FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K040857 |
05/10/2004 |
MODIFICATION TO ADPER PROMPT |
3M ESPE AG DENTAL PRODUCTS |
ANDREAS PETERMANN |
K040371 |
05/19/2004 |
A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR |
A & D ENGINEERING, INC. |
JERRY WANG |
K040410 |
05/05/2004 |
GREENLIGHT 300 |
A C COSSOR & SON (SURGICAL) LIMITED |
A J COSSOR |
K040954 |
05/11/2004 |
FOX PLUS PTA CATHETER |
ABBOTT LABORATORIES INC |
JOANNA KUSKOWSKI |
K040629 |
05/05/2004 |
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE |
ACCU-STAT DIAGNOSTICS, INC. |
JAMES G BARRONS |
K040274 |
05/03/2004 |
ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
K040445 |
05/19/2004 |
ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
K040587 |
05/14/2004 |
MINI GAMMA CAMERA, MODEL MGC-500 |
ACRORAD CO., LTD. |
T. WHIT ATHEY |
K040949 |
05/07/2004 |
VIADUCT MINISCOPE AND ACCESSORIES |
ACUEITY, INC. |
NANCY LINCE |
K041218 |
05/24/2004 |
GRIFFIN SPECT/CT IMAGING SYSTEM |
ADAC LABORATORIES |
COLEEN A COLEMAN |
K041182 |
05/21/2004 |
SYNTEGRA |
ADAC LABORATORIES |
JOY M SACMAR |
K032644 |
05/28/2004 |
KOLPEXIN SPHERE |
ADAMED LTD. |
NORMAN I BRUCKNER |
K040017 |
05/14/2004 |
ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE) |
AESCULAP, INC. |
JONI L SWOVELAND |
K040463 |
05/12/2004 |
AESKULISA CARDIOLIPIN AGM |
AESKU, INC |
STANLEY AMMONS |
K040555 |
05/26/2004 |
IMPAX CLIENT EMBRACE |
AGFA CORP. |
PHIL CUSCUNA |
K040344 |
05/12/2004 |
IMPAX OT3000 ORTHOPEDIC WORKSTATION |
AGFA CORP. |
PHIL CUSCUNA |
K033008 |
05/13/2004 |
AIR SAFETY HEPA AND NON-HEPA FILTERS |
AIR SAFETY LTD |
PAUL DRYDEN |
K040293 |
05/28/2004 |
HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY |
AKERS LABORATORIES, INC. |
BARBARA A BAGBY |
K040735 |
05/21/2004 |
ALM X'TEN (X10) SURGICAL LIGHT SYSTEM |
ALM S.A. |
FREDERICK R CATT |
K033990 |
05/12/2004 |
ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM |
ALVEOLUS, INC. |
HOWARD L SCHRAYER |
K040464 |
05/17/2004 |
AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST |
AMEDICA BIOTECH, INC. |
Jeff Chen |
K040623 |
05/17/2004 |
AMS PERIGEE SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
ELSA A LINKE |
K040995 |
05/25/2004 |
SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150 |
ANALOGIC CORP. |
DONALD J SHERRATT |
K033722 |
05/07/2004 |
APAPORE BONE GRAFT SUBSTITUTE |
APATECH LTD. |
BARRY SALL |
K041137 |
05/14/2004 |
NEWTOM 3G QR-DVT 9000 |
APERIO SERVICES, LLC |
K. ROBERT WISNER |
K041131 |
05/13/2004 |
APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR |
APPLE MEDICAL CORP. |
JOHN C PULFORD |
K041152 |
05/24/2004 |
THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A |
APPLIED DIABETES RESEARCH, INC. |
JIM BARLEY |
K040666 |
05/14/2004 |
STEP-TIP CHRONIC HEMODIALYSIS CATHETER |
ARROW INTERNATIONAL, INC. |
BRANDON EPTING |
K040801 |
05/06/2004 |
INTRA-AORTIC BALLOON (IAB) |
ARROW INTL., INC. |
WILLIAM PAQUIN |
K040381 |
05/12/2004 |
HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15 |
ARTHREX, INC. |
SALLY FOUST |
K040500 |
05/25/2004 |
ARTHROTEK LACTONAIL |
ARTHROTEK, INC. |
TRACY J BICKEL |
DEN040003 |
05/21/2004 |
GLUCATELL |
ASSOCIATES OF CAPE COD, INC. |
STACY SUBERG |
K030396 |
05/07/2004 |
OMNI~NEB; OMNI~MAX |
B & B MEDICAL TECHNOLOGIES, INC. |
STEPHEN W BRIGGS |
K041071 |
05/14/2004 |
BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381 |
BECTON DICKINSON & CO. |
JING ZHANG |
K040603 |
05/19/2004 |
PARADIGM LINK BLOOD GLUCOSE METER |
BECTON DICKINSON & CO. |
JOHN SCHALAGO |
K033458 |
05/28/2004 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
K040716 |
05/14/2004 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PENICILLIN (GP) 0.0625-32 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
K040822 |
05/19/2004 |
LIQUICHEK TORCH PLUS IGM CONTROL |
BIO-RAD LABORATORIES, INC. |
MARIA KEBALLOS |
K040600 |
05/07/2004 |
GENEX BONE GRAFT SUBSTITUTE |
BIOCOMPOSITES LTD. |
J. STEPHEN BRATT |
K040265 |
05/28/2004 |
LITTLE GRAFTER SCREW |
BIOCOMPOSITES LTD. |
J. STEPHEN BRATT |
K033627 |
05/21/2004 |
Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM |
BIOMEDIX, INC. |
JUDY S CHEN |
K041046 |
05/21/2004 |
MAXIM ACCEL (VANGUARD) PS+ BEARINGS |
BIOMET, INC. |
TRACY J BICKEL |
K040475 |
05/21/2004 |
MICROMAX SUTURE ANCHOR |
BIOMET, INC. |
KACY ARNOLD |
K032747 |
05/11/2004 |
BIOTOP DJT-A SAFETY SYRINGE |
BIOTOP TECHNOLOGY CO., LTD. |
Ke-Min Jen |
K040893 |
05/06/2004 |
EASY CORE BIOPSY SYSTEM |
BOSTON SCIENTIFIC CORP. |
CHRISTINE M CAMERON |
K040736 |
05/18/2004 |
VAXCEL PLUS CHRONIC DIALYSIS CATHETER |
BOSTON SCIENTIFIC CORP. |
NICHOLAS CONDAKES |
K040585 |
05/11/2004 |
EXACTRAC 4.0 AND EXACTRAC X-RAY 6D |
BRAINLAB AG |
RAINER BIRKENBACH |
K033316 |
05/14/2004 |
TABLE TILT DEVICE |
BRAINLAB AG |
RAINER BIRKENBACH |
K040504 |
05/14/2004 |
BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS |
C.R. BARD, INC. |
JOHN C KNORPP |
K040957 |
05/21/2004 |
NOA III ENTERAL NUTRITION PUMP |
CAESAREA MEDICAL ELECTRONICS LTD. |
GALI TZURY |
K040152 |
05/19/2004 |
BONE CEMENT FOR CRANIOPLASTY |
Cardinal Health |
SHARON NICHOLS |
K033789 |
05/07/2004 |
LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING |
Cardinal Health |
ERICA SETHI |
K033364 |
05/11/2004 |
CHAD THERAPEUTICS SAGE |
CHAD THERAPEUTICS, INC. |
KEVIN MCCULLOH |
K041060 |
05/07/2004 |
E-Z LUBRICATING JELLY |
CHESTER LABS, INC. |
JOHN B ARMSTRONG |
K040424 |
05/11/2004 |
LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120 |
CLARUS MEDICAL, LLC. |
TOM BARTHEL |
K033983 |
05/21/2004 |
VITALAB IRON REAGENT |
CLINICAL DATA, INC. |
WYNN STOCKING |
K040927 |
05/17/2004 |
LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS |
CLINIQA CORPORATION |
CAROL RUGGIERO |
K040740 |
05/10/2004 |
ENDOTINE TRANSBLEPH DEVICE |
COAPT SYSTEMS, INC. |
LORI DONDIEGO |
K040403 |
05/10/2004 |
COLLAGEN WOUND DRESSING - ORAL |
COLLAGEN MATRIX, INC. |
PEGGY HANSEN |
K033869 |
05/17/2004 |
CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.) |
COLOPLAST CORP. |
ELIZABETH BOOTS |
K041098 |
05/13/2004 |
COOL TEMP NATURAL |
COLTENE AG |
H.J. VOGELSTEIN |
K030810 |
05/05/2004 |
COOLAN 300 |
COOLANALGESIA LTD. |
PETER WILKINSON |
K033912 |
05/11/2004 |
CRADLE PACS |
CRADLE TECHNOLOGY CORP. |
JEN KE-MIN |
K041028 |
05/14/2004 |
CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL |
CROWN DELTA CORP. |
MARK P KONOPKA |
K040809 |
05/21/2004 |
CRYMED CRYO-ABLATOR |
CRYMED TECHNOLOGIES, INC. |
FRANK MAJEROWICZ |
K040552 |
05/28/2004 |
MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130 |
CRYOCOR, INC. |
JAMI MILLER |
K031327 |
05/12/2004 |
VERICOR |
CVP DIAGNOSTICS, INC. |
T. WHIT ATHEY |
K041095 |
05/26/2004 |
PHOTOSILK PULSED LIGHT SYSTEM |
CYNOSURE, INC. |
GEORGE CHO |
K033550 |
05/05/2004 |
DXL CALSCAN |
DEMETECH AB |
JOAKIM ARWIDSON |
K040895 |
05/21/2004 |
INTEGRITY TEMPORARY CEMENT |
DENTSPLY INTL. |
P. JEFFERY LEHN |
K041064 |
05/13/2004 |
BIOKNOTLESS RC ANCHOR |
Depuy Mitek |
ALLYSON BARFORD |
K041065 |
05/07/2004 |
PANALOK RC LOOP ANCHOR |
Depuy Mitek |
ALLYSON BARFORD |
K041117 |
05/28/2004 |
PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732 |
Depuy Mitek |
ALLYSON BARFORD |
K041116 |
05/28/2004 |
SUPER QUICKANCHOR PLUS |
Depuy Mitek |
ALLYSON BARFORD |
K041115 |
05/28/2004 |
GII QUICKANCHOR PLUS |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
ALLYSON BARFORD |
K041135 |
05/10/2004 |
VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
RUTH C FORSTADT |
K033273 |
05/06/2004 |
DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADS |
DEPUY ORTHOPAEDICS, INC. |
Natalie Heck |
K040268 |
05/05/2004 |
DEPUY PRESERVATION UNICONDYLAR TIBIA |
DEPUY ORTHOPAEDICS, INC. |
ABRAHAM WRIGHT |
K040383 |
05/12/2004 |
TRIFLANGE II ACETABULAR CUP SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
DINA L WEISSMAN |
K040544 |
05/28/2004 |
DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062 |
DEPUY, INC. |
DINA L WEISSMAN |
K040602 |
05/10/2004 |
SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS |
DESIGN STANDARDS CORP. |
MICHELE LUCEY |
K041061 |
05/06/2004 |
D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS |
DIDECO S.P.A. |
BARRY SALL |
K040939 |
05/12/2004 |
SKY BONE EXPANDER SYSTEM (SKY SYSTEM) |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
YAEL RUBIN |
K041087 |
05/12/2004 |
INFINITY GAMMA |
Draeger Medical Systems, Inc. |
PENELOPE H GRECO |
K033957 |
05/14/2004 |
INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL |
Draeger Medical Systems, Inc. |
PENELOPE H GRECO |
K040945 |
05/12/2004 |
MODIFICATION TO INFINITY EXPLORER |
Draeger Medical Systems, Inc. |
PENELOPE H GRECO |
K040069 |
05/05/2004 |
DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR |
DYMEDIX, INC. |
Gary Syring |
K040457 |
05/19/2004 |
NOMAD FROM DYNAMIS MOBILITY LTD. |
DYNAMIS MOBILITY LTD. |
RUTH LYTLE |
K040378 |
05/24/2004 |
KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 |
EASTMAN KODAK COMPANY |
SUSAN PATE |
K040480 |
05/25/2004 |
SONOTRAX ULTRASONIC POCKET DOPPLER |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
K040982 |
05/13/2004 |
COLOR LCD MONITOR, MODEL RADIFORCE R12 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
K040397 |
05/06/2004 |
MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEM |
ENCORE MEDICAL, L.P. |
DEBBIE DE LOS SANTOS |
K024215 |
05/14/2004 |
ENERTRON CPR JACK |
ENERTRON ENGINEERING CO. |
Ke-Min Jen |
K040641 |
05/05/2004 |
ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1 |
EPICOR MEDICAL, INC. |
KATHI GUERRANT |
K040877 |
05/04/2004 |
ARTOSCAN C |
ESAOTE S.P.A. |
CARRI GRAHAM |
K041145 |
05/14/2004 |
MODIFICATION TO E-SCAN XQ MRI SYSTEM |
ESAOTE S.P.A. |
CARRI GRAHAM |
K033596 |
05/10/2004 |
CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT |
EXACTECH, INC. |
GARY MILLER |
K032522 |
05/28/2004 |
TECRES SPACER-K TEMPORARY KNEE PROSTHESIS |
EXACTECH, INC. |
GARY J MILLER |
K040914 |
05/27/2004 |
POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS |
EXERO PRODUCTS, INC. |
MARTIN DALSING |
K040506 |
05/05/2004 |
FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A |
FISHER & PAYKEL HEALTHCARE, LTD. |
JAMES THOMPSON |
K041164 |
05/20/2004 |
L-TENS |
FUJI DYNAMICS LIMITED |
ANTHONY AH YIN, SHUM |
K040246 |
05/26/2004 |
FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR |
FUKUDA DENSHI USA, INC. |
LARRY D WALKER |
K040255 |
05/24/2004 |
POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE |
GAMBRO RENAL PRODUCTS, INC. |
JEAN WILLEY |
K041267 |
05/27/2004 |
CARDIQ ANALYSIS III |
GENERAL ELECTRIC MEDICAL SYSTEMS |
LARRY A KROGER |
K041270 |
05/27/2004 |
CT COLONOGRAPHY II |
GENERAL ELECTRIC MEDICAL SYSTEMS |
LARRY A KROGER |
K040442 |
05/20/2004 |
PROTEX STABILIZATION SYSTEM |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
K041025 |
05/03/2004 |
BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED |
GOLDEN TECHNOLOGIES, INC. |
GENE R KULON |
K040881 |
05/25/2004 |
METACRYL |
GREAT LAKES ORTHODONTICS, LTD. |
MARK LAUREN |
K041067 |
05/25/2004 |
HEARTSINE SAMARITAN PAD |
HEARTSINE TECHNOLOGIES, INC. |
WILLIAM J SMIRLES |
K041230 |
05/20/2004 |
CLINICAL LABORATORY ANALYZING SYSTEM |
HEMOCUE, INC. |
R.J. SLOMOFF |
K031673 |
05/25/2004 |
REFOBACIN -PALACOS G |
HERAEUS KULZER GMBH & CO. KG |
K.-D. KUHN |
K040859 |
05/20/2004 |
HERACERAM PRESS |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
K040779 |
05/17/2004 |
RESTORE WOUND CLEANSER |
HOLLISTER, INC. |
JOSEPH S TOKARZ |
K040964 |
05/28/2004 |
SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS |
HOWMEDICA OSTEONICS CORP |
KAREN ARIEMMA |
K033971 |
05/28/2004 |
SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING |
HOWMEDICA OSTEONICS CORP |
DENISE DUCHENE |
K040267 |
05/05/2004 |
TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE |
HOWMEDICA OSTEONICS CORP |
MARGARET F CROWE |
K041160 |
05/27/2004 |
AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT |
HOWMEDICA OSTEONICS CORP. |
MARGARET F CROWE |
K040337 |
05/24/2004 |
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP) |
I-FLOW CORP. |
SHANE NOEHRE |
K041185 |
05/14/2004 |
TORSO ARRAY COIL, MODEL 558GE-64 |
IGC-MEDICAL ADVANCES, INC. |
ANTHONY DIETZLER |
K040153 |
05/21/2004 |
I-TEC PORTABLE DENTAL OPERATORY |
INDIGENOUS PEOPLES TECHNOLOGY AND EDUCATION CENTER |
JESSE SAINT |
K033623 |
05/21/2004 |
CELSIUS CONTROL SYSTEM |
INNERCOOL THERAPIES, INC. |
STEVE REITZLER |
K032818 |
05/13/2004 |
INOGEN ONE OXYGEN CONCENTRATOR |
INOGEN, INC. |
JOHN WELLS |
K041295 |
05/24/2004 |
RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANT |
INSTITUT STRAUMANN AG |
JOHN KING |
K040879 |
05/10/2004 |
QUANTEX FERRITIN |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K040146 |
05/04/2004 |
INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM |
INTERLAB S.R.L. |
Gary Lehnus |
K032322 |
05/13/2004 |
CLEAR-THERM MICRO HME, MODEL 1441 |
INTERSURGICAL, INC. |
MICHAEL ZALEWSKI |
K040948 |
05/05/2004 |
INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170 |
INTUITIVE SURGICAL, INC. |
MICHAEL H YRAMATEGUI |
K041072 |
05/12/2004 |
KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHT |
INVACARE CORPORATION |
CARROLL L MARTIN |
K040639 |
05/21/2004 |
ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE |
ISURGICAL |
KEN LEISER |
K032897 |
05/27/2004 |
C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96 |
IVD RESEARCH, INC. |
DAVE LAMBILLOTTE |
K040795 |
05/17/2004 |
MULTICORE HB; MULTICORE FLOW |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
K040951 |
05/19/2004 |
SR ADORO |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
K032977 |
05/25/2004 |
JMS BYPASS TUBE |
JMS NORTH AMERICA CORP. |
SWEE C CHONG |
K040388 |
05/17/2004 |
NEXT GENERATION SALEM SUMP |
KENDALL |
JIM WELSH |
K041006 |
05/19/2004 |
TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR |
KENDALL |
JAMES WELSH |
K041291 |
05/21/2004 |
RINSPIRATION SYSTEM |
KERBEROS PROXIMAL SOLUTIONS, INC. |
TOM MASON |
K033189 |
05/04/2004 |
KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305 |
KING SYSTEMS CORP. |
TOM MCGRAIL |
K040677 |
05/20/2004 |
COMBI SELF PROPELLED SHOWER COMMODE |
KJAERULFF REHABILITATION A/S |
PHILIP L HARRIS |
K040598 |
05/13/2004 |
KLS MARTIN HAND PLATING SYSTEM |
KLS-MARTIN L.P. |
JENNIFER DAMATO |
K040891 |
05/28/2004 |
KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES) |
KLS-MARTIN L.P. |
JENNIFER DAMATO |
K040825 |
05/17/2004 |
LAKE REGION HYDROPHILIC GUIDEWIRE |
LAKE REGION MFG., INC. |
KAREN MORTENSEN |
K040936 |
05/03/2004 |
PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE |
LEDA CO., LTD. |
DAVID J BLOCH |
K033899 |
05/20/2004 |
LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR |
LIFESTREAM TECHNOLOGIES, INC. |
JACKSON CONNOLLY |
K033885 |
05/19/2004 |
BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) |
Lin-Zhi International, Inc. |
CHENG-I LIN, PH.D. |
K032894 |
05/07/2004 |
OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, |
LINVATEC BIOMATERIALS, INC. |
TUIJA ANNALA |
K040317 |
05/07/2004 |
IVC SYSTEM |
MARK H. FRIEDMAN |
MARK H FRIEDMAN |
K033849 |
05/25/2004 |
SIMPLANT SYSTEM |
MATERIALISE N.V. |
CARL VAN LIERDE |
K040427 |
05/03/2004 |
FIBREX CATHETER PATENCY DEVICE |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
K033197 |
05/13/2004 |
INOGEN SATELLITE CONSERVER |
MEDICAL ELECTRONIC DEVICES, INC. |
THOMAS WENZEL |
K032170 |
05/28/2004 |
TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 |
MEDICAL INDUSTRIES AMERICA, INC. |
ANNE B CARLSON |
K040461 |
05/25/2004 |
ECONOLITH E3000, MODEL 3000 (SW-6) |
MEDISPEC, LTD. |
SHERYL D SKINNER |
K041054 |
05/25/2004 |
MEDLINE STRIDER MAXI 3 |
MEDLINE INDUSTRIES, INC. |
ANDREA HAFERKAMP |
K041055 |
05/25/2004 |
MEDLINE STRIDER MAXI 4 |
MEDLINE INDUSTRIES, INC. |
MARGARET STEPHENS |
K041053 |
05/25/2004 |
MEDLINE STRIDER MICRO 3 |
MEDLINE INDUSTRIES, INC. |
MARGARET STEPHENS |
K040818 |
05/07/2004 |
MEDLINE STRIDER MINI 3 |
MEDLINE INDUSTRIES, INC. |
ANDREA HAFERKAMP |
K040838 |
05/07/2004 |
MEDLINE STRIDER MINI 4 |
MEDLINE INDUSTRIES, INC. |
MARGARET STEPHENS |
K032517 |
05/18/2004 |
MEDSAFE CLICKSAFE SAFETY ANTISTICK SYRINGE WITH HYPODERMIC NEEDLE |
MEDSAFE TECHNOLOGIES LLC. |
JAY MANSOUR |
K040676 |
05/21/2004 |
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715 |
MEDTRONIC MINIMED |
MIRIELLE MENGOTTO |
K041118 |
05/28/2004 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K040962 |
05/14/2004 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K040536 |
05/05/2004 |
MODIFICATION TO VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K041217 |
05/28/2004 |
MODIFICATION TO BONE GRAFT WASHER |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
K033540 |
05/25/2004 |
TRANSXCHANGE SUPPORT CATHETER |
MEDTRONIC VASCULAR |
LEISA MARTINEZ |
K024245 |
05/10/2004 |
ENVOY PATIENT MONITOR |
MENNEN MEDICAL LTD. |
EREZ NIMROD |
K041056 |
05/12/2004 |
10-SECOND DIGITAL THERMOMETER, MODELS ST87, ST89, ST80, ST88 |
MESURE TECHNOLOGY CO.,LTD. |
ROGER LU |
K033688 |
05/19/2004 |
MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY |
MICRO DIRECT, INC. |
DAVID STASZAK |
K033457 |
05/25/2004 |
M2 COMPATIBLE MICROKERATOME BLADE |
MICRO SPECIALTIES, INC. |
LEIGH S AYRES |
K041073 |
05/21/2004 |
DOCUMENT SALICYLATE CAL VER |
MICROGENICS CORP. |
DAVID CASAL |
K040411 |
05/27/2004 |
DRI OXYCODONE ASSAY |
MICROGENICS CORP. |
DAVID CASAL |
K040758 |
05/28/2004 |
MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT |
MICROGENICS CORP. |
DAVID CASAL |
K041058 |
05/17/2004 |
MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS |
MISONIX, INC. |
RONALD R MANNA |
K040652 |
05/17/2004 |
VUE 100 ULTRASOUND IMAGING SYSTEM |
MOBILSONIC, INC. |
BAO LE |
K032965 |
05/13/2004 |
LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
DAVID LOU |
K033003 |
05/13/2004 |
SUCTION COAGULATOR |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
DAVID LOU |
K030413 |
05/11/2004 |
Y2K2 ENTERNAL FEEDING MANAGER |
MOSS MEDICAL PRODUCTS |
GERALD MOSS |
K033642 |
05/25/2004 |
SMARTLANK WIRELESS, MODEL 001970 |
MRL, A WELCH ALLYN COMPANY |
DAVID KLEMENTOWSKI |
K041228 |
05/17/2004 |
MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODEL HPL-200 |
MYTECH TECHNOLOGY CO., LTD. |
JEN KE-MIN |
K033142 |
05/19/2004 |
POWERED WHEELCHAIR |
NATS CORP. |
STEPHEN T MLCOCH |
K033324 |
05/10/2004 |
COMPRESSION ANASTOMOSIS CLIP (CAC) |
NITI MEDICAL TECHNOLOGIES LTD. |
ORLY MAOR |
K041283 |
05/28/2004 |
PROCERA BRIDGE ZIRCONIA |
NOBEL BIOCARE AB |
ELIZABETH J MASON |
K041236 |
05/26/2004 |
PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 |
NOBEL BIOCARE AB |
ELIZABETH J MASON |
K041275 |
05/27/2004 |
PROCERA ABUTMENT OCTAGON |
NOBEL BIOCARE UAS INC |
ELIZABETH J MASON |
K033307 |
05/06/2004 |
NVISION DATA MANAGEMENT SOFTWARE |
NONIN MEDICAL, INC. |
JOHN R DALPEE |
K032397 |
05/27/2004 |
DUAL YELLOW LASER, MODEL DUAL YELLOW D10B |
NORSELD PTY., LTD. |
ROGER W BARNES |
K041016 |
05/07/2004 |
NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
K041093 |
05/06/2004 |
NUMED MULLINS X PTA CATHETER |
NUMED, INC. |
NICHELLE LAFLESH |
K040696 |
05/26/2004 |
MODIFICATION TO NXSTAGE SYSTEM ONE |
NXSTAGE MEDICAL, INC. |
NORMA LEMAY |
K040664 |
05/28/2004 |
OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004 |
OMNILIGHT, INC. |
RICK MURDOCK |
K041032 |
05/10/2004 |
MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS |
ORBUS MEDICAL TECHNOLOGIES |
DAVID L CAMP |
K040011 |
05/13/2004 |
POLARIS 2004 CAPNOGRAPH |
ORIDION LTD. |
DOMINIC CORSALE |
K040514 |
05/03/2004 |
EOVIA CALCIUM PHOSPHATE CERAMIC |
ORTHOTEC, L.L.C. |
PATRICK BERTRANOU |
K040225 |
05/06/2004 |
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM |
OSTEOIMPLANT TECHNOLOGY, INC. |
SAM SON |
K033018 |
05/05/2004 |
STIMULONG PLUS CATHETER SET MODEL, VARIOUS |
PAJUNK GMBH |
BURK A BRANDT |
K033833 |
05/05/2004 |
EFLOW ELECTRONIC INHALER/NEBULIZER |
PARI INNOVATIVE MANUFACTURERS, INC. |
LAWRENCE WEINSTEIN |
K040519 |
05/20/2004 |
SLIP UROLOGY CATHETER |
PERCUTANEOUS SYSTEMS, INC. |
HOWARD M HOLSTEIN |
K040520 |
05/20/2004 |
SLIP UROLOGY INTRODUCER SHEATH |
PERCUTANEOUS SYSTEMS, INC. |
HOWARD M HOLSTEIN |
K040575 |
05/20/2004 |
PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 |
PHAMATECH INC. |
CARL MONGIOVI |
K040452 |
05/11/2004 |
VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096 |
PHARMACIA DEUTSCHLAND GMBH |
MICHAEL LINSS |
K040450 |
05/11/2004 |
VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996 |
PHARMACIA DEUTSCHLAND GMBH |
MICHAEL LINSS |
K040449 |
05/11/2004 |
VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 |
PHARMACIA DEUTSCHLAND GMBH |
MICHAEL LINSS |
K040451 |
05/11/2004 |
VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896 |
PHARMACIA DEUTSCHLAND GMBH |
MICHAEL LINSS |
K040810 |
05/14/2004 |
VARELISA HISTONE ANTIBODIES, MODEL 16496 |
PHARMACIA DEUTSCHLAND GMBH |
MICHAEL LINSS |
K040811 |
05/13/2004 |
VARELISA SSDNA ANTIBODIES, MODEL 14896 |
PHARMACIA DEUTSCHLAND GMBH |
MICHAEL LINSS |
K040404 |
05/04/2004 |
HEARTSTART MRX, MODEL M3535A |
PHILIPS MEDICAL SYSTEMS, INC. |
PETER OHANIAN |
K040955 |
05/12/2004 |
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN |
PHILIPS MEDICAL SYSTEMS, INC. |
DAVID OSBORN |
K040294 |
05/05/2004 |
LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980 |
PHOTOMEDEX, INC. |
BOB ROSE |
K040090 |
05/27/2004 |
COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS) |
PNEUPAC LTD. |
DONALD ALEXANDER |
K040013 |
05/18/2004 |
ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT |
POSSIS MEDICAL, INC. |
MARK STENOIEN |
K031357 |
05/18/2004 |
GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM |
POSSIS MEDICAL, INC. |
MARK STENOIEN |
K041337 |
05/28/2004 |
PRO WALKER ML-300 FOLDABLE WHEELCHAIR |
PRO WALKER INC. |
JEN KE-MIN |
K040312 |
05/03/2004 |
TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS |
PROCTER & GAMBLE CO. |
MARK M ANDERSON |
K040296 |
05/24/2004 |
PHOSPHOPLASTIN RL |
R2 DIAGNOSTICS, INC. |
PEGGY S CARTER |
K040350 |
05/12/2004 |
RANDOX AMPHETAMINE CLASS ASSAY |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
K040570 |
05/10/2004 |
RANDOX METHADONE ASSAY |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
K040856 |
05/03/2004 |
RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER |
RAPID AID LTD. |
ANNA OLASZ |
K033566 |
05/17/2004 |
MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062 |
RAPID DIAGNOSTICS, INC. |
ROBIN J HELLEN |
K032914 |
05/25/2004 |
MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS |
RAVEN BIOLOGICAL LABORATORIES, INC. |
WENDY ROYALTY-HANN |
K034033 |
05/05/2004 |
RESCAN |
RESMED LTD. |
DAVID D'CRUZ |
K032755 |
05/21/2004 |
MODEL 509M PULSE OXIMETER, MODEL 509M |
RESPIRONICS NOVAMETRIX, INC. |
MICHAEL MALIS |
K041010 |
05/05/2004 |
REMSTAR AUTO WITH C-FLEX CPAP SYSTEM |
RESPIRONICS, INC. |
ZITA A YURKO |
K021845 |
05/20/2004 |
STARDUST II, MODEL 1011176 |
RESPIRONICS, INC. |
ZITA YURKO |
K033747 |
05/17/2004 |
RAMP CK-MB ASSAY |
RESPONSE BIOMEDICAL CORP. |
WILLIAM J RADVAK |
K033745 |
05/17/2004 |
RAMP TROPONIN I ASSAY |
RESPONSE BIOMEDICAL CORP. |
WILLIAM J RADVAK |
K040679 |
05/07/2004 |
RICH-MAR AUTOPRISM INFRARED LAMP |
RICH-MAR CORP. |
DAVID RICHARDS |
K040174 |
05/14/2004 |
BILIRUBIN ASSAY ON THE OMNI S ANALYZER |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
K040733 |
05/17/2004 |
ELECSYS TROPONIN T STAT TEST |
ROCHE DIAGNOSTICS CORP. |
THERESA M AMBROSE |
K041227 |
05/27/2004 |
MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA |
ROCHE DIAGNOSTICS CORP. |
THERESA M AMBROSE |
K030474 |
05/28/2004 |
PH BUFFERING PLASTIC APPLICATOR TAMPON |
ROSTAM LTD. |
JONATHAN S KAHAN |
K030869 |
05/14/2004 |
BITESTRIP |
S.L.P. LTD. |
TAMAR SHOCHAT |
K040454 |
05/07/2004 |
BIOFILL BONE VOID FILLER |
SCIENT'X |
J.D. WEBB |
K040376 |
05/04/2004 |
SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE |
SECTRA-IMTEC AB |
CARL ALLETTO |
K032927 |
05/07/2004 |
FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR |
SEIN ELECTRONICS CO., LTD. |
JAY MANSOUR |
K040870 |
05/17/2004 |
SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS |
SHIMADZU CORP. |
TAKESHI OZAKI |
K040406 |
05/14/2004 |
POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE) |
SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. |
JANNA P TUCKER |
K041166 |
05/17/2004 |
SIEMENS ENHANCED IMAGING SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
FRANK POKROP |
K040656 |
05/25/2004 |
MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW |
SMITH & NEPHEW, INC. |
JANET AKIL |
K040929 |
05/25/2004 |
TRIGEN ADOLESCENT TAN |
SMITH & NEPHEW, INC. |
KIM KELLY |
K040636 |
05/19/2004 |
CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET |
SMITHS MEDICAL MD, INC. |
PATRICIA A LAFORTE |
K031738 |
05/27/2004 |
SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER |
SMITHS MEDICAL MD, INC. |
RUSS DAVIES |
K041176 |
05/17/2004 |
URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM |
SOFRADIM PRODUCTION |
MARY MCNAMARA-CULLINANE |
K033663 |
05/27/2004 |
SPINAL CONCEPTS INC. CODA |
SPINAL CONCEPTS, INC. |
LISA PETERSON |
K041099 |
05/06/2004 |
MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP |
SPS MEDICAL SUPPLY CORP. |
GARY J SOCOLA |
K041154 |
05/18/2004 |
S-SCORT...JR QUICKDRAW, MODEL 2400 |
SSCOR |
SAM D SAY |
K040165 |
05/12/2004 |
REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805 |
ST. JUDE MEDICAL |
GLENN JACQUES |
K040688 |
05/11/2004 |
STANDARD IMAGING E.IMRT CALCULATOR |
STANDARD IMAGING, INC. |
RAYMOND T RIDDLE |
K032945 |
05/25/2004 |
SIMPLEX X |
STRYKER CORP. |
DANNIELLE WHEELER |
K040390 |
05/17/2004 |
STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM |
Stryker Endoscopy |
CHRISTOPHER L COOK |
K040412 |
05/25/2004 |
TRIDENT T ACETABULAR SHELLS |
STRYKER ORTHOPAEDICS |
GINNY STAMBERGER |
K040477 |
05/18/2004 |
MONODERM |
SURGICAL SPECIALTIES CORP. |
ELIZABETH LAZARO |
K040588 |
05/07/2004 |
SYNTHES (USA) 2.4 MM LCP WRIST PLATE |
SYNTHES (USA) |
LISA M BOYLE |
K041290 |
05/24/2004 |
RTA MODEL D RETINAL THICKNESS ANALYZER |
TALIA TECHNOLOGY LTD. |
JONATHAN S KAHAN |
K040920 |
05/10/2004 |
AMYLASE LIQUID REAGENT, MODEL A532-200 |
TECO DIAGNOSTICS |
JIAN VAECHES |
K040669 |
05/03/2004 |
CERAFORM BONE VOID FILLER |
TEKNIMED SA |
J.D. WEBB |
K041358 |
05/28/2004 |
VENOJECT LUER ADAPTER |
TERUMO EUROPE N.V. |
SANDI HARTKA |
K033216 |
05/04/2004 |
BZ-576 NON-INVASIVE AUTOMATIC BLOOD PRESSURE MONITOR |
THE BUZZ GROUP, LLC |
DANIEL KAMM, P.E. |
K040646 |
05/03/2004 |
STRAUMANN GRANULES |
THE STRAUMANN CO. |
LINDA JALBERT |
K030941 |
05/14/2004 |
AEQUALIS REVERSED SHOULDER PROSTHESIS |
TORNIER |
DONALD F GRABARZ |
K041027 |
05/14/2004 |
DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR, MODEL DFP8000D |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
MICHAELA MAHL |
K040196 |
05/05/2004 |
KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS |
TYCO HEALTHCARE/KENDALL |
BRIDGET GARDNER |
K040208 |
05/11/2004 |
NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND |
TZ MEDICAL, INC. |
MADALYN DUNCAN |
K032761 |
05/14/2004 |
KMC-950 C-ARM MOBILE SYSTEM |
UNITED RADIOLOGY SYSTEMS, INC. |
JOHN W LEE |
K040829 |
05/20/2004 |
GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR |
VASCUTEK LTD. |
STEVEN ARICK |
K032400 |
05/07/2004 |
LAFACI |
VISION PRO, L.L.C. |
WAYNE H MATELSKI |
K040581 |
05/27/2004 |
MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM |
VITEL NET |
ALLEN IZADPANAH |
K032154 |
05/07/2004 |
G-FREEZEKIT BLAST |
VITROLIFE AB |
GARY L YINGLING |
K032155 |
05/07/2004 |
G-THAWKIT BLAST |
VITROLIFE AB |
GARY L YINGLING |
K032877 |
05/07/2004 |
G-OOCYTE |
VITROLIFE SWEDEN AB |
GARY L YINGLING |
K033101 |
05/07/2004 |
G-PGD |
VITROLIFE SWEDEN AB |
GARY L YINGLING |
K033704 |
05/27/2004 |
MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS |
VYGON US LLC |
COURTNEY SMITH |
K033670 |
05/05/2004 |
GORE TRI-LOBE BALLOON CATHETER |
W. L. GORE & ASSOCIATES, INC. |
BRANDON HANSEN |
K032575 |
05/19/2004 |
FIRST SIGN DRUG OF ABUSE SCREENING TEST |
W.H.P.M., INC. |
FRAN WHITE |
K041273 |
05/20/2004 |
ONE-STEP PREGNANCY TEST |
W.H.P.M., INC. |
FRAN WHITE |
K040918 |
05/17/2004 |
WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2 |
WAKO CHEMICALS, USA, INC. |
LORI CREASY |
K030425 |
05/14/2004 |
LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
K040983 |
05/05/2004 |
LORENZ SELF-DRILLING IMF SCREW |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
K040990 |
05/13/2004 |
MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
K040384 |
05/14/2004 |
MYDON C |
WAVELIGHT LASER TECHNOLOGIE AG |
MAUREEN O'CONNELL |
K040433 |
05/19/2004 |
SINON |
WAVELIGHT LASER TECHNOLOGIE AG |
MAUREEN O'CONNELL |
K041190 |
05/25/2004 |
A&I POWER WHEELCHAIR, PC-401 |
WELL SUCCESS BIOTECH INC. |
JEN KE-MIN |
K041187 |
05/25/2004 |
A&I SCOOTER, SC-301 |
WELL SUCCESS BIOTECH INC. |
JEN KE-MIN |
K041193 |
05/25/2004 |
A&I SCOOTER, SC-402 |
WELL SUCCESS BIOTECH INC. |
JEN KE-MIN |
K040512 |
05/27/2004 |
LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401 |
WELL-LIFE HEALTHCARE, INC. |
MIKE PRICE |
K040672 |
05/27/2004 |
PORTA REFLEX |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
K040524 |
05/20/2004 |
PORTA SOLDER 1090 W |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
K040981 |
05/07/2004 |
USW NEEDLEKNIFE PAPILLOTOME |
WILSON-COOK MEDICAL, INC. |
MARGE WALLS-WALKER |
K040324 |
05/20/2004 |
WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH |
WILSON-COOK MEDICAL, INC. |
MARGE WALLS-WALKER |
K041114 |
05/28/2004 |
PROFEMUR TAPERED HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KATIE LOGEROT |
K032016 |
05/11/2004 |
DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC ACID AND VITAMIN E, AND WITH PROTEIN CONTENT |
WRP SPECIALTY PRODUCTS SDN. BHD. |
V. NADARAJAN |
K031517 |
05/26/2004 |
ZARGIS ACOUSTIC CARDIOSCAN |
ZARGIS MEDICAL CORP. |
SHAHRAM HEJAZI |
K040389 |
05/17/2004 |
COONRAD/MORREY ELBOW CEMENT RESTRICTOR |
ZIMMER, INC. |
NOAH J BARTSCH |
K033474 |
05/21/2004 |
ZOLL AED PLUS |
ZOLL MEDICAL CORP. |
PAUL DIAS |