| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K182835 |
03/27/2019 |
WOLF Thrombectomy Device |
880 Medical, LLC |
Micheal P. Wallace |
| K173191 |
03/21/2019 |
A&D Medical Blood Pressure Monitors |
A&D Company, Ltd. |
Jerry Wang |
| K182981 |
03/29/2019 |
Confirm Rx Insertable Cardiac Monitor |
Abbott |
Laura Sparks |
| K190294 |
03/15/2019 |
CELL-DYN Emerald 22 AL System |
Abbott Laboratories |
Madhu Gill |
| K181610 |
03/12/2019 |
ActivOrtho Nitinol Compression Screw System |
ActivOrtho, Inc |
Paul Hindrichs |
| K182123 |
03/29/2019 |
ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card |
Advin Biotech, Inc. |
Lorraine Cogan |
| K183180 |
03/12/2019 |
Caiman 5 Maryland |
Aesculap, Inc. |
Jessica Stigliano |
| K182013 |
03/11/2019 |
EasyInstruments |
Agency for Medical Innovations GmbH |
Martin Hohlrieder |
| K181777 |
03/29/2019 |
AggreGuide A-100 ADP |
Aggredyne, Inc. |
Phillip Speros |
| K190392 |
03/26/2019 |
WaveLight FS200 Patient Interface |
Alcon Laboratories, Inc. |
Ophelia Biggs |
| K190204 |
03/18/2019 |
ID NOW Influenza A & B 2 |
Alere Scarborough, Inc. |
Angela Drysdale |
| K181823 |
03/11/2019 |
KardiaAI |
AliveCor, Inc. |
Prabhu Raghavan |
| K183705 |
03/01/2019 |
IdentiTi Porous Ti Interbody System |
Alphatec Spine, Inc. |
Cynthia Adams |
| K182948 |
03/22/2019 |
Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs |
Ansell Healthcare Products, LLC. |
Don Cronk |
| K183508 |
03/29/2019 |
Micro Transgastric-Jejunal Feeding Device |
Applied Medical Technology, Inc. |
Joy Tubero |
| K182804 |
03/01/2019 |
Traditional Length GJ Feeding Device |
Applied Medical Technology, Inc. |
Joy Tubero |
| K183628 |
03/26/2019 |
Arthrex TensionLoc System |
Arthrex Inc. |
Stacy Valdez |
| K182799 |
03/08/2019 |
Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads |
Arthrex Inc. |
David L Rogers |
| K182965 |
03/29/2019 |
BL-Cart IOL Delivery Cartridge |
AST Products, Inc. |
William Lee |
| K182870 |
03/07/2019 |
Introcan Safety 3 Closed IV Catheter |
B. Braun Medical Inc. |
Tracy Larish |
| K173064 |
03/08/2019 |
ZAPnea Oral Appliance |
B. Fareid, DDS, PC |
Behzad Fareid |
| K182918 |
03/21/2019 |
Ballast 088 Long Sheath |
Balt USA LLC |
Bilal Chamas |
| K182064 |
03/21/2019 |
ExpanSure Transseptal Dilation System |
Baylis Medical Company Inc. |
May Tsai |
| K181929 |
03/27/2019 |
MiMo(TM) Negative Pressure Wound Therapy System |
Baymax Research, Inc. |
Richard Chen |
| K183592 |
03/21/2019 |
ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer |
Beckman Coulter |
Anthony Dennis |
| K181475 |
03/01/2019 |
DxH 520 Hematology Instrument |
Beckman Coulter |
Samy Puccio |
| K181599 |
03/18/2019 |
Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application |
Beckman Coulter |
Radha Goolabsingh |
| K183399 |
03/20/2019 |
BD Nexiva Closed IV Catheter System |
Becton Dickinson Infusion Therapy Systems Inc. |
Kimberly Geisler |
| K182589 |
03/14/2019 |
BD Plastipak Syringe |
Becton, Dickinson and Company |
Leslie Robinson-Frye |
| K181730 |
03/01/2019 |
BD Vacutainer Eclipse UltraFill Blood Collection Needle |
Becton, Dickinson and Company |
Eileen Hiller |
| K181447 |
03/12/2019 |
Safety insulin needle for single use |
Berpu Medical Technology Co., Ltd |
Jundong Tan |
| K183446 |
03/12/2019 |
BioPlex 2200 Lyme Total |
Bio-Rad Laboratories |
Arlene Carillo |
| K182344 |
03/07/2019 |
RhythmAnalytics |
Biofourmis Singapore Pte. Ltd. |
Kuldeep Singh Rajput |
| K190311 |
03/13/2019 |
BIOK7600 Flat Panel Detector |
Biokinemetrics Inc. |
Steven Kraus |
| K190300 |
03/13/2019 |
BIOK7600W Wireless Flat Panel Detector |
Biokinemetrics Inc. |
Steven Kraus |
| K183551 |
03/07/2019 |
VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL) |
bioMerieux, Inc. |
Craig Buehler |
| K183524 |
03/12/2019 |
VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) |
bioMerieux, Inc. |
Esther Hernandez |
| K190285 |
03/14/2019 |
L300 Go System |
Bioness Inc. |
Mercedes Bayani |
| K190184 |
03/07/2019 |
iSLEEVE Introducer Set |
Boston Scientific |
Kripa Pandya |
| K181905 |
03/25/2019 |
AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System |
Boston Scientific Corporation |
Kayla Mackey |
| K183085 |
03/08/2019 |
CoreDxÖ Pulmonary Mini-Forceps |
Boston Scientific Corporation |
Elena Nieves |
| K190401 |
03/15/2019 |
MAMBA and MAMBA Flex Microcatheters |
Boston Scientific Corporation |
Kevin Catalano |
| K183177 |
03/08/2019 |
Nitinol Thermocouple (TCN) Electrode |
Boston Scientific Corporation |
Adele Shoustal |
| K183610 |
03/12/2019 |
Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces |
Bovie Medical Corporation |
Rubiela Maldonado |
| K183303 |
03/08/2019 |
Brainsway Deep TMS System |
Brainsway Ltd. |
Moria Ankri |
| K183702 |
03/01/2019 |
Polar Care Wave |
Breg Inc. |
Monique Zamora |
| K181669 |
03/14/2019 |
ConvertX Biliary Stent System |
BrightWater Medical |
Bob Smouse |
| K190023 |
03/29/2019 |
BTL-084 |
BTL Industries, Inc. |
David Chmel |
| K183657 |
03/15/2019 |
Vantage Galan 3T, MRT-3020/A9, V5.0 |
Canon Medical Systems Corporation |
Paul Biggins |
| K190368 |
03/13/2019 |
Enhanced Feature Software Pack CXDI Series |
Canon, Inc. |
Yamazaki Tatsuya |
| K181682 |
03/06/2019 |
VISULAS green |
Carl Zeiss Meditec AG |
Christian Munster |
| K183448 |
03/08/2019 |
NewTom 5G XL |
Cefla S.C. |
Elena Arcangeli |
| K190302 |
03/27/2019 |
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, |
Centers for Disease Control and Prevention |
Yon Yu |
| K181882 |
03/27/2019 |
eKuore One electronic interface for stethoscope |
Chip Ideas Electronics S.L |
Bernardo Plaza Trujillo |
| K183397 |
03/06/2019 |
ChoiceSpine Stealth Cervical Spacer System |
ChoiceSpine, LP |
Kim Finch |
| K183259 |
03/01/2019 |
IdysÖ TLIF TiVac |
Clariance SAS |
Clement Chaumont |
| K190234 |
03/01/2019 |
ODI HD Dental Sensor |
CND Global Technologies, Inc. |
Neeti Rathor |
| K182074 |
03/21/2019 |
Mineral Collagen Composite Bioactive Moldable |
Collagen Matrix, Inc. |
Gloria Zuclich |
| K190303 |
03/28/2019 |
AirSeal |
ConMed Corporation |
Lisa Anderson |
| K183600 |
03/13/2019 |
Anchor Bag-Alone Tissue Retrieval System by ConMed |
ConMed Corporation |
Jessica Swafford |
| K190333 |
03/18/2019 |
Paradigm All-Suture Anchor 1.8mm, White/Black #2 |
ConMed Corporation |
Orjada Dervishleri |
| K181165 |
03/07/2019 |
Philips wearable biosensor-G5 Solution |
Connected Sensing- A Division of Philips Medical Systems |
Katie Pacheco |
| K181770 |
03/29/2019 |
Intrauterine Access Balloon Catheter, Selective Salpingography Catheter |
Cook Incorporated |
Ian Herrman |
| K181735 |
03/27/2019 |
Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set |
Cook Incorporated |
Paul Meyer |
| K181722 |
03/22/2019 |
Polyethylene Catheter |
Cook Incorporated |
Reuben Lidster |
| K190099 |
03/15/2019 |
Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch |
Corinth MedTech, Inc. |
Sandeep Saboo |
| K183437 |
03/12/2019 |
AirRay Subdural Cortical Electrodes |
CorTec GmbH |
Mara Assis |
| K182813 |
03/15/2019 |
COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT |
Cotton High Tech, SL |
Anna Garcia Llado |
| K182861 |
03/22/2019 |
Shiley Neonatal/Pediatric Tracheostomy Tube |
Covidien |
Yaara Basevitch |
| K182475 |
03/14/2019 |
Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters) |
Covidien |
Katherine Y. Choi |
| K183285 |
03/08/2019 |
cmTriage |
CureMetrix, Inc |
Kevin Harris |
| K190073 |
03/27/2019 |
Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub |
Current Health Ltd |
Edwin Lindsay |
| K180050 |
03/01/2019 |
CurvaFix Intramedullary Rodscrew System |
CurvaFix, Inc. |
Steve Dimmer |
| K190366 |
03/18/2019 |
BRAUN Silk Expert Pro 3 |
CyDen Limited |
Adam Stephens |
| K190354 |
03/18/2019 |
BRAUN Silk.expert Pro 5 |
CyDen Limited |
Adam Stephens |
| K183201 |
03/06/2019 |
Hearing Healthcare Pro |
dB Diagnostic Systems, Inc. |
Steven Levine |
| K182609 |
03/29/2019 |
Delphos Implants Rigid Fixation System |
Delphos Implants - Ind.Com. Importacao e Exportacao de |
Vitor Monsanto |
| K190423 |
03/19/2019 |
Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System |
Devon Medical Products (Jiangsu) Ltd |
Neil Cheng |
| K182966 |
03/06/2019 |
PLANET Onco Dose |
DOSIsoft |
Marc Uszynski |
| K182537 |
03/08/2019 |
RADMAX Digital Imaging Software |
DRGEM Corporation |
Ki-Nam Yang |
| K182164 |
03/29/2019 |
Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand |
Ecolab Inc. |
Jennifer Willner |
| K190186 |
03/28/2019 |
Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System |
Edan Instruments, Inc. |
Melody Huang |
| K190153 |
03/08/2019 |
RadiForce MX216 |
EIZO Corporation |
Hiroaki Hashimoto |
| K183260 |
03/18/2019 |
Sensilight Pro / Pistol IPL |
EL Global Trade Ltd. |
Shachar Raz |
| K190178 |
03/29/2019 |
Monaco RTP System |
Elekta, Inc. |
Kathryn Stinson |
| K181173 |
03/22/2019 |
ELMED Laparoscopic Instruments and Accessories |
ELMED Incorporated |
Werner Hausner |
| K183400 |
03/22/2019 |
EnVisio Navigation Sytem |
Elucent Medical, Inc |
Debra Kridner |
| K173793 |
03/01/2019 |
XactTrace Single Use Respiratory Effort Belt System |
Embla Systems |
Sanjay Mehta |
| K190098 |
03/07/2019 |
Endophys Pressure Sensing Sheath |
Endophys Holdings LLC |
Phillip Purdy |
| K190256 |
03/08/2019 |
Rulo Radiofrequency Lesion Probe |
Epimed International, Inc. |
Preston H. Frasier |
| K182502 |
03/13/2019 |
Alteon Acetabular Cup System |
Exactech, Inc |
Patrick Hughes |
| K183603 |
03/12/2019 |
INnate Cannulated Screw System |
Exsomed Corporation |
Moira Barton-Varty |
| K181656 |
03/05/2019 |
ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color) |
Eyemed Technologies S.r.l. |
Franco Ceravolo |
| K182511 |
03/20/2019 |
SimplCath |
F&S Medical Solutions, LLC |
Sonia M. Rocha-Sanchez |
| K183142 |
03/14/2019 |
PathVisionXL |
Faxitron Bioptics LLC |
Ciaran Purdy |
| K183289 |
03/06/2019 |
ClearGrasp Snare |
Finemedix Co., Ltd. |
Hee Kyung Kwon |
| K181745 |
03/28/2019 |
FUJIFILM Duodenoscope Model |
FUJIFILM Corporation |
Randy Vader |
| K190232 |
03/26/2019 |
Synapse PACS |
FUJIFILM Corporation |
Randy Vader |
| K190476 |
03/15/2019 |
FUJIFILM Sonosite Vevo MD Imaging System |
FUJIFILM SonoSite, Inc. |
Anoush Frankian |
| K183210 |
03/29/2019 |
Thoracic VCAR with GSI Pulmonary Perfusion |
GE Medical Systems SCS |
Peter Uhlir |
| K183366 |
03/06/2019 |
GenePOC Strep A |
GenePOC Inc. |
Dany Leblanc |
| K182571 |
03/15/2019 |
CardioFlux with Faraday Analytical Cloud |
Genetesis Inc. |
Robert Sokolowski |
| K190168 |
03/14/2019 |
Aquas Probes |
Genicon, Inc. |
Katlyn Kachman |
| K190296 |
03/13/2019 |
GammaTile |
GT Medical Technologies |
Jessica Newhard |
| K182413 |
03/07/2019 |
Electric Breast Pump |
Guangdong Horigen Mother & Baby Products Co., Ltd. |
Jun Deng |
| K181360 |
03/22/2019 |
ON-Q* Pump with Bolus |
Halyard Health |
Neerav Parikh |
| K182738 |
03/27/2019 |
Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick |
Hangzhou AllTest Biotech Co., Ltd |
Feng-Yu Lee |
| K190412 |
03/21/2019 |
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup |
Hangzhou Clongene Biotech Co.,Ltd. |
Zheng Shujian |
| K190357 |
03/15/2019 |
Star-X, Intraoral X-ray System |
HDX WILL Corp. |
Myoung-Joon Lee |
| K182554 |
03/22/2019 |
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs |
He Chuang Plastic & Rubber Co., Ltd |
Coco Wang |
| DEN180017 |
03/12/2019 |
Quantra Hemostasis Analyzer, QPlus Cartridge |
HemoSonics, LLC |
Anne Zavertnik |
| K182793 |
03/19/2019 |
AP3600 Automated Instrument |
Hitachi Chemical Diagnostics, Inc. |
Donald Postel |
| K190347 |
03/15/2019 |
HIVOX OTC Electrical Stimulator |
Hivox Biotek Inc. |
Marx Lee |
| K183154 |
03/26/2019 |
SM Electrodes |
Hong Qiangxing (Shen Zhen) Electronics Limited |
Xu Jianhua |
| K182468 |
03/19/2019 |
Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System |
Howmedica Osteonics Corp aka Stryker Orthopaedics |
Shahrir Alam |
| K180924 |
03/29/2019 |
Reflect Implant System |
ids - integrated dental systems |
Elizabeth Marrero |
| K182771 |
03/12/2019 |
ISS-JAZZ Screw System and JAZZ CAP SP |
Implanet, S.A. |
Fabienne Larquey Cadiere |
| K181778 |
03/25/2019 |
MUTARS Proximal Femur Replacement System |
implantcast GmbH |
Juliane Hoppner |
| K182022 |
03/15/2019 |
ApexMV |
InControl Medical, LLC |
Corey Olson |
| K182311 |
03/07/2019 |
Cervella |
Innovative Neurological Devices LLC |
Bart Waclawik |
| DEN180012 |
03/28/2019 |
LOADPROÖ Intraoperative Rod Strain Sensor |
Intellirod Spine, Inc. |
Richard R. Navarro |
| K181716 |
03/25/2019 |
InTouch Thermal Camera |
InTouch Technologies, Inc., d.b.a. InTouch Health |
Karen Mullin |
| K182371 |
03/14/2019 |
da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories |
Intuitive Surgical, Inc. |
Mike Yramategui |
| K180903 |
03/29/2019 |
3880 MRI Patient Monitoring System |
Iradimed Corporation |
Francis X. Casey |
| K183380 |
03/14/2019 |
Tetric PowerFill |
Ivoclar Vivadent, AG |
Schaan Cakebread |
| K183408 |
03/20/2019 |
Jensen Shade Effect Liquids |
Jensen Industries, Inc. |
Jordan Schreck |
| K180852 |
03/01/2019 |
Manual Wheelchair |
Jiangyin Newrise Medical Equipment Co., Ltd |
Huang Bing |
| K182203 |
03/14/2019 |
JKH Stimulator Plus |
JKH USA, LLC |
Bill Quanqin Dai |
| K182186 |
03/22/2019 |
CMOS Video-Rhino-Laryngoscope System |
KARL STORZ Endoscopy-America, Inc. |
Nozomi Yagi |
| K183543 |
03/20/2019 |
ACTIV.A.C. Therapy Unit |
KCI USA, Inc. |
Teri Feeley |
| K181505 |
03/28/2019 |
V.A.C. DERMATAC Drape |
KCI USA, Inc. |
Melanie Avila |
| K181788 |
03/01/2019 |
Lead-free Chemical Indicators for Steam Sterilization |
Kem Medical Products Corp. |
Douglas A. Kruger |
| K182789 |
03/11/2019 |
KLS Martin Individual Patient Solutions (IPS) Planning System |
KLS-Martin L.P. |
Jennifer Damato |
| K183092 |
03/08/2019 |
Kuros TLIF Cage |
Kuros Biosciences BV |
Yvonne P. Bovell |
| K190425 |
03/21/2019 |
CastleLoc-P Anterior Cervical Plate System |
L&K BIOMED Co., Ltd. |
Jihyeon Seo |
| K183247 |
03/14/2019 |
dpl Faceware |
LED Technologies, Inc. |
Lloyd Nelson |
| DEN180024 |
03/28/2019 |
Leica FL400 |
Leica Microsystems (Schweiz) AG |
Grainne Griffin |
| K183430 |
03/13/2019 |
Modular Spinal Fixation System |
Life Spine Inc. |
Angela Batker |
| K183527 |
03/19/2019 |
MTS Ciprofloxacin 0.002 - 32 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K190252 |
03/22/2019 |
MTS Gentamicin 0.016 - 256 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K190141 |
03/07/2019 |
HANAROSTENT LowAx Colon/Rectum (NNN) |
M.I.Tech Co., Ltd. |
Inae Kim |
| K180842 |
03/05/2019 |
MAC Medical D-Series Blanket and Solution Warming Cabinets |
MAC Medical Inc. |
Dennis Cooper |
| K182853 |
03/15/2019 |
HORIZON TMS Therapy System |
Magstim Company Ltd. |
Tom Campbell |
| K180098 |
03/19/2019 |
SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 |
Maquet Critical Care AB |
Jerker Aberg |
| K182887 |
03/22/2019 |
Masimo Rad-67 Pulse CO-Oximeter and Accessories |
Masimo Corporation |
Sindura Penubarthi |
| K183105 |
03/27/2019 |
Mimics Medical |
Materialise NV |
Carina Martins |
| K181843 |
03/04/2019 |
MLP Special Locking Bone Plate System |
Maxxion Medical, LLC / Baumer SA |
Bruno Baumer |
| K183373 |
03/07/2019 |
Bonebridge |
MED-EL Elektromedizinische Geraete GmbH |
Stephanie Haselwanter |
| K183426 |
03/15/2019 |
MectaLIF Anterior Stand Alone Extension |
Medacta International SA |
Stefano Baj |
| K183582 |
03/21/2019 |
MPACT Extension |
Medacta International SA |
Stefano Baj |
| K182313 |
03/11/2019 |
BoneTrust Implant System |
Medical Instinct Deutschland GmbH |
Jan Worlitz |
| K190224 |
03/08/2019 |
Medline Burn and Wound Dressing (OTC) |
Medline Industries, Inc. |
Claire Pigman |
| K181782 |
03/04/2019 |
Medline Reinforced Epidural Catheter |
Medline Industries, Inc. |
Claire Pigman |
| K182848 |
03/22/2019 |
ROSA ONE Spine application |
Medtech S.A. |
Serge Tabet |
| K183453 |
03/04/2019 |
VS3-IR |
Medtronic |
Alex Chanin |
| K183511 |
03/18/2019 |
Affinity PixieÖ Oxygenator with BalanceÖ Biosurface (Model BBP211), Affinity PixieÖ Oxygenator and Cardiotomy/Venous Reservoir with BalanceÖ Biosurface (Model BBP241), Affinity PixieÖ Oxygenator with CortivaÖ BioActive Surface (Model CBP211), Affinity Pix |
Medtronic Inc |
Tyler Senjem |
| K183493 |
03/15/2019 |
SelectSite C304-HIS Deflectable Catheter System |
Medtronic Inc. |
Sharon Fahy |
| K183353 |
03/22/2019 |
Telescope Guide Extension Catheter |
Medtronic Inc. |
Sharon Fahy |
| K181859 |
03/06/2019 |
Visualase Thermal Therapy System |
Medtronic Navigation Inc. |
Rishi Sinha |
| K190015 |
03/25/2019 |
Ballancer Gold, 1212 |
Mego Afek AC Ltd. |
Reuven Yunger |
| K181658 |
03/26/2019 |
MobileECG 2 BT |
Memtec Corporation |
Dennis Garboski |
| K181807 |
03/06/2019 |
Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device) |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Jennifer Correa |
| K190030 |
03/05/2019 |
Embrella Endoscopic Distal Attachment |
Micro-Tech (Nanjing) Co., Ltd. |
Becky Li |
| K183469 |
03/12/2019 |
Microlife Digital Blood Pressure Monitor |
Microlife Intellectual Property GmbH |
Gerhard Frick |
| K190379 |
03/19/2019 |
MIM on Linux |
MIM Software Inc. |
Lynn Hanigan |
| K180337 |
03/14/2019 |
EUROPA Pedicle Screw System |
MiRus, LLC |
Jordan Bauman |
| K182920 |
03/13/2019 |
MiRusÖ Lumbar Interbody Fusion System consisting of CALLISTOÖ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERIONÖ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSOÖ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARESÖ PEEK Anterior Lumbar |
MiRus, LLC |
Jordan Bauman |
| K182995 |
03/08/2019 |
Bariatric Power Positioning System (BPPS) |
Motion Concepts |
Dona Bhamra |
| K181633 |
03/15/2019 |
MTF Pre-Sutured Tendon |
Musculoskeletal Transplant Foundation |
Katrina Carroll |
| K183579 |
03/29/2019 |
Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneou |
Nalu Medical, Inc |
Michele Chin-Purcell |
| K183047 |
03/22/2019 |
Nalu Neurostimulation System |
Nalu Medical, Inc |
Michele Chin-Purcell |
| K183492 |
03/13/2019 |
JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd. |
Zilong Liang |
| K183236 |
03/11/2019 |
Rotium Bioresorbable Wick |
Nanofiber Solutions, LLC |
Ronald L. Bracken |
| K190377 |
03/21/2019 |
UroLift System UL400 |
NeoTract, Inc. |
Brian Gall |
| K182700 |
03/22/2019 |
Nexstim Navigated Brain Therapy (NBT) System 2 |
Nexstim Plc |
Anna Honkanen |
| K183529 |
03/19/2019 |
AE-120A EEG Head Set |
Nihon Kohden Corporation |
Tom Bento |
| K181932 |
03/01/2019 |
DTX Studio design |
Nobel Biocare AB |
Charlemagne Chua |
| K190418 |
03/21/2019 |
NuVasive« VersaTie« System |
NuVasive, Incorporated |
Joseph De La Rosa |
| K190380 |
03/21/2019 |
nvc |
Nvision Biomedical Technologies, Inc. |
Diana Langham |
| K190093 |
03/25/2019 |
Rezum Delivery Device, Rezum Generator |
NxThera (A Boston Scientific Company) |
Justin Kapitan |
| K183053 |
03/05/2019 |
Olympus Small Intestinal Capsule Endoscope System |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K182834 |
03/29/2019 |
CS-series-FP with Optional ROI Accessory CA-100S |
Omega Medical Imaging, LLC |
John Newman Newman |
| K182579 |
03/14/2019 |
Omron Model BP7900 Blood Pressure Monitor + EKG |
Omron Healthcare, Inc. |
Renee Thornborough |
| K181624 |
03/22/2019 |
Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line |
Oridion Medical 1987 Ltd. |
Dalia Givony |
| K190490 |
03/27/2019 |
VITROS XT Chemistry Products TRIG-CHOL Slides |
Ortho-Clinical Diagnostics, Inc. |
Alexandra Chamberlain |
| K190326 |
03/14/2019 |
VITROS XT Chemistry Products UREA-CREA Slides |
Ortho-Clinical Diagnostics, Inc. |
Darlene Phillips |
| K190430 |
03/22/2019 |
OsteoCentric Bone Plate and Screw System |
OsteoCentric Trauma |
Todd Evans |
| K181959 |
03/22/2019 |
HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) |
Owens& Minor Halyard, Inc. |
Shriya Kafle |
| K183573 |
03/14/2019 |
Vstrip H. pylori Antigen Rapid Test |
Panion & BF Biotech Inc. |
Ching Sui A. Yi |
| K183690 |
03/01/2019 |
Tenodesis Screw System |
Paragon 28,Inc. |
Eric Lintula |
| K183501 |
03/15/2019 |
Parcus Twist AP Suture Anchors |
Parcus Medical, LLC |
Paul Vagts |
| K183296 |
03/18/2019 |
REAL Immersive System |
Penumbra, Inc. |
Mary Rose |
| K190404 |
03/26/2019 |
OTIS Optical Coherence Tomography SYstem |
Perimeter Medical Imaging, Inc. |
Elizabeth Munro |
| K181871 |
03/01/2019 |
EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay |
Phadia AB |
Carina Magnusson |
| K183518 |
03/18/2019 |
Preat Abutments |
Preat Corporation |
Chris Bormes |
| K183440 |
03/12/2019 |
CRYOcheck FVIII Inhibitor Kit |
Precision BioLogic Inc. |
Karen M. Black |
| K190201 |
03/08/2019 |
CORUS Spinal System |
Providence Medical Technology, Inc. |
Janie Mandrusov |
| K182176 |
03/28/2019 |
Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs |
PT. Medisafe Technologies |
Sajeev Joseph |
| K183414 |
03/20/2019 |
ABSOLU |
Quantel Medical |
Bruno Pages |
| K182395 |
03/22/2019 |
OARtrac System |
RadialDyne, LLC |
John Isham |
| K183478 |
03/01/2019 |
ClearON Mobile |
Rayence Co.,Ltd |
Kevin Kim |
| K190446 |
03/27/2019 |
Responsive Arthroscopy Wedge Push-In Suture Anchors |
Responsive Arthroscopy LLC |
Douglas Kohrs |
| K190431 |
03/21/2019 |
Route 92 Medical Delivery Catheter |
Route 92 Medical Inc. |
Kathy Tansey |
| DEN180021 |
03/01/2019 |
Early Bird Bleed Monitoring System |
Saranas, Inc. |
Zaffer Syed |
| K183266 |
03/01/2019 |
EP-TRACER System |
Schwarzer CardioTek GmbH |
Tatjana Nuber |
| K183608 |
03/22/2019 |
Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile |
Scientia Vascular LLC |
David Sabodski |
| K180880 |
03/07/2019 |
DARI Health |
Scientific Analytics, Inc. |
Joel Hungate |
| K182173 |
03/06/2019 |
Joule System |
Sciton, Inc |
Jay M. Patel |
| K182628 |
03/05/2019 |
Imagio Ultrasound Imaging System |
Seno Medical Instruments, Inc. |
Katherin Harris |
| K183187 |
03/15/2019 |
nextaro Transfer System, nextaro va |
SFM Medical Devices GmbH |
Olaf Br÷msen |
| K183164 |
03/22/2019 |
uWS-MR |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K182495 |
03/03/2019 |
Electronic Blood Pressure Monitor |
Shenzhen Jumper Medical Equipment Co., Ltd. |
Jinhui Tang |
| K190206 |
03/08/2019 |
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System |
Shenzhen Mindray Bio-medical Electronics Co., LTD |
Zhang Wei |
| K182821 |
03/27/2019 |
Accutorr 7/VS-900/VS-900c Vital Signs Monitor |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
Yanhong Bai |
| K183238 |
03/13/2019 |
BeneVision Central Monitoring System |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
Yanhong Bai |
| K182710 |
03/01/2019 |
Fetal Doppler, Model FD88 |
ShenzZhen Luckcome Technology Inc., Ltd. |
Can He |
| K190373 |
03/15/2019 |
SonialVision G4 |
SHIMADZU corporation |
Toshio Kadowaki |
| K182225 |
03/04/2019 |
Dimension Vista High-Sensitivity Troponin I (TNIH) Assay |
Siemens Healthcare Diagnostics, Inc. |
Laura J. Duggan |
| K183575 |
03/20/2019 |
ACUSON S3000, S2000 Diagnostic Ultrasound System |
Siemens Healthineers |
Christine Dunbar |
| K182639 |
03/15/2019 |
MOBILETT Elara Max |
Siemens Medical Solutions, Inc. |
Denise Adams |
| K181822 |
03/21/2019 |
RENASYS Touch; RENASYS Y-Connector |
Smith & Nephew Medical Limited |
Lavinia Tompkins |
| K190253 |
03/11/2019 |
EVOS Small Fragment Upper Extremity Plates Line Additions |
Smith & Nephew, Inc |
Shereen Bienz |
| K183232 |
03/12/2019 |
Double ENDOBUTTON Fixation Device |
Smith and Nephew, Inc. |
Dharaben Desai |
| K190039 |
03/08/2019 |
EchoSure Diagnostic Ultrasound System |
Sonavex, Inc |
David Narrow |
| K190359 |
03/16/2019 |
Sonendo GentleWave System |
Sonendo, Inc. |
Eric Simon |
| K183176 |
03/12/2019 |
Endotoxin Activity Assay (EAA) |
Spectral Medical Inc. |
Danijela Domljanovic |
| K173518 |
03/07/2019 |
Spectrum Spine Expandable Cages (SSEC) |
Spectrum Spine, LLC |
James Robinson |
| K190322 |
03/04/2019 |
SCARLET« AC-T Secured Anterior Cervical Cage |
Spineart |
Franck Pennesi |
| K190193 |
03/04/2019 |
SpineEX Sagittae« Lateral Lumbar Interbody Fusion Devices |
SpineEX Inc. |
Andrew Rogers |
| K190055 |
03/07/2019 |
Duo Lumbar Interbody Fusion Device |
Spineology Inc. |
Andrew Adams |
| K181352 |
03/29/2019 |
Loop System |
Spry Health, Inc. |
Elad Ferber |
| K182241 |
03/11/2019 |
Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs |
Sri Trang Gloves (Thailand) Co., LTD |
Anan Pruksanusak |
| K190276 |
03/08/2019 |
Provident II Hip Stem |
StelKast, Inc. |
David Stumpo |
| K183410 |
03/27/2019 |
AMSCO 600 Steam Sterilizer |
STERIS Corporation |
Anthony Piotrkowski |
| K183402 |
03/01/2019 |
PRO-LITE Sterilization Tray |
STERIS Corporation |
Jennifer Nalepka |
| K183401 |
03/01/2019 |
Vis-U-All Low Temperature Sterilization Pouch/Tubing |
STERIS Corporation |
Jennifer Nalepka |
| K190104 |
03/22/2019 |
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System |
Steris Corporations |
Jennifer Nalepka |
| K182720 |
03/29/2019 |
Freedom Spinal Cord Stimulator (SCS) System |
Stimwave Technologies Incorporated |
Elizabeth Greene |
| K183464 |
03/13/2019 |
AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm) |
Stryker |
Germaine Fu |
| K183463 |
03/13/2019 |
AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm |
Stryker |
Germaine Fu |
| K183172 |
03/05/2019 |
Stryker SternalPlate System |
Stryker |
Hans Geiger |
| K183019 |
03/19/2019 |
SIS Software version 3.3.0 |
Surgical Information Sciences, Inc. |
Ann Quinlan-Smith |
| K181738 |
03/22/2019 |
Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors |
Surgical Instrument Service and Savings Inc (dba Medline |
Stephanie Boyle Mays |
| K182553 |
03/11/2019 |
Inno-Pathwire |
Suzhou Innomed Medical Device Co.,Ltd |
Irene Ding |
| K182947 |
03/26/2019 |
Dental Pain Eraser |
Synapse Dental, LLC |
Cosmo Haralambidis |
| K183113 |
03/13/2019 |
DePuy Synthes Maxillofacial Portfolio - MR Conditional |
Synthes (USA) Products LLC |
Rebecca Reiter |
| K183472 |
03/13/2019 |
DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio û MR Conditional |
Synthes (USA) Products LLC |
Fredy Varela |
| K182822 |
03/01/2019 |
Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System |
Taiwan Aulisa Medical Devices Technologies, Inc. |
Paul Liu |
| K183067 |
03/01/2019 |
Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System |
Taiwan Aulisa Medical Devices Technologies, Inc. |
Paul Liu |
| K183344 |
03/18/2019 |
The Progressive Orthopaedic Company Total Knee System II |
The Progressive Orthopaedic Company, LLC. |
Andy Rynearson |
| K180127 |
03/15/2019 |
TCAT (R) THA Instrument Tray Set |
THINK Surgical Inc. |
John Hahn |
| DEN170044 |
03/14/2019 |
ClearMate |
Thornhill Research, Inc. |
Kipton Lade |
| K183596 |
03/29/2019 |
Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly |
Total Joint Orthopedics, Inc. |
Chris Weaber |
| K190280 |
03/15/2019 |
Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly |
Total Joint Orthopedics, Inc. |
Chris Weaber |
| K181817 |
03/26/2019 |
transGlideXT Expandable Introducer |
TransAortic Medical, Inc. |
Richard Ginn |
| K190242 |
03/27/2019 |
Tyto Thermometer |
Tyto Care Ltd. |
Stella Raizelman Perry |
| K183384 |
03/04/2019 |
JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant |
United Consortium |
Stephanie Morris |
| K190146 |
03/08/2019 |
Nexus DR Digital X-ray Imaging System |
Varex Imaging Corporation |
Michael G. Van Ryn |
| K182570 |
03/13/2019 |
Venture 0.014 Catheter |
Vascular Solutions, LLC |
Becky Astrup |
| K190318 |
03/14/2019 |
VASOBand Vascular Compression Device |
VASOInnovations Inc. |
Raj Sardesai |
| K182897 |
03/26/2019 |
Velano Vascular Q2 Extension Set |
Velano Vascular |
Tiffini Wittwer |
| K181668 |
03/13/2019 |
FasTouch Absorbable Fixation System |
Via Surgical Ltd. |
Ofek Levin |
| K183078 |
03/07/2019 |
VitalConnect Platform, VitalPatch Biosensor |
VitalConnect, Inc. |
Cynthia Merrell |
| K183147 |
03/01/2019 |
BrackFix |
VOCO GmbH |
M. Th. Plaumann |
| K190007 |
03/01/2019 |
Vydence Laser Family |
Vydence Medical Industria E Comercio Ltda |
Kathy Maynor |
| K181858 |
03/26/2019 |
Electric Handpiece Motor |
W&H Dentalwerk Buermoos GmbH |
Anja Lindner |
| K190283 |
03/14/2019 |
PROSTIM Injectable Inductive Graft |
Wright Medical Technology, Inc. |
Rachel Roberts |
| K183026 |
03/13/2019 |
Wright Jones Fracture System |
Wright Medical Technology, Inc. |
Antonio Ayala |
| K183491 |
03/24/2019 |
Arm Blood Pressure Monitor |
Xuzhou Yongkang Electronic Science Technology Co., Ltd |
Kai Li |
| K182383 |
03/19/2019 |
Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue |
YTY Industry (Manjung) Sdn Bhd |
Punitha Samy |
| K190361 |
03/18/2019 |
Zavation Spinal System |
Zavation Medical Products LLC |
Matt Jones |
| K190648 |
03/29/2019 |
Pusen Eview Medical Video Endoscope Image Processor |
Zhuhai Pusen Medical Technology Co., Ltd. |
Wang ChangShen |
