| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| DEN170046 |
03/06/2018 |
23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) |
23andMe, Inc. |
Lisa Charter |
| K173437 |
03/19/2018 |
3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H |
3M Company |
Hilary B. Hovde |
| K180404 |
03/16/2018 |
3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System |
3M Health Care |
Lam Duong |
| K173628 |
03/10/2018 |
Acclarent ENT Navigation System |
Acclarent, Inc |
James Patrick Garvey |
| K180504 |
03/28/2018 |
Mission Lipid Panel Monitoring System |
ACON Laboratories, Inc. |
Qiyi Xie |
| K180196 |
03/07/2018 |
On Call Express Mobile Blood Glucose Monitoring System |
ACON Laboratories, Inc. |
Qiyi Xie |
| K173310 |
03/26/2018 |
SmartTouch |
Adherium (NZ) Ltd |
Chris Mander |
| K172799 |
03/09/2018 |
Positional Sleep Assessment System (PoSAS) software |
Advanced Brain Monitoring |
Daniela Soll |
| K173223 |
03/02/2018 |
ologen Collagen Matrix |
Aeon Astron Europe B.V. |
Horng Ji Lai |
| K172235 |
03/28/2018 |
CoreHip« System |
Aesculap Implants Systems, LLC |
Paul Amudala |
| K180321 |
03/07/2018 |
Aesculap Optilene Nonabsorbable Suture |
Aesculap, Inc. |
Kathy A. Racosky |
| K172461 |
03/23/2018 |
AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin |
Aesku.Diagnostics GmbH & Co. KG |
Sandra Reuter |
| K173660 |
03/27/2018 |
LenSx Laser System |
Alcon Laboratories, Inc. |
James Arganda |
| K173128 |
03/22/2018 |
Alamo« C |
Alliance Partners, LLC |
Kristiina Gilkey |
| K170957 |
03/20/2018 |
ReConnex Pre-Sutured Tendon |
AlloSource |
Pamela Vetter |
| K173727 |
03/28/2018 |
Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor |
Ambu A/S |
Maja Brons |
| K173453 |
03/05/2018 |
Valeo« C+CSC with Lumen Interbody Fusion Device |
Amedica Corp. |
Jason Parberry |
| K171857 |
03/30/2018 |
AMSure« Enteral Feeding Syringe with ENFit Tip |
Amsino International, Inc. |
Cathy Hong |
| K171863 |
03/19/2018 |
Anjon Bremer Halo System |
Anjon Holdings, LLC |
Tommy Mitchell |
| K173788 |
03/01/2018 |
Arthrex Corkscrew FT |
Arthrex Inc. |
David L Rogers |
| K171841 |
03/29/2018 |
Arthrex Shoulder System |
Arthrex Inc. |
David L. Rogers |
| K172371 |
03/22/2018 |
Arthrex UNIVERS REVERS COATED BASEPLATE |
Arthrex, Inc. |
Courtney Smith |
| K170304 |
03/02/2018 |
Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers |
Astell Scientific Limited |
Gary Doughty |
| K173203 |
03/14/2018 |
Athena GTX Device Management Suite (ADMS) Software |
Athena GTX |
Sean Mahoney |
| K173760 |
03/22/2018 |
Monarch Endoscopy Platform (Monarch Platform) |
Auris Surgical Robotics, Inc. |
Joy Sacmar |
| K180061 |
03/09/2018 |
UltraCor Twirl Breast Tissue Marker |
Bard Peripheral Vascular, Inc. |
Meghan McKelvey |
| K180319 |
03/27/2018 |
Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution |
Bausch and Lomb Incorporated |
Melissa Thomas |
| K171802 |
03/07/2018 |
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) |
Bayer HealthCare LLC |
Cindy R. Abraham |
| K180438 |
03/20/2018 |
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit |
BD |
Brad Spring |
| K173873 |
03/16/2018 |
BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial |
Becton Dickinson and Company |
Ashanti Brown |
| K172366 |
03/16/2018 |
Wrist Pulse Oximeter |
Beijing Choice Electronic Technology Co., Ltd. |
Lei Chen |
| DEN160029 |
03/01/2018 |
SkinPen Precision System |
BELLUS MEDICAL, LLC. |
JENNIFER BLOCK |
| K173682 |
03/09/2018 |
L300 Go System |
Bioness, Inc. |
Mercedes Bayani |
| K180315 |
03/26/2018 |
DISKOM |
Biopsybell s.r.l. |
Tiziana Bellini |
| K171851 |
03/16/2018 |
SOFTXIL |
BISTOOL |
Eunhyun Bae |
| K173180 |
03/15/2018 |
Mega Plus Spine System |
BK MEDITECH Co., Ltd. |
Byoungjun Park |
| K172843 |
03/29/2018 |
TwitchView System |
Blink Device Corporation |
Justin Hulvershorn |
| K180211 |
03/21/2018 |
Freezpoint |
Bovie Medical Corp. |
Sam Niedbala |
| K172820 |
03/01/2018 |
Microscope Navigation Software |
Brainlab AG |
Alexander Schwiersch |
| K172035 |
03/24/2018 |
EKOS ultrasound EVD Device, EVD Control Unit |
BTG International, Inc. |
Brit Baird |
| K173839 |
03/15/2018 |
Tissue of Origin Test Kit-FFPE |
Cancer Genetics, Inc. |
Janet Graff |
| K180323 |
03/30/2018 |
Vitrea Software Package; VSTP-001A |
Canon Medical Systems Corporation |
Paul Biggins |
| K180475 |
03/19/2018 |
CapLOX II« / TowerLOX« MIS Pedicle Screw System |
Captiva Spine, Inc. |
Jackie Ferro |
| K173812 |
03/09/2018 |
Catalyst CSR 3 Peg Glenoids |
Catalyst OrthoScience, Inc |
Dale Davison |
| K173904 |
03/09/2018 |
CATS Tonometer Prism |
CATS Tonometer, LLC |
Sean J. McCafferty |
| K180274 |
03/21/2018 |
Ventix Link Knotless Anchor with Inserter |
Cayenne Medical, Inc |
Shima Hashemian |
| K173942 |
03/05/2018 |
Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs |
Central Medicare Sdn. Bhd. |
Arivalagan Subramaniam |
| K173840 |
03/16/2018 |
Xpert CT/NG |
Cepheid |
Yi-Ping Lin |
| K180531 |
03/29/2018 |
NovoStitch Pro Meniscal Repair System |
Ceterix Orthopaedics, Inc. |
Tarhan Kayihan |
| K180104 |
03/14/2018 |
Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant |
Church & Dwight Co., Inc |
Joelle Reinson |
| K180057 |
03/09/2018 |
VORTEK URETERAL DOUBLE LOOP STENT |
Coloplast Corp |
Cori Ragan |
| K172516 |
03/16/2018 |
SurgiQuest AIRSEAL iFS System |
ConMed Corporation |
Lisa Anderson |
| K171817 |
03/13/2018 |
Biodesign Diaphragmatic Hernia Graft |
Cook Biotech Incorporated |
Perry W. Guinn |
| K172017 |
03/26/2018 |
Black Silicone Filiform Double Pigtail Stent Set |
Cook Incorporated |
Karthik Pillai |
| K171810 |
03/07/2018 |
Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter |
Cook Incorporated |
Yan Li |
| K171912 |
03/19/2018 |
Double Flexible Tip Wire Guides |
Cook Incorporated |
Jennifer Allman |
| K173105 |
03/22/2018 |
Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter |
Cook Incorporated |
Samuel Engelman |
| K171764 |
03/09/2018 |
Fixed Core Wire Guides |
Cook Incorporated |
Jennifer Allman |
| K171997 |
03/30/2018 |
Mandril Wire Guide |
Cook Incorporated |
Jennifer Allman |
| K171915 |
03/01/2018 |
Nathanson Transcystic Bile Duct Stone Exploration Pack |
Cook Incorporated |
Colin Jacob |
| K171988 |
03/30/2018 |
Performer Guiding Sheath |
Cook Incorporated |
Reuben G. Lidster |
| K171820 |
03/09/2018 |
Transjugular Liver Access Sets |
Cook Incorporated |
David Lehr |
| K172057 |
03/09/2018 |
Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set |
Cook Ireland Ltd. |
Orla Gunning |
| K173731 |
03/02/2018 |
SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) |
CooperSurgical, Inc |
Tove Kjaer |
| K180429 |
03/14/2018 |
Advincula Delineator Uterine Manipulator |
CooperSurgical, Inc. |
Roaida Johnson |
| K180052 |
03/23/2018 |
UriSwab-Urine Collection, Transport and Preservation System |
Copan Italia S.p.A. |
Elisabetta Zanella |
| K180517 |
03/29/2018 |
CorPath GRX System |
Corindus, Inc. |
Robert Lavado |
| K173806 |
03/01/2018 |
CorPath GRX System |
Corindus, Inc. |
Robert Lavado |
| K173281 |
03/02/2018 |
LigaSure Exact Dissector, Nano-coated |
Covidien |
Celso Duran |
| K180192 |
03/21/2018 |
Emprint Ablation Visualization Application |
Covidien, LLC |
Patti L. Arndt |
| K180149 |
03/26/2018 |
Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide |
Covidien, llc |
Nancy Sauer |
| K173922 |
03/26/2018 |
C-PTFETM Surgical Suture |
CP Medical Inc. |
John Hartigan |
| K172601 |
03/02/2018 |
Next Generation iBOT |
DEKA Research & Development Corp |
Roger Leroux |
| K172256 |
03/02/2018 |
SoftVue |
Delphinus Medical Technologies |
Francis X. Dobscha |
| K173465 |
03/28/2018 |
Concentrix MX-AC High-Speed Handpiece |
DentalEZ, Inc. |
Dan Laskowitz |
| K180044 |
03/08/2018 |
SIROLaser Blue |
Dentsply Sirona |
Karl J Nittinger |
| K172872 |
03/05/2018 |
DePuy Synthes Femoral Neck System |
DePuy Synthes |
Ana Sala Roca |
| K173785 |
03/13/2018 |
Custom Clear Aligner System |
Derby Dental Laboratory |
Reed Nunnally |
| K173846 |
03/21/2018 |
DermaScalp Laser Cap |
DermaScalp LLC |
John Carullo |
| K172648 |
03/23/2018 |
Drive DeVilbiss iGo 2 Portable Oxygen Concentrator |
DeVilbiss Healthcare, LLC |
Betty Miller |
| DEN170088 |
03/27/2018 |
Dexcom G6 Continuous Glucose Monitoring System |
Dexcom, Inc. |
Neeta Sharma |
| K173798 |
03/14/2018 |
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack |
DiaSorin Molecular LLC |
Sharon Young |
| K180074 |
03/22/2018 |
Diazyme Lipoprotein (a) Assay |
Diazyme Laboratories, Inc. |
Abhijit Datta |
| K172381 |
03/06/2018 |
Digitimer DS7AP Constant Current Stimulator |
Digitimer Ltd. |
John Smale |
| K171750 |
03/06/2018 |
Citric Complete Dry Citric Acid (45X) |
Dimesol USA, LLC |
Marlene Van Dyke |
| K171952 |
03/30/2018 |
Dimesol Tubing Sets for Hemodialysis |
Dimesol, Inc. |
Stephen P. Callaghan |
| K170608 |
03/30/2018 |
UF(II) Implant System |
DIO Corporation |
Jiae Park |
| K173769 |
03/08/2018 |
DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid |
DMAX CO., LTD. |
Hyeon Seok Cho |
| K180350 |
03/07/2018 |
Dornier Medilas H Solvo 35 Laser |
Dornier MedTech America |
John Hoffer |
| K180106 |
03/13/2018 |
ThinkQA |
DOSIsoft |
Marc Uszynski |
| K171542 |
03/16/2018 |
TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges |
Dr. Harold Katz, LLC (dba TheraBreath |
Harold Katz |
| K173075 |
03/08/2018 |
ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850╡l, 3ml) |
DxNow, Inc. |
William T. Sharp |
| K172266 |
03/14/2018 |
Dynarex Three-Way Stopcock |
Dynarex Corporation |
Pablo Martinez |
| K180473 |
03/23/2018 |
ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR |
ECOTRON Co., Ltd |
Sang Bond Lee |
| DEN160044 |
03/16/2018 |
Acumen Hypotension Prediction Index (HPI) Feature Software |
Edwards Lifesciences LLC |
Lisa Gilman |
| K172312 |
03/30/2018 |
eego amplifiers |
eemagine Medical Imaging Solutions GmbH |
Frank Zanow |
| K180538 |
03/30/2018 |
gammaCore Sapphire |
electroCore, LLC |
Mike Romaniw |
| K173789 |
03/30/2018 |
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon |
Elekta Instrument AB |
Alf Laurell |
| K180224 |
03/15/2018 |
ELEMENT-TL |
Elemenic Co., Ltd. |
Jo Won Ju |
| K180406 |
03/15/2018 |
Ellipse Ydun |
Ellipse A/S |
Ole Kofod |
| K180165 |
03/20/2018 |
Habib EndoHPB |
EMcision Ltd. |
Francois Poulin |
| K173723 |
03/05/2018 |
EMPOWR Universal Tibial Baseplate |
Encore Medical, L.P. |
Teffany Hutto |
| K180592 |
03/30/2018 |
G-scan Brio |
Esaote S.p.A |
Massimo Polignano |
| K173388 |
03/09/2018 |
Exactech Equinoxe Stemless Shoulder |
Exactech Inc |
Thomas McNamara |
| K173583 |
03/12/2018 |
Exactech« Novation« and AcuMatch« E-HXL Acetabular Liners |
Exactech, Inc. |
Shing Jen Tai |
| K173777 |
03/08/2018 |
BreathID Hp Lab System |
Exalenz Bioscience Ltd. |
Raffi Werner |
| K173772 |
03/08/2018 |
BreathID Hp System |
Exalenz Bioscience Ltd. |
Raffi Werner |
| K173439 |
03/29/2018 |
Bloom2 Programmable Electrophysiology Stimulator |
Fischer Medical |
Wes Rogers |
| K180405 |
03/15/2018 |
FUJIFILM Endoscope Models EC-600HL and EC-600LS |
FUJIFILM Corporation |
Randy Vader |
| K172916 |
03/01/2018 |
FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 |
Fujifilm Corporation |
Randy Vader |
| K173494 |
03/06/2018 |
OrthoSteady G Bone Cement |
G21 s.r.l. |
Filippo Foroni |
| K180023 |
03/21/2018 |
WIRION |
Gardia Medical Ltd. |
Vardit Segal |
| K180092 |
03/08/2018 |
Intellitorq |
Gauthier Biomedical, Inc. |
Austin Braganza |
| K173500 |
03/08/2018 |
NMF004A |
GC America Inc. |
Mark Heiss |
| K180535 |
03/29/2018 |
Voluson P6 and Voluson P8 |
GE Healthcare |
Bryan Behn |
| K180374 |
03/13/2018 |
Voluson S8/ Voluson S10/ Voluson S10 Expert |
GE Healthcare |
Bryan Behn |
| K180056 |
03/28/2018 |
Genesys Spine AIS-C Cervical Anchored Interbody System |
Genesys Spine |
Benjamin V. Keller |
| K180579 |
03/19/2018 |
Ezee Retrieval |
Genicon, Inc |
Katlyn Kachman |
| K172810 |
03/07/2018 |
PORT-X IV |
GENORAY Co., Ltd. |
Ji-Yeon Choi |
| K172103 |
03/02/2018 |
Flowtron DVT5 Small Calf Garment |
Getinge (Suzhou) Co., Ltd. |
Daisy Qin |
| K180171 |
03/08/2018 |
PillCam Patency System |
Given Imaging Ltd. |
Hilla Debby |
| K180156 |
03/07/2018 |
SP-Fix« Spinous Process Fixation Plate, RELIEVE« Laminoplasty Fixation System |
Globus Medical Inc. |
Lori Burns |
| K171939 |
03/07/2018 |
ALVUE Balloon Dilation System |
Globus Medical, Inc. |
Lori Burns |
| K172269 |
03/27/2018 |
FORTRESSÖ Radiopaque Bone Cement (FORTRESSÖ and FORTRESS-PlusÖ), CREO« Fenestrated Screw System, REVLOK« Fenestrated Screw System |
Globus Medical, Inc. |
Kelly J. Baker |
| K171867 |
03/30/2018 |
DrÆs Finder NEO |
Good Doctors Co.,Ltd. |
Sungro Joo |
| K173229 |
03/12/2018 |
Preview Digital Pregnancy Test |
Guangzhou Wondfo Biotech Co., Ltd. |
Bin Chen |
| K180086 |
03/08/2018 |
Gyrus ACMI û EZDilate 3-Stage Balloon Dilatation Catheter |
Gyrus ACMI, Inc. |
Mary Anne Patella |
| K173903 |
03/22/2018 |
Granada Medium |
Hardy Diagnostics |
Rianna Malherbe |
| K173312 |
03/02/2018 |
ProBx Software |
Harmonus Inc. |
Nicole Mauro |
| K172168 |
03/21/2018 |
WillCeph |
HDX WILL CORP. |
Myoung-Joon Lee |
| K172892 |
03/08/2018 |
Neuro Assessment System NAS-1000 |
HeadSense Medical Inc. |
Richard A. Lotti |
| K171982 |
03/21/2018 |
DROPLET PEN NEEDLE |
HTL-STREFA S.A. |
Aleksandra Prazmowska-Wilanowska |
| K173919 |
03/20/2018 |
HX Device |
Human Extension Ltd. |
Dalit Doron |
| K171241 |
03/27/2018 |
Pulse Oximeter |
Hunan Accurate Bio-Medical Technology Co., Ltd. |
Zhou Le |
| K180326 |
03/08/2018 |
icobrain |
icometrix |
Dirk Smeets |
| K180129 |
03/16/2018 |
Imbio Segmentation Editing Tool software |
Imbio, LLC |
Vipul Goel |
| K172078 |
03/30/2018 |
ImmuLisa Enhanced RNA POL III Antibody ELISA |
IMMCO Diagnostics, Inc. |
Kevin Lawson |
| K173811 |
03/15/2018 |
TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System |
In2Bones SAS |
Morgane Grenier |
| K173571 |
03/21/2018 |
Element System with IBT Electrodes |
Infinite Biomedical Technologies, LLC |
Rahul Kaliki |
| K173120 |
03/16/2018 |
CCM Abutment System |
InnoBioSurg Co., Ltd. |
Bo-reum Yoo |
| K173262 |
03/06/2018 |
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter |
Innovative Health, Llc. |
Amy Stoklas-Oakes |
| K172760 |
03/26/2018 |
REST EAZY Appliance |
Insert Molding Solutions, Inc. |
Paul Hendrixson |
| K173379 |
03/30/2018 |
Straumann Variobase for Crown AS |
Institut Straumann AG |
Gordon Dodds |
| K180486 |
03/22/2018 |
HemosIL Factor XII Deficient Plasma |
Instrumentation Laboratory Co. |
Carol Marble |
| K171778 |
03/14/2018 |
MR Wireless Gating System, Model WGS-100 |
Ivy Biomedical Systems, Inc |
Nicole Bush |
| K170605 |
03/27/2018 |
Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D |
Jiangsu Yuyue Medical Equipment& Supply Co., Ltd |
Rong Zhong |
| K172264 |
03/19/2018 |
OTW Takeru PTCA Balloon Dilatation Catheter |
Kaneka Corporation |
Toshihiko Motomine |
| K173426 |
03/09/2018 |
PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System |
KCI USA, INC. |
Margaret Marsh |
| K173447 |
03/02/2018 |
V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit |
KCI USA, Inc. |
Melanie Avila |
| K172723 |
03/23/2018 |
Dario LC Blood Glucose Monitoring System |
LabStyle Innovation, Ltd. |
Erez Raphael |
| K173886 |
03/23/2018 |
CPRmeter 2 CPR Feedback Device |
Laerdal Medical AS |
Mari Kaada |
| K172818 |
03/07/2018 |
LMT-3000 |
Lameditech Co., Ltd. |
Jong Seuk Choi |
| K173323 |
03/08/2018 |
AnastoClip GC Closure System |
LeMaitre Vascular, Inc. |
Xiang Zhang |
| K173346 |
03/02/2018 |
LENSAR Laser System - fs 3D (LLS-fs 3D) |
Lensar, Inc. |
Keith Peck |
| K172331 |
03/02/2018 |
Type I, Type II, Type III, Type IV |
Lepu Medical Technology (Beijing) Co., Ltd. |
Xiangdan Jin |
| K180114 |
03/27/2018 |
AEON Retrieval Bag |
Lexington Medical Inc. |
Donna Gasper |
| K180330 |
03/15/2018 |
Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K170410 |
03/23/2018 |
Longeviti PMMA Static Cranial Implant |
Longeviti Neuro Solutions, LLC |
Kevin Lee |
| DEN170029 |
03/19/2018 |
PrimeStore MTM |
Longhorn Vaccines and Diagnostics LLC |
Jeff Fischer |
| K173619 |
03/21/2018 |
Mimics inPrint |
Materialise NV |
Oliver Clemens |
| K171129 |
03/02/2018 |
CO Check Pro, CO Screen |
MD Diagnostics Limited |
Glen Hillsley |
| K173794 |
03/14/2018 |
AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared |
Medacta International SA |
Stefano Baj |
| K171966 |
03/27/2018 |
Mpact« 3D MetalÖ Implants and Augments 3D MetalÖ |
Medacta International SA |
Stefano Baj |
| K180308 |
03/27/2018 |
Prelude |
MedCom GmbH |
Johannes Messow |
| K173605 |
03/08/2018 |
iQMR |
Medic Vision - Imaging Solutions Ltd |
Eyal Aharon |
| K173134 |
03/22/2018 |
SENTIO MMG Pedicle Access Needles |
Medos International SARL |
Sheree Geller |
| K172062 |
03/05/2018 |
AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray |
MedScience Science Research Group, Inc. |
Marvin Smollar |
| K172444 |
03/28/2018 |
ROSA BRAIN (v3.0.0.5) |
MEDTECH S.A. |
Elise Lagacherie |
| K180453 |
03/22/2018 |
Bio-Medicus Adult Cannulae and Introducer |
Medtronic Inc |
Huda Yusuf |
| K180456 |
03/22/2018 |
Bio-Medicus Adult Cannulae Kit |
Medtronic Inc. |
Huda Yusuf |
| K173249 |
03/08/2018 |
CD HORIZONÖ Spinal System |
Medtronic Sofamor Danek USA, Inc. |
Ankit K. Shah |
| K171320 |
03/08/2018 |
ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, AR |
Meril Healthcare Pvt. Ltd. |
Umesh Sharma |
| K180450 |
03/12/2018 |
Corvocet Biopsy System |
Merit Medical Systems, Inc. |
Angela Brady |
| K173548 |
03/30/2018 |
Merit Pursue Microcatheter |
Merit Medical Systems, Inc. |
Niloufar Samimi |
| K172663 |
03/05/2018 |
Cytology Brush |
Micro-Tech (Nanjing) CO., Ltd. |
Becky Li |
| K171937 |
03/16/2018 |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor |
Microlife Intellectual Property GmbH |
Gerhard Frick |
| K171150 |
03/08/2018 |
AW-100 |
Micron Corporation |
Takashi Terui |
| K180396 |
03/15/2018 |
miraDry System |
Miramar Labs, Inc. |
Cynthia Kada |
| K173326 |
03/16/2018 |
MIS CONNECT Conical Connection Abutment |
MIS Implants Technologies LTD. |
Noa Ofer |
| K180393 |
03/15/2018 |
AIRO Computed Tomography (CT) X-ray System |
Mobius Imaging, LLC |
Norma LeMay |
| K173544 |
03/02/2018 |
Phoenix Wound Matrix |
Nanofiber Solutions, Inc. |
Ronald L. Bracken |
| K173690 |
03/09/2018 |
Grass TWin |
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
Shane Sawall |
| K180421 |
03/14/2018 |
Natus NeuroWorks |
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
Shane Sawall |
| K173082 |
03/29/2018 |
ArcoÖ-SA Lumbar Cage System |
NeuroStructures, Inc. |
Kathleen Wong |
| K180431 |
03/22/2018 |
Cortina [MAX] Lumbar Cage System |
NeuroStructures, Inc. |
Kathleen Wong |
| K172485 |
03/02/2018 |
Footmotion HammerToe |
Newclip Technics |
Gaelle Lussori |
| K173980 |
03/14/2018 |
Specular Microscope CEM-530 |
Nidek Co., Ltd. |
Yoneji Mizuno |
| K173029 |
03/30/2018 |
Nipro Syringe |
Nipro Medical Corporation |
Jessica Oswald-McLeod |
| K173214 |
03/27/2018 |
NES Reprocessed RF Stylet (RFS) |
Northeast Scientific, Inc. (NES) |
Matthew Farley |
| K180198 |
03/15/2018 |
NuVasive« VuePoint« II OCT System |
NuVasive, Incorporated |
Michelle Cheung |
| K173459 |
03/13/2018 |
Olympus Small Intestinal Capsule Endoscope System |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K172298 |
03/29/2018 |
OLYMPUS URF-P6/P6R |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K172246 |
03/30/2018 |
OLYMPUS URF-V2/V2R |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K173680 |
03/01/2018 |
Sapphire II PRO |
OrbusNeich Medical Trading Inc. |
John Pazienza |
| K173624 |
03/02/2018 |
ORIGIO« HandlingÖ without phenol red (Cat. No. 8310), ORIGIO« HandlingÖ with phenol red (Cat. No. 8311) |
Origio a/s |
Tove Kjaer |
| K173440 |
03/08/2018 |
Carriere SLX 3D Clear |
Ortho Organizers, Inc. |
Colleen Boswell |
| K172115 |
03/08/2018 |
Navigated Instrument System |
Orthofix Inc. |
Jacki Koch |
| K180109 |
03/01/2018 |
STARband, STARlight, St. Louis Band |
Orthomerica Products, Inc |
David C. Kerr |
| K172354 |
03/26/2018 |
OssBuilder System |
Osstem Implant Co., Ltd.. |
Jungmin Yoo |
| K162366 |
03/02/2018 |
Omega VL |
OV WORLD CO., LTD |
GEUNG-GYU GANG |
| K171703 |
03/01/2018 |
PUMA System |
Panther Orthopedics, Inc. |
Kathryn Stecco |
| K171715 |
03/05/2018 |
HammerTube System |
Paragon 28 |
Frank S. Bono |
| K180172 |
03/16/2018 |
FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroP |
Paragon Vision Sciences |
Rich Jefferies |
| K180194 |
03/30/2018 |
SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System |
Paragonix Technologies, Inc. |
Leo Basta |
| K180105 |
03/08/2018 |
Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister |
Penumbra, Inc. |
Richard Kimura |
| K173114 |
03/07/2018 |
primeMidline Catheters |
PFM Medical, Inc. |
Jessica Jho |
| K173792 |
03/13/2018 |
EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay |
Phadia AB |
Carina Magnusson |
| K173704 |
03/02/2018 |
ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip |
Phadia AB |
Carina Magnusson |
| K180195 |
03/16/2018 |
Frigitronics adapter |
Phakos |
Olivier Aumaitre |
| K180015 |
03/20/2018 |
Philips Incisive CT |
Philips Healthcare (Suzhou) Co., Ltd. |
Gordon Shu |
| K173451 |
03/20/2018 |
Ingenia Elition S and Ingenia Elition X |
Philips Medical Systems Nederland B.V. |
Jan van de Kerkhof |
| K173356 |
03/06/2018 |
Ingenia Elition S and Ingenia Elition X R5.4 |
Philips Medical Systems Nederland B.V. |
Jan van de Kerkhof |
| K172431 |
03/14/2018 |
Cardiovascular Analzyer |
PhysioWave, Inc. |
Laurent Giovangrandi |
| K173241 |
03/23/2018 |
MED-TAB |
PLUM Medical Solutions GmbH |
Arpad Bischof |
| K173533 |
03/29/2018 |
Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter |
Poiesis Medical, LLC |
Greg Wiita |
| K173734 |
03/12/2018 |
RocaJJ Soft Stents |
Promepla SAM |
Alexandre Bareille |
| K180426 |
03/16/2018 |
Empower H35 |
Quanta System Spa |
Francesco Dell'Antonio |
| K180423 |
03/15/2018 |
Empower H65 |
quanta system spa |
Francesco Dell'Antonio |
| K180265 |
03/02/2018 |
COMPACT TOUCH Ophthalmic Ultrasound System |
Quantel Medical |
Maureen O'Connell |
| K173939 |
03/09/2018 |
Quantib Brain |
Quantib BV |
Floor van Leeuwen |
| K163661 |
03/21/2018 |
P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil |
RAPID Biomedical GmbH |
Christian Zimmermann |
| K173741 |
03/05/2018 |
Reprocessed ArthoCare Ablation Wand |
ReNovo, Inc. |
Mark K. Wells |
| K173740 |
03/19/2018 |
Reprocessed DePuy Mitek Ablation Wand |
ReNovo, Inc. |
Mark K. Wells |
| K173181 |
03/16/2018 |
ExSpiron 1Xi |
Respiratory Motion Inc. |
Susan Hamann |
| K173358 |
03/16/2018 |
ARTAS System |
Restoration Robotics, Inc. |
Raymond Lee |
| K171655 |
03/02/2018 |
cobas m 511 integrated hematology analyzer |
Roche Diagnostics Hematology, Inc. |
Dan Bracco |
| K173887 |
03/21/2018 |
cobas CT/NG for use on cobas 6800/8800 systems |
Roche Molecular Systems, Inc. |
Nobuko Nakajima |
| K172928 |
03/16/2018 |
Portable X-ray System |
Rolence Enterprise Inc. |
Sterling Cheng |
| K170753 |
03/23/2018 |
Acculoc Total Knee System |
RootLoc Co., Ltd. |
Jungsun Ha |
| K172627 |
03/28/2018 |
David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette |
Runbio BioTech Co.,Ltd |
Chandler Chen |
| K173713 |
03/08/2018 |
HS70A Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Ji Yea Lee |
| DEN170023 |
03/26/2018 |
ThermoNeuroModulation Device, TNM Device |
Scion NeuroStim, LLC |
Robert Black |
| K180148 |
03/21/2018 |
ATS Thermal Imaging Probe, ATS Patient Interface Unit |
Securus Medical Group, Inc. |
William J. Gorman |
| K173425 |
03/23/2018 |
SRT-100+ |
Sensus Healthcare, Inc. |
Nicolas Soro |
| K180335 |
03/08/2018 |
Accutension Smartphone Auscultatory Blood |
Shanghai Hulu Devices Co., Ltd |
Junfeng Zhao |
| K172135 |
03/02/2018 |
uCT Computed Tomography X-ray System |
Shanghai United Imaging Healthcare Co., Ltd. |
Shumei Wang |
| K171214 |
03/02/2018 |
Infrared Thermometer |
Shenzhen Brav Electronic Technologies Co., Ltd. |
Aaron Wan |
| K171430 |
03/15/2018 |
Incontinence Treatment Device, Model LT2061 |
Shenzhen Dongdixin Technology Co., Ltd |
Truman Shen |
| K172972 |
03/02/2018 |
Wrist Type Automatic Blood Pressure Monitor |
Shenzhen Jiacom Technology Co., Ltd |
Luo Tianfeng |
| K172795 |
03/14/2018 |
Infrared Thermometer |
Shenzhen Jumper Medical Equipment Co., Ltd. |
Rambo Yang |
| K180016 |
03/20/2018 |
Home Use IPL Beauty Device |
Shenzhen Mismon Technology Co., Ltd |
Vicky Yang |
| K173517 |
03/30/2018 |
RADspeed fit |
SHIMADZU corporation |
Toshio Kadowaki |
| K180262 |
03/12/2018 |
SICAT Endo |
SICAT GmbH & Co. KG |
Manfred Breuer |
| K172322 |
03/29/2018 |
Atellica IM Total hCG (ThCG) |
Siemens Healthcare Diagnostics Inc. |
Anoop Joy |
| K173617 |
03/30/2018 |
MAGNETOM Vida with Compressed Sensing GRASP-VIBE |
Siemens Medical Solutions USA, Inc. |
Cordell L. Fields |
| K173607 |
03/21/2018 |
SOMATOM Edge Plus |
Siemens Medical Solutions USA, Inc. |
Alaine Medio |
| K173630 |
03/30/2018 |
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K173625 |
03/08/2018 |
syngo.CT Clinical Extensions |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K173637 |
03/30/2018 |
syngo.CT Coronary Analysis; syngo.CT Vascular Analysis |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K173408 |
03/21/2018 |
Mammomat Revelation |
Siemens Medical Solutions, Inc. |
Denise Adams |
| K173611 |
03/16/2018 |
syngo Application Software |
Siemens Medical Solutions, USA Inc. |
Patricia D. Jones |
| K173779 |
03/12/2018 |
REXMONO, PDREX |
SM ENG CO., LTD |
Soon-Gu Lee |
| K180334 |
03/05/2018 |
LEGION Knee System |
Smith & Nephew, Inc. |
Michael Scott |
| K172335 |
03/30/2018 |
Bleep DreamPort |
snapCPAP |
Stuart Heatherington |
| K173796 |
03/09/2018 |
Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) |
Sofradim Production |
Benjamin Rochette |
| K180443 |
03/22/2018 |
Tumark Vision |
SOMATEX Medical Technologies GmbH |
Burkhard Jakob |
| K180448 |
03/15/2018 |
INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter |
Sorin Group Italia S.r.l |
Luigi Vecchi |
| K180411 |
03/16/2018 |
MEMO 4D |
Sorin Group Italia S.r.l. |
Mauro Ercolani |
| K173591 |
03/28/2018 |
Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas |
Spectrum Medical Ltd |
Mark Drain |
| K180558 |
03/28/2018 |
PressureWire X |
St. Jude Medical (now part of Abbott Medical) |
Josh Johnson |
| K172012 |
03/14/2018 |
star RF Electrode, VIVA RF Electrode |
STARmed Co., Ltd. |
Jun-Young Jung |
| K172593 |
03/16/2018 |
XCelliStem Wound Powder |
StemSys |
Clay Fette |
| K173481 |
03/09/2018 |
Amsco Evolution Medium Steam Sterilizer |
STERIS Corporation |
Anthony Piotrkowski |
| K173488 |
03/01/2018 |
CELERITY 20 HP Challenge Pack |
STERIS Corporation |
Anthony Piotrkowski |
| K173256 |
03/02/2018 |
System 1 endo Liquid Chemical Sterilant Processing System |
Steris Corporation |
Marcia L Benedict |
| K173428 |
03/02/2018 |
VERIFY Chemical Indicator for S40 Sterilant |
STERIS Corporation |
Marcia L. Benedict |
| K173841 |
03/18/2018 |
AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm |
Stryker |
Angelica Beckmann |
| K172148 |
03/19/2018 |
Anchorage Bone Plating System |
Stryker GmbH |
Jackie Perri |
| K173499 |
03/19/2018 |
Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads |
Stryker Orthopaedics |
Kirsten Lehmuller |
| K171624 |
03/29/2018 |
IXOS Radius Plate System |
Stuckenbrock Medizintechnik GmbH |
Fabian Stuckenbrock |
| K173237 |
03/19/2018 |
Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist |
Syendgen, Inc. |
Shenda Baker |
| K180394 |
03/09/2018 |
BrightMatter Plan 1.6.0 |
Synaptive Medical Inc. |
Maham Ansari |
| K171808 |
03/15/2018 |
TDM Plate and Screw System |
TDM Co. Ltd. |
Babu Periasamy |
| K172590 |
03/02/2018 |
Spectra Optia Apheresis System |
Terumo BCT, Inc. |
Nicholas Wong |
| K172071 |
03/29/2018 |
Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation) |
Terumo Cardiovascular Systems Corporation |
Garry A. Courtney |
| K173799 |
03/29/2018 |
NaviCross 0.018 |
Terumo Corporation |
Yuko Watanabe |
| K180135 |
03/08/2018 |
THD Anopress with THD SensyProbe |
THD SpA |
Maurizio Pantaleoni |
| K180063 |
03/27/2018 |
OCM-G1 Attachment |
The Anspach Effort, Inc. |
Tamara J West |
| K173915 |
03/22/2018 |
Test of Variables of Attention (T.O.V.A.) |
The TOVA Company |
Chris Holder |
| K172267 |
03/06/2018 |
IRENE Thoracolumbar Fixation System |
Tianjin Zhengtian Medical Instrument Co.,Ltd. |
Ou Changli |
| K172496 |
03/23/2018 |
SUPERCATH 5 (26G) |
TOGO Medikit Co., Ltd. |
Daisuke Nagamizu |
| K180159 |
03/09/2018 |
Klassic« Knee System |
Total Joint Orthopedics, Inc. |
Chris Weaber |
| K173930 |
03/19/2018 |
PYTHON Plate Trial Instruments |
Treace Medical Concepts, Inc. |
Rachel Osbeck |
| K173694 |
03/13/2018 |
STERIZONE VP4 Sterilizer |
TSO3, Inc. |
Alexandre Jokci |
| K173879 |
03/05/2018 |
MiniMed Mio Advance infusion set |
Unomedical A/S |
Heidi Bjerre Lovkvist |
| K172611 |
03/21/2018 |
Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths |
Varian Medical Systems, Inc |
Peter J. Coronado |
| K173489 |
03/28/2018 |
GYN-Pump PH304 |
W.O.M. World of Medicine GmbH |
Soeren Markworth |
| K171989 |
03/20/2018 |
Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber R |
Wilson-Cook Medical Inc. |
Ashley Howard |
| K171973 |
03/21/2018 |
Captura« Disposable Hot Biopsy Forceps |
Wilson-Cook Medical, Inc. |
Ashley Howard |
| K171969 |
03/28/2018 |
Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Ext |
Wilson-Cook Medical, Inc. |
Ashley Howard |
| K180153 |
03/15/2018 |
X-spine Cortical Bone Screw System |
X-spine Systems, Inc. |
Charlene Brumbaugh |
| K162616 |
03/09/2018 |
Wrist Type Blood Pressure Monitor |
Xuzhou Yongkang Electronic Science Technology Co., Ltd |
YanLi Li |
| K173078 |
03/09/2018 |
Powder-free Clear Vinyl Patient Examination Gloves |
Yongsheng Medical Products Co., Ltd |
Jason Wei |
| K172500 |
03/01/2018 |
Technoweb Surgical Mask |
YTS GLOBAL INC. |
Eddie Nguyen |
| K180537 |
03/27/2018 |
Zavation Buttress Plate System |
Zavation Medical Products LLC |
Matt Jones |
| K173752 |
03/16/2018 |
SI Screw System |
Zavation Medical Products, LLC |
James M. Phillips |
| K172758 |
03/07/2018 |
Rotatable Snares, Non-Rotatable Snares |
Zhejiang Chuangxiang Medical Technology Co., LTD. |
Lucius Long |
| K172762 |
03/20/2018 |
Single Use Hemoclip |
Zhejiang Chuangxiang Medical Technology Co., LTD. |
Lucius Long |
| K180227 |
03/15/2018 |
Polaris Spinal Growth System |
Zimmer Biomet Spine, Inc. |
Anthony Michael Maahs |
| K173057 |
03/29/2018 |
Zimmer Knee Joint Replacement Prostheses MR Labeling |
Zimmer, Inc. |
Jason Heckaman |
