| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K043015 |
08/15/2005 |
3L SURGICAL DRAPES |
3L MEDICAL PRODUCTS CO., LTD. |
GEORGE SU |
| K052128 |
08/16/2005 |
3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER |
3M COMPANY |
CYNTHIA LAMANRUCCIOLA |
| K051657 |
08/30/2005 |
A-DEC SELF-CONTAINED WATER SYSTEM |
A-DEC, INC. |
TOM LOUISELL |
| K051802 |
08/09/2005 |
FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM |
ABBOTT DIABETES CARE INC. |
KIMBERLEY KLINE |
| K051327 |
08/03/2005 |
ABBOTT AXSYM B12 |
ABBOTT LABORATORIES |
MARGARET PROCHNIAK |
| K051962 |
08/25/2005 |
ULTRA HDL |
ABBOTT LABORATORIES |
LINDA MORRIS |
| K052072 |
08/29/2005 |
THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES |
ABBOTT SPINE, INC. |
NOAH BARTSCH |
| K052198 |
08/31/2005 |
RELIEVA SINUS BALLOON INFLATION DEVICE |
ACCLARENT, INC. |
SU-MIEN CHONG |
| K051231 |
08/05/2005 |
VERIFYNOW-P2Y12 ASSAY |
ACCUMETRICS, INC. |
BARBARA STEVENS |
| K051941 |
08/09/2005 |
CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM |
ACCURAY, INC. |
ANNE SCHLAGENHAFT |
| K052044 |
08/16/2005 |
ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL |
ACMI CORPORATION |
TERRENCE E SULLIVAN |
| K050468 |
08/31/2005 |
TRIABSORB COMPOSITE SCREW |
ADVANCED BIOMATERIALS |
PATRICK JANIN |
| K051643 |
08/19/2005 |
STERRAD STERILIZER CYCLESURE TEST PACK |
ADVANCED STERILIZATION PRODUCTS |
JOSEPH M ASCENZI |
| K052251 |
08/31/2005 |
DRYSTAR MODEL 5500 |
AGFA CORPORATION |
JEFF JEDLICKA |
| K052064 |
08/25/2005 |
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
| K052065 |
08/22/2005 |
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
| K052062 |
08/25/2005 |
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
| K051529 |
08/04/2005 |
AMBU NEUROLINE GROUND |
AMBU, INC. |
SANJAY PARIKH |
| K051485 |
08/03/2005 |
AMS PELVIC FLOOR REPAIR SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
ELSA LINKE |
| K051042 |
08/05/2005 |
METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000 |
ANGIOMETRX INC. |
TIM VERSPAGEN |
| K052136 |
08/25/2005 |
GR17 DIGITAL DETECTOR |
ANRAD CORP. |
DONALD J SHERRATT |
| K051793 |
08/17/2005 |
ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE) |
ANSELL HEALTHCARE PRODUCTS, LLC |
CYNTHIA A INGRAM |
| K050969 |
08/18/2005 |
INCLOSE SURGICAL MESH SYSTEM |
ANULEX TECHNOLOGIES, INC |
TIM MILLER |
| K051639 |
08/02/2005 |
AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM |
AS SOFTWARE, INC. |
KIM A NATHANSON |
| K052022 |
08/25/2005 |
ASAHI PTCA GUIDE WIRE FIELDER |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K050320 |
08/15/2005 |
FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT |
ASCENDIA MEDTECH AB |
JANE B CAMPBELL |
| K051413 |
08/29/2005 |
ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100 |
AVENT AMERICA, INC. |
RICHARD MORRONEY |
| K051135 |
08/11/2005 |
AXIOM NVP8500 |
AXIOM WORLDWIDE, INC. |
JAMES J GIBSON |
| K050798 |
08/15/2005 |
ECLIPSE NEUROLOGICAL WORKSTATION |
AXON SYSTEMS, INC. |
HOWARD BAILIN |
| K051983 |
08/05/2005 |
MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR |
AXYA MEDICAL, INC. |
Howard Schrayer |
| K052006 |
08/03/2005 |
POWDER-FREE VINYL EXAM GLOVES |
BAODING GUANZHONG GLOVE CO., LTD. |
MARY ANN DOUCETTE |
| K051902 |
08/11/2005 |
NIO 2MP-21 |
BARCOVIEW |
LIEVEN DE WANDEL |
| K051901 |
08/17/2005 |
NIO 3MP-21 |
BARCOVIEW |
LIEVEN DE WANDEL |
| K052236 |
08/23/2005 |
BARD ATLAS PTA BALLOON DILATATION CATHETER |
BARD PERIPHERAL VASCULAR, INC. |
GENEVIEVE BALUTOWSKI |
| K052114 |
08/25/2005 |
BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP |
BARD PERIPHERAL VASCULAR, INC. |
DENNIS SALZMANN |
| K051370 |
08/12/2005 |
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 |
BAXTER HEALTHCARE CORP. |
NANETTE HEDDEN |
| K051619 |
08/01/2005 |
LIPOPROTEIN FOR MULTIPLE ANALYTES |
BAYER HEALTHCARE, LLC |
ANDERS HOLLE |
| K052082 |
08/19/2005 |
FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 |
BECKMAN COULTER, INC. |
CAROLYN ANDERSON |
| K051122 |
08/01/2005 |
ITAG MHC TETRAMER CMV ASSAY |
BECKMAN COULTER, INC. |
MARA CALER |
| K051689 |
08/05/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - DAPTOMYCIN 0.125 - 32 UG/ML |
BECTON, DICKINSON & CO. |
Monica Giguere |
| K052066 |
08/26/2005 |
CEEGRAPH/SLEEPSCAN NETLINK TRAVELER |
BIO-LOGIC SYSTEMS CORP. |
NORMAN E BRUNNER |
| K052053 |
08/09/2005 |
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK |
BIO-RAD |
SUZANNE S PARSONS |
| K051816 |
08/26/2005 |
LUMIWAVE 1X4 INFRARED THERAPY DEVICE |
BIOCARE SYSTEMS, INC. |
CLAY ANSELMO |
| K050170 |
08/26/2005 |
FORTOSS VITAL BONE GRAFT SUBSTITUTE |
BIOCOMPOSITES LTD. |
SIMON FITZER |
| K050613 |
08/16/2005 |
QUANTIA BETA-2 MICROGLOBULIN |
BIOKIT S.A. |
JOAN GUIXER |
| K050493 |
08/16/2005 |
QUANTIA IGE |
BIOKIT S.A. |
JOAN GUIXER |
| K050824 |
08/10/2005 |
100W CERALAS D 980 LASER SYSTEM, MODEL D100 |
BIOLITEC, INC. |
JONATHAN S KAHAN |
| K050182 |
08/09/2005 |
Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM |
BIOMEDIX, INC. |
JUDY S CHEN |
| K051849 |
08/16/2005 |
VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
Nancy Weaver |
| K051479 |
08/10/2005 |
RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS |
BIOMET MANUFACTURING, INC. |
GARY BAKER |
| K051570 |
08/05/2005 |
AVL HINGE KNEE SYSTEM |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K051496 |
08/04/2005 |
COBALT BONE CEMENT |
BIOMET, INC. |
LONNIE WITHAM |
| K051532 |
08/03/2005 |
COBALT G HV BONE CEMENT |
BIOMET, INC. |
LONNIE WITHAM |
| K043547 |
08/05/2005 |
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM |
BIOMET, INC. |
GARY BAKER |
| K051385 |
08/05/2005 |
EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K050222 |
08/16/2005 |
VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS |
BIOMET, INC. |
GARY BAKER |
| K050971 |
08/16/2005 |
BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS) |
BIOVALVE TECHNOLOGIES, INC. |
SCOTT HUIE |
| K051985 |
08/17/2005 |
BIOVALVE MINI-JECT NEEDLEFREE INJECTOR |
BIOVALVE TECHNOLOGIES, INC. |
SCOTT HUIE |
| K050840 |
08/16/2005 |
MODIFICATION TO DUET SYSTEM |
BIOVIEW LTD. |
DORIT WINITZ |
| K051999 |
08/22/2005 |
BISCOVER LED |
BISCO, INC. |
BENJAMIN LICHTENWALNER |
| K052194 |
08/24/2005 |
SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR |
BOSTON SCIENTIFIC CORP. |
ALLYSON BARFORD |
| K052038 |
08/16/2005 |
PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM |
Boston Scientific Corporation |
RENUKA KRISHNAN |
| K051819 |
08/15/2005 |
C CHANGE SOLUTION WARMER |
C CHANGE SURGICAL LLC |
ROBERT KELLY |
| K051748 |
08/12/2005 |
HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS |
C.R. BARD, INC. |
MICHAELA RIVKOWICH |
| K050558 |
08/29/2005 |
MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F |
C.R. BARD, INC. |
KAREN HUTCHISON |
| K051649 |
08/02/2005 |
VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0 |
CAMTRONICS MEDICAL SYSTEMS |
STEVE KRUEGER |
| K052035 |
08/31/2005 |
CANADY PLASMA PROBES |
CANADY TECHNOLOGY, LLC |
JEROME CANADY |
| K050994 |
08/03/2005 |
AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM |
Cardinal Health |
SHARON NICHOLS |
| K051853 |
08/22/2005 |
CARDIOSTREAM SONOAIM |
CARDIOSTREAM, LLC |
IAN P GORDON |
| K050250 |
08/10/2005 |
AQUIFY MULTIPURPOSE SOLUTION |
CIBA VISION CORPORATION |
STEVEN DOWDLEY |
| K051038 |
08/12/2005 |
506 PATIENT MONITOR |
CIRITICARE SYSTEMS, INC. |
ALEX KAPLAN |
| K051533 |
08/11/2005 |
I-STOP |
CL MEDICAL |
VINCENT GORIA |
| K043034 |
08/04/2005 |
OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS |
COLLAGEN MATRIX, INC. |
PEGGY HANSEN |
| K051660 |
08/04/2005 |
DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM |
COLTENE/WHALEDENT INC. |
LORETTA MOONEY |
| K052045 |
08/24/2005 |
ACCESS BREAST COIL |
CONFIRMA, INC. |
PATRICIA A MILBANK |
| K052036 |
08/25/2005 |
ATB ADVANCE PTA DILATATION CATHETER |
COOK, INC. |
KAREN BRADBURN |
| K051785 |
08/23/2005 |
FORMULA 418 BILIARY STENT |
COOK, INC. |
KAREN BRADBURN |
| K050764 |
08/24/2005 |
UNIGLIDE UNICONDYLAR KNEE PROSTHESIS |
CORIN U.S.A. |
JOEL BATTS |
| K051405 |
08/31/2005 |
REGENSIS PERICARDIAL PATCH |
CORMATRIX CARDIOVASCULAR, INC. |
PUNAM GOLLAMUDI |
| K050889 |
08/26/2005 |
FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH |
CRS MEDICAL DIAGNOSTICS INC. |
JOSEPH M MATTANO |
| K051916 |
08/05/2005 |
POLAR CATH PERIPHERAL DILATATION SYSTEM |
CRYOVASCULAR SYSTEMS, INC. |
ELAINE APLAON |
| K051305 |
08/18/2005 |
CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5 |
CS Medical LLC |
BEN CHEMELLI |
| K051131 |
08/15/2005 |
VCS S3T |
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER/CHC |
CHANG WAN LAN |
| K051597 |
08/17/2005 |
STRATUS CS D-DIMER |
DADE BEHRING, INC. |
KATHLEEN A DRAY-LYONS |
| K051897 |
08/12/2005 |
TRIO MONITOR |
DATASCOPE CORP. |
SUSAN E MANDY |
| K051177 |
08/29/2005 |
PVC AND SILICONE MANUAL RESUSCITATORS |
DAVID MEDICAL PRODUCTS CO.,LTD |
DAVID LU |
| K051848 |
08/11/2005 |
SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079 |
DAVOL INC., SUB. C.R. BARD, INC. |
LUCINDA L FOX |
| K051960 |
08/19/2005 |
CARDIONAVIGATOR + |
DEL MAR REYNOLDS MEDICAL, LTD. |
GEORGE MYERS |
| K050851 |
08/19/2005 |
DELTA PUNCTUM PLUG |
DELTA LIFE SCIENCE, INC. |
GEORGE W MURRAY |
| K052097 |
08/12/2005 |
CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE |
DENTSPLY INTERNATIONAL |
HELEN LEWIS |
| K051989 |
08/05/2005 |
GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
DENISE LUCIANO |
| K040627 |
08/05/2005 |
DEPUY ASR MODULAR ACETABULAR CUP SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
Natalie Heck |
| K051296 |
08/26/2005 |
SIJF CANNULATED SCREW SYSTEM |
DEPUY SPINE, INC. |
SHARON STAROWICZ |
| K051786 |
08/15/2005 |
MELIDE FIBEROPTIC LIGHT |
DESIGNS FOR VISION, INC. |
CYNTHIA J M. NOLTE |
| K050827 |
08/22/2005 |
NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE) |
DIALYSIS SOLUTIONS, INC. |
MARCY MACDONALD |
| K051996 |
08/18/2005 |
DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30 |
DIOMED, LTD. |
TIM PHIPPS |
| K052090 |
08/05/2005 |
SPLASH! IMPRESSION MATERIAL DEVICE |
DISCUS DENTAL INC. |
SUZANNE RIDGWAY |
| K051014 |
08/09/2005 |
SILENT PARTNER SERIES OSA APPLIANCES |
DREAMWRX DENTAL LABORATORY |
NICOLAAS BESSELING |
| K050234 |
08/25/2005 |
REMOTE CARE |
E.CARE SOLUTIONS, INC. |
CONSTANCE G BUNDY |
| K051273 |
08/19/2005 |
DIVAS DUAL PLEASURE MALE LATEX CONDOM |
EAGLE TWE, INC. |
BILL TAFFS |
| K050446 |
08/09/2005 |
BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE |
ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE |
PETER S REICHERTZ |
| K052132 |
08/24/2005 |
MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM |
EDWARDS LIFESCIENCES, LLC. |
KEVIN DRISKO |
| K052071 |
08/16/2005 |
LYSUS INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
| K051932 |
08/12/2005 |
ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 |
ELEKTA, INC |
PETER STEGAGNO |
| K051420 |
08/15/2005 |
HABIB 4X |
EMCISION, LTD. |
NAGY HABIB |
| K052086 |
08/31/2005 |
ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER |
ENCORE MEDICAL, INC. |
CHRISTIE SHUMAKER |
| K051860 |
08/22/2005 |
FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 |
EPIMED INTERNATIONAL, INC. |
CHRISTOPHER LAKE |
| K051171 |
08/26/2005 |
STINGRAY EPIDURAL CATHETER CONNECTOR |
EPIMED INTERNATIONAL, INC. |
CHRISTOPHER LAKE |
| K052077 |
08/16/2005 |
G-SCAN CERVICAL SPINE COIL |
ESAOTE, S.P.A. |
CARRI GRAHAM |
| K051301 |
08/30/2005 |
PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES |
ETHICON ENDO-SURGERY, INC. |
KIMBERLY MCCOY |
| K051732 |
08/09/2005 |
ENDOSCOPIC APPLICATOR |
ETHICON INC. |
PETER CECCHINI |
| K052111 |
08/17/2005 |
XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382 |
EXCEL TECH. LTD. |
NICOLE LANDREVILLE |
| K050927 |
08/01/2005 |
RT019 INSPIRATORY/EXPIRATORY FILTER |
FISHER & PAYKEL HEALTHCARE, LTD. |
RENETA MONEY |
| K052058 |
08/22/2005 |
MODIFICATION TO: TITANIUM TELEGRAPH HUMERAL NAIL |
FOURNITURES HOSPITALIERES INDUSTRIE |
CHRISTINE QUENDEZ |
| K051522 |
08/17/2005 |
SILBRONCHO DOUBLE LUMEN TUBE |
FUJI SYSTEMS CORP. |
PAUL E DRYDEN |
| K050575 |
08/15/2005 |
FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM |
FUTUMEDS SDN BHD |
LEONG PEI PING |
| K051427 |
08/22/2005 |
GC FUJI FIL LC |
GC AMERICA, INC. |
TERRY L JORITZ |
| K052145 |
08/23/2005 |
DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES |
GE HEALTHCARE |
JOEL KENT |
| K051883 |
08/05/2005 |
DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES. |
GE HEALTHCARE |
JOEL KENT |
| K051967 |
08/09/2005 |
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS |
GE HEALTHCARE |
JOHN L SCHMIDT |
| K051855 |
08/02/2005 |
VENTRI |
GE MEDICAL SYSTEMS F.I. HAIFA |
ELI WERNER |
| K052157 |
08/25/2005 |
INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ |
GE MEDICAL SYSTEMS, LLC |
LARRY A KROGER |
| K052039 |
08/11/2005 |
GE OEC ALTITUDE |
GE OEC MEDICAL SYSTEMS |
SUSAN SCHMIDT |
| K043224 |
08/09/2005 |
GEN-PROBE APTIMA COMBO 2 ASSAY |
GEN-PROBE, INC. |
ALAN MADERAZO |
| K051666 |
08/23/2005 |
GAV - GENERAL ANAESTHETIC VAPORIZER |
GENERAL ANAESTHETIC SERVICES LIMITED |
ANDREW JW WALL |
| K051606 |
08/12/2005 |
GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING |
GISH BIOMEDICAL, INC. |
J. HARVEY KNAUSS |
| K052069 |
08/17/2005 |
PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
| K052166 |
08/18/2005 |
MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM |
GUIDANT CORPORATION |
JULIA ANASTAS |
| K052165 |
08/16/2005 |
RX ACCUNET EMBOLIC PROTECTION SYSTEM |
GUIDANT CORPORATION |
JULIA ANASTAS |
| K051777 |
08/12/2005 |
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE) |
HARTALEGA SDN BHD |
KUAN KAM HON |
| K052052 |
08/24/2005 |
HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5 |
HOSPIRA, INC. |
PATRICIA MELERSKI |
| K052037 |
08/05/2005 |
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM |
HOWMEDICA OSTEONICS CORP |
VIVIAN KELLY |
| K051380 |
08/30/2005 |
TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM |
HOWMEDICA OSTEONICS CORP |
TIFFANI ROGERS |
| K051642 |
08/22/2005 |
FR.O.H. CALCANEUS REPAIR SYSTEM |
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
AL LIPPINCOTT |
| K052011 |
08/10/2005 |
PILONPLATE WITH ANGULAR STABILITY |
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
AL LIPPINCOTT |
| K051437 |
08/03/2005 |
CML 1000 |
ICU MEDICAL, INC. |
JIM COOMBES |
| K051980 |
08/19/2005 |
DVT SCANNER |
IMAGING SCIENCES INTL., INC. |
DAVID W COWAN |
| K050465 |
08/04/2005 |
IMMUNALYSIS COCAINE ELISA FOR HAIR |
Immunalysis Corporation |
MICHAEL VINCENT |
| K051715 |
08/02/2005 |
STARPACS DENTAL |
INFINITT CO., LTD. |
CARL ALLETTO |
| K051285 |
08/02/2005 |
GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM |
INFOPIA CO., LTD |
BYEONG WOO BAE |
| K051362 |
08/04/2005 |
INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000 |
INION OY |
HANNA MARTILA |
| K051129 |
08/12/2005 |
DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
INNOVA VISION INC. |
JENNIFER REICH |
| K052060 |
08/31/2005 |
OPTI-AMP DC-POWERED |
INTELLIGENT HEARING SYSTEMS |
EDWARD MISKIEL |
| K051917 |
08/08/2005 |
DIVER C.E. CATHETER |
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. |
STEPHANIE K ISGRIGG ROBINSON |
| K050399 |
08/26/2005 |
MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160 |
INVIVO RESEARCH, INC. |
NEIL BATTISTE |
| K051918 |
08/17/2005 |
RESOLVE OPEN BACK HALO RINGS |
JEROME MEDICAL |
BERNIE TATRO |
| K051814 |
08/04/2005 |
JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET |
JMS NORTH AMERICA CORP. |
CHONG SWEE CHEAU |
| K051900 |
08/12/2005 |
ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR |
JOHNSON & JOHNSON VISION CARE, INC. |
SUSAN MORRIS |
| K051827 |
08/12/2005 |
JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE |
JOIMAX GMBH |
KARIN GASTINEAU |
| K050657 |
08/08/2005 |
MONDEAL CONTOUR HO SYSTEM |
KAPP SURGICAL INSTRUMENT, INC. |
ALBERT SANTILLI |
| K050655 |
08/08/2005 |
MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005 |
KAPP SURGICAL INSTRUMENT, INC. |
ALBERT SANTILLI |
| K051972 |
08/15/2005 |
KARL STORZ TRANS-NASAL ESOPHAGOSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
YVONNE FERNANDEZ |
| K051505 |
08/11/2005 |
SCB/STERIS OR-LIGHT INTERFACE BOX |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
PAUL S LEE |
| K030146 |
08/03/2005 |
KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ |
KAVO AMERICA |
J0HN R FRANZ |
| K042394 |
08/02/2005 |
DIAGNODENT PERIO TIP (ACCESSORY) |
KAVO AMERICA CORPORATION |
DANIEL KAMM |
| K051586 |
08/04/2005 |
VIEWSEND MEDICAL SYSTEM |
KENEI CO., LTD. |
JENNIFER LI |
| K043259 |
08/15/2005 |
BIOBLANKET SURGICAL MESH |
KENSEY NASH CORP. |
DEBORAH RACIOPPI |
| K050984 |
08/11/2005 |
BIOPLANT |
KERR DENTAL MATERIALS CENTER |
COLLEEN BOSWELL |
| K051236 |
08/22/2005 |
RESORB-X SF |
KLS-MARTIN L.P. |
JENNIFER DAMATO |
| K051796 |
08/09/2005 |
CLEARFIL TRI-S BOND SINGLE DOSE |
KURARAY MEDICAL KURASHIKI PLANT |
SATOSHI YAMAGUCHI |
| K051473 |
08/31/2005 |
LEARDO, AVANTICARE ELECTRICAL SCOOTERSM3021 |
LERADO CHINA LIMITED |
JEN KE-MIN |
| K052080 |
08/25/2005 |
MATRYX INTERFERENCE SCREW |
LINVATEC BIOMATERIALS, INC. |
TUIJA ANNALA |
| K052129 |
08/30/2005 |
LUMENIS 1000 INTEGRATED SLIT LAMP |
LUMENIS, INC. |
KAREN L BAKER |
| K051567 |
08/23/2005 |
APTUS TITANIUM OSTEOSYNTHESIS SYSTEM |
MEDARTIS, INC. |
FLOYD G LARSON |
| K051946 |
08/22/2005 |
MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM |
MEDARTIS, INC. |
FLOYD G LARSON |
| K051700 |
08/15/2005 |
OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR |
MEDCHANNEL, LLC |
FREDERICK TOBIA |
| K051930 |
08/16/2005 |
DRUG ACCESS SPIKE |
MEDEGEN MEDICAL MANUFACTURING SERVICES |
SALVADORE F PALOMARES |
| K051939 |
08/01/2005 |
MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR |
MEDEGEN MEDICAL MANUFACTURING SYSTEM |
TIM TRUITT |
| K051421 |
08/30/2005 |
INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KRISTINE LIBERACKI |
| K051809 |
08/15/2005 |
EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM |
MEDICAL INSIGHT A/S |
GARY J ALLSEBROOK |
| K051378 |
08/03/2005 |
POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) |
MEDLINE |
JENNIFER MASON |
| K051302 |
08/15/2005 |
EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
| K052180 |
08/23/2005 |
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K052187 |
08/22/2005 |
MODIFICATION TO: CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K052144 |
08/31/2005 |
TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K052054 |
08/16/2005 |
TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K051846 |
08/05/2005 |
7F SHERPA NX GUIDE CATHETER |
MEDTRONIC VASCULAR |
FRED L BOUCHER |
| K050421 |
08/31/2005 |
MS 4/5 HEMATOLOGY ANALYZER |
MELET SCHLOESING LABORATORIES USA |
JACKIE COLEMAN |
| K050430 |
08/04/2005 |
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR |
MERITS HEALTH PRODUCTS CO., LTD. |
Lee Leichter |
| K051618 |
08/02/2005 |
SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64 |
MIDWEST R.F. LLC. |
DAVID M PETERSON |
| K051445 |
08/22/2005 |
MILLIKEN SILVER WOUND DRESSINGS |
MILLIKEN CHEMICAL |
MARY MCNAMARA-CULLINANE |
| K050896 |
08/24/2005 |
H12+ HOLTER RECORDER |
MORTARA INSTRUMENT, INC. |
HARLAN L VAN MATRE |
| K052200 |
08/19/2005 |
TEM 3000 HEAD COIL |
MR INSTRUMENTS INC. |
MARK WATSON |
| K052067 |
08/29/2005 |
DOPPLER GUIDED PROCTOSCOPE, MODEL 500H |
MULTIGON INDUSTRIES, INC. |
WILLIAM STERN |
| K051352 |
08/11/2005 |
OXIMAX NPB-40 HANDHELD PULSE OXIMETER |
NELLCOR PURITAN BENNETT, INC. |
SARAH HARRINGTON |
| K052246 |
08/22/2005 |
MODIFICATION TO EN-BLOC BIOPSY SYSTEM |
NEOTHERMIA CORPORATION |
DAVID JACOBS |
| K051434 |
08/09/2005 |
COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV |
NEW STAR LASERS, INC. |
DONALD V JOHNSON |
| K051406 |
08/01/2005 |
OSTEOCURE RESORBABLE BEAD KIT |
NEXA ORTHOPEDICS, INC. |
LOUISE M FOCHT |
| K050336 |
08/24/2005 |
OPD-STATION SOFTWARE |
NIDEK, INC. |
CAROL PATTERSON |
| K051178 |
08/17/2005 |
MEE-1000A NEUROMASTER |
NIHON KOHDEN AMERICA, INC. |
SERRAH NAMINI |
| K051574 |
08/26/2005 |
NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE |
NIPRO MEDICAL CORP. |
KAELYN HADLEY |
| K051889 |
08/30/2005 |
CAREVENT CA AND DRA |
O-TWO MEDICAL TECHNOLOGIES, INC. |
AMMAR AL-DOJAILY |
| K051979 |
08/30/2005 |
ORS MODEL 6000 ENDOSCOPE HOLDER |
O.R. SOLUTIONS, INC. |
E.J. Smith |
| K042915 |
08/31/2005 |
O'MY NATURAL LUBRICANT, O'MY NATURAL FLAVORED LUBRICANT |
O'MY PRODUCTS INCORPORATED |
ROB LOGAN |
| K051794 |
08/16/2005 |
GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS |
OFFICE OF THE SURGEON GENERAL, U.S. ARMY |
DIANE ULLMAN |
| K051564 |
08/22/2005 |
OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH |
OLYMPUS AMERICA, INC. |
BEV HARDING |
| K051613 |
08/15/2005 |
MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K051095 |
08/16/2005 |
55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
OPTICAL CONNECTION, INC. |
GAROLD L EDWARDS |
| K043260 |
08/12/2005 |
ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY |
ORTHOCON, LLC |
Howard Schrayer |
| K051754 |
08/09/2005 |
ORTHOSCAN, ORTHOSCAN HD |
ORTHOSCAN, INC. |
ARLEN ISSETTE |
| K033863 |
08/22/2005 |
OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03 |
OX-GEN INC. |
FRANK FOSELLA |
| K043388 |
08/05/2005 |
PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH |
PEGASUS BIOLOGICS, INC. |
MUIR S MEINHOLD |
| K051758 |
08/17/2005 |
PENUMBRA ASPIRATION PUMP, MODEL 115V |
PENUMBRA, INC. |
THERESA B BRANDNER-ALLEN |
| K052049 |
08/26/2005 |
PHILIPS 12-LEAD ALGORITHM |
PHILIPS MEDICAL SYSTEMS |
SONGHUA ZHANG |
| K052013 |
08/02/2005 |
ACHIEVA 1.5T & INERA 1.5T FAMILY |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
LYNN T HARMER |
| K051428 |
08/09/2005 |
VTRAC EXCIMER LAMP SYSTEM |
PHOTO MEDEX, INC. |
BOB ROSE |
| K050216 |
08/09/2005 |
OMNILUX REVIVE AND OMNILUX PLUS |
PHOTO THERAPEUTICS LIMITED |
STEVE HUTSON |
| K042758 |
08/29/2005 |
POLYTECH PULMONARY FUNCTION FILTER |
POLYTECHNIC RESOURCES, INC. |
TIMOTHY BYRD |
| K052100 |
08/11/2005 |
MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH |
PROXY BIOMEDICAL LTD. |
ELAINE DUNCAN |
| K051851 |
08/03/2005 |
AVISO OPHTHALMIC ULTRASOUND SYSTEM |
QUANTEL MEDICAL |
GEORGE MYERS |
| K051609 |
08/04/2005 |
QUILL SYNTHETIC ABSORBABLE BARBED SUTURE |
QUILL MEDICAL, INC. |
LOIS V SMART |
| K040428 |
08/09/2005 |
MULTIPLE EROZONE BODYGLIDE FLUID, EROZONE BODYGLIDE GEL, EROZONE LATEX DRESSING, EROZONE BODYGLIDE NATURAL FOAM |
R & K INTERNATIONAL COSMETICS |
GARYN L LOTRIDGE |
| K050869 |
08/11/2005 |
MODIFICATION TO ABL800 FLEX |
RADIOMETER MEDICAL APS |
MARK A HELLER |
| K051947 |
08/22/2005 |
RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE |
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
KEVIN J O'CONNELL |
| K051615 |
08/15/2005 |
STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES |
REGENERATION TECHNOLOGIES, INC. |
CARRIE HARTILL |
| K050899 |
08/12/2005 |
BIOGEL LATEX STERILE POWDER-FREE GLOVE |
REGENT MEDICAL AMERICAS, LLC |
KATHLEEN HARRIS |
| K051364 |
08/16/2005 |
VPAP ADAPT |
RESMED LTD. |
DAVID D'CRUZ |
| K051468 |
08/04/2005 |
INNER-LOCK INTRODUCER SHEATH |
REX MEDICAL |
SUSAN D GOLDSTEIN-FALK |
| K052188 |
08/23/2005 |
CUTANEOUS ELECTRODE |
RHYTHMLINK INTERNATIONAL, LLC |
JAMES M MEWBORNE |
| K051376 |
08/23/2005 |
ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE |
Roche Diagnostics |
JENNIFER TRIBBETT |
| K052101 |
08/26/2005 |
C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C |
Roche Diagnostics |
THERESA M AMBROSE |
| K052002 |
08/22/2005 |
IRON STANDARD |
ROCHE DIAGNOSTICS CORP. |
CORINA HARPER |
| K051890 |
08/04/2005 |
ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K051409 |
08/08/2005 |
SLIVASURE |
SCANDINAVIAN FORMULAS, INC. |
CATHERINE P PEKLAK |
| K051368 |
08/09/2005 |
BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM |
SCHILLER AG |
MARKUS BUETLER |
| K050836 |
08/08/2005 |
CRP DIAGNOSTIC ASSAY |
SENTINEL CH. SRL |
Maria E Donawa |
| K051115 |
08/25/2005 |
SENTINEL IRON LIQUID |
SENTINEL CH. SRL |
DAVIDE SPADA |
| K051683 |
08/01/2005 |
POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING |
SHEN WEI (USA), INC. |
STANLEY DUAN |
| K052113 |
08/09/2005 |
DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K051935 |
08/02/2005 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) |
SHIJIAZHUANG WONDER PLASTIC CO., LTD. |
CHU XIAOAN |
| K051923 |
08/16/2005 |
POWDERED VINYL PATIENT EXAMINATION GLOVES WHITE (NON-COLORED) |
SHIJIAZHUANG WONDER PLASTIC CO., LTD. |
CHU XIAOAN |
| K051818 |
08/03/2005 |
BEAUTIFIL FLOW |
SHOFU DENTAL CORP. |
DAVID P MORAIS |
| K052029 |
08/09/2005 |
SYNGO CIRCULATION |
SIEMENS AG, MEDICAL SOLUTIONS |
RUEDIGER KOERNER |
| K052021 |
08/17/2005 |
V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ISKRA MRAKOVIC |
| K052096 |
08/16/2005 |
NUBIC SPINAL IMPLANT |
SIGNUS MEDICAL LLC. |
TRACY L GRAY |
| K050183 |
08/16/2005 |
SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES |
SILVESTRIN FABRIS S.R.L. |
FEDERICO SILVESTRIN |
| K051605 |
08/10/2005 |
SBI K-WIRES |
SMALL BONE INNOVATIONS, LLC |
DONALD GUTHNER |
| K051322 |
08/05/2005 |
PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS |
SMITHS MEDICAL INTERNATIONAL, LTD. |
DONALD ALEXANDER |
| K051426 |
08/02/2005 |
CARLO SURGICAL GOWN |
SOFILM TECHNOLOGY CO., LTD. |
JEFFRY O STULL |
| K051503 |
08/05/2005 |
UGYTEX SUAL KNIT MESH |
SOFRADIM PRODUCTION |
PAMELA PAPINEAU |
| K052042 |
08/09/2005 |
SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS |
SONOSCAPE COMPANY LIMITED |
BOB LEIKER |
| K052109 |
08/11/2005 |
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES) |
SONOSITE,INC. |
DAINA L GRAHAM |
| K052001 |
08/11/2005 |
MODEL SR-115 PORTABLE X-RAY SYSTEM |
SOURCE-RAY, INC. |
RAY MANEZ |
| K043465 |
08/18/2005 |
2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011 |
SPECTRANETICS CORP. |
ADRIAN E ELFE |
| K051045 |
08/02/2005 |
SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30 |
SPECTRX, INC. |
WILLIAM M VONDERSMITH |
| K051840 |
08/15/2005 |
ENSITE VERISMO SOFTWARE |
ST. JUDE MEDICAL |
KAREN MCKELVEY |
| K051633 |
08/16/2005 |
CD-CHEX PLUS BC |
Streck |
CAROL THOMPSON |
| K051706 |
08/17/2005 |
IQ BODY FLUIDS CONTROL |
Streck |
MARK LEWALLEN |
| K051973 |
08/18/2005 |
MODIFICATION TO: XIA STAINLESS STEEL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
| K051199 |
08/08/2005 |
IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER |
SYSMEX AMERICA, INC. |
NINA M GAMPERLING |
| K051936 |
08/08/2005 |
CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEMS |
TaiDoc Technology Corporation |
SHU-MEI WU |
| K051854 |
08/05/2005 |
CLEVER CHEK TD-4225, MODEL TD-4225 |
TaiDoc Technology Corporation |
SHU-MEI WU |
| K051703 |
08/12/2005 |
CLEVER TD-3018A BLOOD PRESSURE MONITOR |
TaiDoc Technology Corporation |
SHU-MEI WU |
| K051121 |
08/08/2005 |
DIRECT LDL CHOLESTEROL, MODEL L530-60H |
TECO DIAGNOSTICS |
JIAN VAECHES |
| K051200 |
08/08/2005 |
HEMOGLOBIN A1C REAGENT SET |
TECO DIAGNOSTICS |
JIAN VAECHES |
| K051526 |
08/16/2005 |
URITEK-720+ URINE ANALYZER |
TECO DIAGNOSTICS |
STEPHANIE LOW |
| K051766 |
08/11/2005 |
ORTHOMEND |
TEI BIOSCIENCES INC. |
KENNETH JAMES |
| K043075 |
08/18/2005 |
TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING |
TENACORE HOLDINGS, INC. |
Brand Caso |
| K051601 |
08/04/2005 |
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| K052034 |
08/16/2005 |
TERUMO SYRINGE WITH/WITHOUT NEEDLE |
TERUMO MEDICAL CORP. |
BARBARA SMITH |
| K051824 |
08/18/2005 |
INVADER UGT1A1 MOLECULAR ASSAY |
THIRD WAVE TECHNOLOGIES, INC. |
Sam Rua |
| K051808 |
08/08/2005 |
ESTELITE FLOW QUICK |
TOKUYAMA DENTAL CORPORATION |
KEITH A BARRITT |
| K051949 |
08/05/2005 |
4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040 |
TRIAGE MEDICAL, INC. |
GAYLE HIROTA |
| K051186 |
08/18/2005 |
MICROPULSE PHACOEMULSIFICATION SYSTEM |
TRILLIUM MEDICAL, INC. |
MICHAEL H CURTIS |
| K051282 |
08/16/2005 |
VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU |
TRIPATH IMAGING, INC. |
BRYAN J TUCKER |
| K051971 |
08/04/2005 |
OPTIMA SPINAL SYSTEM |
U&I CORP. |
BETTY LIM |
| K051344 |
08/18/2005 |
COLONIC AND ENEMA NOZZLE |
ULTIMATE CONCEPTS, INC. |
GRACE HOLLAND |
| K051813 |
08/15/2005 |
ULTRAPACS |
ULTRARAD CORPORATION |
CARL ALLETTO |
| K050269 |
08/29/2005 |
U1 HIP SYSTEM - BIPOLAR |
UNITED ORTHOPEDIC CORP. |
GENE HUANG |
| K050262 |
08/15/2005 |
U2 ACETABULAR COMPONENT |
UNITED ORTHOPEDIC CORP. |
GENE HUANG |
| K051905 |
08/29/2005 |
UROPLASTY RIGID ENDOSCOPIC NEEDLE |
UROPLASTY, INC. |
MICHAEL MORRELL |
| K051644 |
08/11/2005 |
VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR |
VALLEYLAB |
HERBERT VINSON |
| K050644 |
08/17/2005 |
VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT |
VANCOUVER BIOTECH LTD. |
ANDREW LEE |
| K051193 |
08/08/2005 |
VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER |
VASCULAR SOLUTIONS, INC. |
SARA L COON |
| K052130 |
08/15/2005 |
VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40 |
VIDENT |
BARBARA J LEWANDOWSKI |
| K051709 |
08/15/2005 |
HIPPOCAMPE WHEELCHAIR |
VIPAMAT TECHNOLOGIE |
MARY MCNAMARA-CULLINANE |
| K051169 |
08/11/2005 |
BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT |
VIRAMED BIOTECH AG |
BARRY E MENEFEE |
| K051071 |
08/11/2005 |
VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT |
VIRAMED BIOTECH AG |
BARRY E MENEFEE |
| K050906 |
08/23/2005 |
VITALCARE I.V. ADMINISTRATION SET |
VITALCARE GROUP, INC. |
MICHAEL MCAVENIA |
| K051337 |
08/18/2005 |
EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-001 |
VOLCANO CORPORATION |
LORRY HUFFMAN |
| K051920 |
08/19/2005 |
VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001 |
VOLCANO CORPORATION |
Michelle J Badal |
| K051690 |
08/19/2005 |
VYGON NUTRILINE CATHETERS |
VYGON CORP. |
COURTNEY SMITH |
| K051841 |
08/22/2005 |
WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST |
W.H.P.M., INC. |
FRAN WHITE |
| K052051 |
08/05/2005 |
OMNI SPHINCTEROTOME |
WILSON-COOK MEDICAL, INC. |
MARGE WALLS-WALKER |
| K051908 |
08/10/2005 |
CHARLOTTE COMPRESSION PLATE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
WESLEY L REED |
| K051884 |
08/05/2005 |
CHARLOTTE SMALL MTP FUSION PLATE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
WESLEY L REED |
| K051348 |
08/19/2005 |
CONSERVE TOTAL FEMORAL HEAD |
WRIGHT MEDICAL TECHNOLOGY, INC. |
THERESA LEISTER |
| K051995 |
08/22/2005 |
PROFEMUR RENAISSANCE HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
THERESA LEISTER |
| K051863 |
08/19/2005 |
AMLUCK, YA HORNG |
YA HORNG ELECTRONIC CO., LTD. |
JEN KE-MIN |
| K051862 |
08/23/2005 |
PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R; AUTOMATIC DIGITAL WRIST BLOOD PRESS. MONITOR. |
YA HORNG ELECTRONIC CO., LTD. |
JEN KEN-MIN |
| K051539 |
08/05/2005 |
TRICOT BLOOD PRESSURE CUFF |
YA HORNG ELECTRONIC CO., LTD. |
JEN KE-MIN |
| K051955 |
08/10/2005 |
QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE |
Z-MEDICA CORPORATION |
ROBERT V PACKARD |
| K050821 |
08/16/2005 |
COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM |
ZYCARE |
STEVE D HOLDAWAY |
