FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K111316 |
07/20/2011 |
AAP CANNULATED SCREWS |
AAP IMPLANTATE AG |
MARC SEEGERS |
K111417 |
07/15/2011 |
THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER |
ACCESS SCIENTIFIC, INC. |
ALBERT MISAJON |
K111110 |
07/22/2011 |
APNEA GUARD |
ADVANCED BRAIN MONITORING, INC. |
PAUL DRYDEN |
K111194 |
07/07/2011 |
APNEA RISK EVALUATION SYSTEM (ARES) |
ADVANCED BRAIN MONITORING, INC. |
ADRIENNE LENZ |
K101114 |
07/26/2011 |
ADVANCIS ACTIVON TUBE |
Advancis Medical |
Toni Miller |
K111076 |
07/12/2011 |
SOLANAS AVALON POSTERIOR FIXATION SYSTEM |
ALPHATEC SPINE, INC. |
KARLA SCHAFFNER |
K111864 |
07/15/2011 |
E-CUBE 9 |
ALPINION MEDICAL SYSTEMS CO., LTD |
YUCHI CHU |
K111034 |
07/14/2011 |
AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE |
AM USA |
KAREN THOMISON |
K111118 |
07/01/2011 |
AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE |
AMERICAN MEDICAL SYSTEMS |
MONA INMAN |
K110328 |
07/15/2011 |
ACG-8511 PORTABLE ECG MONITOR |
ANDON HEALTH CO.,LTD |
LIU YI |
K093755 |
07/15/2011 |
AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM |
ANDON MEDICAL CO., LTD. |
YI LIU |
K111750 |
07/21/2011 |
EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE |
ANGIOSLIDE, LTD |
CLAY ANSELMO |
K111531 |
07/08/2011 |
RHA2020 |
ANNIDIS HEALTH SYSTEMS CORP. |
MICHAEL MCDONNELL |
K103714 |
07/07/2011 |
ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA |
ANSELL HEALTHCARE PRODUCTS, LLC |
MARY L ARMSTRONG |
K111856 |
07/14/2011 |
SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE |
APOTHECARY PRODUCTS, INC. |
JAMES JENKINS |
K110824 |
07/11/2011 |
ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC INSTRUMENT |
ARAGON SURGICAL INC. |
ALAN CURTIS |
K110994 |
07/06/2011 |
PARKER 500 |
ARJOHUNTLEIGH INC |
BRENDA AMMONETTE |
K111399 |
07/20/2011 |
SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75 |
ARTHROCARE CORP. |
LAURA KASPEROWICZ |
K111397 |
07/12/2011 |
TITAN TI SUTURE ANCHOR SYSTEM |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
K110189 |
07/18/2011 |
REPROCESSED ELECTROSURGICAL INSTRUMENT |
ASCENT HEALTHCARE SOLUTIONS |
AMANDA BABCOCK |
K111851 |
07/08/2011 |
MEDIOSTAR NEXT |
ASCLEPION LASER TECHNOLOGIES GMBH |
ANTJE KATZER |
K111215 |
07/05/2011 |
ASCOM MOBILE MONITORING GATEWAY (MMG) |
ASCOM (SWEDEN) AB |
TANIA OTTEBRINK |
K102643 |
07/15/2011 |
SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT |
ASTORIA-PACIFIC,INC. |
JASON C REYNOLDS |
K102719 |
07/01/2011 |
ATLANTEAN TRIGGER NEBULIZER |
ATLANTEAN CORPORATION |
TOM SHANKS |
K110842 |
07/13/2011 |
ATLAS SPINE PEDICLE SCREW SYSTEM |
ATLAS SPINE INC. |
JEANNETTE G DAILEY |
K110696 |
07/07/2011 |
NEURO CHECK DEVICE WITH IO-FLEX WIRE |
BAXANO, INC. |
EDWARD SINCLAIR |
K110443 |
07/19/2011 |
BD INSYTE AUTOGUARD BC |
BECTON DICKINSON & CO. |
RAND PUGMIRE |
K110703 |
07/27/2011 |
BD AUTOSHIELD DUO PEN NEEDLE |
Becton, Dickinson and Company |
CYNTHIA LACATENA |
K103685 |
07/15/2011 |
PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA |
BEIJING RONGRUI-CENTURY SCIE. & TECH. CO., LTD. |
Diana Hong |
K103631 |
07/21/2011 |
SLEEPMINDER BREATHING FREQUENCY INDICATOR |
BIANCAMED LIMITED |
PAUL PHILLIPS |
K110778 |
07/29/2011 |
BIODENTA CUSTOMIZED ABUTMENT |
BIODENTA SWISS AG |
ANGELA BLACKWELL |
K102051 |
07/29/2011 |
PAIN BUDDY |
BIOMEDICAL LIFE SYSTEMS, INC. |
GARY BUSSETT |
K110320 |
07/21/2011 |
COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM |
BIOMET MANUFACTURING CORP. |
PATRICIA S BERES |
K110271 |
07/22/2011 |
MAESTRO WRIST PLATING SYSTEM |
BIOMET MANUFACTURING CORP. |
PATRICIA S BERES |
K110201 |
07/21/2011 |
EXPLOR RADIAL HEAD PLATING SYSTEM |
BIOMET, INC. |
PATRICIA S BERES |
K102405 |
07/21/2011 |
INFUSION SET FOR POWERPICC SOLO 2 CATHETER |
C.R. BARD, INC. |
LYNN M KIRCHOFF |
K111850 |
07/13/2011 |
VACCESS PTA DILATATION CATHETER |
C.R. BARD, INC. |
CANDACE WADE |
K111144 |
07/18/2011 |
CANDELA GENTLELASE FAMILY OF LASERS |
CANDELA CORP. |
SCOTT BLOOD |
K094048 |
07/14/2011 |
PERCUPRO MESSENGER BALLOON CATHETER |
CARDIOSOLUTIONS INC |
MICHELE LUCEY |
K111388 |
07/26/2011 |
DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM |
CARDIOVASCULAR SYSTEMS, INC. |
MEGAN M BRANDT |
K110809 |
07/05/2011 |
WIRELESS MONITORING SYSTEM |
CAREFUSION 303, INC. |
SIMON PEARMAIN |
K101194 |
07/11/2011 |
NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010 |
CARTICEPT MEDICAL INC |
Tanya Eberle |
K110682 |
07/01/2011 |
STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS |
CASE MEDICAL, INC. |
TANIA LUPU |
K111348 |
07/22/2011 |
RE / STASIS (TM) GINGIVAL RETRACTION PASTE |
CENTRIX, INC. |
JOHN DISCKO |
K110600 |
07/29/2011 |
COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN |
COLLAGEN MATRIX, INC. |
PEGGY HANSEN |
K111619 |
07/06/2011 |
MODIFIED CONCENTRIC MICROCATHETER |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
K110156 |
07/27/2011 |
AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER, |
CONTEC MEDICAL SYSTEM CO., LTD. |
Diana Hong |
K111263 |
07/25/2011 |
CXI TRIFORCE |
COOK INCORPORATED |
MOLLY BUSENBARK |
K103431 |
07/21/2011 |
COREN TOTAL HIP SYSTEM |
CORENTEC CO., LTD |
KEVIN A THOMAS |
K111187 |
07/26/2011 |
PATCH, PLEDGET AND INTRACARDIAC |
CORMATRIX CARDIOVASCULAR, INC. |
KIT CARIQUITAN |
K094026 |
07/12/2011 |
STERI-DENT, STERI-SURE |
CPAC, INC. |
JEFFREY CRANE |
K110867 |
07/20/2011 |
STERI-DENT, STERI-SURE |
CPAC, INC. |
JEFFREY S CRANE |
K110529 |
07/22/2011 |
ENDOFLIP GASTRIC TUBE |
CROSPON, LTD. |
PAUL DRYDEN |
K111774 |
07/20/2011 |
PATHWAY MODEL 07XXXX |
CUSTOM SPINE |
SAAD ATTIYAH |
K110213 |
07/20/2011 |
GE DATEX-OHMEDA AISYS |
DATEX-OHMEDA, INC. |
JIM RASKOB |
K103220 |
07/29/2011 |
VOYAGER PERITONEAL DIALYSIS SYSTEM |
DEKA RESEARCH & DEVELOPMENT CORP. |
ROGER A LEROUX |
K103831 |
07/21/2011 |
DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
DEEP PAL |
K111631 |
07/22/2011 |
GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN.. |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
DEEP PAL |
K111077 |
07/12/2011 |
ORTHOSORB RESORBABLE PINS |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
K110546 |
07/27/2011 |
MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY |
DERMA SCIENCES, INC. |
RONALD S WARREN |
K110869 |
07/14/2011 |
CARA |
DIAGNOS, INC |
Aron Shapiro |
K111362 |
07/21/2011 |
REXIOUS SPINAL FIXATION SYSTEM |
DIO MEDICAL CO., LTD. |
APRIL LEE |
K103285 |
07/25/2011 |
DIXTAL DZ-4100 SERIES PULSE OXIMETER |
DIXTAL MEDICAL, INC. |
ROBERT H SCHIFFMAN |
K110439 |
07/18/2011 |
DOMAIN SURGICAL SYSTEM |
DOMAIN SURGICAL, INC. |
CURTIS JENSEN |
K110577 |
07/14/2011 |
OSSEOFUSE DENTAL IMPLANT SYSTEM |
DYNAMIC INNOVATIONS INC. |
APRIL LEE |
K110922 |
07/20/2011 |
PATIENT MONITOR |
EDAN INSTRUMENTS, INC. |
RANDY JIANG |
K110915 |
07/22/2011 |
CERVICAL CAGE |
EISERTECH, LLC |
LUKAS EISERMANN |
K101997 |
07/12/2011 |
ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM |
ELLIPSE TECHNOLOGIES, INC. |
John McIntyre |
K111009 |
07/22/2011 |
ACRYLIC HERBST APPLIANCE |
EMBASSY DENTAL LABORATORY |
KAREN E WARDEN, PHD |
K111061 |
07/20/2011 |
REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP) |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
K111821 |
07/28/2011 |
BIOPSY VALVE |
ENDOCHOICE, INC. |
THERON GOBER |
K111747 |
07/12/2011 |
ENDOLOGIX AFX INTRODUCER SYSTEM |
ENDOLOGIX, INC. |
Janet M Fauls |
K111803 |
07/15/2011 |
G-SCAN |
ESAOTE, S.P.A. |
Allison Scott |
K111302 |
07/22/2011 |
MYLABSEVEN, MYLABALPHA |
ESAOTE, S.P.A. |
Allison Scott |
K110197 |
07/15/2011 |
EXACTECH GIBRALT SPINAL SYSTEM |
EXACTECH, INC. |
VLADISLAVA ZAITSEVA |
K111400 |
07/28/2011 |
OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT |
EXACTECH, INC. |
PATRICK HUGHES |
K110541 |
07/06/2011 |
FIGURE 8 STERNOTOMY CLOSURE DEVICE |
FIGURE 8 SURGICAL, INCORPORATED |
KIT CARIQUITAN |
K110797 |
07/20/2011 |
COMMUNIFY PACS VIEWER |
FLYING SQUIRREL STORAGE LLC |
CHRIS RELYEA |
K110044 |
07/07/2011 |
FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM |
FORA CARE INC. |
TELING HSU |
K101306 |
07/01/2011 |
SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A |
FOTONA D.D. |
STOJAN TROST |
K103676 |
07/19/2011 |
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL |
FUJIREBIO DIAGNOSTICS, INC. |
DIANA LYN DICKSON |
K103129 |
07/19/2011 |
ENTROPY EASYFIT SENSOR |
GE HEALTHCARE |
JOEL KENT |
K111209 |
07/26/2011 |
INTEGRATED INNOVA - S5I SYSTEM OPTION |
GE HEALTHCARE |
FAYCAL KHERRA |
K110943 |
07/22/2011 |
LOGIQ E9 |
GE HEALTHCARE |
BRYAN BEHN |
K111582 |
07/26/2011 |
LOGIQ S8 |
GE HEALTHCARE |
BRYAN BEHN |
K110227 |
07/20/2011 |
OPTIMA CT660 |
GE MEDICAL SYSTEMS, LLC |
TRACEY ORTIZ |
K111304 |
07/19/2011 |
OPTIMA XR120 |
GE MEDICAL SYSTEMS, LLC |
NIDHI CHAUDHARY |
K103671 |
07/21/2011 |
GENESYS SPINE TILOCK SYSTEM |
GENESYS SPINE |
BRIAN J BERGERON |
K103745 |
07/20/2011 |
BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF |
GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) |
WENDY A MCMANUS |
K110280 |
07/06/2011 |
REVLOK FENESTRATED SCREW SYSTEM |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
K110990 |
07/25/2011 |
GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM |
GOLD STANDARD ORTHOPEDICS LLC |
JAMES RITTER |
K111326 |
07/06/2011 |
OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM |
GRAHAM MEDICAL TECHNOLOGIES, L.L.C. |
JULIE POWELL |
K111560 |
07/15/2011 |
WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
K111328 |
07/15/2011 |
POWDER FREE NITRILE EXAMINATION GLOVES |
GX CORPORATION SDN BHD |
GANESAN SUPIRAMUNIAM |
K110852 |
07/19/2011 |
DOLPHIN 3 FLUID MANAGEMENT SYSTEM |
GYRUS ACMI, INC. |
GRAHAM BAILLIE |
K110390 |
07/29/2011 |
ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR |
HANDELSHAUS DITTMAN GMBH |
KANG JIANG PING |
K111065 |
07/14/2011 |
STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT |
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPEADICS |
CALUDIA WIESEMANN |
K100305 |
07/21/2011 |
ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER |
ICOTEC |
BARBARA ATZENHOEFER STEGMEIER |
K101407 |
07/19/2011 |
ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 |
IMMUNO-MYCOLOGICS, INC. |
SEAN K BAUMAN, PH.D |
K102286 |
07/20/2011 |
CRAG LATERAL FLOW ASSAY (CRAG LFA) |
IMMUNO-MYCOLOGICS, INC. |
SEAN BAUMAN |
K103130 |
07/28/2011 |
XELIS 3D |
INFINITT CO., LTD. |
CARL ALLETTO |
K102528 |
07/28/2011 |
N-FORCE FIXATION SYSTEM |
INNOVISION, INC. |
MICHELLE MCDONOUGH |
K111529 |
07/29/2011 |
MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN- |
INSERT MOLDING SOLUTIONS, INC |
PAUL HENDRIXSON |
K110237 |
07/08/2011 |
HEMOSIL FACTOR VIII DEFICIENT PLASMA |
INSTRUMENTATION LABORATORY CO. |
Jacqueline Emery |
K101381 |
07/07/2011 |
HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS |
INTEGRA LIFESCIENCES CORPORATION |
DONNA MILLISKY |
K110987 |
07/22/2011 |
CARDIAC TRIGGER MONITOR |
IVY BIOMEDICAL SYSTEMS, INC. |
DICK LISTRO |
K103830 |
07/29/2011 |
JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK) |
JIANGSU SHENLI MEDICAL PRODUCTION FACTORY |
DARREN REEVES |
K111571 |
07/06/2011 |
VIPER SYSTEMS |
JOHNSON & JOHNSON |
DAPHNEY GERMAIN-KOLAWOLE |
K110548 |
07/29/2011 |
OSI O-BALL ABUTMENT HEAD IMPLANTS |
JUELL DENTAL |
ANGELA BLACKWELL |
K111280 |
07/21/2011 |
V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT |
KCI USA, INC. |
MARGARET MARSH |
K110960 |
07/14/2011 |
ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE |
KOON SENG SDN.BHD |
Kevin Walls |
K103414 |
07/22/2011 |
VENUS CERVICAL SPINAL FIXATION SYSTEM |
L&K BIOMED CO.,LTD. |
SUN YI LEE |
K110984 |
07/22/2011 |
SLIM E30 II CO2 LASER |
LASERING S.R.L. |
ALLEN R HOWES |
K103574 |
07/28/2011 |
PREGNANCY ONE STEP RAPID TEST |
Lehnus & Associates Consulting |
Gary Lehnus |
K111884 |
07/29/2011 |
OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME |
LEMAITRE VASCULAR, INC. |
ANDREW HODGKINSON |
K111569 |
07/06/2011 |
PLATEAU SPACER SYSTEM |
LIFE SPINE |
RANDY LEWIS |
K111835 |
07/19/2011 |
PLATEAU SPACER SYSTEM |
LIFE SPINE, INC |
RANDY LEWIS |
K110847 |
07/15/2011 |
SMR SHOULDER SYSTEM - CTA HUMERAL HEADS |
LIMACORPORATE S.P.A. |
CHERYL HASTINGS |
K111212 |
07/28/2011 |
SMR SHOULDER SYSTEM- REVISION STEMS |
LIMACORPORATE S.P.A. |
CHERYL HASTINGS |
K110298 |
07/15/2011 |
OPIATE ENZYME IMMUNOASSAY |
Lin-Zhi International, Inc. |
BERNICE LIN |
K111598 |
07/20/2011 |
POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE |
LPL (HUI ZHOU) GLOVE CO., LTD. |
CAMILLE D THORNTON |
K111213 |
07/25/2011 |
VISION ONE LASER SYSTEM |
LUMENIS INC. |
JACE R MCLANE |
K103776 |
07/01/2011 |
XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
LUBNA SYED |
K110880 |
07/05/2011 |
VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT |
MAINE STANDARDS COMPANY, LLC |
HOLLY CRESSMAN |
K111524 |
07/22/2011 |
MP 719 |
MARINE POLYMER TECHNOLOGIES, INC. |
SERGIO FINKIELSZTEIN |
K110723 |
07/28/2011 |
M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS |
MASIMO CORPORATION |
SHELLY HARRIS |
K110300 |
07/01/2011 |
SIMPLANT 2011 |
MATERIALISE DENTAL NV |
PETER VANDEPUT |
K093548 |
07/20/2011 |
AVIE A1C TEST SYSTEM |
MEC DYNAMICS CORP |
EMMANUEL MPOCK |
K101089 |
07/13/2011 |
EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR |
MEDICA CORP. |
Photios Makris |
K111036 |
07/12/2011 |
EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT |
MEDICA CORPORATION |
Photios Makris |
K111601 |
07/08/2011 |
HERO |
MEDICAL PREDICTIVE SCIENCE CORP. |
WILL KING |
K110956 |
07/18/2011 |
MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR |
MEDIVANCE, INC. |
LYNNE ARONSON |
K111147 |
07/19/2011 |
MEDLINE VESSEL CANNULA |
MEDLINE, INDUSTRIES, INC. |
MATT CLAUSEN |
K111424 |
07/29/2011 |
VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH |
MEDPRO SAFETY PRODUCTS, INC. |
Judi Smith |
K111972 |
07/27/2011 |
AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF |
MEDTRONIC INC. |
JESSICA SIXBERRY |
K103731 |
07/18/2011 |
CAPSTONE R SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
THAO PHAN |
K103077 |
07/13/2011 |
ECG PEN |
MERIDIAN DYNAMICS BIOMEDICAL, INC |
JENNIFER REICH |
K111611 |
07/29/2011 |
ENDOMAXX FULLY COVERED ESOPHAGEAL STENT |
MERIT MEDICAL SYSTEMS, INC. |
JOHN C KNORPP |
K110643 |
07/01/2011 |
MERIT MARQUIS FLOW SWITCH |
MERIT MEDICAL SYSTEMS, INC. |
MARK MULLANEY |
K111536 |
07/21/2011 |
METASURG DIGIFUSE IMPLANT |
METASURG |
JOSHUA SCOTT |
K111652 |
07/13/2011 |
MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
K111259 |
07/05/2011 |
SV DBS VRAIN ARRAY |
MIDWEST RF, LLC |
HELMUT KEIDI |
K111906 |
07/29/2011 |
XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY |
NAVILYST MEDICAL, INC. |
Lorraine M Hanley |
K102815 |
07/07/2011 |
SURELIFT PROLAPSE SYSTEM |
NEOMEDIC INTERNATIONAL |
JEFFREY R SHIDEMAN |
K110285 |
07/14/2011 |
NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER |
NEPHROS, INC. |
JAMES SUMMERTON |
K111493 |
07/27/2011 |
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI |
NIDEK CO., LTD. |
MICHAEL J BILLIG |
K110376 |
07/29/2011 |
PE-210AK SWITCH BOX |
NIHON KOHDEN CORP. |
STEVE GEERDES |
K110925 |
07/05/2011 |
NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT |
NovaBone Products, LLC |
DAVID M GAISSER |
K111866 |
07/22/2011 |
NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM |
NUVASIVE, INC. |
Sheila Bruschi |
K101453 |
07/21/2011 |
VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE |
OBI BIOLOGICS, INC. |
DUSTYN WEBB |
K111062 |
07/13/2011 |
APEX KNEE SYSTEM, APEX ALL POLY TIBIA |
OMNILIFE SCIENCE INC. |
CHRISTINE NASSIF |
K111045 |
07/15/2011 |
CENTRO FAMILY OF MANUAL WHEELCHAIRS |
OTTO BOCK HEALTHCARE, LP |
WILLIAM KABITZ |
K111000 |
07/28/2011 |
PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR |
PARCUS MEDICAL, LLC |
BARTON BRACY |
K111380 |
07/19/2011 |
NEURON MAX SYSTEM |
PENUMBRA, INC. |
MICHAELA MAHL |
K111517 |
07/27/2011 |
PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI |
PHARMAJET, INC. |
MICHAEL J RYAN |
K111804 |
07/28/2011 |
INTELLISPACE PACS 4.X |
PHILIPS HEALTHCARE INFORMATICS, INC. |
VICTORIA S MACKINNON |
K111245 |
07/29/2011 |
HEARTNAVIGATOR RELEASE 1 |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
LYNN HARMER |
K110608 |
07/20/2011 |
SEVOFLURANE VAPORIZER ADAPTOR |
PIRAMAL CRITCAL CARE, INC (FORMERLY MINRAD, INC) |
JAMIE KELLER |
K111031 |
07/08/2011 |
PAINFUSOR CATHETER |
PLAN 1 HEALTH, S.R.L. |
SIGI CARON |
K110970 |
07/21/2011 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
PPP MEDICAL AND SAFETY PRODUCTS COMPANY LIMITED |
CHU XIAOAN |
K110966 |
07/21/2011 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (NON-COLORED) |
PPP MEDICAL AND SAFETY PRODUCTS COMPANY LIMITED |
CHU XIAOAN |
K103563 |
07/01/2011 |
PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150 |
PRECISION MEDICAL, INC. |
JAMES PARKER |
K111291 |
07/20/2011 |
AIDITE ZIRCONIA DENTAL CERAMICS |
QINHUANGDAO AIDITE HIGH-TECHNICAL CERAMICS CO, LTD |
STUART R GOLDMAN |
K111555 |
07/25/2011 |
CIRCUMAURAL ADHESIVE REPLACEMENT |
R & D MEDICAL PRODUCTS, INC. |
JAMES PERRAULT |
K111897 |
07/19/2011 |
ABL90 |
RADIOMETER MEDICAL APS |
Martin Gabler |
K111222 |
07/28/2011 |
MRI-Q SYSTEM |
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD |
GREG HOLLAND |
K111226 |
07/01/2011 |
ENDOSCOUT TRACKING SYSTEM |
ROBIN MEDICAL, INC. |
RAYMOND KELLY |
K111506 |
07/08/2011 |
ELECSYS PRECICONTROL VARIA 3 |
Roche Diagnostics |
Sarah Baumann |
K111552 |
07/21/2011 |
ELECSYS T3 CALCHECK 5 |
Roche Diagnostics |
KELLY FRENCH |
K110897 |
07/01/2011 |
CORTEX CO2 / ER:YAG LASER SYSTEM |
SANDSTONE MEDICAL TECHNOLOGIES, LLC |
MARK ROHRER |
K111725 |
07/19/2011 |
MOBILEDIAGNOST WDR |
SEDECAL SA |
JENNIFER CARTLEDGE |
K111312 |
07/13/2011 |
SANTEVIEW |
SEHYUN CO., LTD. |
Priscilla Chung |
K111752 |
07/27/2011 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
SHANDONG JIANHONG NEW MATERIAL COMPANY |
CHU XIAOAN |
K110857 |
07/15/2011 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR |
SHANDONG ZHANPENG MEDICAL PRODUCTS CO., LTD |
FRANK LIU |
K102648 |
07/01/2011 |
ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK |
SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD |
LYNN FU |
K110928 |
07/15/2011 |
BODY ANALYSIS SCALE, MODEL BG 17 |
SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD |
CHARLIE MACK |
K111435 |
07/08/2011 |
DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN |
K111596 |
07/05/2011 |
TOTAL SHOULDER SYSTEM |
SHOULDER INNOVATIONS, LLC |
ANDREW RODENHOUSE |
K111205 |
07/20/2011 |
MICROSCAN (R) MICROSTREP PLUS (R) PANELS |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
SHANNON POPSON |
K111179 |
07/01/2011 |
ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN |
SIESTA MEDICAL, INC. |
MICHAEL KOLBER |
K101886 |
07/21/2011 |
DSC/ALF SPINAL SYSTEM |
SINTEA PLASTEK, LLC |
DANIELLE WERNIKOWSKI |
K111025 |
07/01/2011 |
TRIGEN LOW PROFILE BONE SCREW |
SMITH & NEPHEW, INC. |
NATALIE P WILLIAMS |
K110670 |
07/12/2011 |
VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE SCREWS, PERI-LOC ANKLE FUSION PLATES |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
K110261 |
07/28/2011 |
ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS |
SOFLEX LIMITED |
Kevin Walls |
K103740 |
07/29/2011 |
SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE |
SPECTRA MEDICAL DEVICES, INC. |
DAVID L ROSEN, B.S. PHARM., J.D. |
K110507 |
07/13/2011 |
CARDIAC SCANNER AND PROCESSING SYSTEM |
SPECTRUM DYNAMICS (ISRAEL) LTD. |
ILAN SHARON |
K111469 |
07/19/2011 |
STAXXSD SYSTEM |
SPINE WAVE, INC. |
DENISE DUCHENE |
K110906 |
07/26/2011 |
APEX SPINE SYSTEM |
SPINECRAFT LLC |
AMI AKALLAL-ASAAD |
K111006 |
07/21/2011 |
CI-SNAP WOUND CARE SYSTEM |
SPIRACUR, INC. |
SARAH CANIO |
K111393 |
07/28/2011 |
SNAP (R) WOUND CARE SYSTEM |
SPIRACUR, INC. |
SARAH CANIO |
K111002 |
07/18/2011 |
REPROCESSED ENDOSCOPIC TROCARS |
STERILMED, INC. |
GARRETT AHLBORG |
K111870 |
07/29/2011 |
AMSCO WARMING CABINET |
STERIS Corporation |
ROBERT F SULLIVAN |
K111150 |
07/08/2011 |
STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR |
STERITEC PRODUCTS MFG. CO., INC. |
JONATHAN RUTIGLIANO |
K110419 |
07/28/2011 |
AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS |
STRYKER SPINE |
TIFFANI D ROGERS |
K110538 |
07/12/2011 |
PRO FIXATION SYSTEM |
SYNOVIS ORTHOPEDIC & WOUNDCARE |
AMY BOUCLY |
K110789 |
07/28/2011 |
SYNTHES STERNAL ZIPFIX SYSTEM |
SYNTHES (USA) |
ANDREA M TASKER |
K110592 |
07/25/2011 |
3.7MM/5.0MM DYNAMIC LOCKING SCREW |
SYNTHES USA |
CHRISTOPHER HACK, ESQ |
K111029 |
07/01/2011 |
FORA POCT MANAGMENT SYSTEM |
TaiDoc Technology Corporation |
TELING HSU |
K092688 |
07/06/2011 |
FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
TELING HSU |
K101181 |
07/19/2011 |
BEL-CAT |
TAKARA BELMONT CORP. |
DANIEL KAMM |
K110571 |
07/28/2011 |
TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE |
TELCARE, INC. |
JONATHAN C JAVITT |
K111556 |
07/29/2011 |
GLIDECROSS SUPPORT CATHETER |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
K111231 |
07/13/2011 |
PANOURA 18S |
THE YOSHIDA DENTAL MFG. CO., LTD. |
FUMIAKI KANAI |
K110697 |
07/14/2011 |
TIGER SYRINGES AND NEEDLES |
TIGER MEDICAL PRODUCTS LTD |
DAVID WANG |
K110942 |
07/26/2011 |
PICA WHOLE-BODY MRI SYSTEM |
TIME MEDICAL LIMITED |
JOHN BABY |
K111012 |
07/06/2011 |
SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS) |
TRUE GLOVE FACTORY |
FRANK YANG |
K111546 |
07/01/2011 |
U2 HIP SYSTEM |
UNITED ORTHOPEDIC CORP. |
FANG-YUAN HO |
K103694 |
07/27/2011 |
TISSUE SAMPLING NEEDLE |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL L MARTIN |
K110631 |
07/28/2011 |
VENNER TRACHEAL SEAL MONITOR |
VENNER MEDICAL (SINGAPORE) PTE LTD |
HCHRISTINE BRAUER, PH.D. |
K102674 |
07/22/2011 |
CUFF SENTRY |
VENTLAB CORP. |
JAMES COCHIE |
K111416 |
07/15/2011 |
FALCON |
VIASONIX LTD. |
WILLIAM STERN |
K102401 |
07/20/2011 |
HEMI IMPLANT; MINI HEMI IMPLANT |
VILEX, INC. |
SYLVIA SOUTHARD |
K111152 |
07/22/2011 |
ROTOGRAPH EVO 3D |
VILLA SISTEMI MEDICALI S.P.A. |
PAOLO CASAGRANDE SANTIN |
K111892 |
07/28/2011 |
VITREAVIEW SOFTWARE 6.1 |
VITAL IMAGES, INC. |
Ian Nemerov |
K111706 |
07/15/2011 |
VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM |
VOLCANO CORPORATION |
JWALA JAWHARKAR |
K110418 |
07/13/2011 |
POWDER FREE NITRILE EXAMINATION GLOVES |
W.A. RUBBERMATE CO., LTD. |
TERENCE LIM SIN KOOI |
K110884 |
07/12/2011 |
EASYFIT SILKGEL NASAL MASK |
WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG |
RALF EGENOLF |
K102786 |
07/01/2011 |
WELL-LIFE OTC EMS SYSTEM |
WELL-LIFE HEALTHCARE LIMITED |
JENNY HSIEH |
K111191 |
07/28/2011 |
AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE |
WET NOSE TECHNOLOGIES, LLC |
LIONEL NEWMAN |
K111495 |
07/19/2011 |
COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K |
WILSON-COOK MEDICAL INC. |
MARGE WALLS-WALKER |
K110556 |
07/19/2011 |
MINI TELEMETRY SYSTEM |
WIPRO GE HEALTHCARE PRIVATE, LTD. |
AGATA SMIEJA |
K111299 |
07/20/2011 |
AXXENT RADIATION SHIELD - RIGID |
XOFT, AN ICAD COMPANY |
STEVE LIN |
K111240 |
07/14/2011 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR |
XUZHOU FULL SUN MEDICAL PRODUCTS LTD. |
ELIZABETH DENG |
K110940 |
07/01/2011 |
ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN |
ZIMMER, INC. |
CAROL VIERLING |
K111801 |
07/21/2011 |
SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM |
Zyga Technology, Inc. |
Diane Brinza |