Saboo |
| K191394 |
05/24/2019 |
ILLUMISITE Platform |
Covidien llc |
Kristi Fox |
| K191342 |
05/20/2019 |
CrossRoads Screw System |
CrossRoads Extemity Systems, LLC |
Chad Hollis |
| K191272 |
05/13/2019 |
Wearable Device, Wearable Package |
Current Health Ltd. |
Edwin Lindsay |
| K191287 |
05/13/2019 |
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 |
| K191313 |
05/15/2019 |
Unity Subcutaneous Infusion System for Remodulin |
DEKA Research & Development |
Jason Demers |
| K191361 |
05/21/2019 |
DemeDIOX Barbed Absorbable Surgical Suture |
DemeTECH Corporation |
Tracy Chadwrick |
| K191389 |
05/24/2019 |
Allcem Veneer APS |
Dentscare Ltda |
Roberta Uyara |
| K191306 |
05/14/2019 |
Llis, Vittra APS |
Dentscare LTDA |
Roberta Uyara |
| K191427 |
05/29/2019 |
Halley resin system |
Dentsply Sirona |
Karl Nittinger |
| K191152 |
05/01/2019 |
MIS Ti-base Abutment |
Dentsply Sirona |
Karl Nittinger |
| K191425 |
05/29/2019 |
Hydro-Temp Neonatal Skin Temperature Probe Cover |
DeRoyal Industries, Inc. |
Sarah Bennett |
| K191450 |
05/31/2019 |
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System |
Dexcom, Inc. |
Emily Chung |
| K191166 |
05/01/2019 |
DigniCap Delta |
Dignitana Inc. |
William Cronin |
| K191209 |
05/06/2019 |
Aneroid Type Blood Pressure Kit |
Dongguan Mars Medical Products Co., Ltd |
Lily Liao |
| K191187 |
05/03/2019 |
Dornier MINNOW Ureteral Catheter |
Dornier MedTech America Inc |
John Hoffer |
| K191370 |
05/22/2019 |
DreaMed Advisor Pro |
DreaMed Diabetes Ltd |
Eran Atlas |
| K191319 |
05/15/2019 |
Dunamis Fixation Button System |
Dunamis LLC |
Prithviraj Chavan |
| K191221 |
05/07/2019 |
Cybird LED Curing Light |
DXM Co., Ltd |
Seung Hyun Kim |
| K191258 |
05/10/2019 |
Intraosseous infusion device |
Einstein Works, L.L.C. |
Linda Taylor |
| K191325 |
05/16/2019 |
EMPOWR Partial Knee |
Encore Medical, L.P. |
Teffany Hutto |
| K191254 |
05/10/2019 |
EndoClot |
EndoClot Plus Co., Ltd. |
Hendry Zhang |
| K191387 |
05/24/2019 |
ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube |
Envizion Medical Ltd. |
Doron Besser |
| K191234 |
05/08/2019 |
APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets |
Erbe Elektromedizin GmbH |
Henry Kutz |
| K191438 |
05/30/2019 |
ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector |
Erbe USA, Inc. |
John Tartal |
| K191257 |
05/10/2019 |
Erchonia EVRL |
Erchonia Corporation |
Steven Shanks |
| K191373 |
05/23/2019 |
VICRYL Mesh |
Ethicon, Inc. |
Melina Escobar |
| K191262 |
05/10/2019 |
aBSI |
EXINI Diagnostics AB |
Aseem Anand |
| K191388 |
05/24/2019 |
FloPatch (FP110) |
Flosonics Medical (r/a 1929803 Ontario Corp.) |
Joe Eibl |
| K191407 |
05/28/2019 |
Novalung System |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K191190 |
05/03/2019 |
Steerable Introducer |
Freudenberg Medical LLC |
Mary Prunty |
| K191364 |
05/22/2019 |
T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01 |
Fujimori Kogyo Co., Ltd. |
Jeffrey Dahlen |
| K191432 |
05/29/2019 |
cortiQ PRO |
g.tec medical engineering GmbH |
Christoph Guger |
| K191249 |
05/09/2019 |
CARESCAPE B450 |
GE Healthcare Finland Oy |
Joel Kent |
| K191323 |
05/15/2019 |
Carescape B850 |
GE Healthcare Finland OY |
Joel Kent |
| K191322 |
05/15/2019 |
E-EEGX, N-EEGX |
GE Healthcare Finland Oy |
Joel Kent |
| K191243 |
05/09/2019 |
HEDRON Cervical Spacers |
Globus Medical Inc. |
Kelly Baker |
| K191391 |
05/24/2019 |
HEDRON Lumbar Spacers |
Globus Medical Inc. |
Kelly Baker |
| K191239 |
05/08/2019 |
Smart Peak Flow Meter |
Guangzhou Homesun Medical Technology Co., Ltd |
Jinqun Li |
| K191305 |
05/14/2019 |
Hereaeus Poseidon Microcatheter |
Heraeus Medical Components, LLC |
Chelsea Pioske |
| K191216 |
05/06/2019 |
Voxel DosimetryÖ v1.0 |
Hermes Medical Solutions AB |
Joakim Arwidson |
| K191321 |
05/15/2019 |
Primelase Excellence |
High Technology Products SLU |
Sergi Lozano |
| K191201 |
05/06/2019 |
EM SA Implant System |
Hiossen, Inc. |
Peter Lee |
| K191233 |
05/08/2019 |
ARIETTA 750 |
Hitachi Healthcare Americas |
Aaron Pierce |
| K191281 |
05/13/2019 |
Omni Hysteroscope, Omni Lok cervical seal |
Hologic, Inc. |
Rachelle D. Fitzgerald |
| K191245 |
05/09/2019 |
Yumizen C1200 ALP, Yumizen C1200 Albumin |
HORIBA ABX SAS |
Caroline Ferrer |
| K191396 |
05/24/2019 |
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe |
Horiba ABX SAS |
Caroline Ferrer |
| K191358 |
05/21/2019 |
Trident II Acetabular System |
Howmedica Osteonics Corp. aka Stryker Orthopaedics |
Valerie Giambanco |
| K191310 |
05/15/2019 |
Insight Essentials DRF Digital Imaging System |
Imaging Engineering, LLC |
George Jachode |
| K191229 |
05/08/2019 |
TrapIt |
IMDS Operations B.V. |
Edwin Schulting |
| K191350 |
05/20/2019 |
ACTIVE« Free Testosterone RIA |
Immunotech s.r.o. |
Vit Oburka |
| K191217 |
05/06/2019 |
JAZZ PF |
Implanet, S.A. |
Fabienne Larquey Cadiere |
| K191458 |
05/31/2019 |
Legacy SMARTBase Abutments |
Implant Direct Sybron Manufacturing LLC |
Reina Choi |
| K191433 |
05/29/2019 |
AGILON« XO Shoulder Replacement System |
Implantcast GmbH |
Juliane Hoppner |
| K191380 |
05/23/2019 |
Quantum« Total Ankle Prosthesis |
In2Bones SAS |
Morgane Grenier |
| K191368 |
05/22/2019 |
FlowTriever Retrieval/Aspiration System |
Inari Medical |
Eben Gordon |
| K191170 |
05/01/2019 |
Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter |
Innovative Health, LLC. |
Amanda Babcock |
| K191256 |
05/10/2019 |
Straumann BLX ╪3.5 mm Implants |
Institut Straumann AG |
Ana C. M. Vianna |
| K191372 |
05/22/2019 |
Lyra |
Interacoustics A/S |
Erik Nielsen |
| K191280 |
05/13/2019 |
E-100 Electrosurgical Generator, SynchroSeal |
Intuitive Surgical, Inc. |
Melissa Gonzalez |
| K191159 |
05/01/2019 |
Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentra |
Invacare Corporation |
Elijah Wreh |
| K191448 |
05/31/2019 |
Barrier Sleeves |
Ivoclar Vivadent, AG |
Sandra Cakebread |
| K191453 |
05/31/2019 |
Cervitec F |
Ivoclar Vivadent, AG |
Sandra Cakebread |
| K191382 |
05/23/2019 |
IPS e.max CAD Abutment Solutions- extra systems |
Ivoclar Vivadent, AG |
Sandra Cakebread |
| K191191 |
05/03/2019 |
Neodent Implant System - Temporary Abutments |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Mariana Soares Hartmann |
| K191151 |
05/01/2019 |
JKH Stimulator Plus |
JKH USA, LLC |
Bill Quanqin Dai |
| K191357 |
05/21/2019 |
Flexible HD Cysto-Urethroscope System |
KARL STORZ Endoscopy-America, Inc. |
Irina Fedorov |
| K191293 |
05/14/2019 |
LCCS VC-S RF Cannula |
LCCS Products Limited |
Nick XU |
| K191235 |
05/08/2019 |
Leltek Ultrasound Imaging System |
Leltek Inc |
Kiefe Chang |
| K191188 |
05/03/2019 |
ASHK100G |
LG Electronics |
Jinhwan Jun |
| K191402 |
05/24/2019 |
Heater-Cooler System 3T |
LivaNova Deutschland GmbH |
Scott Light |
| K191210 |
05/06/2019 |
Longeviti ClearFit Cranial Implant |
Longeviti Neuro Solutions, LLC |
Jesse Christopher |
| K191161 |
05/01/2019 |
xTAG Gastrointestinal Pathogen Panel (GPP) |
Luminex Molecular Diagnostics, Inc. |
Tina Ip |
| K191160 |
05/01/2019 |
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) |
Luminex Molecular Diagnostics, Inc. |
Tina Ip |
| K191334 |
05/17/2019 |
Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 |
MATIA Robotics (US) Inc |
Necati Hacikadiroglu |
| K191441 |
05/30/2019 |
Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) |
Maxstar Industrial Co., Ltd. |
Jonghwa Lim |
| K191457 |
05/31/2019 |
BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) |
MED-EL Elektromedizinische Geraete GmbH |
Ines Roman Santiago |
| K191300 |
05/14/2019 |
MectaLock Ti Suture Anchor |
Medacta International SA |
Stefano Baj |
| K191266 |
05/10/2019 |
VitalScan ANS |
Medeia, Inc. |
Slav Danev |
| K191443 |
05/30/2019 |
MSDI Dental Implants System |
Medical Systems and Devices International Ltd. |
Iman Khorshid |
| K191378 |
05/23/2019 |
0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe |
Medline Industries, Inc. |
Stephanie Augsburg |
| K191212 |
05/06/2019 |
CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, |
Medos International SARL |
Sergio M. Cordeiro |
| K191242 |
05/09/2019 |
HEALIX ADVANCE SP BIOCOMPOSITE Anchor |
Medos International SARL |
Elizabeth Messana |
| K191267 |
05/10/2019 |
ImagingRing System on Rails |
MedPhoton GmbH |
Daniel Schaffarzick |
| K191296 |
05/14/2019 |
Pointe Scientific Creatinine Kinase (CK) Reagent Set |
MedTest Dx |
William Cripps |
| K191444 |
05/31/2019 |
Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir |
Medtronic, Inc. |
Harsh Dharamshi |
| K191328 |
05/16/2019 |
Megadyne Foot Switch |
Megadyne Medical Products, Inc. |
Sharon Sussex |
| K191307 |
05/14/2019 |
Palm Bladder Scanner - PBSV5.1 |
Mianyang Meike Electronic Equipment Co., Ltd. |
Wenjun Zhao |
| K191172 |
05/01/2019 |
Cepheid Xpert MRSA NxG Control Panel |
Microbiologics, Inc. |
Tina Sobania |
| K191168 |
05/01/2019 |
Cepheid Xpert SA Nasal Complete Control Panel |
Microbiologics, Inc. |
Tina Sobania |
| K191451 |
05/31/2019 |
CMDR 2CW (Multiple models) |
MinXray, Inc |
Keith Kretchmer |
| K191371 |
05/22/2019 |
MolecuLight i:X |
MolecuLight Inc. |
Anil Amlani |
| K191376 |
05/23/2019 |
Modular Power Standing System |
Motion Concepts |
Dona Bhamra |
| K191220 |
05/07/2019 |
Pure Vu System |
Motus GI Medical Technologies Ltd. |
Ravit Peled |
| K191400 |
05/24/2019 |
Voyager Trajectory Array Guide (V-TAG) |
MRI Interventions, Inc. |
Pete Piferi |
| K191278 |
05/13/2019 |
RSI-MRI+ |
MultiModal Imaging Services Corporation (dba HealthLytix) |
Stephen Kosnosky |
| K191435 |
05/30/2019 |
IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 |
Nalu Medical, Inc. |
Michele Chin-Purcell |
| K191363 |
05/22/2019 |
Neocis Planning Software Application (NPSA) for 3rd Party PCs |
Neocis Inc. |
Thomas ("Ted") E. Claiborne |
| K191424 |
05/29/2019 |
Interphalangeal Joint Fusion Device Range |
Neosteo |
Anne-Cecile Grandremy |
| K191415 |
05/28/2019 |
Pathfinder Endoscope Overtube |
Neptune Medical, Inc. |
Alex Tilson |
| K191181 |
05/02/2019 |
NXPRO Neuromuscular Electrical Stimulation Device |
NeuX Technologies, Inc. |
Scot Minniear |
| K191275 |
05/13/2019 |
AllÆInCath 035M PTA Balloon Dilatation Catheter |
NexStep Medical |
Angela Mallery |
| K191408 |
05/28/2019 |
Nexxt Matrixx System |
Nexxt Spine LLC |
Andy Elsbury |
| K191359 |
05/21/2019 |
Nipro Syringe |
Nipro Medical Corporation |
Jessica Oswald-McLeod |
| K191403 |
05/24/2019 |
Pulse Oximeter |
Nonin Medical, Inc. |
Walter Holbein |
| K191365 |
05/22/2019 |
Stat Profile Prime ES Comp Plus Analyzer System |
Nova Biomedical Corporation |
Cesidio Tempesta |
| K191336 |
05/17/2019 |
PRECICE System |
NuVasive Specialized Orthopedics, Inc. |
Aditya Sharma |
| K191169 |
05/01/2019 |
NuVasive« Camber Laminoplasty System |
NuVasive, Incorporated |
Thao Huynh |
| K191401 |
05/24/2019 |
PregSense |
Nuvo-Group Ltd. |
Adar Shani |
| K191230 |
05/08/2019 |
Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves |
O & M Halyard, Inc. |
Steve Dowdlley |
| K191183 |
05/02/2019 |
EyeBOX |
Oculogica, Inc. |
Rosina Samadani |
| DEN190026 |
05/15/2019 |
iTEAR Neurostimulator |
Olympic Ophthalmics, Inc. |
Michael Gertner |
| K191288 |
05/13/2019 |
Acuitas AMR Gene Panel |
OpGen, Inc. |
Autumn Collasius |
| DEN190025 |
05/13/2019 |
OraQuick Ebola Rapid Antigen Test |
OraSure Technologies, Inc. |
Tiffany Miller |
| K191158 |
05/01/2019 |
The AIO Solution |
Orfit Industries NV |
Eddy Marivoet |
| K191317 |
05/15/2019 |
StitchKit |
Origami Surgical |
John Gillespie |
| K191316 |
05/15/2019 |
VITROS XT Chemistry Products ALB-TP Slides |
Ortho-Clinical Diagnostics, Inc. |
Darlene Phillips |
| K191241 |
05/08/2019 |
AutoStrut |
OrthoSpin |
Oren Cohen |
| K191179 |
05/02/2019 |
Myo Plus |
Otto Bock Healthcare Products GmbH |
Rene Urtz |
| K191227 |
05/07/2019 |
Paratrooper Plantar Plate Repair System |
Paragon 28, Inc. |
Eric Lintula |
| K191440 |
05/30/2019 |
Paragonix SherpaPak Pancreas Transport System |
Paragonix Technologies |
Lisa M. Anderson |
| K191270 |
05/13/2019 |
Proneb Max |
PARI Respiratory Equipment, Inc. |
Michael Judge |
| K191282 |
05/13/2019 |
PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family |
PENTAX of America, Inc. |
William Goeller |
| K191195 |
05/03/2019 |
PiccGuard |
PiccGuard LLC |
Katie Justus |
| K191222 |
05/07/2019 |
Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV |
Prismatik Dentalcraft, Inc. |
Herbert Schoenhoefer |
| K191200 |
05/06/2019 |
TULSA-PRO System |
PROFOUND MEDICAL INC. |
Goldy Singh |
| K191295 |
05/14/2019 |
Percutaneous Introducer Needle |
Progressive Medical, Inc. |
Roland D. Sullivan |
| K191356 |
05/21/2019 |
i3 Foldable Mobility Scooter |
PUC Perfect Union Co., LTD. |
Anita Chen |
| K191384 |
05/23/2019 |
RayCare 2.3 |
RaySearch Laboratories AB (publ) |
David Hedfors |
| K191315 |
05/15/2019 |
Remington Medical, Inc. Automatic Cutting Needle (NAC) |
Remington Medical, Inc. |
Caitlin Senter |
| K191419 |
05/28/2019 |
Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire |
Rex Medical, L.P. |
Colin Valentis |
| K191225 |
05/07/2019 |
EEG Electrode Template |
Rhythmlink International, LLC |
Gabriel Orsinger |
| K191162 |
05/01/2019 |
EpiLaze Multi-wavelength Laser |
Rohrer Aesthetics, LLC |
Mark Rohrer |
| K191436 |
05/30/2019 |
Saalio |
Saalmann medical GmbH & Co. KG |
Rolf Eilers |
| DEN190028 |
05/24/2019 |
MyCare Psychiatry Clozapine Assay Kit |
Saladax Biomedical Inc |
Sue Werner |
| K191349 |
05/20/2019 |
980nm Diode Laser Therapy Device |
Shanghai Apolo Medical Technology Co., Ltd. |
Felix Li |
| K191157 |
05/01/2019 |
uMR 780, uMR 790 |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K191180 |
05/02/2019 |
Electronic Blood Pressure Monitor |
Shenzhen AOJ Medical Technology Co., Ltd. |
Qihuan Zhao |
| K191251 |
05/09/2019 |
Infared Thermometer |
Shenzhen Calibeur Industries Co., Ltd. |
Weibin He |
| K191279 |
05/13/2019 |
Disposable SpO2 Sensor |
Shenzhen Caremed Medical Technology Co., Ltd. |
Alan Xie |
| K191428 |
05/29/2019 |
ECG Cable |
Shenzhen Changke Connect Electronics Co., Ltd. |
Yahui Zhou |
| K191253 |
05/09/2019 |
Reusable NIBP Cuff |
Shenzhen Changke Connect Electronics Co., Ltd. |
Yahui Zhou |
| K191420 |
05/28/2019 |
Reusable SpO2 Sensor |
Shenzhen Changke Connect Electronics Co., Ltd. |
Yahui Zhou |
| K191347 |
05/20/2019 |
Paragon XHD Diagnostic Ultrasound System |
Shenzhen Wisonic Medical Technology Co., Ltd. |
Jiang Xiaosan |
| K191430 |
05/29/2019 |
Pulse Oximeter |
Shenzhen Yimi Life-Technology Co.,Ltd. |
Shande Peng |
| K191454 |
05/31/2019 |
Atellica CH Amylase_2 (AMY_2) |
Siemens Healthcare Diagnostics Inc. |
Catherine Daigle |
| K191418 |
05/28/2019 |
Multix Fusion Max |
Siemens Medical Solutions USA, Inc. |
Martin Rajchel |
| K191309 |
05/14/2019 |
syngo.via MI Workflows VB40A, Scenium |
Siemens Medical Soultions USA, Inc. |
Veronica Padharia |
| K191299 |
05/14/2019 |
Silhouette Featherlift / Silhouette Lift |
Silhouette Lift Inc. |
Anthony DiBernardo |
| K191320 |
05/15/2019 |
Slow Wave DS8 |
Slow Wave, Inc. |
Wayne R. Wagner |
| K191231 |
05/08/2019 |
Andorate Auxiliary Water Connector, Andorate Valves Set |
Smartdata Suzhou Co., Ltd |
Cindy Ye |
| K191366 |
05/22/2019 |
Vacutore Air/Water Bottle Tubing |
Smartdata Suzhou Co., Ltd |
Cindy Ye |
| K191211 |
05/06/2019 |
JOURNEY II Unicompartmental Knee System |
Smith & Nephew, Inc. |
Meenakshi Gupta |
| K191177 |
05/02/2019 |
LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head |
Smith and Nephew, Inc. |
Kathleen Solomon |
| K191421 |
05/28/2019 |
Sofacia System |
Sofwave Medical Ltd. |
Ruthie Amir |
| K191422 |
05/29/2019 |
Neural Navigator |
Soterix Medical, Inc. |
Abhishek Datta |
| K191250 |
05/09/2019 |
Southern Implants PEEK Abutments |
Southern Implants (Pty) Ltd |
Lauranda Breytenbach |
| K191184 |
05/03/2019 |
ImmuView S pneumoniae and L pneumophila Urinary Antigen Test |
SSI Diagnostica A/S |
Pernille Landsbo Elverdal |
| K191343 |
05/20/2019 |
SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 |
STERIS Corporation |
Jennifer Nalepka |
| K191259 |
05/10/2019 |
Stryker CrossFlow Integrated Arthroscopy Pump |
Stryker Corp. |
Justin Florence |
| K191412 |
05/28/2019 |
VariAx 2 System, VariAx 2 Mini Fragment System |
Stryker GmbH |
Sanja Jahr |
| K191414 |
05/28/2019 |
EXETER Centralizer, EXETER 2.5mm Plug |
Stryker Orthopaedics |
Denise Daugert |
| K191271 |
05/13/2019 |
T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System |
Stryker Trauma Gmbh |
Heike Gustke |
| K191192 |
05/03/2019 |
SurgTech GENOLL Total Knee System |
SurgTech, Inc. |
Xuegong Yu |
| K191283 |
05/13/2019 |
Infrared Thermometer, Breeze model |
Suzhou Melodicare Medical Technology Co.,Ltd. |
Xiaoqian Zou |
| K191207 |
05/06/2019 |
Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System |
Taiwan Aulisa Medical Devices Technologies, Inc. |
Paul Liu |
| K191456 |
05/31/2019 |
Campylobacter Quik Chek |
Techlab, Inc |
Donna Link |
| K191442 |
05/30/2019 |
Campylobacter Chek |
Techlab, Inc. |
Donna Link |
| K191247 |
05/09/2019 |
SmartSPACE Shoulder System |
TechMah Medical LLC |
Mohamed R. Mahfouz |
| K191268 |
05/13/2019 |
Force Fiber Suture |
Teleflex Medical Incorporated |
Andrea Curria |
| K191312 |
05/15/2019 |
Perfect PFE |
TensCare Ltd. |
Andrew Brown |
| K191297 |
05/14/2019 |
iNSitu Bipolar Hip System |
Theken Companies, LLC |
Garrett Spurgeon |
| K191369 |
05/22/2019 |
TSolution One Total Knee Application |
THINK Surgical, Inc. |
Meliha Mulalic |
| K191318 |
05/15/2019 |
AEQUALIS FLEX REVIVE Shoulder System |
Tornier, Inc. |
Katie Molland |
| K191399 |
05/24/2019 |
BIOLOX CONTOURA Ceramic Femoral Head |
Total Joint Othopedics, Inc. |
Chris Weaber |
| K191264 |
05/10/2019 |
Every Second Matters-Uterine Balloon Tamponade (ôESM-UBTö) |
Ujenzi Charitable Trust |
Thomas Burke |
| K191171 |
05/01/2019 |
EchoGo Core |
Ultromics Ltd |
Melissa Clark |
| K191214 |
05/06/2019 |
JO Premium Jelly Original Personal Lubricant |
United Consortium |
Stephanie Morris |
| K191308 |
05/14/2019 |
U-Aligner |
Universal Orthodontic Laboratory Inc |
Jiahe Li |
| K191208 |
05/06/2019 |
Spectra Cashmere |
Uzinmedicare Co. |
Nathan Ahn |
| K191289 |
05/13/2019 |
Bone Screw Line Addition |
Vilex in Tennessee, Inc |
Victor Lavi |
| K191397 |
05/24/2019 |
OxySoft (olifilcon C) silicone hydrogel soft contact lens |
Visco Vision Inc. |
Evan Huang |
| K191273 |
05/13/2019 |
Multi-Link X2 ECG and SpO2 Adapter |
Vyaire Medical, Inc. |
Suzanne Moreno |
| K191154 |
05/01/2019 |
Hair Boom 69 |
Wontech |
Gyuri (Erin) Park |
| K191393 |
05/24/2019 |
INFINITY Total Ankle System, INBONE Total Ankle System |
Wright Medical Technology, Inc. |
Rachel Roberts |
| K191332 |
05/16/2019 |
XACT Robotic System |
XACT Robotics Ltd. |
Chen Levin |
| K191423 |
05/29/2019 |
Normandy VBR System |
Zavation Medical Products LLC |
Frankie Cummins |
| K191354 |
05/21/2019 |
Ti3Z Cervical Interbody System |
Zavation Medical Products, LLC |
Katie Motley |
| K191339 |
05/20/2019 |
Zavation eZspand Interbody System |
Zavation Medical Products, LLC |
Matt Jones |
| K191398 |
05/24/2019 |
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System |
ZEUS Scientific Inc. |
Mark J. Kopnitsky |
| K191240 |
05/08/2019 |
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System |
ZEUS Scientific Inc. |
Mark J. Kopnitsky |
| K191238 |
05/08/2019 |
Zimmer Guide Wire Devices |
Zimmer, Inc |
Annette Minthorn |
| K191449 |
05/31/2019 |
ZCA All-Poly Acetabular Cups |
Zimmer, Inc. |
Caleb Barylski |
