FDA 510(k) Decisions During May, 2004  

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
K032373 05/21/2004 GLUCATELL ASSOCIATES OF CAPE COD, INC. STACY SUBERG
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
K040962 05/14/2004 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K041118 05/28/2004 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
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