| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K100756 |
06/02/2010 |
MALTA |
3M ESPE AG DENTAL PRODUCTS |
DESI SOEGIARTO |
| K100908 |
06/22/2010 |
UNICEM HM |
3M ESPE AG DENTAL PRODUCTS |
DESI W SOEGIARTO |
| K092638 |
06/15/2010 |
FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23 |
ABBOTT DIABETES CARE INC. |
ARUL STERLIN |
| K101116 |
06/23/2010 |
HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH |
ABBOTT VASCULAR-CARDIAC THERAPIES |
KAY SETZER |
| K100623 |
06/09/2010 |
AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM |
AESCULAP IMPLANT SYSTEMS |
LISA M BOYLE |
| K091859 |
06/03/2010 |
AESKU PR3 |
AESKU.DIAGNOSTICS |
SASCHA PFEIFFER |
| K091327 |
06/25/2010 |
ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES |
ALDEN OPTICAL LABS., INC. |
CHARLES CREIGHTON |
| K100001 |
06/25/2010 |
MOBIVISION |
ALMANA MEDICAL IMAGING |
DANIEL KAMM, P.E. |
| K100685 |
06/18/2010 |
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM |
ALPHATEC SPINE, INC. |
CHERYL ALLEN |
| K100129 |
06/11/2010 |
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X |
AMBU A/S |
SANJAY PARIKH |
| K100746 |
06/11/2010 |
FIBER ONE |
AMERICAN MEDICAL SYSTEMS |
DARLENE CROCKETT-BILLIG |
| K100807 |
06/07/2010 |
MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 |
AMERICAN MEDICAL SYSTEMS, INC. |
DONNA SEMLAK |
| K100940 |
06/29/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K101017 |
06/17/2010 |
ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS |
ANGIODYNAMICS, INC. |
S. MICHAEL SHARP |
| K082102 |
06/14/2010 |
GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 |
APOLLO ENDOSURGERY, INC. |
DENNIS MCWILLIAMS |
| K092938 |
06/18/2010 |
HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 |
APP PHARMACEUTICALS, LLC |
ARTHUR WARD |
| K093819 |
06/09/2010 |
ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) |
ARKRAY Factory USA, Inc. |
TOM SPEIKERS |
| K100652 |
06/23/2010 |
ACL TIGHTROPE |
ARTHREX, INC. |
GEENA AUGUSTINE |
| K101448 |
06/21/2010 |
OPUS SPEEDSCREW SYSTEM |
ARTHROCARE CORP. |
LAURA N KASPEROWICZ |
| K100176 |
06/16/2010 |
ASCENSION ANKLE FUSION PLATE SYSTEM |
ASCENSION ORTHOPEDICS, INC. |
DEBBIE STEARNS |
| K092233 |
06/25/2010 |
SURGIMESH XD |
ASPIDE MEDICAL |
HOWARD M HOLSTEIN |
| K093679 |
06/10/2010 |
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0 |
ATRICURE, INC. |
JAMES LUCKY |
| K100501 |
06/18/2010 |
MULTIFUNCTIONAL LINEAR PEN |
ATRICURE, INC. |
JAMES LUCKY |
| K094056 |
06/03/2010 |
HOTDOG MULTI FUNCTION CONTROLLER |
AUGUSTINE BIOMEDICAL & DESIGN, LLC |
JAMES ECKLEIN |
| K093197 |
06/23/2010 |
CORONIS FUSION 10MP, MODEL MDCG-10130 |
BARCO NV |
LIEVEN DE WANDEL |
| K101111 |
06/18/2010 |
HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200 |
BARRX MEDICAL INC |
VIORICA FILIMON |
| K101385 |
06/22/2010 |
DUAL LUER LOCK CAP, MODEL 2C6250 |
BAXTER HEALTHCARE CORP. |
NANETTE HEDDEN |
| K101529 |
06/14/2010 |
BD DIRECTIGEN EZ FLU A+B ASSAY |
BECTON DICKINSON & CO. |
Gregory P Payne |
| K101502 |
06/29/2010 |
BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774 |
BECTON DICKINSON & CO. |
MARY ANNE ALSBERGE |
| K100775 |
06/03/2010 |
BD INTIMA II CLOSED IV CATHETER |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
LESLIE WOOD |
| K101461 |
06/24/2010 |
BD DIRECTIGEN EX FLU A+B |
Becton, Dickinson and Company |
GREGORY PAYNE |
| K091912 |
06/23/2010 |
B-GENIN AND R-GENIN |
BERKELEY ADVANCED BIOMATERIALS, INC. |
FRANCOIS GENIN |
| K093630 |
06/03/2010 |
BIODENTA DENTAL IMPLANT SYSTEM |
BIODENTA SWISS AG |
DAVID EILER |
| K101481 |
06/23/2010 |
BIOMERS TRANSLUCENT ORTHODONTIC BRACKET |
BIOMERS PRODUCTS, LLC |
GEORGE ALIPHTIRAS |
| K101475 |
06/18/2010 |
COMPRESS ANTI-ROTATION SPINDLES |
BIOMET MANUFACTURING CORP. |
PATRICIA SANDBORN BERES |
| K100409 |
06/23/2010 |
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
VIVIAN KELLY MS, RAC |
| K101063 |
06/23/2010 |
SLEEVE WITH ZIPLOOP FIXATION DEVICES |
BIOMET SPORTS MEDICINE |
ROBERT FRIDDLE |
| K092052 |
06/18/2010 |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550 |
BIONIME CORPORATION |
SUSAN D GOLDSTEIN-FALK |
| K101030 |
06/03/2010 |
MODIFICATION TO HBS HEADLESS BONE SCREW |
BIOPRO, INC. |
DAVID MRAK |
| K091928 |
06/16/2010 |
10 X 10 VISION |
BIOPTICS, INC. |
AKIF BAYSAL |
| K093566 |
06/18/2010 |
CARTO XP EP NAVIGATION SYSTEM, VERSION 10 |
BIOSENSE WEBSTER, INC. |
WAYNE R HOHMAN |
| K093376 |
06/18/2010 |
LASSO NAV CATHETER |
BIOSENSE WEBSTER, INC. |
WAYNE HOHMAN |
| K101138 |
06/22/2010 |
SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 |
BIOSENSE WEBSTER, INC. |
MELISSA C SCHULTZ, RAC, MMS |
| K101345 |
06/22/2010 |
WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, |
BIOSENSE WEBSTER, INC. |
Balaka Das |
| K092987 |
06/11/2010 |
INRATIO/INRATIO2 TEST STRIPS |
BIOSITE INCORPORATED |
KARIN A HUGES |
| K100885 |
06/07/2010 |
FETAL MONITOR MODEL: BT-200T |
BISTOS CO., LTD. |
YOUNG CHI |
| K100929 |
06/16/2010 |
UNIMOM ALLEGRO |
BLUE EGG CO |
HONG J HYUN |
| K093078 |
06/23/2010 |
UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS |
BONUTTI RESEARCH, INC. |
PATRICK G BALSMANN |
| K093118 |
06/11/2010 |
BRAINLAB KNEE ARTHROSCOPY |
BRAINLAB AG |
RAINER BIRKENBACH |
| K101431 |
06/25/2010 |
ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS |
C.R. BARD, INC. |
Joni Creal |
| K100947 |
06/28/2010 |
FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 |
CALIBRA MEDICAL, INC. |
RICHARD J MEADER |
| K101639 |
06/25/2010 |
CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
CLAY ANSELMO |
| K093211 |
06/03/2010 |
CARECENTER MD |
CARDIAC SCIENCE CORPORATION |
THERESA MYERS |
| K101018 |
06/25/2010 |
CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100 |
CARDICA, INC. |
MATTHEW E CHROUST |
| K092915 |
06/23/2010 |
CEDARA WEBACCESS, MODEL: 2.4 |
CEDARA SOFTWARE CORP. |
CAROL NAKAGAWA |
| K092917 |
06/24/2010 |
STERN'S S250 NORDAM |
CEFLA S.C. |
BERTHOIN CLAUDE |
| K101564 |
06/22/2010 |
CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
HYE-JOO KIM |
| K100822 |
06/01/2010 |
XPERT MRSA/SA NASAL ASSAY |
CEPHEID |
RUSSEL K ENNS |
| K093931 |
06/10/2010 |
BLOOD PRESSURE METER, MODEL CH-4532 |
CITIZEN SYSTEMS JAPAN CO., LTD. |
NATHAN A BEAVER |
| K094022 |
06/11/2010 |
THE WATER LILY |
CLEARWATER PRODUCTS, LLC |
E.J. Smith |
| K093351 |
06/16/2010 |
COLLAWOUND ART |
COLLAMATRIX, INC |
DENNIS J.N. SEAH |
| K093320 |
06/18/2010 |
DRYODINE CADEXOMER-IODINE GEL |
COLLEGIUM PHARMACEUTICAL INCORPORATED |
MARK W TRUMBORE |
| K101297 |
06/03/2010 |
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 |
COLOPLAST A/S |
ANGELA BYLAND |
| K100542 |
06/24/2010 |
CONSENSUS REVISION KNEE SYSTEM |
Consensus Orthopedics, Inc |
LUKE ROSE |
| K101127 |
06/11/2010 |
PATIENT MONITOR, MODEL PM50 |
CONTEC MEDICAL SYSTEM CO., LTD. |
Diana Hong |
| K093619 |
06/17/2010 |
EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E |
COOK IRELAND LTD |
Jacinta Kilmartin |
| K101131 |
06/17/2010 |
FIDUCIAL MARKERS |
COSMAN MEDICAL, INC. |
LOUIS FALCONE |
| K093196 |
06/25/2010 |
BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09 |
COUSIN BIOTECH S.A.S. |
FRANCK PELLETIER |
| K100045 |
06/25/2010 |
OCTO |
DALIM SURGNET CORPORATION |
PETER CHUNG |
| K100638 |
06/18/2010 |
VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
SUSAN KAGAN |
| K101421 |
06/15/2010 |
MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204 |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K101523 |
06/17/2010 |
CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE |
DEVON MEDICAL INC. |
RUTH WU |
| K093357 |
06/24/2010 |
DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D |
DIAMOND DIAGNOSTICS, INC. |
KATHY CRUZ |
| K101612 |
06/30/2010 |
ZEN CORDLESS PROPHY SYSTEM |
DISCUS DENTAL, LLC |
WINKIE WONG |
| K100438 |
06/23/2010 |
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM |
EBI, L.P. |
VIVIAN KELLY |
| K101080 |
06/21/2010 |
NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX |
EGON FAULHABER SURGICAL INSTRUMENTS PINZETTEN |
HARALD JUNG |
| K100425 |
06/17/2010 |
HASKAL TORQUE DEVICE |
ELCAM MEDICAL A.C.A.L. |
SHAY SHAHAM |
| K100902 |
06/24/2010 |
AEDIS(TM) |
EMBED TECHNOLOGY LLC |
HOWARD STAMER |
| K100711 |
06/09/2010 |
SUCTION IRRIGATION ELECTRODES AND ADAPTERS |
ENCISION, INC. |
JUDITH V KING |
| K100900 |
06/18/2010 |
MOTIVATION KNEE SYSTEM |
ENCORE MEDICAL, L.P. |
ELIZABETH ONDERLINDE |
| K101333 |
06/14/2010 |
CRYOCARE CS SURGICAL SYSTEM |
ENDOCARE, INC. |
DEVONNE PAVLAK |
| K093297 |
06/09/2010 |
EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE |
EPOCAL, INC. |
ROY LAYER |
| K101430 |
06/22/2010 |
MLS-AC DERMA SCANNER |
ERCHONIA CORPORATION |
Kevin Walls |
| K100509 |
06/08/2010 |
THL1 LASER |
ERCHONIA CORPORATION |
Kevin Walls |
| K100931 |
06/25/2010 |
MYLABTWICE, MODEL 6200 |
ESAOTE, S.P.A. |
Allison Scott |
| K093340 |
06/11/2010 |
PASR/QUIETNITE |
EXACT SUPPLIES LTD. |
JONATHAN PARKINSON |
| K100333 |
06/21/2010 |
FIAB SPA, MODELS F7244, F7233, F7234, F7277 |
FIAB SPA |
FRANCESCO BATISTINI |
| K101277 |
06/04/2010 |
ORION II (HEAVY DUTY 350 LBS AND 500 LBS) |
FUTURE MOBILITY HEALTHCARE INC. |
ABDULSAMAD PANCHBHAYA |
| K101492 |
06/23/2010 |
8 CHANNEL CARDIAC PHASED ARRAY COIL |
GE HEALTHCARE COILS (USA INSTRUMENTS INC.) |
MICHAEL S PRETO |
| K092992 |
06/29/2010 |
A4-XLR8 FOAM DRESSING |
GENADYNE BIOTECHNOLOGIES, INC. |
E.J. Smith |
| K101440 |
06/18/2010 |
GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012 |
GENERIC MEDICAL DEVICES, INC. |
JEFF MORGAN |
| K092667 |
06/03/2010 |
GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT |
GENX INTL., INC. |
MICHAEL D CECCHI |
| K100563 |
06/02/2010 |
GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA |
GEON CORPORATION |
JENNIFER REICH |
| K101344 |
06/28/2010 |
G+ SYSTEM |
GLYTEC, LLC (FORMALLY KNOWN AS GLUCOTEC, INC.) |
WILLIAM MATTHEWS |
| K100896 |
06/17/2010 |
GYRUS ACMI HALO PKS CUTTING FORCEPS |
GYRUS ACMI, INC. |
LORRAINE CALZETTA |
| K094009 |
06/14/2010 |
HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI |
HALT MEDICAL INC |
RUSS DELONZOR |
| K090803 |
06/30/2010 |
HANSON MEDICAL FACIAL IMPLANTS |
HANSON MEDICAL, INC. |
GERALD HANSON |
| K101002 |
06/08/2010 |
A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200 |
HEALTHSTATS INTERNATIONAL PTE. LTD. |
STEPHEN GORSKI |
| K101362 |
06/17/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) |
HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K093729 |
06/08/2010 |
GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 I |
HEMCON MEDICAL TECHNOLOGIES EUROPE LTD |
KEVIN HAWKINS |
| K093466 |
06/17/2010 |
HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUGH THISTLETHWAITE |
| K101242 |
06/11/2010 |
GENESIS DM MODEL: 6053000A1 |
HONEYWELL HOMMED, LLC |
EMILY HEI |
| K101137 |
06/22/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVE |
HONGZE PLASTIC TECHNOLOGY CO., LTD |
KATHY LIU |
| K101438 |
06/17/2010 |
T2 GREATER TROCHANTER NAIL |
HOWMEDICA OSTEONICS CORP |
MELISSA MATARESE |
| K100884 |
06/25/2010 |
STRYKER KNIFELIGHT |
HOWMEDICA OSTEONICS CORP. |
AVITAL MERL-MARGULIES |
| K101713 |
06/29/2010 |
LIPCOLLECTOR II |
HUMAN MED AG |
INGE MATTHIESEN |
| K100989 |
06/25/2010 |
ZURA TEE SYSTEM WITH CLARITEE PROBE |
IMACOR INC. |
RICHARD LANZILLOTTO |
| K091849 |
06/25/2010 |
IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET |
IMMUNODIAGNOSTIC SYSTEMS, INC. |
KEN GIBBS |
| K100233 |
06/14/2010 |
SUDOSCAN |
IMPETO MEDICAL |
KYE CHEUNG |
| K093993 |
06/30/2010 |
LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 |
Infraredx, Inc. |
STEVEN J CHARTIER |
| K093623 |
06/18/2010 |
GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K101178 |
06/29/2010 |
MODIFICATION TO INTEL HEALTH GUIDE PHS6000 |
INTEL CORP. |
MAUREEN GLYNN |
| K100773 |
06/23/2010 |
KAI SPOT MODEL KMS 200 |
KAI MEDICAL, INC. |
ROBERT NAKATA |
| K100821 |
06/11/2010 |
PREVENA INCISION MANAGEMENT SYSTEM |
KCI USA, INC. |
MARGARET MARSH |
| K093810 |
06/18/2010 |
BF-NAVI |
KGT INC. |
RICHARD VINCINS |
| K092194 |
06/16/2010 |
POLYBONE DENTAL |
KYUNGWON MEDICAL CO., LTD. |
JOYCE BANG |
| K100373 |
06/30/2010 |
TYCHE PEDICLE SCREW SYSTEM |
KYUNGWON MEDICAL CO., LTD. |
JOYCE BANG |
| K093193 |
06/08/2010 |
LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ GREEN/ VIOLET) |
LA GLOVE (M) SDN. BHD. |
G BASKARAN |
| K100429 |
06/11/2010 |
URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER |
LABORATOIRES URGO |
SOPHIE FORTIN |
| K100430 |
06/11/2010 |
URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER |
LABORATOIRES URGO |
SOPHIE FORTIN |
| K093335 |
06/18/2010 |
LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR) |
LAGLOVE (M) SDN. BHD. |
G BASKARAN |
| K101320 |
06/24/2010 |
VASOVAPOR |
LEXION MEDICAL, LLC. |
BERNARD HORWATH |
| K092985 |
06/28/2010 |
BELLECUP |
LIBRETTE, INC |
NEAL KOLBER |
| K093662 |
06/24/2010 |
ECHOBRIGHT |
LIFE-TECH, INC. |
JEFF KASOFF |
| K093537 |
06/04/2010 |
HANAROSTENT ESOPHAGUS (CCC) |
M.I. TECH CO., LTD. |
BRANDON CHOI |
| K092781 |
06/23/2010 |
MAM TWISTER |
MAM INTERNATIONAL AG |
MICHAEL TEDESCO |
| K101274 |
06/11/2010 |
VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM |
MAQUET CARDIOVASCULAR, LLC |
MARK H SMITH |
| K101399 |
06/17/2010 |
COAXIAL INTRODUCER SET |
MARTECH MEDICAL PRODUCTS |
Susan Pileggi |
| K100403 |
06/23/2010 |
MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7 |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K100366 |
06/14/2010 |
MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY |
MAXTER CATHETERS |
M. BERNARD DAURELLE |
| K100217 |
06/08/2010 |
LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 |
MEDIANA CO., LTD. |
CHARLIE MACK |
| K100388 |
06/22/2010 |
21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS |
MEDICAL ILLUMINATION INTERNATIONAL, INC. |
WAYNE GEROW |
| K101406 |
06/16/2010 |
ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001 |
MEDRAD INTERVENTIONAL/POSSIS |
Doug Atkins |
| K100798 |
06/23/2010 |
MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C |
MEDRAD, INC. |
SUSAN LYNN FELIX |
| K100631 |
06/22/2010 |
AFFIITY CP CENTRIFUGAL BLOOD PUMP |
MEDTRONIC INC. |
SUE FIDLER |
| K092564 |
06/17/2010 |
O-ARM IMAGING SYSTEM |
MEDTRONIC NAVIGATION, INC. (LITTLETON) |
SETH KUZDZAL |
| K100175 |
06/02/2010 |
CLYDESDALE SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
JUSTINE VIERA |
| K100214 |
06/25/2010 |
CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE |
MEDTRONIC SOFAMOR DANEK |
LEE GRANT |
| K094042 |
06/30/2010 |
PEEK PREVAIL CERVICAL INTERBODY DEVICE |
MEDTRONIC SOFAMOR DANEK |
JUSTINE VIERA |
| K101074 |
06/22/2010 |
MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
SARAH FAIRFIELD |
| K093104 |
06/25/2010 |
MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM |
MEDYSSEY CO., LTD. |
PATRICK D MOORE |
| K101546 |
06/23/2010 |
ENDOFORM DENTAL TEMPLATE |
MESYNTHES LTD |
MARY MCNAMARA |
| K100754 |
06/09/2010 |
GRAFT DELIVERY SYSTEM MODEL SA-6115 |
MICROMEDICS, INC. |
THOMAS A LOPAC |
| K101013 |
06/07/2010 |
MODIFICATION TO SCINTRON IV |
MIE GMBH |
NORMAN VON HOLLEN |
| K100905 |
06/02/2010 |
HYDROFIX SURGICAL SHEET |
MIMEDX GROUP, INC |
LOUISE FOCHT |
| K090608 |
06/14/2010 |
MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B) |
MINTA MEDICAL LIMITED |
ANDREW EDWARDS |
| K101228 |
06/23/2010 |
MIRADA XD |
MIRADA MEDICAL LTD. |
GWILYM OWEN |
| K101115 |
06/18/2010 |
ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150 |
MORTARA INSTRUMENT, INC |
CHARLES MORREALE |
| K100447 |
06/25/2010 |
MYOSCIENCE CRYO-TOUCH |
MYOSCIENCE INC |
TRACEY HENRY |
| K100497 |
06/21/2010 |
QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM) |
N.M.B. MEDICAL APPLICATIONS, LTD. |
HILA WACHSLER-AVRAHAMI |
| K093949 |
06/16/2010 |
OLYMPIC BRAINZ MONITOR MODEL OBM70001 |
NATUS MEDICAL, INC. |
GOLDY SINGH |
| K100665 |
06/24/2010 |
MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX |
NEEDLETECH PRODUCTS, INC. |
RICK TRIPP |
| K092107 |
06/15/2010 |
VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010 |
NIDACON INTERNATIONAL AB |
DANIEL KAMM |
| K093102 |
06/03/2010 |
AMBULATORY BLOOD PRESSURE MONITOR, MODELS FB-270 AND DS-270 |
NIHON SEIMITSU SOKKI CO., LTD. |
KOJI KUBO |
| K093643 |
06/24/2010 |
MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS |
NOBELBIOCARE AB |
HERBERT CRANE |
| K093853 |
06/04/2010 |
SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES |
NONIN MEDICAL, INC. |
LORI ROTH |
| K093109 |
06/18/2010 |
NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5') |
NOVO NORDISK INC. |
CINDY CAO |
| K100043 |
06/16/2010 |
COROENT XLR STANDALONE SYSTEM |
NUVASIVE, INC. |
Sheila Bruschi |
| K093319 |
06/23/2010 |
NUVASIVE VUEPOINT OCT SYSTEM |
NUVASIVE, INC. |
Sheila Bruschi |
| K093951 |
06/15/2010 |
OUCHLESS MODEL PN10114 |
OCCAM DESIGN |
VAS ABRAMOV |
| K093395 |
06/17/2010 |
OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K101451 |
06/22/2010 |
APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD |
OMNI LIFE SCIENCE, INC. |
RADHIKA PONDICHERRY |
| K101575 |
06/30/2010 |
APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010 |
OMNLIFE SCIENCE |
RADHIKA PONDICHERRY |
| K100861 |
06/17/2010 |
R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 |
OPTOVUE, INC. |
Azimun Jamal |
| K093442 |
06/10/2010 |
GUIDED GROWTH SYSTEM |
ORTHOFIX INC. |
MARY BIGGERS |
| K100833 |
06/03/2010 |
SYLE SMARTIP |
OSSPRAY LTD |
DAVID GREENSPAN |
| K100815 |
06/16/2010 |
OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316 |
OXYPULSE |
JAMES A DUNNING |
| K093975 |
06/04/2010 |
SIMPLER TOADSTOOL ABUTMENT, MODEL S19000-S19009 |
PAN GLOBAL IMPLANT |
HAROLD BERGMAN |
| K092983 |
06/07/2010 |
PANPAC HSG CATHETER SET |
Panpac Medical Corporation |
Yen-Ming Pan |
| K101044 |
06/10/2010 |
RETRIEVE IMPLANT CEMENT |
PARKELL, INC. |
DANIEL R SCHECHTER |
| K100546 |
06/03/2010 |
PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE |
PARKERMEDICALINC |
LEWIS WARD |
| K101334 |
06/11/2010 |
JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
CYNDY ADAMS |
| K101221 |
06/02/2010 |
JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100 |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
BRIAN CLEARY |
| K092967 |
06/08/2010 |
PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE |
PATHWORK DIAGNOSTICS |
ANNA LONGWELL |
| K100101 |
06/11/2010 |
GSP NEONATALGALT KIT, MODEL 3303-001U |
PERKINELMER, INC. |
KAY TAYLOR |
| K091845 |
06/07/2010 |
CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM |
PHADIA US INC. |
MARTIN ROBERT MANN |
| K100099 |
06/14/2010 |
ORAL/ENTERAL SYRINGES |
PHILIPS CHILDREN'S MEDICAL VENTURES |
LISA CASAVANT |
| K100495 |
06/22/2010 |
PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540 |
PHILIPS ELECTRONICS UK LIMITED |
MIRIAM SHARIF-MURRAY |
| K101449 |
06/18/2010 |
INTELLIVUE PATIENT MONITOR |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
ANDREAS SUCHI |
| K100708 |
06/04/2010 |
PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES |
PIONEER SURGICAL TECHNOLOGY |
EMILY M DOWNS |
| K092731 |
06/10/2010 |
VIBRO-TRAC |
PNEUMEX, INC. |
JEAN ASQUITH |
| K101218 |
06/17/2010 |
PATCHASSIST |
POLYTOUCH MEDICAL LTD |
LEO BASTA |
| K091807 |
06/28/2010 |
MEDPOR FIXATION SYSTEM |
POREX SURGICAL, INC. |
JERRI MANN |
| K100545 |
06/04/2010 |
SLEEPRIGHT |
POWER PRODUCTS, INC.-SPLINTEK |
MELAINE HASEK |
| K101262 |
06/10/2010 |
FLEXI-LITE |
PRESSURE-TECH, INC. |
MARIA GRIFFIN |
| K100539 |
06/17/2010 |
PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE |
PREVENTIVE TECHNOLOGIES, INC. |
KENNETH S PETERSON |
| K100781 |
06/21/2010 |
OBSIDIAN CERAMIC BLOCKS |
PRISMATIK DENTALCRAFT, INC. |
KEITH ALLRED |
| K091281 |
06/01/2010 |
TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA |
PROCTER & GAMBLE CO. |
KIMBERLY A NEMETH |
| K100801 |
06/18/2010 |
PUMA MODEL VERSION 1.0 |
PROWESS, INC. |
RACHEL SCARANO |
| K093159 |
06/24/2010 |
PR CREAM |
PRUGEN IP HOLDINGS, INC |
ROBERT L KNECHTEL |
| K093156 |
06/24/2010 |
PRUCLAIR NONSTEROIDAL CREAM |
PRUGEN IP HOLDINGS, INC |
ROBERT L KNECHTEL |
| K091786 |
06/18/2010 |
PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48) |
PULSION MEDICAL SYSTEMS AG |
Jamie Sulley |
| K092874 |
06/22/2010 |
POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES |
QUALITY GALLANT SDN. BHD. |
TERENCE READ |
| K083878 |
06/25/2010 |
LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA |
R2 DIAGNOSTICS, INC. |
MARC D GOLDFORD |
| K101253 |
06/29/2010 |
RII INFRARED EAR THERMOMETER, MODEL: TH60N |
RADIANT INNOVATION INC. |
JAMES HUANG |
| K101217 |
06/23/2010 |
MAC-MOBILE AQUATIC CHAIR |
REHAMED INTL. LLC. |
JOHN CADEN |
| K100772 |
06/09/2010 |
MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL) |
RESMED LTD. |
DAVID D'CRUZ |
| K100285 |
06/29/2010 |
LITETOUCH MASK |
RESPIRONICS NEW JERSEY, INC. |
Lauren Ziegler |
| K093800 |
06/16/2010 |
ROBINSON MEDSURG QUICKSCREW RACK |
ROBINSON MEDSURG LLC |
RANDOLPH C ROBINSON |
| K093955 |
06/22/2010 |
ANTI-HAV IGM |
Roche Diagnostics |
KELLY FRENCH |
| K100538 |
06/22/2010 |
TINA-QUANT FERRITIN GEN. 4 |
Roche Diagnostics |
KATHIE J GOODWIN |
| K101075 |
06/11/2010 |
ELECSYS INSULIN CALCHECK 5 |
ROCHE DIAGNOSTICS CORP. |
Sarah Baumann |
| K100893 |
06/16/2010 |
CHEVEUX DIODE LASER SYSTEM |
SANDSTONE MEDICAL TECHNOLOGIES, LLC |
MARK ROHRER |
| K100604 |
06/14/2010 |
OTIS -C PLUS |
SCIENCES ET BIO MATERIAUX (SBM) |
DENIS CLEMENT |
| K101008 |
06/08/2010 |
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY |
SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI |
BOB LEIKER |
| K101341 |
06/14/2010 |
POWDERED VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG UNIVERSAL CHANNEL PLASTIC CO., LTD |
CHU XIAOAN |
| K100995 |
06/25/2010 |
SHIKANI SPEAKING VALVE |
SHIKANI MEDICAL, LLC |
PAUL DRYDEN |
| K101119 |
06/16/2010 |
SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CHRISTINE DUNBAR |
| K101491 |
06/30/2010 |
UROSKOP OMNIA |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
GARY JOHNSON |
| K092720 |
06/29/2010 |
WRIST ARTHRODESIS NAIL SYSTEM |
SKELETAL DYNAMICS, LLC |
JOSEPH AZARY |
| K093407 |
06/22/2010 |
ZQUIET MOUTHPIECE |
SLEEPING WELL, LLC |
YOLANDA SMITH |
| K100605 |
06/04/2010 |
MIS SYSTEM |
SPINE WAVE, INC. |
DENISE DUCHENE |
| K092815 |
06/30/2010 |
S-LIF INTERVERTEBRAL BODY FUSION DEVICE |
SPINEFRONTIER, INC. |
JOHN SULLIVAN |
| K101419 |
06/11/2010 |
ENSITE VELOCITY SYSTEM, MODEL EE3000 |
ST. JUDE MEDICAL |
DONNA R LUNAK |
| K101239 |
06/02/2010 |
VIEWFLEX PLUS ICE CATHETER |
ST. JUDE MEDICAL |
LOUCINDA BJORKLUND |
| K100398 |
06/09/2010 |
SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM |
STANDARD DIAGNOSTICS, INC. |
SUSAN GOLDSTEIN-FALK |
| K100707 |
06/25/2010 |
REPROCESSED PINS |
STERILMED, INC. |
GARRETT AHLBORG |
| K093108 |
06/22/2010 |
STRYKER BIPOLAR FORCEPS |
Stryker Leibinger GmbH & Co. KG |
ROB YAMASHITA |
| K093516 |
06/29/2010 |
NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVES |
SUMMIT GLOVE, INC. |
JAMES MOORE |
| K093517 |
06/29/2010 |
NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVE |
SUMMIT GLOVE, INC. |
JAMES MOORE |
| K101444 |
06/14/2010 |
AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY |
SURGICAL DEVICES, A GLOBAL BUSINESS UNIT TYCO |
FRANK GIANELLI |
| K100836 |
06/16/2010 |
CLEARPOINT SYSTEM |
SURGIVISION, INC. |
JOHN J SMITH M.D., J.D. |
| K101378 |
06/29/2010 |
FRANKENMAN SURGICAL STAPLERS |
SUZHOU FRANKENMAN MEDICAL EQUIPMENT CO., LTD. |
JEAN ASQUITH |
| K092889 |
06/25/2010 |
SYNTEC OSTEO-PLATE AND SCREW FIXATION |
SYNTEC SCIENTIFIC CORP. |
CAROL CHANG |
| K100322 |
06/28/2010 |
TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277 |
TaiDoc Technology Corporation |
DEBRA LIANG |
| K101259 |
06/17/2010 |
V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002 |
TaiDoc Technology Corporation |
DEBRA LIANG |
| K090081 |
06/22/2010 |
TALLADIUM INTERNATIONAL IMPLANTOLOGY ABUTMENTS |
TALLADIUM ESPANA S.L. |
Diane Horwitz |
| K100694 |
06/25/2010 |
COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN |
TEKMEDIC (M) SDN BHD |
PATRICK LEONG |
| K101671 |
06/25/2010 |
SINGLE SITE FLEXIBLE BLADELESS OBTURATOR |
Teleflex Medical, Inc. |
Angela Bouse |
| K100800 |
06/14/2010 |
TIDI FACEMASK |
TIDI PRODUCTS, LLC |
DION BRANDT |
| K100562 |
06/29/2010 |
LATITUDE ELBOW PROSTHESIS |
TORNIER, INC. |
BRAHIM HADRI |
| K093707 |
06/23/2010 |
DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820 |
U&I CORP. |
GYEONG-JE KWON |
| K100812 |
06/03/2010 |
ULTICARE DISPOSABLE PEN NEEDLES |
ULTIMED, INC. |
MARY BETH HENDERSON |
| K100981 |
06/14/2010 |
UNITED STEM, PSA TYPE |
UNITED ORTHOPEDIC CORP. |
FANG-YUAN HO |
| K100480 |
06/11/2010 |
ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH |
VITALTEC CORPORATION |
JEN KE-MIN |
| K092625 |
06/29/2010 |
WAVESTATE NEUROMONITOR |
WAVESTATE INC |
E.J. Smith |
| K101445 |
06/08/2010 |
VITAL SIGNS MONITOR-VSM 6000 SERIES |
WELCH ALLYN, INC. |
HY DOAN |
| K100399 |
06/25/2010 |
4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A |
WELL-LIFE HEALTHCARE LIMITED |
JENNY HSEIH |
| K100359 |
06/24/2010 |
DARCO HEADED CANNULATED SCREW |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KELSEY LEE |
| K100630 |
06/11/2010 |
G-FORCE PEEK SUTURE ANCHOR SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KELLEN HILLS |
| K100137 |
06/10/2010 |
SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MEGAN MCCAGH |
| K101227 |
06/23/2010 |
BACK-TEK |
YORK BIOMEDICAL INC |
Calley Herzog |
| K101091 |
06/25/2010 |
Z.ONE ULTRA ULTRASOUND SYSTEM |
ZONARE MEDICAL SYSTEMS, INC. |
LINDA MOORE |
