| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K150547 |
05/15/2015 |
.decimal Astroid Dosimetry App |
.decimal, inc |
KEVIN ERHART |
| K140654 |
05/22/2015 |
Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls |
ABBOTT LABORATORIES |
JUDITH R WALLACH |
| K143434 |
05/06/2015 |
One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series |
ABBOTT MEDICAL OPTICS INC |
Nooshin Azizi |
| K150453 |
05/20/2015 |
TULA Iontophoresis System with Earset |
ACCLARENT, INC. |
PAVAN SETHI |
| K142543 |
05/11/2015 |
Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control |
ACON LABORATORIES, INC. |
Qiyi Xie |
| K150069 |
05/22/2015 |
Fine Structure Analysis(fineSA) |
Acuitas Medical Ltd. |
John Heinrich |
| K142355 |
05/28/2015 |
Vaginal Tactile Imager |
Advanced Tactile Imaging, Inc. |
Vladimir Egorov |
| K150544 |
05/29/2015 |
Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System |
AESCULAP IMPLANT SYSTEMS, LLC |
Julie Tom Wing |
| K143060 |
05/21/2015 |
Intelli-Ox |
AIR LIQUIDE HEALTHCARE |
ANGIE BEYER |
| K151097 |
05/15/2015 |
Active Breathing Coordinator |
AKTINA MEDICAL CORPORATION |
TONY SPACCAROTELLA |
| K143740 |
05/22/2015 |
Battalion Universal Spacer System |
ALPHATEC SPINE, INC. |
Nadine Smith |
| K143750 |
05/07/2015 |
MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System |
APEX BIO TECHNOLOGY CORP |
Hsue-Mei Lee |
| K141036 |
05/01/2015 |
BGM009 BLOOD GLUCOSE MONITORING SYSTEM |
APEX BIOTECHNOLOGY CORP. |
HSUE-MEI LEE |
| K142971 |
05/26/2015 |
AMT Bridle - Nasal Tube Retention System |
Applied Medical Technology, Inc. |
Joshua Meinke |
| K151078 |
05/15/2015 |
Arthrex RetroFusion Screw |
ARTHREX, INC. |
DAVID L ROGERS |
| K150129 |
05/28/2015 |
AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) |
Aseptico, Inc. |
Cherie Tregoning |
| K150138 |
05/08/2015 |
Aspen Laser Systems Therapy Laser System |
ASPEN LASER SYSTEMS, LLC |
PAUL SCHWEN |
| K151102 |
05/22/2015 |
Bausch + Lomb Injector System |
Bausch & Lomb, Inc. |
Joyce Zhong |
| K143462 |
05/08/2015 |
AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use) |
BENQ MATERIALS CORPORATION |
Kenix Chang |
| K150198 |
05/02/2015 |
CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel |
Bio-Detek, Inc. |
Chuck Kolifrath |
| K150055 |
05/02/2015 |
OneStep Pediatric CPR Multi-Function Electrode |
BIO-DETEK, INC. |
CHUCK KOLIFRATH |
| K141910 |
05/04/2015 |
Intraosseous Cannula System Bio-MAC┐ and Bio-CORE |
BIOLOGIC THERAPIES INC |
AL LIPPINCOTT |
| K150125 |
05/11/2015 |
Elite Nitinol Fixation System |
BioMedical Enterprises, Inc. |
Joe Soward |
| K150424 |
05/15/2015 |
JuggerStitch Meniscal Repair Device |
BIOMET MANUFACTURING CORP. |
Patricia S. Beres |
| K151173 |
05/26/2015 |
Biomet Microfixation RibFix Blu Thoracic Fixation System |
Biomet Microfixation |
Lauren Jasper |
| K150522 |
05/01/2015 |
G7 Dual Mobility System |
BIOMET, INC. |
Amy Walriven |
| K141748 |
05/20/2015 |
RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET |
BIOPHOR DIAGNOSTICS, INC. |
Nathaniel G Butlin |
| K141351 |
05/19/2015 |
SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM |
Biotest Medical Corp. |
Yuhua Chen |
| K150679 |
05/29/2015 |
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector |
BOSTON SCIENTIFIC CORP. |
Virginia Garcia |
| K143643 |
05/15/2015 |
Brainscope Ahead 200 |
BRAINSCOPE COMPANY, INC. |
Michael E Singer |
| K150345 |
05/11/2015 |
Magic3 Go Intermittent Urinary Catheter |
C.R. BARD, INC. |
WILLIAM HEARD |
| K142586 |
05/28/2015 |
Captiva Spine FuselOX Cervical IBF System |
CAPTIVA SPINE |
Tamala J Wampler |
| K143496 |
05/29/2015 |
Piccolo Composite Plate System |
CarboFix Orthopedics Ltd. |
Yael Rubin |
| K143714 |
05/04/2015 |
Powerheart G5 AED |
CARDIAC SCIENCE CORPORATION |
Kathleen Roberts |
| K150151 |
05/21/2015 |
SmartGownTM surgical gown |
CARDINAL HEALTH 200, INC. |
Lavenia Ford |
| K150342 |
05/08/2015 |
Touch Ultrasound |
CARESTREAM HEALTH, INC. |
CAROLYN L WAGNER |
| K150467 |
05/21/2015 |
Retina Workplace |
CARL ZEISS MEDITEC AG |
MICHAEL HAISCH |
| K150620 |
05/08/2015 |
740 SELECT |
CAS MEDICAL SYSTEMS, INC. |
Ron Jeffrey |
| K142806 |
05/22/2015 |
DualCap |
CATHETER CONNECTIONS, INC. |
Mark Endo |
| K142469 |
05/01/2015 |
2D Mercy TAPE & 3D Mercy TAPE |
Children's Mercy Hospital |
Susan Abdel-Rahman |
| K150137 |
05/27/2015 |
SpiroThor |
Cohero Health LLC |
Melissa Manice |
| K150927 |
05/27/2015 |
Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff |
COLOPLAST A/S |
LEEANNE SWIRIDOW |
| K150615 |
05/01/2015 |
Vaginal Moisturizing Gel |
COMBE INCORPORATED |
Pushpa Rao |
| K150970 |
05/12/2015 |
Coda LP Balloon Catheter |
COOK INCORPORATED |
Chad Schulenburg |
| K150802 |
05/28/2015 |
Heavy Double Flexible Tipped Wire Guide |
COOK INCORPORATED |
JULIA FERGUSON |
| K150733 |
05/21/2015 |
Vital-Port Vascular Access System Power Injectable Port |
COOK INCORPORATED |
STEVEN LAWRIE |
| K150187 |
05/19/2015 |
ELITECROSS Support Catheter |
Cordis Corporation, A Johnson & Johnson Company |
Michelle Ragozzino Rodgers |
| K150007 |
05/04/2015 |
Modified Bencox Hip System |
Corentec Co., Ltd |
Goon Hee Lee |
| K150778 |
05/29/2015 |
Various Brands of Ultraviolet Lamps |
COSMEDICO LIGHT, INC. |
Steven Schlitt |
| K143263 |
05/29/2015 |
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets |
COVIDIEN |
KARIN DESJARDINS |
| K151163 |
05/29/2015 |
Signia Loading Unit, Tri-Staple 2.0 Cartridge |
Covidien LLC |
Frank Gianelli |
| K150891 |
05/01/2015 |
BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System |
Covidien LLC( Formerly Beacon Endoscopic Corp.) |
Saket Bhatt |
| K150230 |
05/15/2015 |
SculpSure |
CYNOSURE, INC. |
KEVIN O'CONNELL |
| K150359 |
05/07/2015 |
Tensyn Plug |
DALLEN MEDICAL, INC. |
Al Memmolo |
| K142666 |
05/22/2015 |
Scrambler Therapy MC-5 A Device |
Delta International Services & Logistics S.r.l |
Donatella Ruscito |
| K143679 |
05/01/2015 |
Nuance FLOW |
Den-Mat Holdings, LLC |
Helen Ragus |
| K143660 |
05/21/2015 |
Milagro / Milagro Advance Interference Screw |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
Yayoi Fujimaki |
| K142494 |
05/28/2015 |
ViMove |
dorsaVi Ltd. |
Dan Ronchi |
| K141168 |
05/15/2015 |
ANSISTIM |
DYANSYS, INC. |
SRINI NAGESHWAR |
| K143430 |
05/29/2015 |
SmartTENS |
EASYMED INSTRUMENT CO., LTD. |
Jeffery Wu(Tingjie Wu) |
| K141900 |
05/20/2015 |
SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE |
ECKERT & ZIEGLER BEBIG GMBH |
HUB VAN DE BERGH |
| K150999 |
05/06/2015 |
Acclarix Diagnostic Ultrasound System |
EDAN INSTRUMENTS, INC. |
QUEENA CHEN |
| K150885 |
05/29/2015 |
MAGEC 2 Spinal Bracing and Distraction System |
Ellipse Technologies, Incorporated |
REBECCA SHELBURNE |
| K142692 |
05/31/2015 |
Occlusion Balloon Catheter |
EMBOLX, INC. |
Michael P Allen |
| K142319 |
05/14/2015 |
SCIg60 Infuser, Infuset |
EMED TECHNOLOGIES CORPORATION |
PETER KOLLINGS |
| K143242 |
05/15/2015 |
Rebel 3DKNEE System |
ENCORE MEDICAL, L.P. |
Teffany Hutto |
| K150271 |
05/29/2015 |
Prime Adaptive Ultrasonic Scalpel System |
ENDOPRIME, INC. |
RICHARD GRANT |
| K151041 |
05/04/2015 |
ERBECRYO 2 Cryosurgical Unit with accessories |
ERBE USA, INC. |
John Tartal |
| K150446 |
05/21/2015 |
Erchonia Zerona 6 headed scanner EZ6 |
ERCHONIA CORPORATION |
Steve Shanks |
| K150026 |
05/18/2015 |
Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler |
ETHICON ENDO-SURGERY, LLC |
Marjorie Medina |
| K142038 |
05/04/2015 |
EUROIMMUN LYME ELISA(IgG/IgM) |
EUROIMMUN US |
MICHAEL LOCKE |
| K150130 |
05/28/2015 |
Ascendant TM Cervical Spacer System |
EXACTECH, INC. |
DAWN DAVISSON |
| K150458 |
05/14/2015 |
Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere |
EXACTECH, INC. |
Thomas McNamara |
| K150890 |
05/29/2015 |
Exactech Optetrak Logic CC |
EXACTECH, INC. |
PATRICK HUGHES |
| K150152 |
05/11/2015 |
The Octane Straight Intervertebral Fusion Device, Ti Coated |
EXACTECH, INC. |
Dawn Davisson |
| K150900 |
05/15/2015 |
Flexicare Heated Wire Breathing Systems |
FLEXICARE MEDICAL LTD. |
Joel Biddle |
| K150471 |
05/22/2015 |
CalcaNail Orthopedic Arthrodesis Nail |
Fournitures Hospitalieres Industrie |
Patricia Donnard |
| K150463 |
05/22/2015 |
CalcaNail Orthopedic Nail |
Fournitures Hospitalieres Industrie |
Patricia Donnard |
| K142629 |
05/14/2015 |
EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
Mary Moore |
| K142895 |
05/21/2015 |
LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators |
FUJIREBIO DIAGNOSTICS, INC |
Diana Dickson |
| K142719 |
05/20/2015 |
E-App |
GC MEDTECH, LLC |
Robert Ramirez |
| K143667 |
05/07/2015 |
GC KommonBase |
GC Orthodontics America Inc. |
Tom Macari |
| K150420 |
05/26/2015 |
Centricity Universal Viewer |
GE HEALTHCARE |
CHERYL BORK |
| K150681 |
05/12/2015 |
GEMORE OTC TENS |
GEMORE TECHNOLOGY CO., LTD. |
Boden S.P Lai |
| K142291 |
05/19/2015 |
GMX Series Medical Air/Oxygen Blender |
GENTEC (SHANGHAI) CORPORATION |
Dongjian Lin |
| K150171 |
05/14/2015 |
Tinnitus Sound Generator Module |
GN RESOUND A/S |
Lars Hagander |
| K142478 |
05/29/2015 |
opti-Toe |
Graham Medical Technologies, L.L.C. (d.b.a.GraMedica) |
Michael Graham |
| K143734 |
05/02/2015 |
Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810 |
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
Patrick Chow |
| K150356 |
05/13/2015 |
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card |
HEALGEN SCIENTIFIC LLC |
JIANQIU FANG |
| K150056 |
05/06/2015 |
Luxisse+ |
HEANY INDUSTRIES INC |
Cliff Rabidoux |
| K142486 |
05/18/2015 |
HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 |
HEINE Optotechnik GmbH & Co. KG |
Bettina Seim |
| K142482 |
05/07/2015 |
The Vest Airway Clearance System |
Hill-Rom Services Private Limited |
Christina Miracle |
| K140150 |
05/14/2015 |
Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System |
HMD BIOMEDICAL, INC. |
AXEL LIN |
| K150513 |
05/28/2015 |
Imed Technology Intravascular Administration Set, Imed Technology Extension Set |
IMED TECHNOLOGY, INC. |
KYLE ADAMS |
| K143502 |
05/20/2015 |
Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls |
IMMUNALYSIS CORPORATION |
JOSEPH GINETE |
| K143759 |
05/07/2015 |
JAZZ System |
IMPLANET S.A. |
REGIS LE COUEDIC |
| K150954 |
05/07/2015 |
Elite L Expandable Lumbar Fusion System |
INNOVA SPINAL TECHNOLOGIES, LLC |
ARMANDO VARELA |
| K142192 |
05/07/2015 |
Insightra Freedom Ventral Hernia Repair System |
Insightra Medical |
Neerav Parikh |
| K150707 |
05/27/2015 |
IntelePACS |
INTELERAD MEDICAL SYSTEMS INCORPORATED |
Ms. Luce Caron |
| K150284 |
05/15/2015 |
IS4000 da Vinci EndoWrist Instruments |
INTUITIVE SURGICAL, INC. |
Sarah Rizk |
| K140905 |
05/08/2015 |
DERMAFINE |
INVADO PHARMACEUTICALS |
EDWARD D KOBUS |
| K150243 |
05/01/2015 |
Invictus Medical GelShield |
Invictus Medical, Inc. |
Chris Gilmer |
| K143436 |
05/21/2015 |
InvisionECG System |
InvisionHeart Inc. |
Michael Wurst |
| K142549 |
05/26/2015 |
Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste |
J.C.E.C. Company, Inc. (doing business as Fountain Health Ca |
John Canvin |
| K151017 |
05/13/2015 |
JMS Harmony A.V. Fistula Needle Set |
JMS NORTH AMERICA CORPORATION |
SHO HOSOKI |
| K151007 |
05/08/2015 |
21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550) |
JVC KENWOOD CORPORATION |
Tsukasa Tashiro |
| K151134 |
05/27/2015 |
21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210) |
JVC KENWOOD CORPORATION |
Tsukasa Tashiro |
| K142487 |
05/07/2015 |
Chesapeake Stabilization System |
K2M Inc. |
Nancy Giezen |
| K142212 |
05/01/2015 |
Pyrenees Cervical Plate System |
K2M, Inc |
Nancy Giezen |
| K141576 |
05/04/2015 |
Maxima PRO 45L |
KAVO DO BRASIL INDUSTRIA E COMERCIO LTDA |
MARCOS FERNANDES NUNES |
| K151222 |
05/22/2015 |
Cautery Tip Cleaner |
KEY SURGICAL, INC. |
AMY YANTA |
| K141902 |
05/26/2015 |
LAGIS ENDOSCOPIC INSTRUMENTS DISPOSABLE GRASPER |
LAGIS ENTERPRISES CO, LTD. |
CORA CHEN |
| K150126 |
05/11/2015 |
Life Spine Cannulated Screws |
LIFE SPINE INC. |
Randy Lewis |
| K150237 |
05/05/2015 |
ILUMIEN, Drageonfly OPTIS Imaging Catheter |
LIGHTLAB IMAGING, INC. |
ERDIE DE PERALTA |
| K143256 |
05/28/2015 |
SMR Modular Glenoid |
Limacorporate S.P.A. |
Stephen J. Peoples |
| K141320 |
05/28/2015 |
LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls |
Lin-Zhi International, Inc. |
BERNIECE LIN |
| K142567 |
05/19/2015 |
RETeval Visual Electrodiagnostic Device |
LKC Technologies, Inc |
Quentin Davis |
| K150691 |
05/15/2015 |
Datalys Multi-Parameter Patient Monitor |
Lutech Industries, Inc. |
RONALD VACHULA |
| K143531 |
05/08/2015 |
Rapid Therapy System |
MAGSTIM COMPANY LIMITED |
Charles Hounsell |
| K150267 |
05/07/2015 |
QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators |
MAQUET CARDIOPULMONARY AG |
Whitney Torning |
| K142744 |
05/07/2015 |
Mecta-C TiPEEK |
Medacta International |
Adam Gross |
| K150887 |
05/29/2015 |
Para-Fix C&S Medium |
MEDICAL CHEMICAL CORPORATION |
KRIS J KONTIS |
| K143304 |
05/26/2015 |
Sickbay Clinical Platform |
Medical Informatics Corp |
Ralph Krog |
| K143147 |
05/07/2015 |
Gemini Bonded Sterilization Wrap |
MEDLINE INDUSTRIES, INC. |
Matt Clausen |
| K150333 |
05/08/2015 |
MedSource Sharps Dart |
MedSource International, LLC |
Laura Riggen |
| K150297 |
05/21/2015 |
PlasmaBlade UPPP and Suction Coagulator |
MEDTRONIC ADVANCED ENERGY |
Lydia Sakakeeny |
| K151236 |
05/19/2015 |
MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal) |
MEDTRONIC MINIMED, INC. |
Liane R. Miller |
| K142648 |
05/22/2015 |
SPINEDESIGN Spine Surgery Planning (Software Application) |
MEDTRONIC SOFAMOR DANEK USA, INC. |
Lila Joe |
| K151110 |
05/27/2015 |
Intersept Filtered Cardiotomy Reservoir |
Medtronic, Inc |
Chelsea L Pioske |
| K150530 |
05/08/2015 |
Level Sensor, Level Sensor Tape |
Medtronic, Inc |
Rahul Shah |
| K150117 |
05/27/2015 |
Medtronic Patient Asistant |
Medtronic, Inc. |
Eric Kalmes |
| K150269 |
05/26/2015 |
Ballancer 505 System, Model 1201-AC |
Mego Afek AC Ltd. |
Aharon Cohen |
| K151055 |
05/20/2015 |
Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE |
MENTOR WORLDWIDE LLC |
Sarah McManus |
| K142162 |
05/01/2015 |
MERITS TRANSFORMER POWER SCOOTER, S941 |
MERITS HEALTH PRODUCTS CO., LTD. |
VINCENT CHEN |
| K150779 |
05/22/2015 |
LipoFilter - Hospital Pack, LipoFilter - Clinic Pack |
MICROAIRE SURGICAL INSTRUMENTS, LLC |
Chris Spofford |
| K142032 |
05/07/2015 |
MRI PATIENT MONITORING SYSTEM TESLA M3 |
MIPM MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN |
ANDRE KINDSVATER |
| K150341 |
05/12/2015 |
Miromatrix Biological Mesh RS |
MIROMATRIX MEDICAL INC. |
JEFF ROSS |
| K141886 |
05/13/2015 |
MDK HANDPIECES |
MODERN KOREA CO., LTD. |
Priscilla Chung |
| K143101 |
05/01/2015 |
Helio A7 Manual Wheelchair, Move Manual Wheelchair |
MOTION COMPOSITES |
Vincent Leuyer |
| K150407 |
05/15/2015 |
BioFlo Midline Catheter |
NAVILYST MEDICAL, INC. |
Brandon M Brackett |
| K150772 |
05/08/2015 |
Snap-Off Self-Compressive Screw |
NEOSTEO |
JD Webb |
| K142717 |
05/07/2015 |
Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case |
Ni Hau Industrial Co., Ltd. |
Lyn Chiu |
| K141057 |
05/14/2015 |
DISPOSABLE CERVICAL BRUSH |
NINGBO HLS MEDICAL PRODUCTS CO., LTD |
LEON LU |
| K143608 |
05/04/2015 |
NovaCross Microcatheter |
Nitiloop Ltd. |
Michael A Daniel |
| K142260 |
05/11/2015 |
NobelActive |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
| K141907 |
05/29/2015 |
STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A |
NOVA BIOMEDICAL CORPORATION |
PAUL W MACDONALD |
| K150281 |
05/06/2015 |
StatStrip Glucose Hospital Meter |
NOVA BIOMEDICAL CORPORATION |
Paul W. MacDonald |
| K150461 |
05/20/2015 |
StatStrip Xpress Glucose Hospital Meter System |
NOVA BIOMEDICAL CORPORATION |
Paul W. MacDonald |
| K143561 |
05/19/2015 |
ELM PTA Balloon Dilatation Catheter |
O'CONNELL REGULATORY CONSULTANTS, INC. |
Maureen O'Connell |
| K143028 |
05/29/2015 |
Azure Anterior Cervical Plate System |
ORTHOFIX, INC. |
Natalia Volosen |
| K150822 |
05/15/2015 |
Centurion POCT System |
ORTHOFIX, INC. |
JACKI GEREN |
| K150600 |
05/22/2015 |
Response 5.5/6.0 Spine System |
ORTHOPEDIATRICS CORP. |
MARK FOX |
| K150663 |
05/07/2015 |
Diagnostic X-ray System |
OSKO, INC. |
WANG CHOI |
| K150946 |
05/08/2015 |
FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm |
OSTIAL CORPORATION |
Jake Wolenberg |
| K150880 |
05/01/2015 |
Tablo Console with Wireless Capability |
Outset Medical |
Nancy Gallo |
| K141875 |
05/05/2015 |
Pasture 60S Surgical Mask |
PASTURE PHARMA PTE LTD |
SARAH HASSAN |
| K142870 |
05/26/2015 |
Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] |
PENUMBRA, INC. |
Michael Mahl |
| K142458 |
05/22/2015 |
Penumbra System ACE |
PENUMBRA, INC. |
Michaela Mahl |
| K150454 |
05/26/2015 |
Acryfree Denture Base Material and Biosens Denture Base Material |
PERFLEX |
RAY KELLY |
| K143606 |
05/08/2015 |
MultiBand SENSE |
PHILIPS MEDICAL SYSTEMS NETHRLANDS BV |
Jan van de Kerkhof |
| K150310 |
05/13/2015 |
IntelliVue Patient Monitor |
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
JOHANNES SCHMID |
| K141883 |
05/15/2015 |
CLINISCANSM EEG |
PICOFEMTO LLC |
SRIKANT KRISHNA |
| K143435 |
05/14/2015 |
Planmed Verity |
PLANMED OY |
Lars Moring |
| K140068 |
05/22/2015 |
CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K142729 |
05/15/2015 |
Chi Lites Orthodontic Sapphire Bracket |
PROGRESSIVE TECHNOLOGY, INC. |
Shannon Rogers |
| K141863 |
05/14/2015 |
PURICORE WOUND HYDROGEL SPRAY DRESSING |
PURICORE INC. |
ART MORSE |
| K150139 |
05/22/2015 |
Rachel's Remedy |
Rachel's Remedies, LLC |
Rachel E. Jackson |
| K150226 |
05/13/2015 |
Hematocrit and Metabolite QUALICHECK |
RADIOMETER MEDICAL APS |
Mette Skytte Harpsoee |
| K150563 |
05/22/2015 |
Marrow Cellution Bone Marrow Aspiration Needle |
RANFAC CORP |
CHRISTOPHER P. WHELAN |
| K150627 |
05/27/2015 |
Rapid Aid Instant Disposable Infant Heel Warmer |
RAPID AID CORP. |
Rose Ren |
| K150797 |
05/01/2015 |
Digital Dental Intra Oral Sensor, EzSensor Smart |
Rayence Co., Ltd |
Kevin Kim |
| K142516 |
05/15/2015 |
Propeller System |
RECIPROCAL LABS CORPORATION |
David Hubanks |
| K143511 |
05/20/2015 |
K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant |
RECKITT BENCKISER |
ELIZABETH TORRE |
| K143647 |
05/11/2015 |
Renovis Surgical Hip Replacement System |
Renovis Surgical Technologies, Inc. |
Anthony DeBenedictis |
| K143603 |
05/21/2015 |
Darlinghurst Vented, Darlinghurst NV-AAV |
RESMED LTD. |
Jean-Nicholas Boudaud |
| K143694 |
05/15/2015 |
Rhondium One-Visit-Crown(OVC) |
Rhondium, Ltd. |
Greer Fricker |
| K150955 |
05/01/2015 |
Elecsys Progesterone III Cal Check 5 |
ROCHE DIAGNOSTICS |
ADAM CLARK |
| K142422 |
05/20/2015 |
cobas Cdiff Test |
ROCHE MOLECULAR SYSTEMS, INC. |
Wilk von Gustedt |
| K140386 |
05/26/2015 |
LUMINA 24 |
ROGERS SCIENCES INC. |
RAYMOND KELLY |
| K150521 |
05/15/2015 |
Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System |
RTI SURGICAL, INC. dba RTI BIOLOGICS |
Jennifer Bonacci |
| K150816 |
05/08/2015 |
Jumong Series |
SG HEALTHCARE CO LTD |
YOSEP PARK |
| K143585 |
05/06/2015 |
Electric Breast Pump |
SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD |
Jun Deng |
| K150282 |
05/27/2015 |
Shaser Skin Beauty Intense Pulsed Light System Family for Acne |
SHASER, INC. |
Anthony Burns |
| K143196 |
05/12/2015 |
syngo.CT Lung CAD |
SIEMENS AG MEDICAL SOLUTIONS |
JAMES E KUHN JR. |
| K150403 |
05/01/2015 |
ADVIA Centaur TSH3-Ultra |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
MATTHEW GEE |
| K150785 |
05/18/2015 |
syngo.CT Dental |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
EVE DAVIS |
| K150217 |
05/08/2015 |
ORTHOPHOS SL |
Sirona Dental Systems GMBH |
Thomas Diesch |
| K150675 |
05/12/2015 |
Dorsal Spanning Plate |
SKELETAL DYNAMICS, LLC |
ANN M. ESCAGEDO |
| K150091 |
05/26/2015 |
Versatex Monofilament Mesh |
SOFRADIM PRODUCTION |
Benjamin Rochette |
| K150941 |
05/22/2015 |
Somnowell Mandibular Advancement Appliance (MAA) |
Somnowell Ltd. |
Simon Ash |
| K143448 |
05/01/2015 |
Sonendo GentleWave System |
Sonendo, Inc. |
JENNY FAM |
| K150061 |
05/19/2015 |
Lucent; Lucent Ti-Bond Systems |
Spinal Elements Inc. |
Julie Lamothe |
| K143683 |
05/22/2015 |
APEX-DL Spine System |
SPINECRAFT LLC |
AMI AKALLAL-ASAAD |
| K150417 |
05/19/2015 |
ASTRA SPINE SYSTEM |
SPINECRAFT LLC |
AMI AKALLAL-ASAAD |
| K142504 |
05/13/2015 |
SpineFrontier Lumbar Interbody Fusion Device System |
SpineFrontier, Inc. |
Manthan Damani |
| K150036 |
05/07/2015 |
Blue Mountain Cervical Plate System |
SPINEWAY |
JULIEN THAO MY |
| K150185 |
05/12/2015 |
Mont Blanc Spinal System |
SPINEWAY |
Julien Thao My |
| K141146 |
05/01/2015 |
INVISIPORT |
STEALTH THERAPEUTICS, INCORPORATED |
Gary Syring |
| K143562 |
05/20/2015 |
Reprocessed Cordless Ultrasonic Dissection Device |
STERILMED, INC. |
Nicole Boser |
| K142568 |
05/05/2015 |
Stryker MEDPOR TITAN 3D Orbital Floor Implant |
Stryker |
Julie Schoell |
| K143399 |
05/08/2015 |
Stryker Footed Attachments and Cutting Accessories |
STRYKER CORP. |
VISHAL KANANI |
| K150539 |
05/12/2015 |
OASYS System |
Stryker Corporation |
GARRY T. HAYECK |
| K150801 |
05/22/2015 |
Stryker Maestro Air Motors |
STRYKER CORPORATION |
DEVAL PATEL |
| K143540 |
05/01/2015 |
Stryker MIS Attachments and Cutting Accessories |
STRYKER CORPORATION |
Mairead Twomey |
| K151076 |
05/22/2015 |
MicroTaper Needle Introducer Set |
Summit Access, LLC |
Fred Piazza |
| K142768 |
05/29/2015 |
Instru-Safe Instrument Protection System |
SUMMIT MEDICAL, INC. |
NICOLE DOVE |
| K150511 |
05/27/2015 |
Coating Material |
SUN MEDICAL CO., LTD |
MR. YUKIHITO YUKIMUNE |
| K150848 |
05/20/2015 |
Dose Calculator |
SUN NUCLEAR CORPORATION |
JAMES LUKER |
| K143728 |
05/15/2015 |
Minhua Disposable Blood Pressure Cuff |
SUZHOU MINHUA MEDICAL APPARATUS |
Ji Dong Yang |
| K143078 |
05/14/2015 |
Bookwalter Gordon Adjustable Compression Element |
SYMMETRY SURGICAL |
Victoria Rogers |
| K143198 |
05/27/2015 |
Synapse Transcutaneous Electrical Stimulation Device |
Synapse Electroceutical Limited |
JOHN GILDERSLEEVE |
| K143285 |
05/28/2015 |
Mandible External Fixator - MR Conditional |
Synthes USA Products, LLC |
Susan Lewandowski |
| K143326 |
05/14/2015 |
T.A.G. Dental Implant System |
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD |
EREZ ADIV |
| K143185 |
05/07/2015 |
entrΘ Model PD08-U |
TACTILE SYSTEMS TECHNOLOGY INC |
DANIEL G CHASE |
| K143467 |
05/07/2015 |
FORA GD43 Blood Glucose Monitoring System |
TaiDoc Technology Corporation |
C. W. CHEN |
| K140491 |
05/20/2015 |
TANAKA ZIRCOLOR COLORING LIQUID, TANAKA ZIRCOLOR DIPPING LIQUID AND TANAKA ENAMEL ZR BLOCKS |
TANAKA DENTAL |
BETSY A BROWN |
| K150824 |
05/28/2015 |
TD-Wand |
TDM SURGITECH, INC |
MICHAEL WEBER |
| K142103 |
05/08/2015 |
CUFF PILOT, SURE SEAL |
Teleflex Medical, Inc. |
PAUL DRYDEN |
| K150533 |
05/09/2015 |
Terason uSmart3200T Ultrasound System |
TERATECH CORP. |
Steven R Broadstone |
| K150536 |
05/05/2015 |
Terumo Circuit Tubing |
Terumo Cardiovascular Systems Corporation |
Garry Courtney |
| K150542 |
05/01/2015 |
Terumo Pump Tubing |
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
JOSHUA EWING |
| K142954 |
05/28/2015 |
PTA 14 Balloon Dilatation Catheter OTW |
Texas Medical Technologies, Inc. |
Aaron Chiu |
| K143118 |
05/26/2015 |
Human Microalbumin kit for use on SPAPLUS |
THE BINDING SITE GROUP LTD |
Marianne Sender |
| K150526 |
05/30/2015 |
Optilite IgG4 Kit |
THE BINDING SITE GROUP LTD |
Andrea Thomas |
| K142417 |
05/29/2015 |
SP-1PSpecular Microscope |
TOPCON CORPORATION |
Michael Gusel |
| K142087 |
05/01/2015 |
COVA MONITORING SYSTEM |
toSense, Inc. |
NANDINI MIRTHY |
| K143294 |
05/15/2015 |
Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
Paul Biggins |
| K143629 |
05/19/2015 |
U&U Bowie-Dick Test Pack |
U&U MEDICAL TECHNOLOGY CO., LTD |
GARFIELD WANG |
| K150636 |
05/08/2015 |
VariSeed 9.0 |
VARIAN MEDICAL SYSTEMS, INC. |
Peter J. Coronado |
| K150706 |
05/08/2015 |
VitalBeam |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J. CORONADO |
| K150389 |
05/06/2015 |
Spiral Flow Peripheral Vascular Graft |
VASCULAR FLOW TECHNOLOGIES LTD |
Edwin Lindsay |
| K150628 |
05/22/2015 |
VentriPoint Medical System |
VENTRIPOINT, INC. |
JIM BODTKE |
| K150161 |
05/12/2015 |
Venus Viva SR Device |
Venus Concept Ltd. |
Orit Ron Edoute |
| K150035 |
05/01/2015 |
V10 system |
VIORA LTD. |
OMRI KESLER |
| K143212 |
05/01/2015 |
Bifix Temp |
VOCO GMBH |
M. Th. Plaumann |
| K151145 |
05/26/2015 |
2.4mm X 127 cm Phoenix Atherectomy Deflecting System |
Volcano AtheroMed, Inc. |
JEAN CHANG |
| K142055 |
05/11/2015 |
GYMFORM ABS & CORE |
WELL BRAIN INTERNATIONAL, LTD. |
VICTOR K WAI |
| K142385 |
05/22/2015 |
Whisper Pump System |
Wound RX Medical, LLC |
Richard Deslauriers |
| K142724 |
05/20/2015 |
BIOFOAM Bone Wedge |
WRIGHT MEDICAL TECHNOLOGY, INC. |
Val Myles |
| K150213 |
05/08/2015 |
Subtalar Spacer System (STS) |
WRIGHT MEDICAL TECHNOLOGY, INC. |
TARA CONRAD |
| K141874 |
05/28/2015 |
URISCAN OPTIMA |
YD DIAGNOSTICS CORP. |
YANG HO DONG |
| K150224 |
05/12/2015 |
BLUE VINYL GLOVES POWDER FREE |
ZIBO SANYING TRADE CO., LTD |
Jing Li |
| K143528 |
05/01/2015 |
Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System |
ZIMMER DENTAL INC. |
CHRISTINA BOYDSTON |
| K143321 |
05/29/2015 |
ITST Intertrochanteric/Subtrochanteric Fixation System |
ZIMMER, INC. |
PATRICK MCCULLAGH |
| K150626 |
05/01/2015 |
Rush Medullary Pins |
Zimmer, Inc. |
Patrick McCullagh |
| K150818 |
05/01/2015 |
Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System |
ZIMMER, INC. |
PATRICK MCCULLAGH |
| K150090 |
05/20/2015 |
Zimmer Persona Personalized Knee System |
ZIMMER, INC. |
Keith Proctor |
| K151175 |
05/15/2015 |
ZONARE ZS3 Diagnostic Ultrasound System |
ZONARE MEDICAL SYSTEMS, INC. |
STEVE GEERDES |
