FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K040465 |
07/20/2004 |
LATIT FLOW |
AB ARDENT |
CLYDE E INGERSOLL |
K040560 |
07/27/2004 |
ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING |
AB BIODISK |
ANNE BOLMSTROM |
K041221 |
07/13/2004 |
ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY |
ACCU-STAT DIAGNOSTICS, INC. |
JAMES G BARRONS |
K041759 |
07/22/2004 |
ACE CONNECT INTERNAL CONNECTION |
ACE SURGICAL SUPPLY CO., INC. |
J. EDWARDS CARCHIDI |
K041140 |
07/07/2004 |
ACELL UBM SURGICAL MESH ML AND MLPLUS |
ACELL, INC |
PATSY J TRISLER |
K031996 |
07/23/2004 |
EXTENTRAC ELITE |
ADVANCED BACK TECHNOLOGIES |
DAVID F CUCCIA |
K041753 |
07/14/2004 |
AESKULISA ENA 6 S |
AESKU.DIAGNOSTICS |
STANLEY AMMONS |
K033897 |
07/19/2004 |
MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM |
AGA-LINDE HEALTH CARE |
JAMES JOCHEN ROGERS |
K041701 |
07/22/2004 |
AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM |
AGFA CORP. |
JEFFERY A JEDLICKA |
K041241 |
07/06/2004 |
MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 |
ALARIS MEDICAL SYSTEMS, INC. |
STACY L LEWIS |
K040231 |
07/13/2004 |
INTELIPORT OCCLUDING DEVICE |
ALCON, INC. |
KIM B KRACKE |
K041916 |
07/30/2004 |
ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEM |
ALOKA CO. LTD USA |
RICHARD J CEHOVSKY |
K040991 |
07/22/2004 |
AMBU DISPOSABLE PRESSURE MANOMETER |
AMBU, INC. |
SANJAY PARIKH |
K040754 |
07/23/2004 |
AMERICAN BANTEX MS 4 MINI SCOOTER |
AMERICAN BANTEX CORP. |
TRACY S BEST |
K041376 |
07/20/2004 |
C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A |
ANALOGIC CORP. |
DONALD J SHERRATT |
K041420 |
07/26/2004 |
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
K041828 |
07/30/2004 |
APEX MEDICAL CPAP MODEL 9S-003 |
APEX MEDICAL CORP. |
ALAN CHANG |
K041745 |
07/15/2004 |
VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
LINGA SUMARTA |
K041153 |
07/12/2004 |
SHARPSAWAY II LOCKING DISPOSABLE CUP |
ARROW INTL., INC. |
ELIZABETH PRICE |
K040907 |
07/01/2004 |
ARTHREX SMALL FRAGMENT PLATES AND SCREWS |
ARTHREX, INC. |
SALLY FOUST |
K041274 |
07/28/2004 |
RESORBABLE INTERFERENCE SCREW |
ARTHROTEK, INC. |
GARY BAKER |
K041726 |
07/23/2004 |
HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX |
ASAHI MEDICAL CO., LTD. |
DAVID L WEST |
K041670 |
07/06/2004 |
BIS PEDIATRIC SENSOR |
ASPECT MEDICAL SYSTEMS, INC. |
RENEE GOULD |
K041681 |
07/01/2004 |
ATRICURE DISSECTOR |
ATRICURE, INC. |
MARK JOB |
K040913 |
07/23/2004 |
NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) |
BAUSCH & LOMB |
DAVID THOMAS |
K031431 |
07/13/2004 |
BAWMED RESCUE MASK |
BAWMED UK |
BARBARA WOODS |
K041738 |
07/09/2004 |
BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME) |
BAXTER HEALTHCARE CORPORATION |
KAREN SPRANGER |
K041133 |
07/02/2004 |
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER |
BAYER HEALTHCARE, LLC |
ANDRES HOLLE |
K041561 |
07/06/2004 |
LIQUICHEK WHOLE BLOOD VOLATILES CONTROL |
BIO-RAD |
MARIA ZEBALLOS |
K041938 |
07/22/2004 |
MAXIMUS OS (OVERDENTURE SYSTEM) |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON GREER |
K041564 |
07/16/2004 |
Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01 |
BIOJECT MEDICAL TECHNOLOGIES INC. |
LAURENCE A POTTER |
K031140 |
07/07/2004 |
WATERLASE |
BIOLASE TECHNOLOGY, INC. |
IOANA M RIZOIU |
K040007 |
07/07/2004 |
INTERFERENTIAL STIMULATOR, MODEL BMLS02-6 |
BIOMEDICAL LIFE SYSTEMS, INC. |
RICHARD SAXON |
K041466 |
07/01/2004 |
TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC) |
BIOMET MANUFACTURING CORP. |
TRACY J BICKEL, RAC |
K031454 |
07/08/2004 |
ACUMEN SURGICAL NAVIGATION SYSTEM |
BIOMET, INC. |
KRISTINE C ARNOLD |
K041352 |
07/30/2004 |
COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM |
BIOMET, INC. |
GARY BAKER |
K040459 |
07/06/2004 |
TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS |
BIOSITE INCORPORATED |
JEFFREY R DAHLEN |
K041293 |
07/09/2004 |
BIOPORE BALLOON DILATION CATHETER |
BIPORE, INC. |
KEITH PALUCH |
K041606 |
07/07/2004 |
EXTRACTOR RX RETRIEVAL BALLOON |
BOSTON SCIENTIFIC CORP. |
JAMES D MCMAHON |
K040155 |
07/01/2004 |
PERIPHERAL CUTTING BALLOON |
BOSTON SCIENTIFIC CORP. |
RENUKA KRISHNAN |
K041716 |
07/22/2004 |
PTFE FELTS AND PLEDGETS |
BOSTON SCIENTIFIC CORP. |
MAUREEN MONTBRIAND |
K041727 |
07/23/2004 |
MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 |
BOSTON SCIENTIFIC SCIMED, INC. |
ROBERT Z PHILLIPS |
K040931 |
07/22/2004 |
PATXFER RT |
BRAINLAB, AG |
RAINER BIRKENBACH |
K041641 |
07/01/2004 |
DAVOL DELIVERY SYSTEM |
C.R. BARD, INC. |
SUZANNE LASCALZA |
K041576 |
07/02/2004 |
SOURCELINK |
C.R. BARD, INC. |
JOHN C KNORPP |
K040986 |
07/01/2004 |
CADWELL LIMB MOVEMENT MODULE |
CADWELL LABORATORIES, INC. |
CHRIS BOLKAN |
K040932 |
07/01/2004 |
EASYNET BODY POSITION MODULE |
CADWELL LABORATORIES, INC. |
CHRIS BOLKAN |
K041414 |
07/08/2004 |
CRONO AND CRONO, MODEL 30 |
CANE S.R.L. |
DANIEL KAMM |
K041700 |
07/30/2004 |
CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR |
CANTOR & NISSEL LTD. |
MARTIN DALSING |
K040438 |
07/01/2004 |
POWERHEART AED G3A |
CARDIAC SCIENCE, INC. |
KENNETH OLSON |
K041671 |
07/22/2004 |
IMAGENMD |
CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC |
MALINIE HASEK |
K033679 |
07/07/2004 |
COPSIOS BONE VOID FILLER (BVF) |
CENTERPULSE SPINE-TECH, INC. |
TIM MILLER |
K040031 |
07/28/2004 |
CERAGEM-C THERMAL ACUPRESSURE MASSAGER |
CERAGEM CO., LTD. |
SUZAN ONEL |
K041363 |
07/27/2004 |
AOC BONE WAX |
CEREMED INC. |
TADEUSZ WEKKUSZ MD |
K041645 |
07/09/2004 |
DDS-ZR |
CHARLES SCHARF |
CHRIS SCHARF |
K041773 |
07/15/2004 |
OXYGEN MEDICELS, CITICELS |
CITY TECHNOLOGY LIMITED |
DEBRA WALLACE |
K033592 |
07/27/2004 |
REPROCESSED SURGICAL SCISSORS AND GRASPERS |
CLEAR MEDICAL, INC. |
MIKE KOVACS |
K033488 |
07/07/2004 |
CMI MAGNETOCARDIOGRAPH |
CMI CARDIOMAG IMAGING INC |
STEVEN KARR |
K041020 |
07/07/2004 |
CADSTREAM VERSION 3.1 |
CONFIRMA, INC. |
PATRICIA A MILBANK |
K041044 |
07/29/2004 |
CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET |
COOK, INC. |
JENNIFER BOSLEY |
K041138 |
07/23/2004 |
LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS |
COOPERVISION, INC. |
BONNIE J TSYMBAL |
K041417 |
07/20/2004 |
DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423 |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
K041150 |
07/22/2004 |
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
K041870 |
07/27/2004 |
N APOLIPOPROTEIN STANDARD SERUM |
DADE BEHRING, INC. |
DONNA A WOLF |
K041907 |
07/23/2004 |
TRIO MONITOR |
DATASCOPE CORP. |
SUSAN E MANDY |
K041772 |
07/28/2004 |
DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIES |
DATEX-OHMEDA |
JOEL C KENT |
K041790 |
07/23/2004 |
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE |
DATEX-OHMEDA |
JOEL C KENT |
K041368 |
07/29/2004 |
DENTIUM CO., LTD. IMPLANTIUM |
DENTIUM CO., LTD. |
CATHRYN N CAMBRIA |
K041707 |
07/30/2004 |
CERCON CERAM EXPRESS CERAMIC SYSTEM |
DENTSPLY INTL. |
P. JEFFERY LEHN |
K040281 |
07/09/2004 |
LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM) |
DEPUY ORTHOPAEDICS, INC. |
DINA L WEISSMAN |
K041656 |
07/01/2004 |
MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT |
DEPUY ORTHOPAEDICS, INC. |
TIFFANI ROGERS |
K041119 |
07/19/2004 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
SHARON STAROWICZ |
K033959 |
07/01/2004 |
LPS |
DEPUY, INC. |
DINA L WEISSMAN |
K041085 |
07/22/2004 |
LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY |
DEPUY, INC. |
TIFFANI ROGERS |
K041416 |
07/02/2004 |
EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER |
DEROYAL |
SHARON COOK |
K040362 |
07/12/2004 |
DIAPHARMA FACTOR X KIT |
DIAPHARMA GROUP, INC. |
JENNIFER J KIBLINGER |
K041014 |
07/14/2004 |
TSH-CTK-3 IRMA |
DIASORIN, INC. |
DAVID M IKEDA |
K041213 |
07/22/2004 |
3DSCOPE |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
K041582 |
07/07/2004 |
MODIFICATION TO TRIPTER X-1 COMPACT DUET |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
K041622 |
07/08/2004 |
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM |
DRAEGER MEDICAL, INC. |
MICHAEL A KELHART |
K041178 |
07/16/2004 |
EMPOWER TRANSFER SET, (CAT. NO. 7725) |
E-Z-EM, INC. |
JUDY HAUSER |
K040935 |
07/06/2004 |
EBI XFIX DFS SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
K033463 |
07/28/2004 |
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE |
EDWARDS LIFESCIENCES LLC. |
JASON SMITH |
K041644 |
07/29/2004 |
FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE) |
ELEKON INDUSTRIES U.S.A., INC. |
KRISTA OAKES |
K040979 |
07/23/2004 |
ELEKTA MICRODRIVE, MODEL 916716 |
ELEKTA INSTRUMENT AB |
ANDERS SKOGLUND |
K032905 |
07/06/2004 |
3DKNEE POROUS COATED FEMORAL COMPONENT |
ENCORE ORTHOPEDICS, INC. |
KIMBERLY L PRUITT |
K033949 |
07/02/2004 |
VARILUX VISIONPRINT SYSTEM (VPS) |
ESSILOR INTL. |
MARC J SCHEINESON |
K041325 |
07/02/2004 |
DISPOSABLE COLORED VINYL SYNTHETIC EXAM GLOVE, POWDER FREE |
EST INTERNATIONAL CORPORATION |
ELIZABETH DENG |
K041599 |
07/27/2004 |
COBRA ADHERE SURGICAL SYSTEM |
ESTECH, INC. |
CRAIG COOMBS |
K040678 |
07/14/2004 |
EUSURE BLOOD GLUCOSE MONITORING SYSTEM |
EUMED BIOTECHNOLOGY CO., LTD. |
Ke-Min Jen |
K041575 |
07/16/2004 |
FENZIAN TREATMENT SYSTEM |
EUMEDIC LIMITED |
LEWIS W WARD |
K033858 |
07/12/2004 |
TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE |
EUROPEAN CUSTOM MANUFACTURING BV |
MAARTEN KANTERS |
K041596 |
07/21/2004 |
ARCHITECT STAT CK-MB IMMUNOASSAY |
FISHER DIAGNOSTICS |
JOSEFINA INFANTAS |
K041814 |
07/20/2004 |
FS SERIES WHEELCHAIR |
FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY(LTD) |
PANG JIANXUN |
K041042 |
07/16/2004 |
SPLIT SEPTUM INJECTION SITES |
FRESENIUS MEDICAL CARE NORTH AMERICA |
ARTHUR EILINSFELD |
K040946 |
07/01/2004 |
ANKYLOS DENTAL IMPLANT SYSTEM |
FRIADENT GMBH |
CAROL PATTERSON |
K041813 |
07/23/2004 |
GE LOGIQ 7 ULTRASOUND BT04 |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
ALLEN SCHUH |
K041921 |
07/26/2004 |
GE SIGNA PROFILE 6 INCH GP COIL |
GE MEDICAL SYSTEMS, LLC |
LARRY A KROGER |
K022823 |
07/01/2004 |
VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 |
GEISTER MEDIZINTECHNIK GMBH |
DAGMAR MASER |
K041922 |
07/28/2004 |
GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR |
GENERAL ELECTRIC CO. |
DAVID DUERSTELER |
K041552 |
07/02/2004 |
GE VIVID 7 BT04 |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
K041688 |
07/08/2004 |
GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04 |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
K040010 |
07/19/2004 |
GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS |
GENESIS MEDICAL INTERVENTIONAL, INC. |
ANNE WORDEN |
K041039 |
07/20/2004 |
FERTELL MALE FERTILITY TEST |
GENOSIS LTD. |
SHARON A SEGAL |
K041232 |
07/22/2004 |
GETTIG UNIVERSAL VIAL ACCESS PIN |
GETTIG PHARMACEUTICAL INSTRUMENT CO. |
JAMES A BENZ |
K041225 |
07/15/2004 |
SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES-POWERED |
GRAND WORK PLASTIC PRODUCTS CO., LTD. |
JAMES CHU |
K040682 |
07/28/2004 |
SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE |
GRAND WORK PLASTIC PRODUCTS CO., LTD. |
JAMES CHU |
K041574 |
07/12/2004 |
CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 |
GUIDANT CORPORATION |
AMITA SHENAI |
K041340 |
07/28/2004 |
GUIDANT MICROWAVE ABLATION SYSTEM |
GUIDANT CORPORATION, CARDIAC SURGERY |
NANCY GALLO |
K041636 |
07/02/2004 |
H&S-CONDUCTIVITY STANDARD SOLUTION |
H & S TECHNICAL SERVICES |
JOHN HYTE |
K041081 |
07/01/2004 |
FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES |
HAND INNOVATIONS, INC. |
AL WEISENBORN |
K041157 |
07/30/2004 |
MODIFICATION TO SMALL BONE FIXATION SYSTEM |
HAND INNOVATIONS, INC. |
AL WEISENBORN |
K041391 |
07/09/2004 |
FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES |
HARTALEGA SDN BHD |
TITO ALDAPE |
K040896 |
07/16/2004 |
MODIFICATION TO ENCOMPASS |
HEARTLAB, INC. |
RICHARD PETROCELLI |
K041013 |
07/07/2004 |
SUILE OINTMENT WOUND DRESSING |
HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD. |
ERIC LUO, PH.D. |
K041001 |
07/01/2004 |
OMEGA 2 SYSTEM |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
K041233 |
07/28/2004 |
ARTHROJET XT |
HYDROCISION, INC. |
DEBBIE IMAMPIETRO |
K040923 |
07/22/2004 |
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA |
IBL GMBH |
Gary Lehnus |
K041702 |
07/16/2004 |
EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.) |
IBT SA |
RUTH FEICHT |
K041410 |
07/28/2004 |
PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118 |
ICU MEDICAL INC |
DALE FAIRCHILD |
K040782 |
07/13/2004 |
N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX |
IMAGE ANALYSIS, INC. |
BEN ARNOLD |
K040756 |
07/14/2004 |
THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX |
IMPLEX CORP. |
MARCI HALEVI |
K041761 |
07/13/2004 |
RAPIDIACOLON |
INFINITT CO., LTD. |
CARL ALLETTO |
K041103 |
07/27/2004 |
ACNELIFT |
INNER ACT, LLC |
RONNIE LAMBERTON |
K041583 |
07/22/2004 |
PEEK CEMENT RESTRICTOR X-BOX |
INNOVASIS, INC. |
BRENT A FELIX |
K041620 |
07/16/2004 |
NEURA WRAP NERVE PROTECTOR |
INTEGRA LIFESCIENCES CORP. |
DIANA M BORDON |
K040686 |
07/30/2004 |
M'ATH STD |
INTELLIGENCE IN MEDICAL TECHNOLOGIES |
SCOTT PEASE |
K040766 |
07/22/2004 |
OPTISOURCE, MODEL 1032P |
INTERNATIONAL BRACHYTHERAPY S.A. |
RUTH FEICHT |
K041794 |
07/19/2004 |
C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM |
INTERPORE CROSS INTL. |
WENDY SPIELBERGER |
K041449 |
07/01/2004 |
SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT |
INTERPORE CROSS INTL. |
WENDY SPIELBERGER |
K040237 |
07/07/2004 |
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND ENDOSCOPIC INSTRUMENTS |
INTUITIVE SURGICAL, INC. |
USHA KREADEN |
K041344 |
07/16/2004 |
OPEN BORE SYRINGE |
ISOTIS NV |
ELIANE SCHUTTE |
K041159 |
07/27/2004 |
JMS ABSORBABLE ANCHOR AND APPLICATOR |
JMS, INC. |
JOHN I SHIPP |
K033448 |
07/12/2004 |
ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER |
JOHN MFG., LTD. |
ARTHUR KING MA |
K033930 |
07/28/2004 |
KAPP CUSTOM ULNAR HEAD WRIST IMPLANT |
KAPP SURGICAL INSTRUMENT, INC. |
ALBERT SANTILLI |
K041678 |
07/23/2004 |
KARMA POWER WHEELCHAIR, MODEL KP-25 |
KARMA MEDICAL PRODUCTS CO., LTD. |
JEN KE-MIN |
K041151 |
07/22/2004 |
KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES |
KERBEROS PROXIMAL SOLUTIONS, INC. |
MICHAEL A DANIEL |
K041584 |
07/07/2004 |
KYPHX HV-R BONE CEMENT, MODEL C01A |
KYPHON, INC. |
CINDY DOMECUS |
K041454 |
07/09/2004 |
KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A |
KYPHON, INC. |
CINDY DOMESCUS |
K041624 |
07/16/2004 |
PTCA STEERABLE HYDROPHILIC GUIDEWIRE |
LAKE REGION MFG., INC. |
KAREN MORTENSEN |
K041446 |
07/01/2004 |
NASALCEASE |
LES LABORATORIRES BROTHIER, S.A. |
RICHARD J FREER, PH.D. |
K040844 |
07/23/2004 |
LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM |
LIFE SPINE, LLC. |
MICHAEL S BUTLER |
K041324 |
07/19/2004 |
CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER |
LIFECORE BIOMEDICAL, INC. |
KIM E AVES |
K041713 |
07/22/2004 |
SUPER REVO HERCULINE SUTURE ANCHOR |
LINVATEC CORP. |
ELIZABETH M PAUL |
K041128 |
07/29/2004 |
SUTURE ARROW |
LINVATEC CORP. |
ELIZABETH M PAUL |
K041105 |
07/28/2004 |
MACROPORE HYDROSORB SPINE SYSTEM |
MACROPORE BIOSURGERY, INC. |
KENNETH KLEINHENZ |
K041819 |
07/22/2004 |
GOODKNIGHT 425, MODELM-114500-00 |
MALLINCKRODT DEVELOPPEMENT FRANCE |
JAMES BONDS |
K040554 |
07/16/2004 |
ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256 |
MANUFACTURING TECHNOLOGY, INC. |
JOHN G SCHNEIDER |
K040576 |
07/01/2004 |
MICROMESAM BASIC-SET |
MAP MEDIZINTECHNIK FUR ARZT UND PATIENT GMBH |
DAVID D'CRUZ |
K041223 |
07/29/2004 |
MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E |
MAQUET CRITICAL CARE AB |
JAMIE YIEH |
K041815 |
07/29/2004 |
LNCS OXIMETRY SENSORS |
MASIMO CORP. |
JAMES J CRONIN |
K041327 |
07/20/2004 |
MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES |
MED2000 S.R.L. |
SUSAN D GOLDSTEIN-FALK |
K041326 |
07/27/2004 |
MEDCOMMONS OPEN RADIOLOGY GATEWAY |
MEDCOMMONS, INC. |
CHAS BURR |
K040992 |
07/29/2004 |
15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706 |
MEDCOMP |
JEAN CALLOW |
K041101 |
07/07/2004 |
MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001 |
MEDICAL ADHESIVEONLINE, LLC. |
ADAM SHAW |
K041600 |
07/27/2004 |
QWIKCHECK-BEADS |
MEDICAL ELECTRONICS SYSTEMS LTD. |
Erika B Ammirati |
K041807 |
07/22/2004 |
LUNG CAR 1.1 |
MEDICSIGHT |
CAROL MACDONALD |
K041162 |
07/27/2004 |
ORTHO-CMS |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
J.I. HOLLANDER |
K041789 |
07/15/2004 |
NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T |
MEDITEC CO., LTD. |
RONALD D ARKIN |
K041345 |
07/22/2004 |
PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES |
MEDIX, INC. |
BARBARA LAW |
K040841 |
07/08/2004 |
POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) |
MEDLINE INDUSTRIES, INC. |
JENNIFER MASON |
K041459 |
07/01/2004 |
LIFEPAK 12 DEFIBRILLATOR/MONITOR |
MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. |
MICHELLE ACKERMANN |
K041318 |
07/19/2004 |
MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP |
MEDTRONIC MINIMED |
MARK J FAILLACE |
K041317 |
07/19/2004 |
MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP |
MEDTRONIC MINIMED |
MARK J FAILLACE |
K041000 |
07/27/2004 |
DUREPAIR DURA REGENERATION MATRIX |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
K033926 |
07/07/2004 |
HOURGLASS VERTEBRAL BODY SPACER |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K041556 |
07/01/2004 |
MODIFICATION TO VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K041460 |
07/01/2004 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD TREHARNE |
K040483 |
07/23/2004 |
EQUESTRA FLUID DELIVERY SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
K041338 |
07/19/2004 |
MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES |
MEDTRONIC VASCULAR |
SCOTT CUNDY |
K041523 |
07/23/2004 |
XPS 3000 SYSTEM |
MEDTRONIC XOMED, INC. |
MARTIN D SARGENT |
K041413 |
07/12/2004 |
XPS 3000 SYSTEM |
MEDTRONIC XOMED, INC. |
MARTIN D SARGENT |
K031397 |
07/29/2004 |
MERLIN E-MASK |
MERLIN MEDICAL LIMITED |
ROBERT STEELE |
K031395 |
07/16/2004 |
MERLIN RESUSCITATOR |
MERLIN MEDICAL LIMITED |
ROGERT STEELE |
K041649 |
07/16/2004 |
SAPPHIRE NXT DETACHABLE COIL SYSTEM |
MICRO THERAPEUTICS, INC. |
FLORIN TRUUVERT |
K041302 |
07/01/2004 |
REFUGE SOUND GENERATOR |
MICRO-EAR TECHNOLOGY, INC. |
DEBORAH SHAFFER |
DEN040008 |
07/28/2004 |
CEDIA SIROLIMUS ASSAY |
MICROGENICS CORP. |
DAVID CASAL |
K041411 |
07/21/2004 |
MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP |
MICROLIFE CORP. |
SUSAN D GOLDSTEIN |
K041551 |
07/07/2004 |
MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
VINCENT CUTARELLI |
K030290 |
07/26/2004 |
PERIOLASE ND:YAG DENTAL LASER SYSTEM |
MILLENNIUM DENTAL TECHNOLOGIES, INC. |
DAVID M HARRIS |
K041286 |
07/21/2004 |
DYNACAD V1.0 |
MRI DEVICES CORP. |
TOM TYNES |
K041481 |
07/19/2004 |
MODEL BBC-127 BIOPSY BREAST COIL |
MRI DEVICES CORP. |
THOMAS E TYNES |
K040400 |
07/20/2004 |
MYO-TRODE SG DISPOSABLE ELECTRODE |
MYOTRONICS-NOROMED, INC. |
FRAY ADIB |
K041312 |
07/23/2004 |
NOBELRONDO DENTAL CERAMIC-ALUMINA |
NOBEL BIOCARE UAS INC |
ELIZABETH J MASON |
K040019 |
07/23/2004 |
SILVERSEAL |
NOBLE FIBER TECHNOLOGIES |
PATRICIA DAVIDSON |
K040439 |
07/08/2004 |
MDI TRIGGER GUARD |
NORTH AMERICAN TECHNICAL SERVICES (NATS) CORP. |
RICHARD LANZILLOTTO |
K033614 |
07/29/2004 |
MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215 |
NORTHGATE TECHNOLOGIES, INC. |
CASEY KUREK |
K041719 |
07/22/2004 |
ONCENTRA-VISIR |
NUCLETRON CORP. |
LISA DIMMICK |
K041424 |
07/02/2004 |
NXSTAGE SYSTEM ONE |
NXSTAGE MEDICAL, INC. |
NORMA LEMAY |
K041793 |
07/16/2004 |
OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 |
OLYMPUS AMERICA, INC. |
BEV HARDING |
K041494 |
07/01/2004 |
OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2 |
OLYMPUS CORPORATION |
TINA STEFFANIE-OAK |
K041664 |
07/29/2004 |
PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C |
ON SITE GAS SYSTEMS, INC. |
C. BART GULLONG |
K033826 |
07/01/2004 |
ORTHOPEDIC ALLIANCE SPINE SYSTEM |
ORTHOPEDIC ALLIANCE LLC |
ROGER WILLIAMS |
K031701 |
07/08/2004 |
OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM |
OSTEOMED L.P. |
DAWN T HOLDEMAN |
K041148 |
07/15/2004 |
POCONE INFRARED SPECTROPHOTOMETER |
OTSUKA PHARMACEUTICAL CO., LTD. |
CYNTHIA A SINCLAIR, RAC |
K040988 |
07/07/2004 |
ZIRCON-F PROPHYLAXIS PASTE |
PASCAL CO., INC. |
VINCENT M TENTARELLI |
K041665 |
07/23/2004 |
L1-PRO SYSTEM |
PELIKAN TECHNOLOGIES, INC |
JACK S GREEN |
K041043 |
07/02/2004 |
VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 |
PHARMACIA DEUTSCHLAND GMBH |
MICHAEL LINSS |
K041674 |
07/19/2004 |
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT |
PHILIPS MEDICAL SYSTEMS |
J.P. OUELLETTE |
K041949 |
07/30/2004 |
ALLURA XPER FD10 |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
LYNN HARMER |
K041602 |
07/26/2004 |
PANORAMA 1.0T |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
JOSEPH S ARNAUDO |
K041741 |
07/21/2004 |
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN |
PHILIPS MEDICAL SYSTEMS, INC. |
BARRY WYSHOGROD |
K041955 |
07/29/2004 |
GEMINI PET/CT IMAGING SYSTEM |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
RAE ANN FARROW |
K040416 |
07/02/2004 |
SONICARE ADVANCE TOOTHBRUSH, MODEL 4900 |
PHILIPS ORAL HEALTHCARE, INC. |
ROSE DEGIACOMO |
K041942 |
07/23/2004 |
M2376A DEVICELINK SYSTEM |
PHILLIPS MEDICAL SYSTEMS |
HERBERT VAN DYK |
K040565 |
07/22/2004 |
PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE |
PHYSICIAN INDUSTRIES, INC. |
BRIAN BAKER |
K033739 |
07/12/2004 |
PHYSICIAN INDUSTRIES' DURAMETER SYRINGE |
PHYSICIAN INDUSTRIES, INC. |
BRIAN BAKER |
K041675 |
07/23/2004 |
PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS |
PIE MEDICAL |
CARRI GRAHAM |
K041682 |
07/27/2004 |
CAAS MRV |
PIE MEDICAL IMAGING B.V. |
CARLA DE VRIES |
K041167 |
07/23/2004 |
PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN M GILBERT |
K033951 |
07/01/2004 |
RADIX CERVICAL PLATE |
PISHARODI SURGICALS, INC. |
J. D WEBB |
K041750 |
07/23/2004 |
PTS PANELS CHOL+GLU TEST PANEL |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
K040693 |
07/06/2004 |
PTS PANELS LDL CHOLESTEROL TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
K040851 |
07/16/2004 |
MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM |
POREX SURGICAL, INC. |
HOWARD MERCER |
K032239 |
07/30/2004 |
THERA-CREAM, MODEL TCT004 |
PRIZM MEDICAL, INC. |
JULIE STEPHENS |
K041336 |
07/20/2004 |
PRO WALKER PL-200 POWER WHEELCHAIR |
PRO WALKER INC. |
JEN KE-MIN |
K040999 |
07/09/2004 |
TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES) |
PROCTER & GAMBLE CO. |
MARK M ANDERSON |
K041004 |
07/02/2004 |
ILLUSION POWDER FREE-POLYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE) |
PURNABINA SDN BHD |
LIEW YOON FONG |
K041607 |
07/16/2004 |
QUINTON Q-TE; RMS |
QUINTON CARDIOLOGY, INC. |
KAREN BROWNE |
K040266 |
07/09/2004 |
CORE NEEDLE BIOPSY |
REMINGTON MEDICAL, INC. |
MARIA P GRANITO |
K041362 |
07/15/2004 |
RESMED HOSPITAL FULL FACE MASK |
RESMED LTD. |
DAVID D'CRUZ |
K041209 |
07/01/2004 |
RESMED S8 PIONEER CPAP SYSTEM |
RESMED LTD. |
DAVID D'CRUZ |
K041568 |
07/21/2004 |
EOCD |
RESPIRONICS, INC. |
LOU ANNE KINNEY |
K040417 |
07/28/2004 |
PILLAR PALATAL IMPLANT SYSTEM |
RESTORE MEDICAL INC. |
EDWARD W NUMAINVILLE |
K031858 |
07/29/2004 |
NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
K041321 |
07/09/2004 |
VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
K041812 |
07/27/2004 |
MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC) |
ROCHE DIAGNOSTICS CORP. |
THERESA M AMBROSE |
K041816 |
07/19/2004 |
RTX3320PSTN WIRELESS TELEHEALTH GATEWAY |
RTX HEALTHCARE A/S |
NIELS OLE ANDERSEN |
K041441 |
07/22/2004 |
SAS INFLUENZA A TEST |
SA SCIENTIFIC, INC. |
RICARDO R MARTINEZ |
K041439 |
07/22/2004 |
SAS INFLUENZA B TEST |
SA SCIENTIFIC, INC. |
RICARDO R MARTINEZ |
K041646 |
07/22/2004 |
THERMOTEK Q5 |
SAAT LTD. |
E.J. Smith |
K040498 |
07/02/2004 |
MYSHELL |
SEDAT S.A. |
PETER C WOOD |
K041084 |
07/15/2004 |
CLIP-ON SPACER 20%; 40%; 50% |
SERONO, INC. |
PAMELA WILLIAMSON JOYCE |
K041763 |
07/13/2004 |
SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES |
SHIMADZU CORP. |
TAKESHI OZAKI |
K041111 |
07/16/2004 |
MAGNETOM C! MR SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NEALIE HARTMAN |
K041112 |
07/21/2004 |
MAGNETOM ESPREE SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NEALIE HARTMAN |
K041484 |
07/30/2004 |
UNDECIDED |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
RICHARD K ANDERSEN |
K041029 |
07/08/2004 |
KINETDX |
SIEMENS MEDICAL SOLUTIONS, INC. |
ANA LADINO |
K040970 |
07/08/2004 |
LEONARDO |
SIEMENS MEDICAL SYSTEMS, INC. |
ANA LADINO |
K041465 |
07/23/2004 |
SINON SN-L402 LIGHTWEIGHT WHEELCHAIR |
SINON CORPORATION |
JEN KE-MIN |
K041355 |
07/30/2004 |
HUMERAL STAPLE |
SMITH & NEPHEW, INC. |
JOHN REABE |
K041106 |
07/01/2004 |
REVISION KNEE SYSTEM |
SMITH & NEPHEW, INC. |
KIM KELLY |
K041328 |
07/27/2004 |
SMITH & NEPHEW ELECTROBLADE RESECTOR/ADAPTOR |
SMITH & NEPHEW, INC. |
KAREN PROVENCHER |
K041453 |
07/22/2004 |
SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023 |
SMITH & NEPHEW, INC. |
KAREN PROVENCHER |
K041348 |
07/13/2004 |
PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA |
SMITHS MEDICAL |
BARRY SMITH |
K041399 |
07/28/2004 |
HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE |
SMITHS MEDICAL ASD, INC. |
BRIAN D FARIAS |
K033655 |
07/30/2004 |
SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR |
SOFLEX CONTACT LENS INDUSTRIES LTD. |
Kevin Walls |
K040382 |
07/13/2004 |
CRANEX BASEX D OR CRANEX EXCEL D |
SOREDEX PALODEX GROUP OY |
KAI LANER |
K040096 |
07/01/2004 |
SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM |
SPINAL CONCEPTS, INC. |
LISA PETERSON |
K033953 |
07/06/2004 |
OPTIMESH 500E CEMENT RESTRICTOR |
SPINEOLOGY, INC. |
PAMELA SNYDER |
K041559 |
07/30/2004 |
55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55 |
SPIRE BIOMEDICAL INC |
DONALD FICKETT |
K032937 |
07/01/2004 |
NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500 |
STEREOTAXIS, INC. |
PETER A TAKES |
K041558 |
07/02/2004 |
STOCKERTIR PURGE CONTROL (APC) SYSTEM |
STOCKERT INSTRUMENTE GMBH |
ROSINA ROBINSON |
K040107 |
07/27/2004 |
CYTO-CHEX BCT |
STRECK LABORATORIES, INC. |
KERRIE OETTER |
K041174 |
07/19/2004 |
CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196 |
SWEDEN DIAGNOSTICS (GERMANY) GMBH |
MICHAEL LINSS |
K041354 |
07/16/2004 |
VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 |
SWEDEN DIAGNOSTICS (GERMANY) GMBH |
MICHAEL LINSS |
K041474 |
07/21/2004 |
MAXCEM |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
K041842 |
07/23/2004 |
NORIAN SRS FAST SET PUTTY |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K041350 |
07/08/2004 |
SYNTHES (USA) CHRONOS |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K040978 |
07/22/2004 |
TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE |
TANITA CORP. OF AMERICA |
RHODA L VALERA |
K040466 |
07/16/2004 |
BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS |
THE BINDING SITE |
JAY H GELLER |
K041070 |
07/23/2004 |
STRAUMANN TEMPORARY COPING |
THE STRAUMANN CO. |
LINDA JALBERT |
K041737 |
07/13/2004 |
5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A) |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
K041534 |
07/27/2004 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL |
TREK DIAGNOSTIC SYSTEMS, LTD. |
CYNTHIA C KNAPP |
K031088 |
07/23/2004 |
TRIMED PLAN, VERSION 2.2 |
TRIMED SYSTEMS, INC |
SHERRY ZHANG |
K033105 |
07/13/2004 |
CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT |
TRINITY BIOTECH USA |
BONNIE DEJOY |
K033106 |
07/13/2004 |
CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT |
TRINITY BIOTECH USA |
Bonnie B DeJoy |
K041243 |
07/07/2004 |
DOVER RED RUBBER ROBINSON CATHETER |
TYCO HEALTHCARE |
WEI ZHAO |
K040897 |
07/20/2004 |
DOVER ROB-NEL CATHETER |
TYCO HEALTHCARE |
WEI ZHAO |
K040649 |
07/15/2004 |
KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE |
TYCO HEALTHCARE |
GAIL CHRISTIE |
K041608 |
07/07/2004 |
C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS |
UNILENS CORP., USA |
JOSEPHA BRUNO |
K040961 |
07/08/2004 |
INJECTOR NEEDLE/SNARE |
UNITED STATES ENDOSCOPY GROUP, INC. |
GRETCHEN Y COHEN |
K041544 |
07/22/2004 |
COOK SIDEARM CORE TISSUE BIOPSY DEVICE |
UROLOGICAL INC. |
CINDY RUMPLE |
K041695 |
07/23/2004 |
LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE |
USA INSTRUMENTS, INC. |
JAMES WRENN |
K041403 |
07/26/2004 |
ECLIPSE WITH AAA |
VARIAN MEDICAL SYSTEMS |
VY TRAN |
K041092 |
07/01/2004 |
FAST START TENS, MODEL FS 3001 |
VISION QUEST INDUSTRIES, INC. |
JAIME X PULLEY |
K041473 |
07/15/2004 |
VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
JAMES LEE |
K041423 |
07/21/2004 |
VIABIL BILIARY ENDOPROSTHESIS |
W. L. GORE & ASSOCIATES, INC. |
Michael Ivey |
K033313 |
07/28/2004 |
QUATRO M FEMORAL COMPONENT |
WHITESIDE BIOMECHANICS, INC. |
AMY CRANMER |
K040930 |
07/02/2004 |
ZILVER BILIARY STENT SYSTEM USW |
WILSON-COOK MEDICAL, INC. |
MARGE WALLS-WALKER |
K040980 |
07/14/2004 |
ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE SCAFFOLD, MODELS 860C, 86XC, 86DR, 860D, 860T |
WRIGHT MEDICAL TECHNOLOGY, INC. |
ROGER D BROWN |
K041586 |
07/09/2004 |
PROFEMUR S HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
JEANINE H REDDEN |
K040938 |
07/01/2004 |
RADIAL NAIL SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB ESMAIL |
K041469 |
07/30/2004 |
ANTERIOR COMPACT SYSTEM |
X-SPINE SYSTEMS |
JANET M WEBB |
K041109 |
07/20/2004 |
ZIMMER ANATOMIC II HIP PROSTHESIS |
ZIMMER, INC. |
DALENE T BINKLEY |