| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K183015 |
04/12/2019 |
PuraSinus |
3-D Matrix, Inc. |
Lisa Spirio |
| K173065 |
04/24/2019 |
A&D Medical Blood Pressure Monitors |
A&D Company, Ltd |
Jerry Wang |
| K190295 |
04/10/2019 |
Confirm Rx Insertable Cardiac Monitor |
Abbott (St. Jude Medical) |
Laura Sparks |
| K190581 |
04/05/2019 |
Amplatzer Trevisio Intravascular Delivery System |
Abbott Medical |
Mary Johnson |
| K183090 |
04/19/2019 |
Relieva Tract Balloon Dilation System |
Acclarent, Inc. |
Leena Sorathia |
| K190131 |
04/02/2019 |
AcQMap High Resolution Imaging and Mapping System |
Acutus Medical, Inc. |
Serena Sanginthirath |
| K182017 |
04/29/2019 |
Compex HD |
AdDent, Inc. |
Joshua Friedman |
| K181472 |
04/23/2019 |
AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor |
Advanced Sterilization Products (ASP) |
Andrea L. Ruth |
| K190072 |
04/15/2019 |
BriefCase |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K182396 |
04/12/2019 |
KardiaMobile, KardiaStation |
AliveCor, Inc. |
Prabhu Raghavan |
| K182582 |
04/10/2019 |
Oryum and Ovem Epidermal Deri Prick Test Applicator |
Allergy & Applicator Depot, LLC |
Steve Tramontano |
| K190420 |
04/15/2019 |
NDOHD High Definition Imaging System (NDOHD) |
Altaravision Inc. |
Stuart Bradley |
| K181541 |
04/16/2019 |
Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK |
Andon health Co., Ltd |
Yi Liu |
| K183306 |
04/10/2019 |
GLUCOCARD« W onyx Blood Glucose Monitoring System |
ARKRAY Factory, Inc. |
Yoshiharu Uehata |
| K183398 |
04/11/2019 |
Endoform Restella |
Aroa Biosurgery Ltd. |
Tina OÆBrien |
| K183395 |
04/17/2019 |
Arthrex 2.5 mm Tenodesis Screw |
Arthrex Inc. |
Rebecca R. Homan |
| K190728 |
04/17/2019 |
Arthrex SwiveLock Anchors |
Arthrex Inc. |
Jessica L. Singelais |
| K190110 |
04/23/2019 |
NanoBone SBX PUTTY, NanoBone QD |
Artoss Gmbh |
Walter Gerike |
| K182175 |
04/05/2019 |
TCD-X |
Atys |
Christine Turlat |
| K182341 |
04/09/2019 |
Pantheris SV |
Avinger, Inc. |
Thomas Lawson |
| K183045 |
04/30/2019 |
Eclipse 2L |
Balt USA, LLC |
Nancy Xu |
| K190688 |
04/17/2019 |
VersaCross Steerable Sheath, VersaCross Transseptal Dilator |
Baylis Medical Company Inc. |
May Tsai |
| K190109 |
04/18/2019 |
MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) |
Beckman Coulter, Inc. |
Elaine Duncan |
| K182092 |
04/30/2019 |
BD Intelliport System |
Becton, Dickinson, and Company |
Rahul Ram |
| K173238 |
04/04/2019 |
ToxCO |
Bedfont Scientific Ltd |
Louise Bateman |
| K182516 |
04/22/2019 |
Comprehensive Nano Stemless Shoulder |
Biomet Manufacturing Corp |
Jeff Gensler |
| K183593 |
04/18/2019 |
Lung Vision System |
Body Vision Medical Ltd. |
Dorian Averbuch |
| K182662 |
04/10/2019 |
NAV PAK Needle, NIM NAV PAK Needle |
Boston Endo Surgical Tech, |
James Rogers |
| K183619 |
04/16/2019 |
Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device |
Boston Scientific Corporation |
Laura Kelly |
| K190042 |
04/25/2019 |
Brainlab Elements Image Fusion Angio |
Brainlab AG |
Rainer Birkenbach |
| K190664 |
04/12/2019 |
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review |
Brainlab AG |
Rainer Birkenbach |
| K183332 |
04/16/2019 |
ôBRAXXö Esophageal Brachytherapy Applicator |
BRAXX Biotech Co. Ltd |
Judy Kao |
| K182457 |
04/18/2019 |
Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J |
Brivant Limited (Lake Region Medical) |
Tom J. Healy |
| K181361 |
04/11/2019 |
Brux Night Guard |
Brux Night Guard |
John Scalco |
| K183361 |
04/05/2019 |
EkoSonic Endovascular Device with Control Unit 4.0 |
BTG International, Inc. |
Benjamin Hornsey |
| K183192 |
04/19/2019 |
CapsoCam Plus (SV-3) |
CapsoVision, Inc. |
Azimun Jamal |
| K183638 |
04/17/2019 |
SmartLinx Vitals Plus Patient Monitoring System |
Capsule Technologie |
Maylin Truesdell |
| K182830 |
04/26/2019 |
Cardinal HealthTM Poly-Coated Open-Back Protective Gown |
Cardinal Health 200, LLC |
Caroline Miceli |
| K181787 |
04/25/2019 |
Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes |
Cedic S.r.l. |
Tiziana Melis |
| K190327 |
04/09/2019 |
ENConnect 40 mm Screw Cap to ENPlus Adapter |
Cedic S.r.l. |
Tiziana Melis |
| K190496 |
04/24/2019 |
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS |
CEFLA S.C. |
Elena Arcangeli |
| K190771 |
04/25/2019 |
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System |
Cepheid |
Yi-Ping Lin |
| K190416 |
04/04/2019 |
Dome Electrode |
Coapt, LLC |
Blair Lock |
| K183057 |
04/10/2019 |
PUMA-G System |
CoapTech LLC |
Jack Kent |
| K190114 |
04/30/2019 |
Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) |
ConvaTec Limited |
Karen Howes |
| K181971 |
04/23/2019 |
Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set |
Cook Incorporated |
Paul Meyer |
| K182071 |
04/25/2019 |
Multi-Sideport Catheter Infusion Set |
Cook Incorporated |
Reuben Lidster |
| K182399 |
04/04/2019 |
Park Blade Septostomy Catheter |
Cook Incorporated |
Rebecca Odulio |
| K190965 |
04/29/2019 |
MyDay |
CooperVision, Inc. |
Marie Dutton |
| K182221 |
04/01/2019 |
Bencox Mirabo Cup Multi Hole |
Corentec Co., Ltd |
J.S. Daniel |
| K190113 |
04/24/2019 |
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 |
| K190658 |
04/12/2019 |
MIS Bunion Plating System |
CrossRoads Extremity Systems, LLC |
Chad Hollis |
| K190407 |
04/22/2019 |
CryoLab |
CryoConcepts LP |
Sam Niedbala |
| K183601 |
04/18/2019 |
CryoTouch |
CryoConcepts LP |
Sam Niedbala |
| K182891 |
04/12/2019 |
TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants |
CS Medical L.L.C. |
Kendall Ashe |
| K181988 |
04/17/2019 |
eMurmur ID |
CSD Labs GmbH |
Andreas Reinisch |
| K183094 |
04/26/2019 |
CyclaPlex Correction System |
Cycla Orthopedics Ltd |
Rafi Herzog |
| K180232 |
04/03/2019 |
DAEHAN Disposable CUP Electrodes |
Daehan Medical Systems Co., Ltd. |
Da Roo Ha |
| K180065 |
04/19/2019 |
FUSION Plus Curing Light |
DentLight Inc. |
Richard Liu |
| K190043 |
04/24/2019 |
Halley resin |
Dentsply Sirona |
Karl Nittinger |
| K190789 |
04/24/2019 |
IntelliCartTM System |
Dornoch Medical Systems |
Larry Smith |
| K190629 |
04/01/2019 |
DBSWIN and VISTAEASY Imaging Software |
Durr Dental SE |
Oliver Lange |
| K182770 |
04/09/2019 |
Adult Intraosseous Infusion Device |
Einstein Works, L.L.C |
Linda Taylor |
| K190489 |
04/23/2019 |
Elcam Stopcocks and Manifolds |
Elcam Medical ACAL |
Avital Levertov |
| K190786 |
04/11/2019 |
Eye Prime |
Ellex Medical Pty Ltd. |
Andrew Pfeiffer |
| K190290 |
04/26/2019 |
AltiVate Reverse Humeral Stem, 48mm |
Encore Medical, L.P. |
Teffany Hutto |
| K183445 |
04/04/2019 |
Erbe APCapplicators |
Erbe Elektromedizin GmbH |
Julia Weller |
| K190894 |
04/30/2019 |
TOTIM Patient Cushion Immobilization System |
Essebi Medical SRL |
Pietro Sordina |
| K190791 |
04/19/2019 |
Ez3D-i/E3 |
EwooSoft Co., Ltd. |
Young Seok Kim |
| K183343 |
04/01/2019 |
Vantage Total Ankle Flat Cut Talar Components |
Exactech Inc |
Shing Jen Tai |
| K182049 |
04/25/2019 |
exCellerator Cervical Collection Device |
ExCell Company LLC |
Jim Snyder |
| K182217 |
04/16/2019 |
Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use |
Ezisurg (Suzhou) Medical Co., Ltd. |
Jingtian Ren |
| K173770 |
04/05/2019 |
OJR215 Pressure Relief Manifold |
Fisher & Paykel Healthcare Limited |
Adele Bindon |
| K182268 |
04/05/2019 |
EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) |
Flat Medical Co., Ltd. |
Shao-Wei Tseng |
| K182836 |
04/02/2019 |
FUJIFILM Endoscope Model EG-740N |
FUJIFILM Corporation |
Randy Vader |
| K182253 |
04/04/2019 |
FUJIFILM Video Bronchoscopes |
FUJIFILM Corporation |
Randy Vader |
| K183248 |
04/25/2019 |
Synapse Enterprise Viewer Version 1.0 |
FUJIFILM Corporation |
Randy Vader |
| K183204 |
04/08/2019 |
Bone VCAR (BVCAR) |
GE Medical Systems SCS |
Elizabeth Matthew |
| K183202 |
04/12/2019 |
Deep Learning Image Reconstruction |
GE Medical Systems, LLC. |
Lee Bush |
| DEN180060 |
04/12/2019 |
Plenity |
Gelesis, Inc. |
Eyal Ron |
| K190506 |
04/18/2019 |
NeoForm Annuloplasty Ring |
Genesee BioMedical, Inc |
Woodrow Mathison |
| K182619 |
04/12/2019 |
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel |
GenMark Diagnostics, Incorporated |
Alan Maderazo |
| K182375 |
04/08/2019 |
CREO« Stabilization System, Navigation Instruments, ExcelsiusGPS« |
Globus Medical Inc. |
Kelly J. Baker |
| K190598 |
04/05/2019 |
CROSSWAY Spinal Access System |
Globus Medical Inc. |
Kelly J. Baker |
| K190653 |
04/09/2019 |
ExcelsiusGPS |
Globus Medical Inc. |
Kelly J. Baker |
| K183056 |
04/19/2019 |
ASSURE« Anterior Cervical Plate System |
Globus Medical, Inc. |
Kelly J. Baker |
| K181931 |
04/04/2019 |
GMC Upper Arm Automatic Blood Pressure Monitor |
GMC Inc. |
Yolanda Lin |
| K181919 |
04/05/2019 |
Patient Monitor |
Guangdong Biolight Meditech Co., Ltd. |
Dan Hou |
| K181832 |
04/09/2019 |
Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device |
Guangdong Transtek Medical Electronics Co. Ltd |
Nicole Hu |
| K182108 |
04/26/2019 |
Portable Electro-Stimulation Therapy Device |
Guangzhou Longest Science & Technology Co., Ltd. |
Xiaobing Luo |
| K190553 |
04/29/2019 |
HardyCHROM CRE |
Hardy Diagnostics |
Rianna Malherbe |
| K190248 |
04/02/2019 |
ARIETTA 50 |
Hitachi Healthcare Americas |
Aaron Pierce |
| K182246 |
04/16/2019 |
MIST IC |
Imagine Milling Technologies, LLC |
Felix Chung |
| K182287 |
04/06/2019 |
MEDINAUT Plus |
Imedicom Co., Ltd. |
Bonggu Ha |
| K183043 |
04/17/2019 |
0.071ö ID MantaRay Reperfusion Catheter, 0.055ö ID MantaRay Reperfusion Catheter, 0.045ö ID MantaRay Reperfusion Catheter, 0.035ö ID MantaRay Reperfusion Catheter |
Imperative Care Inc. |
Jake Wolenberg |
| K182513 |
04/22/2019 |
FluChip-8G Influenza A+B Assay |
InDevR, Inc. |
Erica Dawson |
| K183599 |
04/12/2019 |
Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter |
Infraredx, Inc. |
Stephen Sum |
| K182386 |
04/23/2019 |
Reprocessed Supreme Diagnostic Electrophysiology Catheter |
Innovative Health, LLC. |
Amanda Babcock |
| K190088 |
04/17/2019 |
QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents |
Inova Diagnostics, Inc. |
Roger Albesa |
| K190040 |
04/08/2019 |
Straumann BLX Line Extension - New Abutments |
Institut Straumann AG |
Ana C.M. Vianna |
| K190082 |
04/17/2019 |
Straumann BLX Variobase Abutment |
Institut Straumann AG |
Viviana Horhoiu |
| K190180 |
04/01/2019 |
CUSA Clarity Ultrasonic Surgical Aspirator System |
Integra LifeSciences Corporation |
Alexandra Wells |
| K183184 |
04/03/2019 |
FlareHawk Interbody Fusion System |
Integrity Implants Inc |
Lauren Kamer |
| K190305 |
04/30/2019 |
Additive Cap |
International Medical Industries, Inc. |
Peter Lehel |
| K181915 |
04/12/2019 |
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit |
iXensor Co., LTD. |
Ariel Huang |
| K183539 |
04/08/2019 |
Ergoline Sunrise 7200 Hybrid Technology |
JK-Holding GmbH |
Juergen Gerstenmeier |
| K182944 |
04/17/2019 |
Dr. Amplatz Micro Plug |
KA Medical, LLC |
John Oslund |
| K181110 |
04/10/2019 |
PROPHYflex 4 |
Kaltenbach & Voigt GmbH |
Stefan Trampler |
| K182723 |
04/23/2019 |
Flexible HD Cysto-Urethroscope System |
KARL STORZ Endoscopy-America, Inc. |
Nozomi Yagi |
| DEN180013 |
04/19/2019 |
PREVENA 125 and PREVENA PLUS 125 Therapy Units |
KCI USA, Inc. |
Kimberly McCoy |
| K183526 |
04/11/2019 |
Codman Electrosurgical Generator, Foot Pedal |
KLS Martin GmbH + Co. KG |
Hanna Huttmeyer |
| K181597 |
04/01/2019 |
Le'Pen |
KMIHH Ltd |
Or Ramot |
| K183287 |
04/05/2019 |
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fe |
Kossan International Sdn. Bhd. |
Cho Sow Fong |
| K183537 |
04/25/2019 |
PANAVIA SA Cement Universal |
Kuraray Noritake Dental Inc. |
Yasujiro Ohara |
| K182840 |
04/29/2019 |
Element Pediatric Wheelchair |
Leggero llc |
Gabriela Romero |
| K190006 |
04/29/2019 |
Magnetic Surgical System |
Levita Magnetics International Corp. |
Alberto Rodrigues-Navarro |
| K182100 |
04/25/2019 |
Smile Makers Personal Lubricant |
LFBeauty (Thailand) Limited |
Apasara Kaewlor |
| K183376 |
04/03/2019 |
HORIZON TMS Therapy System with Navigation |
Magstim Company Ltd. |
Tom Campbell |
| K181571 |
04/19/2019 |
OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor |
Mark Abramson, D.D.S., Inc |
Mark Abramson |
| K190631 |
04/10/2019 |
M.U.S.T. MINI Posterior Cervical Screws System |
Medacta International SA |
Stefano Baj |
| K182572 |
04/12/2019 |
InstaRISPACS / InstaZFP / InstaMobi v5.0 |
Meddiff Technologies Pvt. Ltd. |
Mr. Sanjeev |
| K181912 |
04/12/2019 |
Ascent Cardiorespiratory Diagnostic Software |
Medical Graphics Corporation |
Jim McGurran |
| K190601 |
04/25/2019 |
MasteRad MX30 |
MedicaTech USA |
George Makar |
| K182172 |
04/24/2019 |
Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora) |
Medline Industries, Inc. |
Pauline Maralit |
| K182349 |
04/03/2019 |
CONCORDE LIFT |
Medos International, SARL |
Desiree Saracino |
| K183490 |
04/12/2019 |
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface |
Medtronic Inc |
Wendy Pinor |
| K183197 |
04/04/2019 |
PYRAMESHÖ Implant System |
Medtronic Sofamor Danek USA, INC. |
ANkit K. Shah |
| K190557 |
04/03/2019 |
Bio-Medicus Insertion Kit |
Medtronic, Inc. |
Huda Yusuf |
| K190825 |
04/30/2019 |
Medtronic Model 5392 External Pulse Generator (EPG) |
Medtronic, Inc. |
Alexandra Theisen |
| K190753 |
04/23/2019 |
EverCrossTM 0.035 OTW PTA Dilatation Catheter |
Medtronic, Inc. (formerly d.b.a. ev3 Inc, Covidien llc.) |
Breanna Fautsch |
| K190619 |
04/29/2019 |
Aspiron(TM) Aspiration Catheter |
Meril Life Sciences Private Limited |
Utpal Thakor |
| K190175 |
04/10/2019 |
S-MAK XL |
Merit Medical Systems Inc. |
David Thomas |
| K183189 |
04/17/2019 |
Ultra OTC Facial Toning System |
Micro Current Technology, Inc. |
David Suzuki |
| K190463 |
04/19/2019 |
Cepheid Xpert C. difficile/Epi Control Panel |
Microbiologics, Inc. |
Tina Sobania |
| K190415 |
04/19/2019 |
ATLAS Plating System |
MiRus, LLC |
Jordan Bauman |
| K182999 |
04/16/2019 |
General Cutting Contra Handpiece |
Nakanishi Inc. |
Kimihiko Satoh |
| K183496 |
04/08/2019 |
JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd |
Zilong Liang |
| K183494 |
04/05/2019 |
R190/R191 LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd. |
Zilong Liang |
| K190447 |
04/01/2019 |
7400 Ultrasound Systems |
Navigant Consulting - on behalf of Esaote S.p.A. |
Allison Scott |
| K183540 |
04/30/2019 |
Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) |
NeoMed, Inc. |
Tony Lair |
| DEN180041 |
04/19/2019 |
Monarch eTNS System |
NeuroSigma, Inc |
Ian A. Cook |
| K190198 |
04/01/2019 |
Microperimeter MP-3, Microperimeter MP-3 Type S |
Nidek Co., Ltd |
Mizuno Yoneji |
| K182737 |
04/12/2019 |
3T 32 Channel Head Coil |
Nova Medical, Inc. |
Cheryl Ledden |
| K190729 |
04/19/2019 |
SPY Portable Handheld Imaging (SPY-PHI) System |
Novadaq Technologies ULC. (now a part of Stryker) |
Agatha Szeliga |
| K182943 |
04/04/2019 |
VERTEX Nitinol Staple System |
Nvision Biomedical Technologies, LLC |
Diana Langham |
| K190164 |
04/04/2019 |
CleverLock Guidewire Locking Device and Biopsy Cap |
Olympus Surgical Technologies America |
Mary Anne Patella |
| K190693 |
04/17/2019 |
HEM-6410T-ZL Wrist Blood Pressure Monitor |
Omron Healthcare, Inc. |
Renee Thornborough |
| K190520 |
04/03/2019 |
VITROS XT Chemistry Products GLU-Ca Slides |
Ortho-Clinical Diagnostics, Inc. |
Darlene Phillips |
| K190807 |
04/26/2019 |
VITROS XT Chemistry Products TBIL-ALKP Slides |
Ortho-Clinical Diagnostics, Inc. |
Darlene Phillips |
| K183342 |
04/30/2019 |
SambaScrew 3D SI Fusion System |
Orthofix Inc. |
Jacki Koch |
| K183682 |
04/08/2019 |
OIC External Fixation System |
Orthopaedic Implant Company |
Douglas Fulton |
| K190365 |
04/12/2019 |
Baby Gorilla/Gorilla Plating System |
Paragon 28, Inc. |
Eric Lintula |
| K190586 |
04/03/2019 |
Monster« Screw System |
Paragon 28, Inc. |
Eric Lintula |
| K190375 |
04/24/2019 |
Parcus ATLAS |
Parcus Medical, LLC |
Paul Vagts |
| K183613 |
04/22/2019 |
exGraft, exGraft Carbon |
PECA Labs |
Doug Bernstein |
| K190464 |
04/26/2019 |
Penumbra System 3D Revascularization Device |
Penumbra, Inc. |
Denise Aycox |
| K180757 |
04/12/2019 |
D-Clip; D-Clip Applier |
Peter Lazic GmbH |
Sven Lazic |
| K182888 |
04/30/2019 |
MRCAT Pelvis |
Philips Medical Systems MR Finland |
Janne Marvola |
| K182637 |
04/26/2019 |
Philips IntelliVue XDS Software |
Philips Medizin Systeme Boeblingen GmbH |
Michael Asmalsky |
| K190691 |
04/04/2019 |
Pixx2430 Digital Diagnostic X-Ray Receptor Panel |
Pixxgen Corporation |
John Ross |
| K190320 |
04/15/2019 |
PreXion3D Explorer |
PreXion Corporation |
Hiroaki Takahashi |
| K182103 |
04/18/2019 |
Psychemedics Microplate EIA for Fentanyl in Hair |
Psychemedics Corporation |
Virginia Hill |
| K183679 |
04/24/2019 |
Occlusion Balloon Catheter |
QXMedical, LLC |
Fernando Di Caprio |
| K190369 |
04/17/2019 |
M-Y Sheath |
RAM Medical Innovations, Inc. |
Mubin Syed |
| K183146 |
04/25/2019 |
Ranfac Cartilage Biopsy Needle |
Ranfac Corporation |
Eric Kreuz |
| DEN170064 |
04/24/2019 |
Comaneci, Comaneci Petit, Comaneci 17 |
Rapid-Medical Ltd. |
Orit Yaniv |
| K190812 |
04/24/2019 |
RAYSCAN a-Expert3D |
RAY Co., Ltd |
Changhwan Lee |
| K190866 |
04/30/2019 |
XmaruView V1 (Xmaru Chiroview, Xmaru Podview) |
Rayence Co., Ltd |
Kevin Kim |
| K183302 |
04/16/2019 |
KY Banksy Aloe |
RB Health (US) LLC |
Elizabeth Viguerie |
| K182333 |
04/09/2019 |
Vera |
Reflexion Health, Inc. |
Walter Cordiglia |
| K180843 |
04/04/2019 |
HIgH-Flo Super26 Subcutaneous Needle Sets |
Repro-Med Systems, Inc. dba RMS Medical Products |
Cynthia Lacatena |
| K181673 |
04/15/2019 |
Rigi10 Malleable Penile Prosthesis |
Rigicon Inc. |
Ahmet Melih Luleci |
| K190773 |
04/16/2019 |
Elecsys TSH |
Roche Diagnostics |
Edie Eads |
| K182778 |
04/22/2019 |
LC GLOSSFILL XR |
S&C Polymer Silicon- und Composite Spezialitaeten GmbH |
Christian Boettcher |
| K183606 |
04/08/2019 |
Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) |
ScandiDos AB |
Thomas Matzen |
| K190655 |
04/29/2019 |
SeaSpine« ShorelineÖ ACS- Anterior Cervical Standalone System |
SeaSpine Orthopedics Corporation |
Alicia McArthur |
| K182702 |
04/17/2019 |
SEKURE Creatine Kinase Assay |
SEKISUI DIAGNOSTICS P.E.I. INC. |
Jeanna MacLeod |
| K182640 |
04/12/2019 |
Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) |
Shandong Hengya Packaging Printing Co.,Ltd |
Sunny Hu |
| K181747 |
04/18/2019 |
Orthodontic Appliance |
Shandong Huge Dental Material Corporation |
Maggie Zheng |
| K183377 |
04/04/2019 |
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
Shi Jufang |
| K183660 |
04/09/2019 |
DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
Jiang Haosen |
| K182597 |
04/03/2019 |
Infrared thermometer |
Shenzhen Pango Electronic Co., Ltd |
Youjian Xie |
| K190230 |
04/03/2019 |
iFuse Implant System« |
SI-BONE, Inc. |
Meirav Harsat |
| K183548 |
04/15/2019 |
SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K190058 |
04/11/2019 |
PureSleep (OTC use) |
Sleep Science Partners, Inc. |
Noel P. Lindsay |
| K182998 |
04/17/2019 |
Andorate Auxiliary Water Connector |
Smartdata Suzhou Co., Ltd |
Cindy Ye |
| K190690 |
04/13/2019 |
INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir |
SORIN GROUP ITALIA S.R.L. |
Luigi Vecchi |
| K190289 |
04/03/2019 |
Karma« Fixation System |
Spinal Elements Inc |
Julie Lamothe |
| K183320 |
04/02/2019 |
Ilumien Optis, Optis Integrated, Optis Mobile |
St. Jude Medical (now Abbott Medical) |
Steve Vitale |
| K190788 |
04/18/2019 |
Disposable Standard Clamp |
Standard Bariatrics |
Alison Sathe |
| K181758 |
04/11/2019 |
ELRA Electrode |
STARmed Co., Ltd. |
Jun-Young Jung |
| K183634 |
04/17/2019 |
Stasis Monitoring System |
Stasis Labs, Inc. |
Derek Nielsen |
| K182272 |
04/15/2019 |
Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis |
Sterilmed, Inc. |
Jan Flegeau |
| K183428 |
04/16/2019 |
Avulsion Forceps |
STERIS Corporation |
Eileen McCafferty |
| K190103 |
04/05/2019 |
V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System |
STERIS Corporation |
Anthony Piotrkowski |
| K190070 |
04/11/2019 |
Sonopet iQ Ultrasonic Aspirator System |
Stryker Corporation |
Julia Helgeson |
| K190212 |
04/24/2019 |
AXS Vecta Aspiration System |
Stryker Neurovascular |
Shazia Hakim |
| K190621 |
04/23/2019 |
SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long |
Sumitomo Bakelite Co., Ltd |
Shiro Agehama |
| K190592 |
04/29/2019 |
YelloPort Elite Port Access System |
Surgical Innovations Limited |
Shazia Chaudhry |
| K182828 |
04/15/2019 |
Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer |
Surgical Instrument Service and Savings Inc |
Stephanie Boyle Mays |
| K190644 |
04/18/2019 |
Guide Sheath |
Surmodics, Inc. |
Peggy Ju |
| K181296 |
04/11/2019 |
Syntec Femoral Nail System |
Syntec Scientific Corporation |
Nicole Tseng |
| K181732 |
04/27/2019 |
InterSpace Knee Extra-Large Size, InterSpace Knee ATS |
Tecres SpA |
Massimo Grazioli |
| K181844 |
04/15/2019 |
One Touch |
Thai Nippon Rubber Industry Public Company Ltd |
Pisut Chanwatarungkull |
| K190079 |
04/12/2019 |
ArgenZ HT+ |
The Argen Corporation |
Craig Jolicoeur |
| K190627 |
04/29/2019 |
VALO Grand Corded |
Ultradent Products, Inc. |
Karen Kakunes |
| K182585 |
04/26/2019 |
JO Actively Trying Personal Lubricant |
United Consortium |
Stephanie Morris |
| K183584 |
04/17/2019 |
JO H2O Jelly Original Personal Lubricant |
United Consortium |
Stephanie Morris |
| K183152 |
04/17/2019 |
Phoenix |
US Bionics, Inc. (DBA suitX) |
Kelly Mettler |
| K190611 |
04/08/2019 |
VIVIX-S 1751S |
Vieworks Co., Ltd. |
Jordin Kim |
| K190453 |
04/11/2019 |
VisCalor bulk |
VOCO GmbH |
Th. Plaumann |
| K190626 |
04/12/2019 |
SyncVision System |
Volcano Corporation |
Rand Daoud |
| K182872 |
04/03/2019 |
LINK GEMINI SL Total Knee System |
Waldemar Link GmbH & Co. KG |
Andre von Malotki |
| K183403 |
04/17/2019 |
JETi 88 Peripheral Thrombectomy System |
Walk Vascular, LLC |
David Look |
| K182924 |
04/15/2019 |
Diode Laser Treatment System |
Weifang KM Electronics Co., LTD |
Andy Pang |
| K190705 |
04/15/2019 |
WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream |
Wholepower Biotech Co., Ltd. |
William Gao |
| K183156 |
04/24/2019 |
V-Laser |
WONTECH Co., Ltd. |
Erin Park |
| K190038 |
04/05/2019 |
Xbody Newave USA |
XBody Hungary Kft. |
Peter Tar |
| K190364 |
04/18/2019 |
CancelleX Porous Titanium Lumbar Interbody Device |
Xenco Medical, LLC |
Jason Haider |
| K190317 |
04/11/2019 |
Zavation Spinal System |
Zavation Medical Products, LLC |
Frankie Cummins |
| K183550 |
04/08/2019 |
Vitality« Spinal Fixation System |
Zimmer Biomet Spine, Inc. |
Brendon Gareth Heyerdahl |
| K181171 |
04/02/2019 |
Zimmer Biomet Ceramic Heads |
Zimmer, Inc |
Carol Vierling |
| K183304 |
04/04/2019 |
Prettau, ICE, Z-White zirconia blanks |
Zirkonzahn srl |
Julian Steger |
