FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K062070 |
07/21/2006 |
3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR |
3M COMPANY |
DIANNE GIBBS |
K062027 |
07/18/2006 |
A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR |
A & D ENGINEERING, INC. |
JERRY WANG |
K061903 |
07/05/2006 |
RELIEVA SINUS BALLOON CATHETER |
ACCLARENT, INC. |
KERI YEN |
K061975 |
07/13/2006 |
PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK |
ACMI CORPORATION |
TERRENCE E SULLIVAN |
K062084 |
07/21/2006 |
7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67 |
ACUMEN MEDICAL, INC. |
Marybeth Gamber |
K062145 |
07/27/2006 |
MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90 |
ACUMEN MEDICAL, INC. |
Marybeth Gamber |
K062059 |
07/20/2006 |
AIE REGION OF INTEREST IMAGE ENHANCEMENT |
ADVANCED IMAGE ENHANCEMENT |
JILLIAN M REED |
K062135 |
07/26/2006 |
ART SHIELDED BREAST APPLICATOR |
ADVANCED RADIATION THERAPY, LLC |
RAYMOND J BRICAULT |
K061899 |
07/03/2006 |
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM |
ADVANCED STERILIZATION PRODUCTS |
JOSEPH M ASCENZI |
K062085 |
07/21/2006 |
S4 SPINAL SYSTEM |
AESCULAP |
KATHY A RACOSKY |
K062009 |
07/17/2006 |
AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T |
AESCULAP, INC. |
MATTHEW M HULL |
K062012 |
07/17/2006 |
S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM |
AESCULAP, INC. |
LISA M BOYLE |
K062048 |
07/20/2006 |
AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM |
AESTHERA CORPORATION |
ANNE WORDEN |
K062143 |
07/27/2006 |
KOZY COMFORT INFANT POSITIONER |
ALFRED E MANN INST. FOR BIOMEDICAL ENGINEERING |
ARMAN H NADERSHAHI |
K062080 |
07/21/2006 |
RESUSCITATION TIMER, MODEL L770-CPR |
ALLIED HEALTHCARE PRODUCTS, INC. |
WAYNE KARCHER |
K061943 |
07/10/2006 |
ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM |
ANATOMICA AB |
MARCOS VELEZ-DURAN |
K062157 |
07/28/2006 |
CONFORM |
APEX DENTAL MATERIALS, INC. |
CHRIS KULTON |
K061981 |
07/13/2006 |
SURPASS |
APEX DENTAL MATERIALS, INC. |
CHRIS KULTON |
K062169 |
07/31/2006 |
APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS |
APPLIED MEDICAL RESOURCES CORP. |
CHERYL BLAKE |
K062100 |
07/24/2006 |
ARJOWRAP 47/100 AND 47/88 |
ARJO WIGGINS MEDICAL, INC. |
ARTHUR WARD |
K061925 |
07/07/2006 |
MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS |
ARTHREX, INC. |
SALLY FOUST |
K061954 |
07/11/2006 |
ARTELON CMC SPACER ARTHRO |
ARTIMPLANT AB |
RUSSELL PAGANO |
K061956 |
07/11/2006 |
ARTELON STT SPACER |
ARTIMPLANT AB |
RUSSELL PAGANO |
K062186 |
07/31/2006 |
ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
K061984 |
07/13/2006 |
TREASURE |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
K062026 |
07/18/2006 |
VAP-NT CHOLESTEROL TEST |
ATHEROTECH, INC. |
Rebecca K Pine |
K062069 |
07/21/2006 |
ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANT |
ATLANTIS COMPONENTS, INC. |
BETSY A BROWN |
K062159 |
07/28/2006 |
RB12 SUCTION RECTAL BIOPSY SYSTEM |
AUS SYSTEMS PTY LTD. |
IAN P GORDON |
K061926 |
07/07/2006 |
CORONIS 2MP AND MDCG 2121 - CB |
BARCOVIEW |
LIEVEN DE WANDEL |
K061924 |
07/07/2006 |
CORONIS 3MP AND MDCG 3120-CB |
BARCOVIEW |
LIEVEN DE WANDEL |
K061928 |
07/07/2006 |
CORONIS COLOR 2MP AND MDCC 2121 |
BARCOVIEW |
LIEVEN DE WANDEL |
K061927 |
07/07/2006 |
CORONIS COLOR 3MP AND MDCC 3120-DL |
BARCOVIEW |
LIEVEN DE WANDEL |
K062131 |
07/26/2006 |
NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB |
BARCOVIEW |
LIEVEN DE WANDEL |
K062079 |
07/21/2006 |
XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210 |
BAXTER HEALTHCARE CORPORATION |
DAVID E CURTIN |
K062058 |
07/20/2006 |
ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 |
BAYER HEALTHCARE |
ROGER SONNENBERG |
K062087 |
07/24/2006 |
BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 |
BD Biosciences |
CARTER NAVARRO |
K061867 |
07/03/2006 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFAZOLIN (GN) 0.5-32 UG/ML |
BECTON, DICKINSON & CO. |
JANINE MATLAK |
K061869 |
07/03/2006 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM (GP) 1/4-128/4 UG/ML |
BECTON, DICKINSON & CO. |
Monica Giguere |
K062044 |
07/19/2006 |
THE 5.0 X 6.0MM DENTAL IMPLANT |
BICON, INC. |
VINCENT J MORGAN |
K062109 |
07/24/2006 |
BINAXNOW INFLUENZA A & B TEST |
BINAX, INC. |
Angela Drysdale |
K061949 |
07/10/2006 |
DOUBLEPLAY SUTURE ANCHOR |
BIOCOMPOSITES LTD. |
SIMON FITZER |
K061898 |
07/03/2006 |
EZLASE |
BIOLASE TECHNOLOGY, INC. |
IOANA M RIZOIU |
K062141 |
07/27/2006 |
MAMMOPAD RADIOLUCENT CUSHION |
BIOLUCENT, INC. |
SHERYL HIGGINS |
K061945 |
07/10/2006 |
VITEK 2 AST-YS FLUCONAZOLE |
BIOMERIEUX, INC. |
Nancy Weaver |
K062126 |
07/26/2006 |
EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 |
BIOSPHERE MEDICAL, INC. |
IRINA KULINETS |
K061919 |
07/06/2006 |
VERSATILE 1 EZCARE WOUND VACUUM SYSTEM |
BLUE SKY MEDICAL GROUP INCORPORATED |
JASPER BENKE |
K062050 |
07/20/2006 |
FLEXVIEW SYSTEM |
BOSTON SCIENTIFIC |
CHRISTINA L ROWE |
K061877 |
07/03/2006 |
WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM |
BOSTON SCIENTIFIC CORP. |
ELENA BICKOFF |
K061884 |
07/03/2006 |
BOVIE ICON GI ELECTROSURGICAL GENERATOR, MODEL GI 120 |
BOVIE MEDICAL |
RICHARD KOZLOFF |
K062086 |
07/21/2006 |
NAVIVISION |
BRAINLAB AG |
RAINER BIRKENBACH |
K061912 |
07/06/2006 |
FUSION |
BURKE, INC. |
DUWAYNE E KRAMER, JR. |
K062164 |
07/28/2006 |
RESOLUTIONMD, VERSION 1.3 |
CALGARY SCIENTIFIC, INC. |
PIERRE LEMIRE |
K061932 |
07/07/2006 |
BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE |
CARDIOPULMONARY CORP. |
JORDAN SCHRECK |
K061960 |
07/11/2006 |
FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040 |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
K062028 |
07/18/2006 |
CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01 |
CELERA DIAGNOSTICS |
VICTORIA MACKINNON |
K062031 |
07/18/2006 |
CHASE CARDIAC ANALYSIS SYSTEM |
CHASE MEDICAL, LP |
DAVID M HERNON |
K062016 |
07/17/2006 |
RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES |
CHOICE SMART HEALTH CARE CO. LTD. |
JANICE MA |
K062015 |
07/17/2006 |
CHRONOS VISION EYE TRACKING DEVICE (C-ETD) |
CHRONOS VISION |
MAUREEN O'CONNELL |
K062120 |
07/25/2006 |
CISBIO RENIN RIA TEST |
CIS BIO INTERNATIONAL |
Gary Lehnus |
K061876 |
07/03/2006 |
CODMAN VPV SYSTEM, MODEL 82-3192 |
Codman & Shurtleff, Inc. |
SUSAN KAGAN |
K061967 |
07/12/2006 |
SCD GARMENT, MODEL VP530 |
COMPRESSION THERAPY CONCEPTS, INC. |
LEN NASS |
K062046 |
07/19/2006 |
MODIFIED MERCI RETRIEVER, MODEL 90050 |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
K062082 |
07/21/2006 |
CONMED ABC DISSECTING BLADE ELECTRODE, MODEL 139330; BLUNT NEEDLE ELECTRODE, MODEL 139331 |
CONMED CORPORATION |
SHAWN RIEDEL |
K061972 |
07/13/2006 |
CONNECT IMAGING PACS |
CONNECT IMAGING, INC. |
PHILIP J MANLY |
K061937 |
07/10/2006 |
COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON |
COOK ENDOSCOPY |
MABEL L HUNTER |
K061948 |
07/10/2006 |
PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS |
COOPERVISION, INC. |
LISA HAHN |
K062025 |
07/18/2006 |
ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 |
CORGENIX, INC. |
KIMBERLY N HASSLER |
K061955 |
07/11/2006 |
RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS |
CREATIVE MEDICAL DESIGNS, INC. |
JANE RAYHACK |
K062140 |
07/27/2006 |
SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1 |
CRYOCATH TECHNOLOGIES, INC. |
FRED MILDER |
K061892 |
07/03/2006 |
PROPATCH SOFT TISSUE REPAIR MATRIX |
CRYOLIFE, INC. |
JOHN D FERROS |
K062152 |
07/27/2006 |
CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27 |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K062024 |
07/18/2006 |
DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
LORRAINE H PIESTRAK |
K061923 |
07/07/2006 |
DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310) |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K061990 |
07/13/2006 |
DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
K062055 |
07/20/2006 |
DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
K062035 |
07/19/2006 |
DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
K062122 |
07/25/2006 |
DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130) |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K062034 |
07/19/2006 |
DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410) |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K062121 |
07/25/2006 |
DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420) |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K062162 |
07/28/2006 |
DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K062191 |
07/31/2006 |
DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516 |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K062182 |
07/31/2006 |
DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K061885 |
07/03/2006 |
DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250 |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K062179 |
07/31/2006 |
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/ML) |
DADE BEHRING, INC. |
SHANNON POPSON |
K061872 |
07/03/2006 |
MICROSCAN MICROSTREP PLUS PANEL |
DADE BEHRING, INC. |
MAUREEN MENDE |
K062128 |
07/26/2006 |
THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS |
DADE BEHRING, INC. |
LORRAINE H PIESTRAK |
K062103 |
07/24/2006 |
DARCO FORCE TITANIUM COMPRESSION SCREW |
DARCO INTERNATIONAL, INC. |
MARK S COOPER |
K062098 |
07/24/2006 |
SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX |
DATASCOPE CORP. |
KATHLEEN KRAMER |
K062099 |
07/24/2006 |
PHASE 3, MODEL DT-1 |
DATREND SYSTEMS, INC. |
RON EVANS |
K062170 |
07/31/2006 |
BIOKNOTLESS AND LUPINE PLUS ANCHORS |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
KRISTINE CHRISTO |
K062116 |
07/25/2006 |
DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
K062148 |
07/27/2006 |
DEPUY PINNACLE ALTRX ACETABULAR CUP LINER |
DEPUY ORTHOPAEDICS, INC. |
ANNE M SCHULER |
K062174 |
07/31/2006 |
MODIFICATION TO EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
MARY GRAY |
K062007 |
07/17/2006 |
DMS 300-7 |
DIAGNOSTIC MONITORING SOFTWARE |
WILLIAM PARSONS |
K062088 |
07/24/2006 |
PREMIER 11 HOLTER |
DIAGNOSTIC MONITORING SOFTWARE |
WILLIAM PARSONS |
K062105 |
07/24/2006 |
DIAZYME CREATININE LIQUID REAGENTS ASSAY |
DIAZYME LABORATORIES |
Abhijit Datta |
K062032 |
07/18/2006 |
ACCUSOFT, ACCUSOFT XL |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
K062147 |
07/27/2006 |
INTEGRA SL |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
K061873 |
07/03/2006 |
VERT-X |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
K062176 |
07/31/2006 |
RELIEF ACP ORAL CARE GEL |
DISCUS DENTAL INC. |
STEVEN L ZIEMBA |
K061864 |
07/03/2006 |
DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560 |
DUKAL CORP. |
PATRICK J LAMB |
K061878 |
07/03/2006 |
ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC |
E SURGICAL, LLC |
LEWIS WARD |
K061996 |
07/14/2006 |
SANDMAN POCKET |
EB NEURO, S.P.A. |
CARRI GRAHAM |
K061978 |
07/13/2006 |
EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM |
EBI, L.P. |
DEBRA BING |
K062134 |
07/26/2006 |
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR |
EDWARDS LIFESCIENCES, LLC. |
JASON SMITH |
K062054 |
07/20/2006 |
5 MEGAPIXEL MONOCHROME LCD MONITOR, RADIFORCE GS510 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
K062053 |
07/20/2006 |
MONOCHROME LCD MONITOR, RADIFORCE, GS320 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
K061941 |
07/10/2006 |
LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000 |
ELEKTA INSTRUMENT AB |
PETER LOWENDAHL |
K062175 |
07/31/2006 |
CRYOCARE CN2 SYSTEM |
ENDOCARE, INC. |
ALDEN KAY |
K062104 |
07/24/2006 |
TALKING TRACH |
ENGINEERED MEDICAL SYSTEMS, INC. |
PAUL DRYDEN |
K061992 |
07/13/2006 |
EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014 |
EPS BIO TECHNOLOGY CORP. |
Y C LEI |
K062000 |
07/17/2006 |
HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH |
ETHICON ENDO-SURGERY, INC. |
CAROL WALSH |
K061962 |
07/12/2006 |
SURGI-CUF REUSABLE, RS SERIES |
ETHOX INTERNATIONAL |
JOHN RIGGI |
K062045 |
07/19/2006 |
EDIA ANTI-CCP |
EURO-DIAGNOSTICA AB |
ANNIKA ANDERSSON |
K062014 |
07/17/2006 |
FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB |
FLAEM NUOVA S.P.A. |
MAUREEN O'CONNELL |
K061930 |
07/07/2006 |
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY |
FONAR CORP. |
LUCIANO BONANNI |
K062090 |
07/24/2006 |
PRISMA SYSTEM R03.10A |
GAMBRO RENAL PRODUCTS |
THOMAS B DOWELL |
K061918 |
07/06/2006 |
FOLEY CATHETERS WITH TEMPERATURE PROBE |
GE HEALTHCARE |
JOEL KENT |
K061907 |
07/05/2006 |
MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES |
GE HEALTHCARE |
JOEL C KENT |
K061942 |
07/10/2006 |
TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237 |
GE HEALTHCARE |
JOEL C KENT |
K061994 |
07/14/2006 |
WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE |
GE HEALTHCARE |
JOEL KENT |
K061953 |
07/10/2006 |
9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS |
GE OEC MEDICAL SYSTEMS |
GREG HANSEN |
K062039 |
07/19/2006 |
BIOPSY DIGIT-AM |
GIOTTO USA, LLC |
Allison Scott |
K062010 |
07/17/2006 |
RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES |
GLOBAL TREASURE INDUSTRIES LTD. |
JANICE MA |
K061865 |
07/03/2006 |
FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 |
GUIDANT CORP. |
CHRISTINA L LOWE |
K062130 |
07/26/2006 |
MEISINGER BENEX, MODEL BE001 |
HAGER & MEISINGER GMBH |
ALEX MILLER |
K061933 |
07/07/2006 |
HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER |
HAGER WORLDWIDE, INC. |
JAMES DELANEY |
K061991 |
07/13/2006 |
PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA |
HELENA LABORATORIES |
PATRICIA FRANKS |
K061879 |
07/03/2006 |
SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM |
HEMODIAGNOSTICA, LLC |
Bruno Borganti |
K061993 |
07/14/2006 |
EQUIVITAL, MODEL EQ-01 |
HIDALGO LIMITED |
JUSTIN PISANI |
K061950 |
07/10/2006 |
HHF1 ECHELON MULTI-PURPOSE COIL |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUGLAS THISTLETHWAITE |
K062107 |
07/24/2006 |
SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003 |
HOLOGIC, INC. |
GAIL YAEKER-DAUNIS |
K062180 |
07/31/2006 |
ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP |
HORIBA ABX |
TIM LAWTON |
K062066 |
07/21/2006 |
OMEGA 3 SYSTEM |
HOWMEDICA OSTEONICS CORP |
FRANCISCO HARO |
K062037 |
07/19/2006 |
TRIATHLON LOW PROFILE TIBIAL TRAY |
HOWMEDICA OSTEONICS CORP |
FRANCISCO HARO |
K062113 |
07/24/2006 |
SOLAR REUNION FRACTURE STEM |
HOWMEDICA OSTEONICS CORP. |
FRANCISCO HARO |
K061979 |
07/13/2006 |
MODIFICATION TO MYALLERGY TEST |
IMMUNETECH CORPORATION |
NANCY BENSON |
K061969 |
07/12/2006 |
PREFORMANCE POSTS AND TEMPORARY CYLINDERS |
IMPLANT INNOVATIONS, INC. |
JIM BANIC |
K061916 |
07/06/2006 |
NEURO II-SE, MODELS OR-MB-DR AND OR-DR |
IMRIS, INC. |
THOMAS M TSAKERIS |
K061902 |
07/05/2006 |
COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1 |
INDITHERM MEDICAL |
M.W. (ANDY) ANDERSON |
K062019 |
07/17/2006 |
RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD |
INNOMED TECHNOLOGIES INC./RESPCARE INC. |
FRANK PELC |
K062151 |
07/27/2006 |
BOX PEEK VBR SYSTEM |
INNOVASIS, INC. |
WARREN M DANSIE |
K061901 |
07/05/2006 |
INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 |
INO THERAPEUTICS |
FREDERICK MONTGOMERY |
K062129 |
07/26/2006 |
P.0004 IMPLANTS |
INSTITUT STRAUMANN AG |
ELAINE ALAN |
K061974 |
07/12/2006 |
GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K061893 |
07/03/2006 |
INTEGRA RADIONICS XKNIFE RT 4 |
INTEGRA RADIONICS, INC. |
KEVIN O'CONNELL |
K062068 |
07/21/2006 |
INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0 |
INTELWAVE, LLC |
ALEXANDER RIFTINE |
K062149 |
07/27/2006 |
SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES |
INTERNATIONAL BUSINESS STRATEGIES |
BILL ROETTGER |
K061874 |
07/03/2006 |
INVACARE'S TWILIGHT II NASAL MASKS |
INVACARE CORP. |
JANICE BROWNLEE |
K061889 |
07/03/2006 |
BIOSTAR OIA SHIGATOX |
INVERNESS MEDICAL-BIOSTAR INC. |
ROBIN C HART |
K061952 |
07/10/2006 |
CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16 |
INVIVO |
THOMAS SCHUBERT |
K062144 |
07/27/2006 |
ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810 |
INVIVO CORPORATION |
RUSTY KELLY |
K061913 |
07/06/2006 |
IBA PROTON THERAPY SYSTEM - PROTEUS 235 |
ION BEAM APPLICATIONS S.A. |
JOHN REISS |
K062074 |
07/21/2006 |
IRIDEX WIRELESS FOOTSWITCH |
IRIDEX CORP. |
JOHN JOSSY |
K061880 |
07/03/2006 |
ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC |
ISOTIS NV |
ELAINE SCHUTTE |
K062033 |
07/18/2006 |
BP 101 DIGITAL BLOOD PRESSURE MONITOR |
KING YIELD HONGKONG LIMITED |
DACHENG GONG |
K061999 |
07/14/2006 |
DRY LASER IMAGER, DRYPRO MODEL 832 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
JOJI MATSUSHIMA |
K062096 |
07/24/2006 |
KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST |
KOREAMEDICO CO. LTD. |
KIM YOUNG-YONG |
K062021 |
07/17/2006 |
KOWA VX-10I |
KOWA CO. LTD. |
RICHARD PHILLIPS |
K061906 |
07/05/2006 |
CLEARFIL CERAMIC PRIMER |
KURARAY MEDICAL INC. |
KOJI NISHIDA |
K061871 |
07/03/2006 |
LEICA MODEL FL800 |
LEICA MICROSYSTEMS, INC. |
MAX STURGIS |
K062003 |
07/17/2006 |
NEURO WAVE 6 |
LHASA OMS, INC. |
MARK W SHEEHAN |
K061966 |
07/12/2006 |
LITETOUCH DENTAL LASER SYSTEM |
LIGHT INSTRUMENT LTD |
YORAM LEVY |
K062052 |
07/20/2006 |
LMT NOMAG IC 3.0 |
LMT LAMMERS MEDICAL TECHNOLOGY GMBH |
THOMAS M BOHNEN |
K061986 |
07/13/2006 |
1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50 |
MEDCOMP |
SUSAN MOTZER |
K061905 |
07/05/2006 |
HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0 |
MEDCON LTD. |
JONATHAN S KAHAN |
K061896 |
07/03/2006 |
MEDIAID DISPOSABLE NON-ADHESIVE SENSORS, MODEL CST050-2101N; REUSABLE FINGER CLIP SP02 SENSORS, MODEL CST060-2101N |
MEDIAID INC. |
MAHESH PATEL |
K062127 |
07/25/2006 |
MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP) |
MEDIC4ALL (ISRAEL) LTD. |
JONATHAN S KAHAN |
K062119 |
07/25/2006 |
HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 |
MEDICAL PRODUCTS MFG., LLC |
ROSINA ROBINSON |
K062136 |
07/26/2006 |
PASS 2 SPINAL SYSTEM |
MEDICREA |
J.D. WEBB |
K062181 |
07/31/2006 |
C-JAWS CERVICAL COMPRESSIVE MINI FRAME |
MEDICREA TECHNOLOGIES |
J.D. WEBB |
K061886 |
07/03/2006 |
ACTIM PROM AND CONTROLS |
MEDIX BIOCHEMICA |
CYNTHIA SINCLAIR |
K062041 |
07/19/2006 |
MODEL 3875 1 X 8 SC TEST STIMULATION LEAD |
MEDTRONIC INC. |
PAULA CORDERO |
K061915 |
07/06/2006 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K062073 |
07/21/2006 |
VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
LEE GRANT |
K061938 |
07/10/2006 |
VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
LEE GRANT |
K062133 |
07/26/2006 |
MODIFICATION TO VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SPINAL AND BIOLOGICS DIV |
LEE GRANT |
K061958 |
07/11/2006 |
MEDTRONIC EXPORT XT CATHETER |
MEDTRONIC VASCULAR |
KAREN A BROZOWSKI |
K062057 |
07/20/2006 |
U-CLIP DEVICE, MODEL NC65 |
MEDTRONIC VASCULAR |
DAVID D COX |
K061963 |
07/12/2006 |
MICRUS MICROCATHETER COURIER PRE-SHAPED, MODELS MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00 |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
K062036 |
07/19/2006 |
MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4 |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
K061904 |
07/05/2006 |
COMPUDENT STA |
MILESTONE SCIENTIFIC, INC. |
DANIEL J MANELLI |
K062163 |
07/28/2006 |
MIMVIEWER |
MIMVISTA CORP. |
PETER SIMMELINK |
K061875 |
07/03/2006 |
MINISPIR; SPIROLAB III |
MIR MEDICAL INTL. RESEARCH SRL |
SIMON FOWLER |
K062153 |
07/27/2006 |
PORTABLE OXYGEN GENERATOR SYSTEM |
MOLECULAR PRODUCTS LTD. |
PAUL DRYDEN |
K062138 |
07/26/2006 |
POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE |
MOLNLYCKE HEALTH CARE, INC. |
STEVE DOWDLEY |
K061959 |
07/11/2006 |
MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-301, HPL-302, HPL-310, 180310 |
MYTECH TECHNOLOGY CO., LTD. |
Ke-Min Jen |
K061947 |
07/10/2006 |
21.3 INCH MONOCHROME LCD MONITOR |
NEC DISPLAY SOLUTIONS, LTD. |
SHUICHI KINO |
K062168 |
07/31/2006 |
CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA |
NEMOTO KYORINDO CO., LTD. |
TOSHIO KANETAKA |
K061917 |
07/06/2006 |
DISTAL RADIUS LOCKING PLATING SYSTEM |
NEWCLIP TECHNICS |
J.D. WEBB |
K062115 |
07/24/2006 |
CARBON DIOXIDE MONITOR, MODEL OLG-2800A |
NIHON KOHDEN AMERICA, INC. |
SERRAH NAMINI |
K062008 |
07/17/2006 |
ENDO CAR COMPRESSION ANASTOMOSIS RING (CAR) |
NITI MEDICAL TECHNOLOGIES LTD. |
ORLY MAOR |
K061971 |
07/12/2006 |
ZIRCONIA IMPLANT |
NOBEL BIOCARE AB |
HERBERT CRANE |
K062020 |
07/17/2006 |
LIFESOUND ESOPHAGEAL STETHOSCOPE |
NOVAMED, LLC |
PAUL DRYDEN |
K061920 |
07/06/2006 |
NOVAPACS, NOVAVIEW, NOVACARDIO, NOVAQC AND NOVAER |
NOVARAD CORP. |
PAUL SHUMWAY |
K062049 |
07/20/2006 |
EVIS EXERA II 180 SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
K061909 |
07/06/2006 |
HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00 |
OMNIGUIDE, INC. |
IRINA KULINETS |
K062043 |
07/19/2006 |
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500 |
OMRON HEALTHCARE, INC. |
DONNA DJINOVICH |
K062171 |
07/31/2006 |
EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES |
ORTHO DEVELOPMENT CORP. |
JOHANNE YOUNG |
K062165 |
07/28/2006 |
VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS |
ORTHO-CLINICAL DIAGNOSTICS |
MARLENE HANNA |
K062077 |
07/21/2006 |
VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A HANNA |
K062123 |
07/25/2006 |
VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV |
Ortho-Clinical Diagnostics, Inc. |
MICHAEL M BYRNE |
K062094 |
07/24/2006 |
VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V |
Ortho-Clinical Diagnostics, Inc. |
Darlene J Phillips |
K061897 |
07/03/2006 |
EXCEL CONTRA ANGLE HANDPIECE |
ORTHOSOURCE, INC. |
LLOYD TAYLOR |
K062156 |
07/28/2006 |
SUPER ORTHODONTIC SCREW |
OSSTEM IMPLANT CO LTD |
CATHRYN CAMBRIA |
K062051 |
07/19/2006 |
SS SYSTEM |
OSSTEM IMPLANT CO.,LTD |
CATHRYN N CAMBRIA |
K062030 |
07/18/2006 |
US SYSTEM |
OSSTEM IMPLANT CO.,LTD |
CATHRYN N CAMBRIA |
K061934 |
07/07/2006 |
XTAC |
OSTEOGENICS, INC. |
MICHAEL DEUTSCH |
K061982 |
07/13/2006 |
PLEXUR P |
OSTEOTECH, INC. |
CHRISTOPHER W TALBOT |
K062192 |
07/31/2006 |
OSTIAL PRO STENT POSITIONING SYSTEM |
OSTIAL SOLUTIONS, LLC |
MICHAEL J BILLIG |
K062047 |
07/20/2006 |
ADAPTABLE MONOPOLAR ADAPTABLE AND/OR RETRACTABLE ELECTRODES |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN QUASS |
K062072 |
07/21/2006 |
PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELECTRODES |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN QUASS |
K062097 |
07/24/2006 |
VERESS CANNULA AND MODULAR VERESS CANNULA |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN QUASS |
K062158 |
07/28/2006 |
LC SPRINT STAR |
PARI INNOVATIVE MANUFACTURERS, INC. |
MIKE JUDGE |
K061995 |
07/14/2006 |
XCELERA |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
LYNN T HARMER |
K062137 |
07/26/2006 |
MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
MARKUS STACHA |
K061961 |
07/11/2006 |
ART LAB SOFTWARE |
PIE MEDICAL |
CARRI GRAHAM |
K061977 |
07/13/2006 |
PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES |
PINMED, INC |
VLADIMIR SHUSTERMAN |
K062108 |
07/24/2006 |
COMCASET SAFETY IV CATHETER |
PITANGO MEDICAL LTD |
BEN LEVIN |
K062042 |
07/19/2006 |
PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM) |
PLETHORA SOLUTIONS |
KIMBERLEY DONEY |
K062118 |
07/25/2006 |
POINTE 360 |
POINTE SCIENTIFIC, INC. |
RON JAMISON |
K061944 |
07/10/2006 |
POLY-CHEM CREATININE |
POLYMEDCO, INC. |
HELEN LANDICHO |
K062091 |
07/24/2006 |
POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION |
POROUS MEDIA CORP. |
KEITH A ROBERTS |
K062155 |
07/28/2006 |
DIGITAL MXR-D FLOWMETER |
PORTER INSTRUMENT CO., INC. |
CYNTHIA J.M. NOLTE |
K061951 |
07/10/2006 |
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120 |
POSSIS MEDICAL, INC. |
FRANK B FREEDMAN |
K062172 |
07/31/2006 |
FETCH ASPIRATION CATHETER |
POSSIS MEDICAL, INC. |
FRANK B FREEDMAN |
K062146 |
07/27/2006 |
UNI KNEE SURGETICS NAVIGATION SYSTEM |
PRAXIM S.A |
MADY BATAILH |
K062061 |
07/20/2006 |
URASSIST |
PREFERRED MEDICAL DEVICES, INC. |
PENELOPE GRECO |
K062092 |
07/24/2006 |
PREVU POINT OF CARE SKIN STEROL TEST |
PREMD, INC. |
THOMAS M TSAKERIS |
K062166 |
07/28/2006 |
ENAMEL PRO |
PREMIER DENTAL PRODUCTS CO. |
VINCE D'ALESSANDRO |
K061998 |
07/14/2006 |
PREMIER SELF-ETCHING BOND ENHANCER |
PREMIER DENTAL PRODUCTS CO. |
VINCE D'ALESSANDRO |
K061997 |
07/14/2006 |
PREMIER SELF-ETCHING ENAMEL SEALANT |
PREMIER DENTAL PRODUCTS CO. |
VINCE D'ALESSANDRO |
K062160 |
07/28/2006 |
GO GO MINI, MODEL SC30 |
PRIDE MOBILITY PRODUCTS CORP. |
THOMAS J SCHAPPERT |
K062004 |
07/17/2006 |
MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT |
QUANTUM ORTHOPEDICS, INC. |
KERRI DIMARTINO |
K061870 |
07/03/2006 |
VITALSENSE XHR |
RESPIRONICS, INC. |
ZITA A YURKO |
K061970 |
07/12/2006 |
ELECSYS IGE II IMMUNOASSAY |
Roche Diagnostics |
KAY A TAYLOR |
K062114 |
07/24/2006 |
CERULOPLASMIN, MODEL 2055953 |
ROCHE DIAGNOSTICS CORP. |
CORINA HARPER |
K062001 |
07/14/2006 |
ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS |
ROSTAM LTD. |
ROBERT J STAAB |
K061935 |
07/10/2006 |
SENSACARE SAW-102 WRIST DIGITAL BLOOD PRESSURE MONITOR |
SENSACARE LTD. |
STEVEN CHANG |
K061922 |
07/07/2006 |
BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000 |
SENTECH KOREA CORP. |
DANIEL PARK |
K062067 |
07/21/2006 |
TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR |
SHEN WEI (USA), INC. |
CYNTHIA LIU |
K062194 |
07/31/2006 |
HYPERVISOR VI CENTRAL MONITORING SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
K061964 |
07/12/2006 |
SYNGO MULTIMODALITY WORKPLACE |
SIEMENS AG, MEDICAL SOLUTIONS |
SIEGLINDE WEST |
K061980 |
07/13/2006 |
SIEMENS ACUSON X500 ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA INC. |
SHEILA W PICKERING |
K061946 |
07/10/2006 |
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHEILA W PICKERING |
K062040 |
07/19/2006 |
SBI TRIHEDRON MTP HEMI GT |
SMALL BONE INNOVATIONS INC. |
ROBERT HOEHN |
K062005 |
07/17/2006 |
PORTEX EPIDURAL CATHETER |
SMITHS MEDICAL ASD, INC. |
CYNTHIA ENGELHARDT |
K061931 |
07/07/2006 |
SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101 |
SOLARIS MEDICAL TECHNOLOGY, INC. |
THOMAS KROENKE |
K062064 |
07/20/2006 |
RIVA BOND LC |
SOUTHERN DENTAL INDUSTRIES, INC. |
RAY CAHILL |
K062065 |
07/20/2006 |
RIVA LUTING PLUS |
SOUTHERN DENTAL INDUSTRIES, INC. |
RAY CAHILL |
K062095 |
07/24/2006 |
MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 |
SPACELABS MEDICAL INC. |
DAVID J GERAGHTY |
K062071 |
07/21/2006 |
PROMETEY, MODEL G1-03 |
SPECTRUM INTERNATIONAL |
GEORGE I BEKOV |
K061914 |
07/06/2006 |
SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS |
SPORT-ELEC S.A. |
ARMELLE LAPRELLE |
K061983 |
07/13/2006 |
STIMUPLEX PEN |
STOCKERT GMBH |
DOMINIKA SCHULER |
K062132 |
07/26/2006 |
AVS PL PEEK SPACER SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
K062112 |
07/24/2006 |
SUNMED FOLEY CATHETERS |
SUNMED, INC. |
ARTHUR WARD |
K062125 |
07/25/2006 |
SUPERSTITCH 5F, 12F, AND EL |
SUTURA, INC. |
GERARD J PRUD'HOMME |
K061910 |
07/06/2006 |
SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS) |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K061973 |
07/12/2006 |
SYNTHES 3.5MM SPRING PLATE |
SYNTHES (USA) |
DEBORAH L JACKSON |
K061940 |
07/10/2006 |
SYNTHES LCP ANKLE ARTHRODESIS PLATES |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K061891 |
07/03/2006 |
SYNEX II |
SYNTHES SPINE CO.LP |
BONNIE J SMITH |
K062083 |
07/21/2006 |
SYNFIX -LR |
SYNTHES SPINE CO.LP |
BONNIE J SMITH |
K061881 |
07/03/2006 |
OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM |
TAKIRON CO., LTD |
KUNIHIRO HATA |
K062102 |
07/24/2006 |
ODONCER |
TEKNIMED SA |
J.D. WEBB |
K062183 |
07/31/2006 |
FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
K061936 |
07/10/2006 |
KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311 |
THE KENDALL COMPANY |
PAUL W EVANS |
K061866 |
07/03/2006 |
NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS |
THERMOTEK, INC. |
TONY QUISENBERRY |
K062081 |
07/21/2006 |
LITHOGOLD |
TISSUE REGENERATION TECHNOLOGIES, INC. |
CHERITA JAMES |
K061976 |
07/13/2006 |
CKIS-004A INJECTOR SYNCHRONIZATION OPTION |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
K062022 |
07/17/2006 |
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K062190 |
07/31/2006 |
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K062013 |
07/17/2006 |
CELLSEARCH CIRCULATING TUMOR CELL KIT |
VERIDEX, LLC |
DEBRA J RASMUSSEN |
K062110 |
07/24/2006 |
VERTEBRON SCP CERVICAL PLATE SYSTEM |
VERTEBRON, INC. |
LUIS NESPRIDO |
K062011 |
07/17/2006 |
MODIFICATION TO FLOWSCREEN |
VIASYS HEALTHCARE GMBH |
Yvette Lloyd |
K061908 |
07/05/2006 |
NICOLETONE SYSTEM V32 AMPLIFIER |
VIASYS NEUROCARE |
Gary Syring |
K062093 |
07/24/2006 |
AVEA VENTILATOR |
VIASYS RESPIRATORY CARE INC |
TOM GUTIERREZ |
K062154 |
07/28/2006 |
VITAL CONNECT 4.0 |
VITAL IMAGES, INC. |
TIMOTHY J KAPPERS |
K062062 |
07/20/2006 |
VOYAGER PACS SYSTEM |
VOYAGER IMAGING |
CARL ALLETTO |
K062161 |
07/28/2006 |
GORE PROPATEN VASCULAR GRAFT |
W.L. GORE & ASSOCIATES,INC |
Michael Ivey |
K061939 |
07/10/2006 |
MODIFICATION TO ALLOMATRIX CUSTOM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
BRIAN YOUNG |
K062173 |
07/31/2006 |
MODIFICATION TO BONE GRAFT SYRINGE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
WESLEY L REED |
K062038 |
07/19/2006 |
X-STEN MILD TOOL KIT, MODEL MTK-0001 |
X-STEN CORP. |
TIMOTHY M REEVES |
K062029 |
07/18/2006 |
ANATOMICAL SHOULDER FRACTURE SYSTEM |
ZIMMER GMBH |
MASON W ROBBINS |
K061882 |
07/03/2006 |
OXYGENLESS PACKAGING CONVERSION OF LEGACY CENTERPULSE STANDARD POLYETHYLENE DEVICES |
ZIMMER, INC. |
MASON W ROBBINS |
K062177 |
07/31/2006 |
ZOLL E SERIES WITH REAL CPR HELP |
ZOLL MEDICAL CORPORATION |
SEAN REYNOLDS |