| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K141770 |
04/22/2015 |
LUNA CPAP AND AUTO-CPAP SYSTEM |
3B MEDICAL, INC |
ALEX LUCIO |
| K143258 |
04/09/2015 |
PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) |
4WEB,INC. |
JESSEE HUNT |
| K150974 |
04/29/2015 |
aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium |
AAP IMPLANTATE AG |
CHRISTIAN ZIETSCH |
| K142820 |
04/30/2015 |
BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS Toric (mangofilcon A) Soft (hydrophilie) Contact Lens for Daily Wear, BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear, BIOLENS Toric M |
ABB Optical Group, LLC |
John Kenyon |
| K150510 |
04/02/2015 |
Total Bilirubin |
ABBOTT LABORATORIES |
SUSHMA RAO |
| K133002 |
04/16/2015 |
i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials |
ABBOTT POINT OF CARE INC. |
MELISSA ROBINSON |
| K150172 |
04/07/2015 |
ACCLARENT SE Inflation Device |
ACCLARENT, INC. |
JAMES PATRICK GARVEY II |
| K143541 |
04/22/2015 |
Relieva SpinPlus Balloon Sinuplasty System |
ACCLARENT, INC. |
Pavan Sethi |
| K143269 |
04/14/2015 |
Delivery Analysis |
ACCURAY INCORPORATED |
Keith Picker |
| K150330 |
04/30/2015 |
Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) |
ACON Laboratories, Inc. |
Qiyi Xie |
| K143385 |
04/06/2015 |
Acumed Ankle Plating System |
Acumed, llc |
Nathan Wolf |
| K142454 |
04/03/2015 |
STERRAD NX Sterilizer, STERRAD 100NX Sterilizer |
ADVANCED STERILIZATION PRODUCTS |
SUN CHOI |
| K141687 |
04/02/2015 |
AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM |
AESCULAP, INC. |
KATHY A RACOSKY |
| K150660 |
04/16/2015 |
Alcyone MEMS Cannula (AMC) System |
ALCYONE LIFESCIENCES, INC. |
ELSA CHI ABRUZZO |
| K150457 |
04/10/2015 |
AlfaSight 9000 Thermographic System |
ALFA THERMODIAGNOSTICS, INC. |
Daniel Beilin |
| K132663 |
04/20/2015 |
I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM |
ALLIANCE INTERNATIONAL CO., LTD. |
JEN KE-MIN |
| K143372 |
04/02/2015 |
AWARE |
AMBIENT CLINICAL ANALYTICS |
ALLEN BERNING |
| K150163 |
04/23/2015 |
Otowave 202 Portable Tympanometer |
AMPLIVOX, LTD. |
Chris Roerig |
| K141984 |
04/29/2015 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO., LTD |
LIU YI |
| K143536 |
04/16/2015 |
Voyant Fine Fusion Device |
APPLIED MEDICAL RESOURCES |
JESSICA CHO |
| K142569 |
04/03/2015 |
Aptis Medical Distal Radio Ulnar Joint Implant |
APTIS MEDICAL, LLC. |
Bryann Babb |
| K150256 |
04/30/2015 |
SILVERLON BURN CONTACT DRESSINGS |
ARGENTUM MEDICAL |
C.Richard Foster |
| K143702 |
04/09/2015 |
Arthrex Blunt Tip Screws with Fiber Tape |
Arthrex, Inc. |
David L Roger |
| K143749 |
04/03/2015 |
Arthrex Distal Radius System |
Arthrex, Inc. |
Laura Medlin |
| K150456 |
04/29/2015 |
Arthrex Plates, Screws, and Staples |
Arthrex, Inc. |
David L Rogers |
| K142056 |
04/09/2015 |
LIOLI IOL DELIVERY SYSTEM |
AST PRODUCTS, INC. |
William Lee |
| DEN140030 |
04/01/2015 |
SpaceOAR System |
AUGMENIX , INC. |
Noel Rolon |
| K150821 |
04/10/2015 |
MDNG-3220 (Nio 3MP LED) |
Barco |
Lieven De Wandel |
| K150860 |
04/16/2015 |
Nitroglycerin Sets with DUO-VENT Spike |
BAXTER HEALTHCARE CORPORATION |
DHIRAJ BIZZUL |
| K141932 |
04/10/2015 |
AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS |
BECKMAN COULTER, INC. |
ANTHONY DENNIS |
| K143610 |
04/09/2015 |
BD INTIMA II CLOSED IV CATHETER |
Becton Dickinson Infusion Therapy Systems Inc. |
John Roberts |
| K150059 |
04/28/2015 |
BD FlowSmart Set |
BECTON, DICKINSON COMPANY |
AVITAL MERL |
| K150191 |
04/17/2015 |
GammaBeam 500 |
Best Theratronics Limited |
Mike de van der Schueren |
| K143336 |
04/01/2015 |
Biomet Microfixation OmniMax MMF System |
BIOMET MICROFIXATION |
Lauren Jasper |
| K150235 |
04/22/2015 |
CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels |
BOSTON SCIENTIFIC CORPORATION |
MAYLIN TRUESDELL |
| K133697 |
04/10/2015 |
BREAST-MED TISSUE MARKER |
BREAST-MED, INC. |
MICHAEL NELSON |
| K143280 |
04/23/2015 |
BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens |
Brien Holden Vision Pty Ltd. |
Randall May |
| K150051 |
04/08/2015 |
Exilite |
BTL Industries, Inc. |
Jan Zarsky |
| K142445 |
04/13/2015 |
PINPOINT GT SAFETY INTRODUCER NEEDLE |
C.R. BARD, INC. |
AMY MCMANUS |
| K142083 |
04/17/2015 |
TRUE FLOW VALVULOPLASTY PERFUSION CATHETER |
C.R. BARD, INC. |
AARON CONOVALOFF |
| K150083 |
04/14/2015 |
Sidecar External Working Channel |
C2 THERAPEUTICS |
THERESA BRANDNER-ALLEN |
| K150016 |
04/06/2015 |
Vertessa Lite |
CALDERA MEDICAL, INC. |
Vicki Gail |
| K150023 |
04/06/2015 |
Vertessa Lite Y-Mesh |
CALDERA MEDICAL, INC. |
Vicki Gail |
| K150326 |
04/16/2015 |
PicoWay Laser System |
Candela Corporation |
Ruthie Amir |
| K150579 |
04/29/2015 |
Cardinal Health External Fixation System |
CARDINAL HEALTH |
TATYANA BOGDAN |
| K143016 |
04/20/2015 |
Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home |
CARDINAL HEALTH |
Tatyana Bogdan |
| K150732 |
04/13/2015 |
Diamondback 360 Peripheral Orbital Atherectomy System |
CARDIOVASCULAR SYSTEMS, INC. |
Blair Buth |
| K143675 |
04/10/2015 |
FORE-SIGHT Elite Absolute Tissue Oximeter |
CAS MEDICAL SYSTEMS, INC. |
Ron Jeffrey |
| K143024 |
04/28/2015 |
CAS-One Liver |
CAScination AG |
Matthias Peterhans |
| K150010 |
04/02/2015 |
Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port |
Cedic S.r.l. |
Tiziana Melis |
| K141880 |
04/16/2015 |
BIOPOR AOC POROUS POLYETHYLENE, CEREPOR |
CEREMED, INC. |
CHELSEA MITCHELL |
| K143599 |
04/17/2015 |
Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 |
Chemtron Biotech, Inc. |
Jane Zhang |
| K142216 |
04/21/2015 |
Tranberg CLS Thermal Therapy System |
Clinical Laserthermia Systems AB |
Lars-Erik Eriksson |
| K150798 |
04/24/2015 |
Codent Low Speed Dental Handpieces and Accessories |
CODENT TECHNICAL INDUSTRY CO., LTD. |
Chin-Ting Wen |
| K142745 |
04/01/2015 |
125mL CT Syringe |
COEUR, INC. |
Erin Rheinscheld |
| K143077 |
04/06/2015 |
Trevo XP ProVue Retriever (6X25mm) |
CONCENTRIC MEDICAL, INC. |
Bill Hyatt |
| K142535 |
04/23/2015 |
ConMed Mixing and Delivery Kit |
CONMED CORPORATION |
Dionne Sanders |
| K141362 |
04/23/2015 |
PULSE OXIMETER CMS50EW |
CONTEC MEDICAL SYSTEMS CO., LTD. |
Diana Hong |
| K141737 |
04/08/2015 |
CONVENTUS PHS SYSTEM |
CONVENTUS ORTHOPAEDICS, INC. |
KENT LIND |
| K142094 |
04/10/2015 |
COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM |
COPAN ITALIA S.P.A. |
TINA WU |
| K150836 |
04/29/2015 |
OUTBACK Elite Re-Entry Catheter |
CORDIS CORPORATION, A JOHNSON & JOHNSON CO. |
MICHELLE RAGOZZINO RODGERS |
| K142761 |
04/03/2015 |
Corin TaperFit Hip Stem |
CORIN USA |
Diana L Nader-Martone |
| K143506 |
04/16/2015 |
BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL |
COVIDIEN |
TIMOTHY HOLWICK |
| K143018 |
04/02/2015 |
Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors |
Covidien |
Wei Zhao |
| K142839 |
04/29/2015 |
GenCut Core Biopsy System |
Covidien LLC |
Jenny Jiang |
| K143654 |
04/03/2015 |
Valleylab LS10 Generator |
COVIDIEN LLC |
DONALD HENTON |
| K150413 |
04/02/2015 |
QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator |
CyMedica Orthopedics, Inc. |
Kereshmeh Shahriari |
| K150400 |
04/06/2015 |
Renu Gel |
CYTOPHIL, INC. |
BOB VOIGTS |
| K150033 |
04/20/2015 |
Air Compressible Limb Therapy System |
DAESUNG MAREF CO., LTD. |
JAE-WHA LEE |
| K143530 |
04/24/2015 |
Aespire View |
Datex-Ohmeda, Inc. |
Michelle Huettner |
| K141747 |
04/20/2015 |
RHINOGUARD |
DAVIS MEDICAL |
MICHELLE LOTT |
| K143475 |
04/03/2015 |
VAPR Tripolar Suction Electrode |
Depuy Mitek |
Susan Kagan |
| K143551 |
04/28/2015 |
Compex Wireless USA |
DJO, LLC |
GINA FLORES |
| K142986 |
04/17/2015 |
SagiNova |
Eckert & Ziegler BEBIG GmbH |
Michel Lafuente |
| K140348 |
04/23/2015 |
INTERBODY CAGE |
EISERTECH, LLC |
LUKAS EISERMANN |
| K150106 |
04/03/2015 |
2MP Color LCD Monitor, RadiForce RS240 |
EIZO CORPORATION |
HIROAKI HASHIMOTO |
| K150516 |
04/13/2015 |
DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS |
EL.EN ELECTRONIC ENGINEERING SPA |
PAOLO PERUZZI |
| K150656 |
04/23/2015 |
PRECICE Intramedullary Limb Lengthening System |
Ellipse Technologies, Incorporated |
Rebecca Shelburne |
| K140360 |
04/10/2015 |
HEALTH KIOSK |
ENGAGEMENTHEALTH, LLC |
JORGE MILLAN |
| K142421 |
04/09/2015 |
G-scan Brio |
ESAOTE, S.P.A. |
Donatella Ragghianti |
| K141827 |
04/17/2015 |
EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE |
EUROIMMUN U.S., Inc. |
MICHAEL A LOCKE |
| K143659 |
04/09/2015 |
Equinoxe Mega Prosthesis |
EXACTECH, INC. |
Thomas McNamara |
| K150223 |
04/28/2015 |
Facet-Link Stabilization Platform |
FACET-LINK, INC. |
Massimo Calafiore |
| K150473 |
04/16/2015 |
FlexPointer 1.5 mm |
FIAGON GMBH |
DR. DIRK MUCHA |
| K143666 |
04/23/2015 |
Noblex Long Pulse Alexandrite Laser |
FINEMEC CO.,LTD. |
GHUN HEE LEE |
| K143723 |
04/09/2015 |
SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro |
FOTONA D.D. |
STOJAN TROST |
| K141997 |
04/01/2015 |
CRIT-LINE IV SYSTEM |
FRESENIUS MEDICAL CARE |
DENISE OPPERMANN |
| K150430 |
04/17/2015 |
Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor |
FUDAKANG INDUSTRIAL CO., LTD |
BOB YU |
| K142456 |
04/10/2015 |
GPS Spacers |
G SURGICAL, LLC |
Donald Grafton |
| K143140 |
04/20/2015 |
G-Premio BOND |
GC AMERICA, INC. |
Dr. Mark Heiss |
| K142646 |
04/30/2015 |
XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and |
Genadyne Biotechnologies, Inc |
Chien Ming |
| K143574 |
04/21/2015 |
Melodi Prime Breast Pump |
Genadyne Biotechnologies, Inc. |
Chien Ming GOH |
| K150649 |
04/30/2015 |
G3 Active Plate Large Fragment System |
GENESIS FRACTURE CARE, INC. |
MICHAEL BOTTLANG, |
| K143591 |
04/15/2015 |
Dorsal Appliance |
GERGENS ORTHODONTIC LAB |
Chris Morrison |
| K143527 |
04/20/2015 |
IPM Wound Gel Bio, IPM Derm Gel Bio |
GLYCOBIOSCIENCES, INC |
Kevin Drizen |
| K143733 |
04/03/2015 |
Digital Automatic Wrist Blood Pressure Monitor MD2400 |
Grandway Technology (Shenzhen) Limited |
Patrick Chow |
| K143312 |
04/21/2015 |
Portrait GBS Assay |
GREAT BASIN CORPORATION |
Chuck Owen |
| K141349 |
04/10/2015 |
Disposable sterile needle retractable safety syringe |
GUANGDONG HAIOU MEDICAL APPARATUS STOCK CO., LTD |
SALON CHEN |
| K150602 |
04/07/2015 |
CR3 Keyless Split Sample Cup Morphine - Methamphetamine |
GUANGZHOU WONDFO BIOTECH CO., LTD. |
BEN CHEN |
| K142824 |
04/14/2015 |
LX-100 Hair Growth Stimulation System |
Hairlabs International Inc |
James Britt |
| K150110 |
04/23/2015 |
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin P |
HARTALEGA NGC SDN. BHD. |
Kuan Mun Leong |
| K150103 |
04/23/2015 |
Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs |
HARTALEGA SDN BHD |
Kuan Kam Hon |
| K150791 |
04/24/2015 |
Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card) |
HEALGEN SCIENTIFIC LLC |
JIANQIU FANG |
| K150490 |
04/17/2015 |
UnicLine Mobile |
Heka Dental A/S |
Claus van der Goot |
| K142551 |
04/16/2015 |
QANS (Quantitative Autonomic Nervous System) Monitoring System |
HHSsystems, LLC |
HOWARD G. HINDIN |
| K133033 |
04/08/2015 |
HIDREX PSP1000 |
HIDREX GMBH |
STEFANIE D BANKSTON |
| K142911 |
04/10/2015 |
ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
HUAILAI ZM PLASTIC PRODUCTS CO., LTD |
ZHUAHAO ZHANG |
| K141619 |
04/06/2015 |
LUOFUCON SILVER FOAM DRESSING |
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD |
CHARLES SHEN |
| K150293 |
04/15/2015 |
EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D) |
I-SEE VISION TECHNOLOGY INC. |
ISAAC HUANG |
| K142994 |
04/21/2015 |
IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
Mick Fenton |
| K143731 |
04/14/2015 |
IMPLANET Spine System (ISS) |
IMPLANET S.A. |
Regis Le Couedic |
| K142519 |
04/15/2015 |
InterActive Complete Surgical Tray |
Implant Direct Sybron Manufacturing , LLC |
Debleena Sinha |
| K150913 |
04/30/2015 |
INCITE ANCHORED CERVICAL INTERBODY DEVICE |
INCITE INNOVATION |
JOHN KIRWAN |
| K150183 |
04/09/2015 |
ApexM |
InControl Medical, LLC |
Jessica Andreshak |
| K150813 |
04/30/2015 |
iTClamp50 |
INNOVATIVE TRAUMA CARE INC |
Ian Atkinson |
| K150155 |
04/08/2015 |
NOVA Lite DAPI ANA Kit |
INOVA DIAGNOSTICS, INC. |
Gabriella Lakos |
| DEN140039 |
04/09/2015 |
NOVA View Automated Fluorescense Microscope |
INOVA DIAGNOSTICS, INC. |
GABRIELLA LAKOS |
| K150428 |
04/16/2015 |
Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs |
INTEGRA LIFESCIENCES CORP. |
Judith E O'Grady |
| K141643 |
04/24/2015 |
YARLAP |
INTERNATIONAL TRADE GROUP, INC. |
BRENT C REIDER |
| K150343 |
04/03/2015 |
V8 Transluminal BAV Catheter |
InterValve, Inc. |
Mark Ungs |
| K143132 |
04/02/2015 |
IS4000 8mm Harmonic ACE Curved Shears |
INTUITIVE SURGICAL, INC. |
EARLE CANTY |
| K150837 |
04/29/2015 |
IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps |
INTUITIVE SURGICAL, INC. |
SARAH RIZK |
| K150164 |
04/03/2015 |
Monobond Etch & Prime |
IVOCLAR VIVADENT AG |
SANDRA CAKEBREAD |
| K143575 |
04/03/2015 |
Accu-Dent XD Tray, Accu-Dent XD Syringe |
IVOCLAR VIVADENT, INC. |
Donna Marie Hartnett |
| K143241 |
04/13/2015 |
MDT Navigable Brain Biopsy Cannula |
IZI MEDICAL PRODUCTS LLC |
Qiang Cao |
| K143034 |
04/22/2015 |
Jintronix |
JINTRONIX INC. |
Mark Evin |
| K150182 |
04/23/2015 |
Neodent Implant System- CM Drive Implants |
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S |
Jacson Cambruzzi |
| K142930 |
04/17/2015 |
Exam Vue DR |
JPI HEALTHCARE CO., LTD |
Wonsik (Stanley) Youn |
| K143465 |
04/09/2015 |
MASTERmatic LUX |
Kaltenbach & Voigt Gmbh |
Stefan Trampler |
| K141781 |
04/09/2015 |
KOGENT SPETZLER LIGHTED SUCTION TUBES |
KATALYST SURGICAL, LLC |
MERYL KOCH |
| K143053 |
04/03/2015 |
KIMGUARD ONE-STEP Sterilization Wrap |
KIMBERLY-CLARK HEALTH CARE |
MONICA KING |
| K150060 |
04/02/2015 |
J2A Dental Implant System, J2C Dental Implant System |
KJ MEDITECH CO., LTD |
Goong-san Nam |
| K142330 |
04/09/2015 |
Kobold Ring and Tandem Applicator Set |
KOBOLD, LLC |
Spencer Fillmore |
| K143332 |
04/14/2015 |
Fast Sphyg by Koven |
KOVEN TECHNOLOGY, INC. |
HEATHER BELL |
| K143360 |
04/03/2015 |
LnK Cervical Interbody Fusion Cage System |
L&K BIOMED Co., Ltd |
Yerim An |
| K143363 |
04/22/2015 |
VENUS Spinal Fixation System |
L&K BIOMED Co., Ltd. |
Ki-Hyang Kim |
| K150507 |
04/03/2015 |
Santis Pedicle Screw System |
LANTERNA MEDICAL TECHNOLOGIES |
Horace Hale |
| K150098 |
04/09/2015 |
LightStim Professional 2-Panel Light |
LED INTELLECTUAL PROPERTIES, LLC |
STEVE MARCHESE |
| K143249 |
04/07/2015 |
SOLSTICE OCT System |
LIFE SPINE, INC |
Randy Lewis |
| K142253 |
04/23/2015 |
SOLSTICE OCT System |
LIFE SPINE, INC |
Randy Lewis |
| K150229 |
04/07/2015 |
SOLSTICE OCT System |
LIFE SPINE, INC |
Randy Lewis |
| K141934 |
04/02/2015 |
PHYSICA KR KNEE SYSTEM |
LIMACORPORATE S.P.A. |
EMANUELE BUTTAZZONI |
| K150747 |
04/02/2015 |
EzDent-i /E2/Prora View |
LK Consulting Group USA, Inc. |
Priscilla Chung |
| K142964 |
04/30/2015 |
VALIDATE Anemia Calibration Verification/ Linearity Test Kit |
MAINE STANDARDS COMPANY, LLC |
James Champlin |
| K142581 |
04/09/2015 |
APTUS Foot System |
MEDARTIS AG |
ANDREA SCHWEIZER |
| K143238 |
04/24/2015 |
C3 Wave |
MEDCOMP (MEDICAL COMPONENTS) |
Courtney Nix |
| K150134 |
04/21/2015 |
Basic, Dominant Flex, KV-6 |
MEDELA AG |
ORLANDO ANTUNES |
| K150499 |
04/21/2015 |
Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty |
MEDELA AG |
ORLANDO ANTUNES |
| K143447 |
04/17/2015 |
Dilapan-S |
Medicem Technology s.r.o. |
Adam Vlcek |
| K142163 |
04/20/2015 |
MALE CIRCUMCISION KITS:RAPIDECLAMP |
MEDICFIT TECHNOLOGY SDN BHD |
JIGAR SHAH |
| K150286 |
04/27/2015 |
Medline Enteral Feeding Sets |
MEDLINE INDUSTRIES, INC. |
Stephanie Blair |
| K143480 |
04/02/2015 |
Euphora Rapid Exchange Balloon Dilatation Catheter |
MEDTRONIC INC. |
John Kilmartin |
| K150460 |
04/28/2015 |
KYPHON (R) HV-R(R) Bone Cement |
MEDTRONIC SOFAMOR DANCK USA, INC. |
Kathy L. Remsen |
| K143019 |
04/08/2015 |
CD HORIZON Spinal System, IPC POWEREASE System |
Medtronic Sofamor Danek USA, Inc. |
Lila Joe |
| K150567 |
04/09/2015 |
MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT |
Medtronic, Inc. |
Bruce Backlund |
| K150777 |
04/24/2015 |
Artoura Breast Tissue Expander |
MENTOR WORLDWIDE LLC |
Manchi Cheung |
| K143255 |
04/09/2015 |
Prelude SNAP Splittable Sheath Introducer |
MERIT MEDICAL SYSTEMS, INC. |
Alina Stubbs |
| K143341 |
04/21/2015 |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
GERHARD FRICK |
| K150302 |
04/10/2015 |
PROFEMUR Preserve Classic Stem |
MICROPORT ORTHOPEDICS INC. |
MATT PAUL |
| K150133 |
04/20/2015 |
PROFEMUR Preserve Size 1-3 Hip Stems |
MICROPORT ORTHOPEDICS, INC. |
BYRON LEDBETTER |
| K142883 |
04/17/2015 |
MindChild Meridian M100 Fetal Heart Rate Monitor |
Mindchild Medical |
Jim Robertson |
| K150705 |
04/13/2015 |
FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic Cannula, FloShield 10mm Conical Blunt Obturator |
Minimally Invasive Devices, Inc. |
Trudie L Seeger |
| K142647 |
04/13/2015 |
mint Lesion |
MINT MEDICAL GMBH |
Jochen Neuhaus |
| K142918 |
04/24/2015 |
EndoTool SubQ |
MONARCH MEDICAL TECHNOLOGIES |
STUART LONG |
| K150746 |
04/14/2015 |
JUSHA-M52C Medical Display |
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD |
MA JING |
| K150842 |
04/28/2015 |
JUSHA-M53 Medical Display |
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD |
JING MA |
| K140233 |
04/06/2015 |
ULTRASONIC SCALER |
NANNING BAOLAI MEDICAL INSTRUMENT CO., LTD. |
MIKE GU |
| K143706 |
04/10/2015 |
FortiBridge Anterior Cervical Plate System |
Nanovis Spine LLC |
Matthew Hedrick |
| K143440 |
04/20/2015 |
Natus Quantum |
NATUS MEDICAL INCORPORATED |
SANJAY MEHTA |
| K143252 |
04/23/2015 |
Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange) |
NEEDLETECH PRODUCTS, INC. |
Dennis Shay |
| K143344 |
04/09/2015 |
NeoMed NeoConnect Enteral Syringes with ENFit Connector |
NEOMED, INC. |
TONY LAIR |
| K143327 |
04/13/2015 |
Neoss Ti Reinforced Membrane |
Neoss Ltd |
Karin Darle Olsson |
| K150647 |
04/08/2015 |
Polyscrew Pedicle Screw System |
New Era Orthopedics, LLC |
Mark De Baca |
| K150993 |
04/23/2015 |
NICO TRIOwand |
NICO CORPORATION |
JAY DITTMAN |
| K142624 |
04/24/2015 |
Neuromaster G1 MEE200 |
Nihon Kohden Corporation |
Natalie Kennel |
| K143351 |
04/29/2015 |
iCase Contact Lens Case |
Novabay Pharmaceuticals, Inc |
Charles Francavilla |
| K143523 |
04/06/2015 |
Airlock osteosynthesis plate system |
NOVASTEP |
Gilles AUDIC |
| K143684 |
04/23/2015 |
NuVasive Reline System |
NUVASIVE INCORPORATED |
OLGA LEWIS |
| K143595 |
04/29/2015 |
NuVasive(R) CCX-L Interbody System |
NuVasive, Incorporated |
Cynthia Adams |
| K141914 |
04/15/2015 |
PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM |
OK BIOTECH CO., LTD. |
Ke-Min Jen |
| K150633 |
04/29/2015 |
ULTRA Telescopes |
OLYMPUS WINTER & IBE GMBH |
KATHARINA SCHNACKENBURG |
| K150212 |
04/20/2015 |
DeScribe Transparent PFD Patch |
ON Light Sciences, Inc. |
David Sell |
| K142141 |
04/23/2015 |
STARBAND, STARLIGHT |
ORTHOMERICA PRODUCTS, INC. |
DAVID L.HOOPER |
| K150506 |
04/08/2015 |
ELIAN Digital Diagnostic X-ray System |
OSKO, INC. |
WANG CHOI |
| K150607 |
04/09/2015 |
Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml |
OSSEON LLC |
Keith Burger |
| K143338 |
04/01/2015 |
Argulated Locking Plates |
OSTEOMED L.P. |
Anita Zacherl |
| K140453 |
04/17/2015 |
OSTEOTEC SILICONE FINGER IMPLANT |
OSTEOTEC LTD |
ELIZABETH CLINTON-PARKER |
| K141812 |
04/02/2015 |
MYGAIT STIMULATION SYSTEM |
OTTO BOCK HEALTHCARE PRODUCTS GMBH |
RENE URTZ |
| K143253 |
04/09/2015 |
O-MAR |
PHILIPS MEDICAL SYSTEMS, NEDERLAND B.V. |
JAN VAN DE KERKHOF |
| K150227 |
04/02/2015 |
Disposable Blood Pressure Cuff Guard |
PINHU SAMA MEDICAL PACKING CO., LTD. |
MA JIANZHONG |
| K150206 |
04/03/2015 |
InFill Interbody Fusion Devices |
PINNACLE SPINE GROUP, LLC |
REBECCA K. PINE |
| K150254 |
04/28/2015 |
Streamline OCT Occipito-Cervico-Thoracic System |
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) |
Sarah Pleaugh |
| K141913 |
04/06/2015 |
PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME! |
PJUR GROUP LUXEMBOURG SA |
CANDACE F CEDERMAN |
| K142282 |
04/23/2015 |
HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) |
PRECEPTIS MEDICAL |
KEITH LELAND |
| K143353 |
04/02/2015 |
Hahn Tapered Implant System |
PRISMATIK DENTALCRAFT, INC. |
Brandon Shepard |
| K150331 |
04/09/2015 |
18ch T/R Knee Coil |
Quality Electrodynamics, LLC |
Kathleen Aras |
| K142262 |
04/10/2015 |
AUTION CHECK PLUS |
QUANTIMETRIX CORP. |
KALYNA SNYLYK |
| K142058 |
04/22/2015 |
RAYSCAN A-EXPERT |
RAY CO., LTD |
ANDEW PAENG |
| K142247 |
04/17/2015 |
RAYSCAN A-EXPERT 3D |
RAY CO., LTD |
KYUNGHA SEO |
| K142217 |
04/02/2015 |
Reliance Interspinous Plate System |
Reliance Medical Systems, LLC |
Jeremy Alsup |
| K142867 |
04/29/2015 |
Reliance Posterior Cervical-Thoracic System |
Reliance Medical Systems, LLC |
Bret M. Berry |
| K150283 |
04/29/2015 |
Republic Spine Dark Star Spinal System |
REPUBLIC SPINE, LLC |
RUSTY MCCARVER |
| K143272 |
04/30/2015 |
ApneaLink Air |
RESMED GERMANY INC. |
Sandra Grunwald |
| K150108 |
04/22/2015 |
Reverse Medical Micro Vascular Plug System |
REVERSE MEDICAL CORPORATION |
LAURA HEATON |
| K143405 |
04/16/2015 |
Option (TM) ELITE Vena Cava Filter 100cm System |
REX MEDICAL, LP |
Erich Bressler |
| K143744 |
04/14/2015 |
MicroCross Catheter |
ROXWOOD MEDICAL, INC. |
GRACE LI |
| K141047 |
04/14/2015 |
LC CALCIUMHYDROXIDE LINER |
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN |
CHRISTIAN BOETTCHER |
| K141482 |
04/24/2015 |
KI-20 |
SAEYANG MICROTECH CO LTD |
Priscilla Chung |
| K150165 |
04/02/2015 |
GC85A |
SAMSUNG ELECTRONICS CO., LTD. |
CHULSIN KIM |
| K150545 |
04/02/2015 |
Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13) |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
REN YUNHUA |
| K142687 |
04/13/2015 |
Pulse Oximeter |
Shanghai Berry Electronic Tech Co., Ltd |
Xuezhi Yin |
| K142186 |
04/17/2015 |
DIODE LASER HAIR REMOVAL SYSTEM |
SHENZHEN GSD TECH. CO., LTD. |
Diana Hong |
| K150204 |
04/10/2015 |
DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
YANG ZHAOHUI |
| K141683 |
04/03/2015 |
ELECTRONIC BLOOD PRESSURE MONITOR |
SHENZHEN URION TECHNOLOGY CO., LTD. |
AUTUMN LIU |
| K150714 |
04/17/2015 |
SI-BONE iFuse Implant System |
SI-BONE, Inc. |
Roxanne Dubois |
| K150843 |
04/24/2015 |
syngo«.via (version VB10A) |
Siemens AG |
Martin Meyer |
| K150132 |
04/13/2015 |
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module |
Siemens Healthcare Diagnostics |
Asha Gartland |
| K141999 |
04/22/2015 |
ADVIA CENTAUR TSH |
Siemens Healthcare Diagnostics Inc. |
Alex Hsu |
| K143400 |
04/08/2015 |
SOMATOM Definition AS/AS+ |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
Kimberly Mangum |
| K143401 |
04/06/2015 |
SOMATOM Definition Edge |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K143416 |
04/16/2015 |
SOMATOM Definition Flash (VA48) |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
Eve Davis |
| K142061 |
04/24/2015 |
SILHOUETTE INSTALIFT |
SILHOUETTE LIFT, INC. |
Juan Carlos Serna |
| K143459 |
04/01/2015 |
Silk Road Acccess Catheter |
SILK ROAD MEDICAL, INC |
RICHARD M RUEDY |
| K142779 |
04/17/2015 |
SCANIP; SCANIP: MEDICAL EDITION; SCANIP: MED |
SIMPLEWARE LTD. |
GARETH JAMES |
| K142473 |
04/13/2015 |
Lubricating Jelly |
SION BIOTEXT MEDICAL LTD |
NADAV REUBEN |
| K143739 |
04/20/2015 |
POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA |
SMITH & NEPHEW, INC. |
JEFF SPRAGUE |
| K142979 |
04/29/2015 |
RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters |
SMITH & NEPHEW, INC. |
Laurea Reynolds |
| K150045 |
04/28/2015 |
S30/S40 Digital Color Doppler Ultraound System |
SONOSCAPE COMPANY LIMITED |
TOKI WU |
| K141227 |
04/02/2015 |
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX |
SOPHYSA SA |
GUSTAVO KOBRIN |
| K150361 |
04/30/2015 |
ViSi Mobile Monitoring System |
Sotera Wireless, Inc. |
Carson Krupp |
| K150065 |
04/13/2015 |
SoundCure Serenade Tinnitus Treatment System |
SoundCure, Inc. |
William Perry |
| K150634 |
04/08/2015 |
AngioSculpt PTA Scoring Baloon Catheters |
Spectranetrics |
Kimberley Kline |
| K150017 |
04/24/2015 |
SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System |
SpineFrontier, Inc. |
Manthan J Damani |
| K142909 |
04/24/2015 |
Flexible 19G EBUS Needle |
SPIRATION, INC. |
Cyndy J Adams |
| K150631 |
04/01/2015 |
St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter |
St. Jude Medical |
Harlan Jones |
| K143333 |
04/14/2015 |
Revital-Ox RESERT Solution Test Strip |
STERIS Corporation |
Anthony Piotrkowski |
| K143320 |
04/23/2015 |
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments |
STRYKER CORP. |
Brittney M. Larsen |
| K150416 |
04/17/2015 |
ProCinch Adjustable Loop Device |
STRYKER ENDOSCOPY |
KELLY KUCHARCZYK |
| K150188 |
04/29/2015 |
SMV Scientific 4.5 mm Bone Screws |
SUMMIT MEDVENTURES |
NEPHI ZUFELT |
| K143265 |
04/14/2015 |
Acrylic Block |
SUN MEDICAL CO., LTD. |
YUKIHITO YUKIMUNE |
| K141826 |
04/02/2015 |
FLASHPAK STERILIZATION CONTAINER SYSTEM |
SYMMETRY MEDICAL INC- MANCHESTER |
ROBERT JOHNSON |
| K142024 |
04/02/2015 |
BRIGHTMATTER NAVIGATION SYSTEM |
SYNAPTIVE MEDICAL INC. |
CAMERON PIRON |
| K150253 |
04/01/2015 |
Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm |
TAIWAN SURGICAL CORPORATION |
HSIU-PING HUANG |
| K142371 |
04/24/2015 |
Luminesse PMMA |
TALLADIUM, INC. |
Elina Faskhutdinova |
| K150438 |
04/02/2015 |
Force Fiber OrthoTape suture |
TELEFLEX MEDICAL, INC. |
VLADISLAVA ZAITSEVA |
| K142153 |
04/29/2015 |
HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML |
Teleflex Medical, Inc. |
JAMES A COCHIE |
| K141888 |
04/15/2015 |
RUSCH ENDOBRONCHIAL TUBES |
Teleflex Medical, Inc. |
LORI PFOHL |
| K142506 |
04/20/2015 |
TensCare KegelFit |
TENSCARE LTD. |
Andrew Brown |
| K150263 |
04/01/2015 |
K-Pack II Needle-21G x 2 |
TERUMO EUROPE N.V. |
M J Aerts |
| K142817 |
04/23/2015 |
IntraNovo 25 Microcatheter |
TEXAS MEDICAL TECHNOLOGIES, INC. |
Aaron Chiu |
| K143592 |
04/16/2015 |
GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC |
THE SURGEON GENERAL, DEPARTMENT OF THE ARMY |
Kenneth A. Bertram |
| K143288 |
04/01/2015 |
Sensititre Susceptibility plates |
THERMO FISHER SCIENTIFIC |
CYNTHIA KNAPP |
| K150072 |
04/14/2015 |
TheyFit Male Condom |
THEYFIT |
MICHAEL CECIL |
| K142073 |
04/29/2015 |
ST'RIM |
THIEBAUD SAS |
PATSY J TRISLER, JD, RAC |
| K150583 |
04/23/2015 |
Aequalis PerFORM+ Shoulder System |
TORNIER, INC. |
Kris Miller |
| K143374 |
04/08/2015 |
BLUEPRINT Patient Specific Instrumentation |
TORNIER, SAS |
AYMEN AZAIEZ |
| K150897 |
04/20/2015 |
Tosama 100% Cotton Menstrual Tampon |
TOSAMA D.O.O. |
Marjetka Kralj Kuncic |
| K150427 |
04/17/2015 |
Vantage Titan 1.5T, V3.1, MRT-1510 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
Janine Reyes |
| K143008 |
04/09/2015 |
Vantage Titan 3T |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
Paul Biggins |
| K150292 |
04/09/2015 |
Chocolate PTCA Balloon Catheter |
TRIREME MEDICAL, LLC |
Shiva Ardakani |
| K140506 |
04/17/2015 |
JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL |
TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA |
MICHAEL SCOTT |
| K142926 |
04/23/2015 |
iBreastExam |
UE LIFESCIENCES, INC. |
MIHIR SHAH |
| K143043 |
04/02/2015 |
Tanning Lamp |
UNILAM CO., LTD. |
YoungBoo Cho |
| K142208 |
04/13/2015 |
Monopolar Laparascopic Accessories |
UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD. |
Weizhong Chen |
| K143664 |
04/14/2015 |
HeartSee |
UNIVERSITY OF TEXAS MEDICAL SCHOOL AT HOUSTON |
K Lance Gould |
| K142196 |
04/28/2015 |
Visage Ease Pro |
VISAGE IMAGING GMBH |
Stefan Strowich |
| K150385 |
04/30/2015 |
NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses |
Visioneering Technologies, Inc. |
Stephen Snowdy |
| K150104 |
04/17/2015 |
Vitrea CT Myocardial Perfusion |
Vital Images, Inc |
Parthiv Shah |
| K150738 |
04/06/2015 |
VitreaView |
Vital Images, Inc |
PARTHIV SHAH |
| K151013 |
04/30/2015 |
Vitaphone Tele ECG Loop Recorder |
Vitasystems GmbH |
Michael Rothhaar |
| K150262 |
04/03/2015 |
Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular |
Volcano Corporation |
Elaine Alan |
| K141324 |
04/14/2015 |
HONGYU DISPOSABLE SURGICAL DRAPES |
WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD |
Diana Hong |
| K142149 |
04/17/2015 |
OXYTOTE INFINITY SERIES VIPR SYSTEMS |
WESTERN/SCOTT FETZER CO. |
DAVID C SIMO |
| K150027 |
04/03/2015 |
CYMA |
WhiteCap Technologies LLC |
Dustin Synider |
| K150580 |
04/07/2015 |
UltraVision 2 Diagnostic Ultrasound System |
WINPROBE CORPORATION |
ROSE MALCHOW |
| K150520 |
04/29/2015 |
DARCO Locking Bone Plate System |
WRIGHT MEDICAL TECHNOLOGY, INC. |
JEANINE REDDEN |
| K150252 |
04/29/2015 |
PHALINX Hammertoe System |
WRIGHT MEDICAL TECHNOLOGY, INC. |
Val Myles |
| K143741 |
04/24/2015 |
Lipofina Laser System |
YOLO MEDICAL, INC. |
Robert J Krznaric |
| K142392 |
04/29/2015 |
Zavation Posterior LEIF |
ZAVATION, LLC |
LAWERENCE WALKER |
| K142740 |
04/06/2015 |
Ziehm Vision RFD 3D |
ZIEHM IMAGING GMBH |
STEFAN FIEDLER |
| K150501 |
04/23/2015 |
Zimmer Nexel Total Elbow Ulnar Cement Diverter |
ZIMMER, INC. |
Keith Proctor |
