FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K042967 |
12/03/2004 |
A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512 |
A & D ENGINEERING, INC. |
JERRY WANG |
K042318 |
12/09/2004 |
AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET |
AALTO SCIENTIFIC LTD. |
ALAN J VEKICH |
K033260 |
12/07/2004 |
AEQUOS |
AAP IMPLANTATE AG |
MARC SEEGERS |
K042392 |
12/13/2004 |
DAPTOMYCIN |
AB BIODISK |
ANNE BOLMSTROM |
K043293 |
12/17/2004 |
MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U |
ACRORAD CO., LTD. |
T. WHIT ATHEY |
K042381 |
12/28/2004 |
CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508 |
ACUMEN MEDICAL, INC. |
Marybeth Gamber |
K032830 |
12/14/2004 |
PLLA CANNULATED INTERFERENCE SCREW |
ADVANCED BIOMATERIALS |
STEVE JANIN |
K040865 |
12/06/2004 |
AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER |
AESCULAP |
MATTHEW M HULL |
K043079 |
12/08/2004 |
BICONTACT HIP SYSTEM WITH U-CAP |
AESCULAP |
KATHY A RACOSKY |
K043041 |
12/09/2004 |
AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX) |
AESCULAP, INC. |
MATTHEW M HULL |
K041623 |
12/13/2004 |
REUSABLE STERILCONTAINER FILTER MODEL #JK090 |
AESCULAP, INC. |
MATTHEW M HULL |
DEN040012 |
12/23/2004 |
AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM |
Affymetrix, Inc. |
ROBERT LIPSHUTZ |
K043085 |
12/20/2004 |
MODIFICATION TO: PNEUTON VENTILATOR |
AIRON CORPORATION |
ERIC GJERDE |
K043299 |
12/10/2004 |
MEDLEY PCA MODULE, MODEL 8120 |
ALARIS MEDICAL SYSTEMS, INC. |
STACY L LEWIS |
K043148 |
12/13/2004 |
ALL FLOW PULMONARY FUNCTION FILTER |
ALLIANCE TECH MEDICAL, INC. |
KEITH LOWREY |
K042252 |
12/06/2004 |
NEXFLEX TOTAL HIP SYSTEM |
ALPHATEC/NEXMED |
ELLEN A YARNALL |
K042975 |
12/29/2004 |
AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II |
AMEDITECH, INC. |
JOHN WU |
K033044 |
12/21/2004 |
DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER |
AMERICAN GREEN DENT. MFG, INC. |
ANDREW ROWE |
K042592 |
12/14/2004 |
INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304 |
AMERICAN MEDICAL SYSTEMS, INC. |
KRISTYN BENSON |
K042873 |
12/10/2004 |
ANIMAS MODEL IR1250 INSULIN INFUSION PUMP |
ANIMAS CORP. |
THOMAS L PARKER |
K042817 |
12/06/2004 |
MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) |
ANSELL HEALTHCARE PRODUCTS, INC. |
LON D MCLLVAIN |
K040671 |
12/14/2004 |
EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES |
ANTHOGYR |
ERIC GENEVE |
K041950 |
12/21/2004 |
APEX K2 HIP SYSTEM |
APEX SURGICAL, LLC. |
EDWARD J CHEAL, PH.D |
K043350 |
12/15/2004 |
MISTAR, MODEL V3.2 |
APOLLO MEDICAL IMAGING TECHNOLOGY PTY LTD. |
QING YANG |
K042413 |
12/09/2004 |
ACS MODEL NCP-2 |
APPLIED CARDIAC SYSTEMS |
R. BEN GHADIMI |
K043027 |
12/02/2004 |
MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20 |
APPLIED MEDICAL TECHNOLOGY, INC. |
DEREK WILLIAMS |
K041477 |
12/09/2004 |
PATHFINDER |
ARMSTRONG HEALTHCARE LIMITED |
PATRICK A FINLAY |
K043337 |
12/14/2004 |
ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR |
ARTHREX, INC. |
SALLY FOUST |
K041553 |
12/10/2004 |
ARTHREX SUTURE GRAFTING KIT |
ARTHREX, INC. |
ANN WATERHOUSE |
K042947 |
12/27/2004 |
PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003 |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
K043241 |
12/23/2004 |
LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER |
ASTRA TECH, INC. |
BRUCE MANNING |
K043140 |
12/08/2004 |
EXPRESS AND OASIS CHEST DRAIN |
ATRIUM MEDICAL CORP. |
JOSEPH P DE PAOLO |
K042638 |
12/17/2004 |
RADIANCE PORCELAIN |
AURIDENT, INC. |
BRUCE D SPIVACK |
K042221 |
12/30/2004 |
CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM |
BARCO NV BARCOVIEW |
FRANK FERGUSON |
K043158 |
12/22/2004 |
ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM |
BAYER HEALTHCARE, LLC |
GEORGE M TANCOS |
K043311 |
12/22/2004 |
ASCENSIA ELITE DIABETES CARE SYSTEM |
BAYER HEALTHCARE, LLC |
GEORGE M TANCOS |
K043397 |
12/29/2004 |
MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE |
BECTON DICKINSON & CO. |
PASQUALE AMATO |
K042862 |
12/03/2004 |
BD ONECATH |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
LESLIE WOOD |
K042932 |
12/02/2004 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM 0.5/4-128/4 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
K042636 |
12/14/2004 |
BIOPLUS |
BERKELEY ADVANCED BIOMATERIALS, INC. |
FRANCOIS GENIN |
K043117 |
12/09/2004 |
BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER |
BEST MEDICAL INTERNATIONAL, INC. |
JOSEPH C WANG |
K041658 |
12/20/2004 |
BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 |
BIO-RAD LABORATORIES, INC. |
CHRISTOPHER BENSTEN |
K043108 |
12/07/2004 |
LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL |
BIO-RAD LABORATORIES, INC. |
SUZANNE S PARSONS |
K042532 |
12/13/2004 |
BIOCARE SYSTEMS PREMIR 818 |
BIOCARE SYSTEMS, INC. |
CLAY ANSELMO |
K041619 |
12/17/2004 |
BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 |
BIOCHECK, INC. |
ROBIN J HELLEN, M.S. |
K041238 |
12/13/2004 |
HELICOBACTER PYLORI IGG ELISA |
BIOHIT PLC |
ROBERT P GEARTY |
K043230 |
12/30/2004 |
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
K043237 |
12/23/2004 |
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
K042963 |
12/13/2004 |
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
K042946 |
12/07/2004 |
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
K041850 |
12/21/2004 |
MEDALLION MODULAR HIP SYSTEM |
BIOMET MANUFACTURING, INC. |
LONNIE WITHAM |
K042552 |
12/14/2004 |
BIO-CORE INTERFERENCE SCREW |
BIOMET, INC. |
SUSAN ALEXANDER |
K042841 |
12/21/2004 |
M2A/C2A ACETABULAR SYSTEM |
BIOMET, INC. |
PATRICIA S ANDBORN BERES |
K043280 |
12/21/2004 |
MIMIX MP BONE VOID FILLER |
BIOMET, INC. |
KACY ARNOLD |
K042409 |
12/02/2004 |
MODULAR ARTHRODESIS NAIL |
BIOMET, INC. |
GARY BAKER |
K042379 |
12/15/2004 |
ANEMIAPRO SELF-SCREENER |
BIOSAFE LABORATORIES, INC. |
JACK A MAGGIORE |
K042723 |
12/07/2004 |
TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 |
BIOSITE INCORPORATED |
JERRREY R DAHLEN |
K033210 |
12/30/2004 |
BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET |
BIOTEQUE CORP. |
JENNIFER REICH |
K043038 |
12/22/2004 |
BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML |
BIOTOP TECHNOLOGY CO., LTD. |
MARK LIEN |
K042395 |
12/01/2004 |
OUTPATIENT III MINOR SURGERY LIGHT |
BURTON MEDICAL PRODUCTS CORP. |
ASLE ASMUL |
K041652 |
12/29/2004 |
ACUPUNCTURE NEEDLES |
C.A.I. INDUSTRIES CORP. |
LU RAO |
K043193 |
12/07/2004 |
BARD INLAYOPTIMA URETERAL STENT WITH SUTURE |
C.R. BARD, INC. |
FRANCES E HARRISON |
K043070 |
12/09/2004 |
LIQUID STABLE HBA1C CONTROL |
CANTERBURY SCIENTIFIC LTD. |
MAURICE OWEN |
K043162 |
12/29/2004 |
PMP4 OXY PRO |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
BORIS ARADOVSKY |
K042574 |
12/08/2004 |
ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL) |
Cardinal Health |
ERICA SETHI |
K041294 |
12/08/2004 |
BIOZDX HEMODYNAMIC MONITOR |
CARDIODYNAMICS INTERNATIONAL CORP. |
DENNIS HEPP |
K042548 |
12/03/2004 |
CERASYS - ZR |
CERASYS, INC. |
JIN KIM |
K041038 |
12/21/2004 |
CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER |
CHURCHILL MEDICAL SYSTEMS, INC. |
KEITH PALUCH |
K040888 |
12/01/2004 |
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE |
COLLAGEN MATRIX, INC. |
PEGGY HANSEN |
K042588 |
12/09/2004 |
CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093 |
CONFLUENT SURGICAL,INC |
Eric Ankerud |
K041833 |
12/10/2004 |
CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER |
CONSOLIDATED MACHINE CORP. |
ARTHUR TRAPOTSIS |
K043481 |
12/29/2004 |
MODIFICATION TO: ZILVER 635 BILIARY STENT |
COOK, INC. |
LELAND KEYT |
K042970 |
12/07/2004 |
COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM |
COPAN DIAGNOSTICS, INC. |
CYNTHIA SINCLAIR |
K040592 |
12/17/2004 |
CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE |
CORDIS CORP. |
DAVID KORNHAUSER |
K042823 |
12/01/2004 |
COSMEDENT PIT & FISSURE SEALANT |
COSMEDENT, INC. |
JAMES L SANDRIK |
K032434 |
12/27/2004 |
CLINICAL ELECTRONIC THERMOMETER |
COTRONIC MANUFACTURING |
SHINE WAN |
K042385 |
12/17/2004 |
DOC BAND-POSTOP |
CRANIAL TECHNOLOGIES, INC. |
TIMOTHY R LITTLEFIELD |
K043332 |
12/13/2004 |
WHEELCHAIR, MODEL 8500-II |
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER |
ZEN-JYE CHEN |
K042333 |
12/01/2004 |
CONTROL PLASMA N, PROC CONTROL PLASMA |
DADE BEHRING, INC. |
RADAMES RIESGO |
K042941 |
12/02/2004 |
DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS |
DADE BEHRING, INC. |
RADAMES RIESGO |
K042687 |
12/10/2004 |
ENZYGNOST F+2 (MONOCLONAL) TEST KIT |
DADE BEHRING, INC. |
DONNA WOLF |
K043276 |
12/23/2004 |
DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE |
DATEX-OHMEDA |
JOEL KENT |
K042931 |
12/08/2004 |
TUF LINK SILICONE RELINER |
DENTATUS USA, LTD. |
THOMAS MURPHY |
K043247 |
12/22/2004 |
DUCERA ALLCERAM |
DENTSPLY INTL. |
HELEN LEWIS |
K043298 |
12/10/2004 |
BLUE ORTHOCORD SUTURE |
Depuy Mitek |
RUTH C FORSTADT |
K042959 |
12/22/2004 |
DEPUY C-STEM AMT HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
DINA L WEISSMAN |
K042664 |
12/08/2004 |
LPS UPPER EXTREMITY |
DEPUY, INC. |
TIFFANI D ROGERS |
K042362 |
12/27/2004 |
MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12 |
DIAGNOSTIC CHEMICALS LTD. |
NANCY OLSCAMP |
K042329 |
12/27/2004 |
SALICYLATE-SL ASSAY |
DIAGNOSTIC CHEMICALS LTD. |
NANCY OLSCAMP |
K041957 |
12/01/2004 |
EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS |
DIOMED, INC. |
MAUREEN O'CONNELL |
K043000 |
12/01/2004 |
MODIFICATION TO D-TRONPLUS |
DISETRONIC MEDICAL SYSTEMS AG |
Scott Thiel |
K042547 |
12/01/2004 |
DRAGON HEART PISTON SYRINGE |
DRAGON HEART MEDICAL DEVICES CO., LTD. |
JINA YU |
K043378 |
12/29/2004 |
DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT |
DREW SCIENTIFIC LTD. |
DIANE HILL |
K042478 |
12/28/2004 |
CAPSULE TENSION RING INSERTER, MODEL 7-810 |
DUCKWORTH & KENT, LTD. |
MARTIN LOCK |
K043164 |
12/10/2004 |
PANALIGHT-BLU, MODEL 4175 |
DUSA PHARMACEUTICALS, INC. |
SCOTT LUNDAHL |
K042772 |
12/13/2004 |
EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIXATION DEVICE |
EBI, L.P. |
FREDERIC TESTA |
K042985 |
12/23/2004 |
LIFESTENT NT35 BILIARY STENT SYSTEM |
EDWARDS LIFESCIENCES, LLC. |
KEVIN DRISKO |
K043103 |
12/09/2004 |
VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2 |
EDWARDS LIFESCIENCES, LLC. |
PAULA A TORRIANNI |
K043269 |
12/22/2004 |
Lysus Infusion System |
EKOS CORP. |
JOCELYN KERSTEN |
K043068 |
12/29/2004 |
DIFOTI USB 2.0 SYSTEM |
ELECTRO-OPTICAL SCIENCES, INC. |
MICHAEL GREENEBAUM |
K042705 |
12/29/2004 |
DISPOSABLE NON-ADHESIVE SPO2 SENSORS |
ELEKON INDUSTRIES U.S.A., INC. |
KRISTA OAKES |
K042675 |
12/06/2004 |
FLEXI-STAT SP02 EAR SENSOR |
ELEKON INDUSTRIES U.S.A., INC. |
KRISTA OAKES |
K042349 |
12/16/2004 |
EMG MODEL SUA01 SUCTION UNIT |
EMG TECHNOLOGY CO., LTD. |
LEONARD FRIER |
K042057 |
12/17/2004 |
INFINITY ELECTROTHERAPY SYSTEM |
EMPI |
MARY MCNAMARA-CULLINANE |
K042777 |
12/01/2004 |
HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P |
ETHICON ENDO-SURGERY, INC. |
KIMBERLY SHOEMAKER |
K042603 |
12/22/2004 |
GYNECARE PROLENE FASTENER SYSTEM |
ETHICON, INC. |
SEAN O'BRYAN |
K043243 |
12/09/2004 |
PRIMUS STENT AND DELIVERY SYSTEM |
EV3 INC |
GLEN D SMYTHE |
K043403 |
12/28/2004 |
CEMEX SYSTEM GENTA FAST BONE CEMENT |
EXACTECH, INC. |
Lisa Simpson |
K041757 |
12/23/2004 |
FEMSPEC DISPOSABLE VAGINAL SPECULUM |
FEMSPEC L.L.C. |
GERALD JAY SANDERS |
K043244 |
12/20/2004 |
FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR |
FRESENIUS MEDICAL CARE NORTH AMERICA |
ARTHUR EILINSFELD |
K042732 |
12/22/2004 |
ARCHITECT CA 15-3 ASSAY |
FUJIREBIO DIAGNOSTICS, INC. |
KIMBERLY PETERSON |
K042148 |
12/03/2004 |
HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES |
GE MEDICAL SYST. INFORMATION TECHNOLOGIES |
LISA M BAUMHARDT |
K043381 |
12/23/2004 |
INFINIA LIGHTSPEED |
GE MEDICAL SYSTEMS F.I. HAIFA |
LAURENCE BIGIO |
K043076 |
12/22/2004 |
GE OEC FLUOROSTAR |
GE OEC MEDICAL SYSTEMS, INC. |
JEFF WAGNER |
K040973 |
12/27/2004 |
BUN REAGENT |
GENCHEM, INC. |
C.C. ALLAIN |
K040972 |
12/27/2004 |
CALCIUM, AZO DYE REAGENT |
GENCHEM, INC. |
C.C. ALLAIN |
K040975 |
12/27/2004 |
GENCHEM CO2 ACID REAGENT |
GENCHEM, INC. |
C.C. ALLAIN |
K040976 |
12/27/2004 |
GENCHEM CREATININE REAGENT |
GENCHEM, INC. |
C.C. ALLAIN |
K040977 |
12/27/2004 |
GENCHEM ELECTROLYTE BUFFER |
GENCHEM, INC. |
C.C. ALLAIN |
K040971 |
12/22/2004 |
GENCHEM ISE ELECTROLYTE REFERENCE |
GENCHEM, INC. |
C.C. ALLAIN |
K040974 |
12/27/2004 |
GLUCOSE OXIDASE, GLUCOSE |
GENCHEM, INC. |
C.C. ALLAIN |
K042427 |
12/03/2004 |
GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER |
GENEMED, INC. |
DAVID BALZER |
K043098 |
12/15/2004 |
GERBER DOUBLE ELECTRIC BREAST PUMP |
GERBER PRODUCTS CO. |
RANGA RANGANATHAN |
K042322 |
12/07/2004 |
STERICHEK BLOOD LEAK REAGENT STRIPS |
HACH COMPANY |
DAVID A MORRIS, PH.D. |
K042860 |
12/03/2004 |
CORRECT DENTAL IMPRESSION MATERIAL |
HANDAE CHEMICAL CO., LTD. |
JAE HO YU |
K041693 |
12/02/2004 |
WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES |
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., |
JI BO |
K043186 |
12/06/2004 |
H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM |
HEALTH & LIFE CO., LTD. |
PAUL HUNG |
K042878 |
12/17/2004 |
FLEXITIME XTREME |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
K030052 |
12/06/2004 |
OSTIM |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
K043239 |
12/22/2004 |
HEALTHSTAR ELITE |
HILL LABORATORIES CO. |
HOWARD A HILL |
K043256 |
12/06/2004 |
HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 |
HOSPIRA, INC. |
PATRICIA MELERSKI |
K043069 |
12/03/2004 |
HOVEROUND E100 POWER CHAIR |
HOVEROUND CORP. |
TONY DIGIOVANNI |
K042920 |
12/03/2004 |
HOVEROUND SE-3 POWERCHAIR |
HOVEROUND CORP. |
TONY DIGIOVANNI |
K043404 |
12/27/2004 |
MODIFICATION TO T2 PROXIMAL HUMERAL NAIL |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
K041078 |
12/23/2004 |
SURGPLAN AND PANPLAN |
IMAGING SCIENCES INTL., INC. |
EDWARD J MARANDOLA |
K042519 |
12/01/2004 |
GAMMA-B 1,25-DIHYDROXY VITAMIN D |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
PAUL PUNTIN |
K043412 |
12/20/2004 |
MODIFICATION TO: VIEWSTATION |
IMPAC MEDICAL SYSTEMS, INC. |
THOMAS H FARIS |
K040487 |
12/21/2004 |
TRABECULAR METAL KNEE SYSTEM AUGMENTS |
IMPLEX CORP. |
MARCI HALEVI |
K033559 |
12/22/2004 |
12-LEAD GLOVE |
INEEDMD |
IRVING WIESEN, ESQ. |
K042679 |
12/10/2004 |
IR VIEWER |
INFRARED IMAGING SYSTEMS, INC. |
DALE SIEGEL |
K043190 |
12/14/2004 |
SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM |
INNOVA LIFE SCIENCES CORP. |
HOWARD HOLSTEIN |
K042631 |
12/22/2004 |
EAR THERMOMETER, MODEL WL-320X |
INNOVATECH, INC |
TONY C CHANG |
K042576 |
12/02/2004 |
COATEST SP FVIII |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K043184 |
12/22/2004 |
HEMOSIL RECOMBIPLASTIN |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K042982 |
12/22/2004 |
QUANTEX MYOGLOBIN |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K042825 |
12/21/2004 |
ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM |
INTEGRA LIFESCIENCES CORPORATION |
DARLENE M WALSH |
K043229 |
12/21/2004 |
MODIFICATION TO ALTIUS OCT SYSTEM |
INTERPORE CROSS INTL. |
WENDY SPIELBERGER |
K041407 |
12/29/2004 |
TITANIUM MESH IMPLANT |
INTERPORE CROSS INTL. |
WENDY SPIELBERGER |
K043153 |
12/15/2004 |
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS1000 |
INTUITIVE SURGICAL, INC. |
MICHAEL H YRAMATEGUI |
K042916 |
12/29/2004 |
WATCH PAT 100S |
ITAMAR MEDICAL |
JONATHAN S KAHN |
K042820 |
12/14/2004 |
SYSTEMP.C&B PLUS |
IVOCLAR VIVADENT, INC. |
DONNA HARTNETT |
K042847 |
12/17/2004 |
SYSTEMP.CEM |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
K042846 |
12/20/2004 |
SYSTEMP.LINK |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
K043221 |
12/20/2004 |
WILLI GELLER CREATION CP PORCELAIN |
JENSEN INDUSTRIES, INC. |
GARY PHELPS |
K042241 |
12/10/2004 |
K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C |
KAMIYA BIOMEDICAL CO. |
BRIAN SCHLIESMAN |
K042461 |
12/10/2004 |
KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304 |
KENDALL |
PAUL W EVANS |
K043272 |
12/22/2004 |
PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP |
KENDALL |
JIM WELSH |
K043114 |
12/10/2004 |
KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE |
KIMBERLY-CLARK CORP. |
S. MCMILLAN |
K042386 |
12/15/2004 |
DIRECT DIGITIZER, REGIUS MODEL 190 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
SHINICHI YAMANAKA |
K042248 |
12/17/2004 |
KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT |
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. |
HEATHER VIELE |
K043177 |
12/17/2004 |
CLEAFIL DC CORE AUTOMIX |
KURARAY MEDICAL INC. |
SATOSHI YAMAGUCHI |
K042929 |
12/06/2004 |
ESTENIA C&B |
KURARAY MEDICAL KURASHIKI PLANT |
KOJI NISHIDA |
K043023 |
12/03/2004 |
PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49 |
LEMAITRE VASCULAR, INC. |
SABA MODJARRAD |
K031425 |
12/15/2004 |
GENTLEWAVES LED PHOTOMODULATION DEVICE |
LIGHT BIOSCIENCE, LLC |
ROBERT T HANDREN, JR. |
K040270 |
12/16/2004 |
OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM |
LUMENIS LTD. |
ANDREA L RUTH |
K042666 |
12/21/2004 |
LUTH-ALL SUB-Q NEEDLE SET |
LUTH-ALL MEDICAL PRODUCTS, LLC |
SHEPARD G BENTLEY |
K032825 |
12/10/2004 |
VITAL VISION ARTERIAL HARDNESS AND BLOOD PRESSURE MONITOR |
MARS MEDICAL PRODUCTS CO., LTD. |
E.J. Smith |
K041125 |
12/30/2004 |
MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM) |
MASEP MED SCIENCE & TECH. DEVELOPMENT (SHENZHEN) C |
SUSAN D GOLDSTEIN-FALK |
K043132 |
12/21/2004 |
UNIVERSAL XACTTRACE |
MEDCARE FLAGA |
KOLBRUN E OTTOSDOTTIR |
K033266 |
12/16/2004 |
VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS |
MEDICAL IMAGING APPLICATIONS LLC |
MILAN SONKA |
K043134 |
12/13/2004 |
METRX WORKSTATION |
MEDICAL METRX SOLUTIONS, INC. |
PATSY J TRISLER |
K043455 |
12/21/2004 |
SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
CARL ALLETTO |
K042784 |
12/10/2004 |
MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM |
MEDRAD, INC. |
JOHN M KISTE |
K041047 |
12/01/2004 |
ULTRADENT CARBON MASK - UPI #342 |
MEDSPRING GROUP, INCORPORATED |
BRUCE DAVIS |
K033732 |
12/01/2004 |
MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450 |
MEDTRADE PRODUCTS LTD. |
JONATHAN D RANFIELD |
K042962 |
12/14/2004 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K043561 |
12/29/2004 |
MODIFICATION TO VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD A TREHARNE |
K043343 |
12/28/2004 |
MODIFICATION TO: CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K042789 |
12/21/2004 |
VERTEX RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K042489 |
12/13/2004 |
6F Z4 GUIDE CATHETER |
MEDTRONIC VASCULAR |
FRED L BOUCHER |
K043291 |
12/21/2004 |
CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884 |
MEDTRONIC VASCULAR |
DAVID D COX |
K043080 |
12/03/2004 |
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR |
MEDTRONIC VASCULAR |
BRUCE BACKLUND |
K043287 |
12/10/2004 |
PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000 |
MICRO MEDICAL DEVICES, INC. |
RAFI ISRAEL |
K043110 |
12/09/2004 |
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1 |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
K041364 |
12/13/2004 |
ML830 LASER SYSTEM |
MICROLIGHT CORPORATION OF AMERICA |
FRED A SIMPSON |
K042000 |
12/21/2004 |
MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS |
MSQ (M2) LTD. |
ANNE WORDEN |
K042038 |
12/23/2004 |
MTF ALLOGRAFT ANCHOR |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NORMAN F ESTRIN |
K033973 |
12/13/2004 |
OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR |
NELLCOR PURITAN BENNETT, INC. |
LUANNE NG |
K030400 |
12/22/2004 |
NEOSCI MEDICAL ENDOLUMINAL BRUSH |
NEOSCI MEDICAL, INC. |
PHIL TRIOLO |
K041406 |
12/15/2004 |
NEWPORT C250 AIR COMPRESSOR MODEL C250 |
NEWPORT MEDICAL INSTRUMENTS |
RICHARD WATERS |
K041063 |
12/01/2004 |
SMARTWAVE MS 2000 |
NEWWAVE MEDICAL LLC |
ROBERT ARMSTRONG |
K042689 |
12/09/2004 |
NICHOLS ADVANTAGE CORTISOL |
NICHOLS INSTITUTE DIAGNOSTICS |
JIMMY WONG |
K042676 |
12/17/2004 |
NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY |
NICHOLS INSTITUTE DIAGNOSTICS |
XIE QIYL |
K042785 |
12/14/2004 |
MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 |
NIDEK, INC. |
CAROL PATTERSON |
K043115 |
12/01/2004 |
LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC) |
NITI MEDICAL TECHNOLOGIES LTD. |
ORLY MAOR |
K042943 |
12/17/2004 |
NOUVAG AG - VACUSON 40 AND VACUSON 60 |
NOUVAG AG |
ERICH FORSTER |
K042822 |
12/22/2004 |
TCM ENDO V, MODEL 1534 |
NOUVAG AG |
ERICH FORSTER |
K043319 |
12/17/2004 |
CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES |
NOVALIS MEDICAL, LLC |
ANTHONY DAVIS |
K042132 |
12/21/2004 |
NOVASYS TRANSURETHRAL RF SYSTEM |
NOVASYS MEDICAL, INC. |
DEBRA REISENTHEL |
K042079 |
12/20/2004 |
OSS/(SCARF)- AND OSW-SCREW |
O.M.T. OBERFLACHEN-UND MATERIALTECHNOLOGIE GMBH |
H. DARREL DARBY II |
K043202 |
12/23/2004 |
OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 |
OLYMPUS AMERICA, INC. |
BEV HARDING |
K042406 |
12/03/2004 |
OLYMPUS LACTATE, OSR6193 |
OLYMPUS AMERICA, INC. |
BEV HARDING |
K043128 |
12/21/2004 |
OLYMPUS ENDOARM |
OLYMPUS CORPORATION |
TINA STEFFANIE-OAK |
K043275 |
12/09/2004 |
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
K041679 |
12/16/2004 |
COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT |
ONYX MEDICAL INC. |
ROGER MACHSON |
K042584 |
12/14/2004 |
OPUS MINIMAGNUM ANCHOR WITH INSERTER |
OPUS MEDICAL, INC. |
LAURA N KASPEROWICZ |
K042838 |
12/09/2004 |
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II |
Ortho-Clinical Diagnostics, Inc. |
Darlene J Phillips |
K042476 |
12/01/2004 |
VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS |
Ortho-Clinical Diagnostics, Inc. |
CAREY A MAYO |
K040047 |
12/17/2004 |
POLYGRAFT BGS; BONE GRAFT SUBSTITUTE |
OSTEOBIOLOGICS, INC. |
GABRIELE G NIEDERAUER |
K043130 |
12/21/2004 |
MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS |
PAJUNK GMBH |
BURK A BRANDT |
K042979 |
12/21/2004 |
MODIFICATION TO: PLEXALONG SETS |
PAJUNK GMBH |
BURK A BRANDT |
K042907 |
12/22/2004 |
NEEDLE INCAPACITATOR (NEEDLE GUARD) |
PDMP, INC. |
E.J. Smith |
K042762 |
12/22/2004 |
PEFAKIT APC-R FACTOR V LEIDEN |
PENTAPHARM LTD. |
M. ELISABETH BIERMAN |
K042760 |
12/22/2004 |
PEFAKIT APC-R FACTOR V LEIDEN CONTROLS |
PENTAPHARM LTD. |
M. ELISABETH BIERMAN |
K042805 |
12/16/2004 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE |
PERUSAHAAN GETAH ASAS SDN BHD |
KK LEONG |
K043167 |
12/29/2004 |
PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X |
PHAMATECH INC. |
CARL MONGIOVI |
K043090 |
12/23/2004 |
EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS |
PHONIC EAR, INC. |
TODD BISSEY |
K043092 |
12/13/2004 |
PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015 |
PROGENY, INC. |
ALAN KREMA |
K042131 |
12/10/2004 |
PROMEDICAL SURGICAL DRAPES |
PROMEDICAL PRODUCTS CO., LTD. |
BOYD HARRIS |
K042111 |
12/10/2004 |
PROMEDICAL SURGICAL GOWNS |
PROMEDICAL PRODUCTS CO., LTD. |
BOYD HARRIS |
K042239 |
12/16/2004 |
FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE |
PT. MANDIRI INTI BUANA |
P. SASITHARAN NAIR |
K041913 |
12/01/2004 |
POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE |
PT. MEDISAFE TECHNOLOGIES |
ANIL TANEJA |
K042099 |
12/10/2004 |
TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) |
RETINAPHARMA TECHNOLOGIES INC. |
TERRY A FULLER, PH.D. |
K042399 |
12/17/2004 |
MODIFICATION TO SHORT INTRODUCER SHEATH |
REX MEDICAL LP |
SUSAN D GOLDSTEIN-FALK |
K030295 |
12/23/2004 |
LTU-904 PORTABLE LASER THERAPY UNIT |
RIANCORP PTY LTD |
ROBERT T HANDREN |
K043320 |
12/17/2004 |
MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
K043318 |
12/23/2004 |
MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
K043211 |
12/29/2004 |
ONLINE DAT BARBITURATES PLUS |
ROCHE DIAGNOSTICS CORP. |
KERWIN KAUFMAN |
DEN040011 |
12/23/2004 |
AMPLICHIP CYP450 TEST, MODEL 04381866190 |
ROCHE MOLECULAR SYSTEMS, INC. |
JAMES F KELLY |
K042654 |
12/17/2004 |
PROTECTION PLUS EARLOOP PROCEDURE MASK |
SAFETY-MED PRODUCTS, INC. |
CHRIS WAGNER |
K041011 |
12/14/2004 |
ULTRALIGHT II ND:YAG LASER SYSTEM |
SANDSTONE MEDICAL TECHNOLOGIES, LLC |
CONNIE WHITE HOY |
K042787 |
12/17/2004 |
IS 40 MICROMOTOR |
SATELEC |
STEVE SALESKY |
K043001 |
12/01/2004 |
MX POLYAXIAL PEDICLE SCREW |
SCIENT'X |
J.D. WEBB |
K043232 |
12/21/2004 |
UCR SPINAL SYSTEM |
SEASPINE |
DIANA SMITH |
K043159 |
12/20/2004 |
POWDER FREE CLEAR SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE |
SHIJAIZHUANG BRILLIANT OCEAN PLASTIC CO., LTD. |
EMMY TJOENG |
K042840 |
12/03/2004 |
SHIMADZU COLLIMATOR R-20J |
SHIMADZU CORP. |
RANDAL WALKERI |
K043030 |
12/09/2004 |
MAGNETOM C! MR SYSTEM |
SIEMENS MEDICAL SOLUTIONS |
NEALIE HARTMAN |
K043087 |
12/15/2004 |
SOMATOM CARE CONTRAST CT |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
DEBBIE PEACOCK |
K043086 |
12/23/2004 |
SOMATOM RESPIRATORY GATING |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
DEBBIE PEACOCK |
K042863 |
12/15/2004 |
SCENIUM |
SIEMENS MOLECULAR IMAGING LTD |
MARIA EBIO |
K043355 |
12/17/2004 |
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X |
SINTEA BIOTECH, INC. |
GUIDO ZORZOLI |
K043452 |
12/21/2004 |
TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM |
SONOSITE,INC. |
DAINA L GRAHAM |
K042481 |
12/14/2004 |
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400 |
SOPHYSA SA |
JACKIE MASSE |
K043307 |
12/17/2004 |
CRANEX D |
SOREDEX PALODEX GROUP OY |
KAI LANER |
K043062 |
12/13/2004 |
MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM |
SOURCE-RAY, INC. |
RAY MANEZ |
K042452 |
12/07/2004 |
RIVA SILVER |
SOUTHERN DENTAL INDUSTRIES, INC. |
SAMANTHA J CHEETHAM |
K042714 |
12/29/2004 |
FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4 |
SPINE NEXT AMERICA CORPORATION |
TOM BREWER |
K042713 |
12/29/2004 |
FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5 |
SPINE NEXT AMERICA CORPORATION |
TOM BREWER |
K030526 |
12/29/2004 |
PEDIGUARD NERVE DETECTOR SYSTEM |
SPINEVISION, INC. |
LYNNETTE WHITAKER |
K042930 |
12/28/2004 |
SPACEVISION CAGE SYSTEM |
SPINEVISION, INC. |
LYNETTE WHITAKER |
K042858 |
12/03/2004 |
55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS |
SPIRE BIOMEDICAL, INC. |
DONALD FICKETT |
K042734 |
12/17/2004 |
SJM RIGID SADDLE RING MODEL RSAR-(SIZE) |
ST. JUDE MEDICAL, INC. |
WILLIAM MCKELVEY |
K043155 |
12/09/2004 |
STARION UNIVERSAL POWER SUPPLY (UPS) |
STARION INSTRUMENTS |
BRIAN GRIGSBY |
K040049 |
12/17/2004 |
THE RELIANCE ENDOSCOPE PROCESSING SYSTEM |
STERIS Corporation |
NANCY A ROBINSON |
K043482 |
12/21/2004 |
THE RELIANCE PI PROCESS INDICATOR, MODEL D5116 |
STERIS Corporation |
MARGARET MARSH |
K041810 |
12/21/2004 |
SERFAS ENERGY SYSTEM |
Stryker Endoscopy |
CHRISTINE REISTETTER |
K042454 |
12/09/2004 |
STRYKER CASSETTE PUMP |
Stryker Endoscopy |
CHRISTOPHER L COOK |
K042902 |
12/27/2004 |
HERBERT ULNAR HEAD PROSTHESIS SYSTEM |
STUCKENBROCK MEDIZINTECHNIK GMBH |
AL WEISENBORN |
K042856 |
12/03/2004 |
CONTOUR FOREHEAD/BROWLIFT THREAD |
SURGICAL SPECIALTIES CORP. |
ELIZABETH LAZARO |
K042629 |
12/08/2004 |
VARELISA SM ANTIBODIES, MODEL 18296 |
SWEDEN DIAGNOSTICS (GERMANY) GMBH |
SABINE KLUGBAUER |
K041834 |
12/03/2004 |
ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM |
TAKARA BELMONT USA, INC. |
ROBERT SCHIFF |
K040778 |
12/23/2004 |
TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9) |
TANITA CORP. OF AMERICA |
RHODA LYNN VALERA |
K042414 |
12/29/2004 |
VISIOPLAST ACRYLIC RESIN |
TECRES |
CHRISTINE BRAUER |
K042911 |
12/27/2004 |
CEMENTEK LV |
TEKNIMED SA |
J.D. WEBB |
K043258 |
12/16/2004 |
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02 |
TELEFLEX MEDICAL |
SUSAN KAGAN |
K043278 |
12/13/2004 |
TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES |
TERATECH CORP. |
CHARLES F HOTTINGER |
K042620 |
12/23/2004 |
SONATA 3-D IMAGING ACCESSORY, MODEL 3DS |
TETRAD CORP. |
DENNIS R DIETZ |
K042783 |
12/17/2004 |
ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM |
THE ANSPACH EFFORT, INC. |
WILLIAM G CONETY |
K042923 |
12/17/2004 |
MD-6W WIRELESS CRITICAL DATA VIEWER |
THE MICROOPTICAL CORPORATION |
DANIEL J DILLON |
K043366 |
12/17/2004 |
PERMACOL SURGICAL IMPLANT |
TISSUE SCIENCE LABORATORIES, PLC |
VICTORIA TAYLOR |
K042370 |
12/17/2004 |
TORAYGUIDE GUIDEWIRE |
TORAY INDUSTRIES (AMERICA), INC. |
LISA S JONES |
K043077 |
12/17/2004 |
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEM |
TORNIER |
LEMERY MIREILLE |
K040426 |
12/17/2004 |
TRANS1 AXIAL FIXATION SYSTEM |
TRANS1, INC. |
CHERYL L JOHNS |
K043119 |
12/17/2004 |
AMELOGEN PLUS |
ULTRADENT PRODUCTS, INC. |
TAMMY LAVERY |
K042288 |
12/27/2004 |
UNICRYL |
UNITED MEDICAL INDUSTRIES CO. LTD. |
MOHAMMED AZEEZ |
K042285 |
12/10/2004 |
UNICRYL M |
UNITED MEDICAL INDUSTRIES CO. LTD. |
MOHAMMED AZEEZ |
K042286 |
12/01/2004 |
UNIESTER C |
UNITED MEDICAL INDUSTRIES CO. LTD. |
MOHAMMED AZEEZ |
K042284 |
12/03/2004 |
UNIMIDE |
UNITED MEDICAL INDUSTRIES CO. LTD. |
MOHAMMED AZEEZ |
K042283 |
12/01/2004 |
UNIPRO |
UNITED MEDICAL INDUSTRIES CO. LTD. |
MOHAMMED AZEEZ |
K042282 |
12/01/2004 |
UNISILK |
UNITED MEDICAL INDUSTRIES CO. LTD. |
MOHAMMED AZEEZ |
K043019 |
12/01/2004 |
VASCULAR SOLUTIONS SCLERO-KIT |
VASCULAR SOLUTIONS, INC. |
SARA L COON |
K043181 |
12/17/2004 |
MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM |
VERTEBRON, INC. |
LUIS NESPRIDO |
K041987 |
12/17/2004 |
CORTRAK |
VIASYS MEDSYSTEMS |
STEPHANIE WASIELEWSKI |
K043333 |
12/15/2004 |
VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM |
VITAL IMAGES, INC. |
TIMOTHY J KAPPERS |
DEN040010 |
12/13/2004 |
VYSIS AUTOVYSION SYSTEM |
VYSIS |
LYNDA HAGUE |
K043081 |
12/22/2004 |
GORE POLYPROPYLENE HERNIA MESH |
W. L. GORE & ASSOCIATES, INC. |
Michael Ivey |
K043056 |
12/22/2004 |
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL |
W.L. GORE & ASSOCIATES,INC |
BRANDON HANSON |
K042530 |
12/17/2004 |
CONSERVE PLUS HA ACETABULAR SHELLS |
WRIGHT MEDICAL TECHNOLOGY, INC. |
JEANINE H REDDEN |
K042828 |
12/01/2004 |
OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 |
YOUNG O/S LLC |
STEPHEN W CONGER |
K043131 |
12/15/2004 |
TORPICALGIN |
ZHERMACK S.P.A. |
GERALD W SHIPPS |
K042871 |
12/21/2004 |
TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3 |
ZIMMER TRABECULAR |
MARCI HALEVI |
K043227 |
12/10/2004 |
PERIARTICULAR LOCKING PLATES, 2358 SERIES |
ZIMMER, INC. |
NOAH BARTSCH |