FDA 510(k) Decisions During April, 2004  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K034051 04/05/2004 DYNATRAC, COD. 50-1A 3D LINE USA, INC. NADER SALEHI
K040814 04/15/2004 MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM ABBOTT LABORATORIES TRACEY H WIELINSKI
K040667 04/07/2004 XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008 ABBOTT LABORATORIES JOANNA KUSKOWSKI
K040761 04/30/2004 AXSYM CYCLOSPORINE ABBOTT LABORATORIES INC GRACE LEMIEUX
K040327 04/19/2004 ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC) ACCU-STAT DIAGNOSTICS, INC. JAMES G BARRONS
K040621 04/14/2004 ACELL UBM SURGICAL MESH ACELL, INC PATSY J TRISLER
K040084 04/07/2004 LIFESTYLE CIRCULATORY ENHANCER ADVANCED CIRCULATORY SYSTEMS, INC. GARY SYRING
K033148 04/12/2004 ART ANTERIOR SPINAL SYSTEM ADVANCED MEDICAL TECHNOLOGIES AG J.D. WEBB
K040742 04/02/2004 MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE ADVANCED STERILIZATION PRODUCTS KEVIN CORRIGAN
K040709 04/28/2004 PROTOS SOFTWARE AKTINA MEDICAL PHYSICS CORP. TONY SPACCAROTELLA
K040537 04/22/2004 AMS APOGEE VAULT SUSPENSION SYSTEM AMERICAN MEDICAL SYSTEMS, INC. ELSA A LINKE
K040402 04/19/2004 ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K033198 04/30/2004 APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2 APOZA ENTERPRISE CO. LTD. SHIH MIN-TEH
K030784 04/01/2004 NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL APPLIED MEDICAL TECHNOLOGY, INC. CHRIS ZANTOPULOS
K040117 04/21/2004 UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT ARROW INDUSTRIES LLC ROBERT SYMINGTON
K040802 04/28/2004 HEMOSONIC 200HEMODYNAMIC MONITOR ARROW INTL., INC. WILLIAM G MCLAIN
K033397 04/09/2004 AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY AVITA CORPORATION GEO LIN
K040365 04/28/2004 COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV FRANK FERGUSON
K040158 04/12/2004 MFCD 2320 BARCO NV FRANK FERGUSON
K033005 04/19/2004 MFGD 1318 18 INCH 1 MEGAPIXEL GREYSCALE LCD DISPLAY BARCO NV BARCOVIEW FRANK FERGUSON
K033004 04/16/2004 MFGD 2320 20 INCH 2 MEGAPIXEL GREYSCALE LCD DISPLAY BARCO NV BARCOVIEW FRANK FERGUSON
K033103 04/16/2004 MGD 2621L MEDICAL GREYSCALE DISPLAY BARCO NV BARCOVIEW FRANK FERGUSON
K033104 04/19/2004 MGD 2621P MEDICAL GREYSCALE DISPLAY BARCO NV BARCOVIEW FRANK FERGUSON
K033006 04/20/2004 MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE BARCO NV BARCOVIEW FRANK FERGUSON
K040339 04/08/2004 BRACHYTHERAPY STRAND DEVICE BEBIG ISOTOPEN-UND MEDIZINTECHNIK GMBH SVEN LANGER
K033362 04/09/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE BECTON DICKINSON & CO. MICHELLE B BANDY
K033907 04/09/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5 - 16/304 UG/ML BECTON, DICKINSON & CO. KATHRYN BABKA POWERS
K040784 04/07/2004 PROTAB ECG TABB ELECTRODE BIO PROTECH, INC. E.J. SMITH
K040056 04/09/2004 BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90 BIO-DETEK, INC. ROBERT MORSE
K040256 04/09/2004 PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005 BIO-DETEK, INC. ROBERT MORSE
K023916 04/15/2004 BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294 BIO-MEDICAL RESEARCH, LTD. MICHELLE SAWYER
K040872 04/15/2004 VARIANT II HEMOGLOBIN A1C BIO-RAD LABORATORIES, INC. JACKIE BUCKLEY
K040824 04/29/2004 INTERFERENTIAL STIMULATOR, MODEL BMLS03-6 BIOMEDICAL LIFE SYSTEMS, INC. GARY BUSSETT
K040770 04/22/2004 VANGUARD PATELLA COMPONENTS BIOMET MANUFACTURING, INC. PATRICIA SANDBORN BERES
K033611 04/27/2004 CALCIGEN -NAP BONE VOID FILLER BIOMET, INC. MARY L VERSTYNEN
K033871 04/16/2004 IM TOTAL FEMUR BIOMET, INC. PATRICIA SANDBORN BERES
K040773 04/09/2004 PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM BIONIX DEVELOPMENT CORP. JAMES HUTTNER
K040352 04/02/2004 NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL) BIORESOURCE TECHNOLOGY, INC. ALAN POSNER
K032976 04/16/2004 BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001 BIOVALVE TECHNOLOGIES, INC. SCOTT HUIE
K031982 04/02/2004 BIRDSONG LEVERHALER, MODEL LH-1000 BIRDSONG MEDICAL DEVICES INC ERIC FUGELSANG
K040787 04/14/2004 MODIFICATION TO SURGICAL MESH POLYMERIC BOSTON SCIENTIFIC DONNA M GARDNER
K040776 04/29/2004 ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 35975 BOSTON SCIENTIFIC CORP. ROBERT Z PHILLIPS
K040785 04/28/2004 CONCERTO BIPOLAR NEEDLE ELECTRODE BOSTON SCIENTIFIC CORP. NICHOLAS CONDAKES
K040342 04/13/2004 INTERLOCKING DETACHABLE COIL SYSTEM (IDC) BOSTON SCIENTIFIC CORP. ARTHUR FRIEDMAN
K040867 04/30/2004 PERIVAC KIT, MODELS 4304, 4305, 4314, 4315 BOSTON SCIENTIFIC CORP. RONALD C ALLEN
K040148 04/22/2004 RESOLUTION HEMOSTASIS CLIPPING DEVICE BOSTON SCIENTIFIC CORP. JAMES D MCMAHON
K040643 04/07/2004 BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES BRANEMARK INTEGRATION AB JAN-OLOF DJERF
K040797 04/02/2004 BRITESMILE MASKING CREAM BRITESMILE, INC. SHEILA HEMEON-HEYER
K033905 04/27/2004 PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING CARDINAL HEALTH ERICA SETHI
K033085 04/27/2004 PORTACLAMP CARDIO LIFE RESEARCH, S.A. JAMES R VEALE
K033123 04/20/2004 STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE CARL ZEISS MEDITEC INC R. MICHAEL CROMPTON
K040468 04/23/2004 CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO CEDARA SOFTWARE CORP. CAROL NAKAGAWA
K040285 04/12/2004 VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER CHATTANOOGA GROUP MICK DAVIS
K040489 04/27/2004 AQUADEX SYSTEM 100, MODEL A1100 CHF SOLUTIONS, INC. AMY PETERSON
K040910 04/21/2004 INFANT INCUBATOR, MODEL CHS-I1000 CHOONGWAE MEDICAL CORP. RONALD D ARKIN
K032951 04/02/2004 CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A CHRONO-LOG CORP. NICHOLAS J VERIABO
K040821 04/23/2004 COALESCENT SURGICAL U-CLIP AND ACCESSORIES COALESCENT SURGICAL MICHAEL A DANIEL
K040194 04/23/2004 COMPUMEDICS SUMMIT IP COMPUMEDICS USA, LTD. ELVIRA GARCIA
K032734 04/08/2004 CONVATEC FECAL MANAGEMENT SYSTEM CONVATEC, A BRISTOL-MYERS SQUIBB CO. NANCY REGULSKI
K040127 04/06/2004 COOK URETERAL BALLOON DILATION CATHETER SET COOK UROLOGICAL, INC. DEBBIE SCHMITT
K033875 04/02/2004 ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER COOK, INC. KAREN BRADBURN
K032139 04/05/2004 REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826 CORGENIX, INC. NANCI DEXTER
K040690 04/29/2004 SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE CRYOCATH TECHNOLOGIES, INC. FLOR DEL PILAR ARANA
K033183 04/15/2004 RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012 CURELIGHT LTD JONATHAN S KAHAN
K040289 04/30/2004 SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER CYNOSURE, INC. GEORGE CHO
K031601 04/02/2004 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML) DADE BEHRING, INC. ROBERT EUSEBIO
K040133 04/08/2004 URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE DADE BEHRING, INC. ANDREA M TASKER
K040743 04/22/2004 MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM DATEX-OHMEDA, INC. DAN KOSEDNAR
K040055 04/07/2004 POLYLASE LP DDC TECHNOLOGIES, INC. DMITRY DONSKOY
K040313 04/06/2004 HRV TOOLS DEL MAR REYNOLDS MEDICAL, LTD. GEORGE MYERS
K033925 04/07/2004 BIOFREE DENTAL COMPONENTS, INC. RICHARD W HANSON
K040144 04/01/2004 QUIXX POSTERIOR RESTORATIVE DENTSPLY INTERNATIONAL P JEFFERY LEHN
K040375 04/02/2004 IDEAL 1 ORTHODONTIC BAND CEMENT DENTSPLY INTL. P. JEFFERY LEHN
K040197 04/02/2004 EAGLE ANTERIOR CERVIAL PLATE SYSTEM DEPUY ACROMED LISA GILMAN
K040004 04/13/2004 ORTHOCORD SUTURE DEPUY MITEK RUTH C FORSTADT
K040827 04/30/2004 PANALOK LOOP ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON COMPANY ALLYSON BARFORD
K040644 04/08/2004 MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD DEPUY ORTHOPAEDICS, INC. REBECCA L LENNARD
K040718 04/02/2004 TRUST DHD HEALTHCARE CORP. DAVID GEARY
K030366 04/19/2004 BICARD MIXING SYSTEM DIALYSIS SYSTEMS, INC. MARK VESLIGAJ
K040553 04/01/2004 MODIFICATION TO ACCULEAF DIREX SYSTEMS CORP. LARISA GERSHTEIN
K040470 04/28/2004 TRIPTER X-1 COMPACT DIREX SYSTEMS CORP. LARISA GERSHTEIN
K032794 04/05/2004 CUSTODIOL DR. FRANZ KOHLER CHEMIE GMBH T. WHIT ATHEY
K040188 04/14/2004 INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K033498 04/26/2004 NARKOMED 6400, MODEL NM6400 DRAEGER MEDICAL, INC. GALE E WINARSKY
K040116 04/20/2004 HAWK INTRAORAL CAMERA AND ACCESSORIES DXM CO., LTD. CAROLANN KOTULA
K040605 04/26/2004 DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100 DYMEDIX, INC. GARY SYRING
K040556 04/07/2004 TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY EASTMAN KODAK COMPANY DONALD ELLIS
K040253 04/08/2004 EASY MED TN-28 C EASYMED INSTRUMENT CO., LTD. WU TINGJIE
K040482 04/16/2004 EBI ESL SPINE SPACER SYSTEM EBI, L.P. FREDERIC TESTA
K040833 04/29/2004 MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM EBI, L.P. FREDERIC TESTA
K040287 04/26/2004 VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR EDWARDS LIFESCIENCES, LLC. PAULA A TORRIANNI
K040367 04/07/2004 MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ ELECTROMED, INC. CHET SIEVERT
K040909 04/20/2004 SONO TT ULTRASONIC FLOWCOMPUTER EM-TEC GMBH ANDREAS KNABE
K033963 04/15/2004 EP DEFLECTABLE CATHETERS EP MEDSYSTEMS, INC. JAMES E KUHN, JR.
K033337 04/01/2004 ULTRAPRO MESH ETHICON, INC. REY LIBROJO
K040653 04/28/2004 PARAMOUNT MINI GPS BILIARY STENT SYSTEM EV3 INC MARIA E BRITTLE
K033153 04/23/2004 DICOM THEATER FERGUSON MEDICAL FRANK FERGUSON
K040052 04/09/2004 FINE SURGICAL CIRCUMCISION CLAMP FINE SURGICAL INSTRUMENT CORP. CAROLANN KOTULA
K033710 04/13/2004 MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU FISHER & PAYKEL HEALTHCARE, LTD. BRETT WHISTON
K040622 04/16/2004 FREEDOM HP FREEDOM DESIGNS, INC. GINNY S MALOCO
K040567 04/22/2004 GC INITIAL MC, AL AND LF GC AMERICA, INC. TERRY L JORITZ
K040172 04/07/2004 MODIFICATION TO GE DISCOVERY LS SYSTEM GE MEDICAL SYSTEMS LARRY A KROGER
K040125 04/19/2004 SENOGRAPHIC STEREO GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K040444 04/14/2004 GE SIGNA 3.0T WITH EXCITE MR SYSTEM GENERAL ELECTRIC CO. LARRY A KROGER
K033864 04/02/2004 GENZYME OSOM TRICHOMONAS RAPID TEST GENZYME CORP. E.V. GOORCHENKO
K040702 04/27/2004 SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE GRAND WORK PLASTIC PRODUCTS CO., LTD. JAMES CHU
K033116 04/12/2004 OPTI-RIDER DELUXE HANSUNG ECONET CO., LTD. CYNTHIA J.M. NOLTE
K033133 04/13/2004 TELECARE D.R. SERVER SOFTWARE SYSTEM HEALTHCARE VISION, INC. CRAIG WALKER
K040902 04/21/2004 HITACHI PRESTO HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUGLAS THISTLETHWAITE
K040793 04/14/2004 FELCARE POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES HL RUBBER PRODUCTS SDN BHD KOK-KEE HON
K040884 04/23/2004 LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM HOLOGIC, INC. GAIL YAEKER-DAUNIS
K033972 04/12/2004 SCORPIO TOTAL KNEE SYSTEM HOWMEDICA OSTEONICS CORP DENISE DUCHENE
K032797 04/05/2004 DELIGHT DENTAL ER: YAG LASER SYSTEM HOYA PHOTONICS, INC. THOMAS HANEY
K040440 04/27/2004 HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS) HTTP HYPOTHERMIA THERAPY DORITH BAR-ADON
K033290 04/12/2004 TALON INFUSION SET, MODEL IP XXXX ICU MEDICAL, INC. DALE FAIRCHILD
K033098 04/27/2004 OSTEOGEN SBRG IMPLADENT, LTD. MAURICE VALEN
K033072 04/01/2004 LUCENTLITE, MODEL IMD 010 INDUSTRIAL & MEDICAL DESIGN, INC. YEVGENIY KUKLIN
K040029 04/05/2004 SAFETYNET GUIDEWIRE INTRODUCER INJECTIMED, INC. GEORGE C BRDLIK
K040714 04/09/2004 HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT INNOVA CORP. HOWARD HOLSTEIN
K040855 04/16/2004 INSTRUMED LAPAROSCOPE AND ACCESSORIES INSTRUMED INTERNATIONAL, INC. HAIKO BELL
K040843 04/30/2004 HEMOSIL VON WILLEBRAND ACTIVITY INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K040235 04/20/2004 LICOX PMO BRAIN MONITORING SYSTEM INTEGRA LIFESCIENCES CORPORATION NANCY MATHEWSON
K040282 04/29/2004 ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID INTERNACIONAL FARMACEUTICA, S.A. DE C.V. CAROLANN KOTULA
K033961 04/14/2004 ALTIUS OCT SYSTEM INTERPORE CROSS INTL. WENDY SPIELBERGER
K040168 04/08/2004 MODIFICATION TO GEO STRUCTURE INTERPORE CROSS INTL. WENDY SPIELBERGER
K032981 04/22/2004 SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09 INVAMED TECHNOLOGIES INC. TIM DUVALL
K034063 04/26/2004 MULTIBLAST MEDIUM IRVINE SCIENTIFIC SALES CO., INC. WENDELL LEE
K033770 04/08/2004 ISOAID ADVANTAGE PD-103, MODEL IAPD-103A ISOAID, L.L.C. MAX TAGHIZADEH
K040614 04/07/2004 BLUEWAND LED DENTAL CURING WAND SYSTEM J.L. BLOSSER, INC. LARRY L BLOSSER
K031457 04/28/2004 ENDOMAT LC PUMP, MODEL 20 3303 20 KARL STORZ ENDOSCOPY-AMERICA, INC. PAUL S LEE
K032806 04/16/2004 KATALYST RADIAL HEAD IMPLANT KINETIKOS MEDICAL, INC. JOHN G SPAMPINATO
K033186 04/14/2004 KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 KING SYSTEMS CORP. TOM MCGRAIL
K040094 04/15/2004 PIGGYBACK IRRIGATING SYSTEM KOSIN TECHNOLOGIES, LLC AVTAR S DHINDSA
K023064 04/06/2004 HEMOCLEAN KRD CO., LTD JEFFERY R SHIDEMAN
K033801 04/01/2004 KYPHX HV-R, MODEL C01A KYPHON, INC. CINDY DOMECUS
K040401 04/12/2004 LANX ANTERIOR CERVIAL PLATE SYSTEM LANX, LLC DAVID W SCHLERF
K040752 04/07/2004 DOSI-FUSER LEVENTON, S.A. JOAQUIM SORIANO
K033866 04/07/2004 CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS) LIN-ZHI INTERNATIONAL, INC. CHENG-I LIN
K032447 04/16/2004 CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED LINVATEC BIOMATERIALS, LTD. TUIJA ANNALA
K040771 04/23/2004 MODIFICATION TO OUTBACK CATHETER LUMEND, INC. MICHAEL A DANIEL
K030071 04/26/2004 SERVO GUARD, MODEL 64 81 290 EH88E MAQUET, INC. JAMIE YIEH
K040259 04/22/2004 MASIMO SET INTELLIVUE PULSE OXIMETER MODULE MASIMO CORP. JAMES J CRONIN
K040122 04/14/2004 MAYO CLINIC BC-10 3.0T MAYO CLINIC JADE SADOSTY
K032568 04/29/2004 BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193 MED TEXTILE, LLC BRITTNEY GILL
K040899 04/30/2004 MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP MEDEX, INC. BARBARA LAW
K040228 04/29/2004 MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122 MEDI-STIM A/S JON H HOEM
K040880 04/28/2004 MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K040193 04/27/2004 MODEL GST-1 MEDICAL EQUIPMENT DEVICE SPECIALISTS C.A. TEKLINSKI
K040852 04/23/2004 PREVIEW TREATMENT PLANNING SOFTWARE MEDICAL MEDIA SYSTEMS, INC. PATSY J TRISLER
K040042 04/01/2004 MEDISIL SILICONE SHEETING MEDISIL CORPORATION ALASTAIR WINN
K032848 04/12/2004 MEDSAFE SYSTEM INSERTER MEDSOLVE TECHNOLOGIES LLC SUSAN MCCONNELL
K033888 04/02/2004 MSI MODEL S-500 RF GENERATOR MEDSPHERE INTERNATIONAL, INC ERIC KAO
K040061 04/08/2004 MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C MEDTRONIC MINIMED GERDA P RESCH
K040775 04/23/2004 LIFEPAK 12 MEDTRONIC PHYSIO-CONTROL CORP. MICHELLE ACKERMANN
K034056 04/21/2004 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K033077 04/30/2004 EASYTEM DUO, FOREHEAD/EAR THERMOMETER, MODEL BT-021 METATECH CO., LTD. GUENTER GINSBERG
K033534 04/22/2004 VITALSENSE MINI-MITTER CO., INC. JACK E MCKENZIE
K033505 04/27/2004 RENACLEAN SH DIALYZER CLEANING SYSTEM MINNTECH CORP. RICHARD M ORMSBEE
K040937 04/23/2004 TEM 3000 HEAD COIL MR INSTRUMENTS, INC. GENE BERGHOFF
K033946 04/05/2004 LOVELY SYSTEM MSQ (M2) LTD. ANNE WORDEN
K040495 04/22/2004 NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405 NAIMCO, INC. ROBERT L MCCLURE
K033114 04/26/2004 KETOCHECKS NEO DIAGNOSTICS, INC SUNG PYO
K040786 04/19/2004 VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING NEO METRICS, INC. GENE CHAMPEAU
K040584 04/22/2004 NMX-1000 NEOMEDIX CORP. SOHEILA MIRHASHEMI
K040131 04/20/2004 COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYSTEM NEW STAR LASERS, INC. DONALD V JOHNSON
K033727 04/22/2004 NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY NICHOLS INSTITUTE DIAGNOSTICS ROBERT L SCHMIDT
K040892 04/29/2004 MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 NIDEK MEDICAL PRODUCTS, INC. JENNIFER MCWILLIAMS
K040573 04/28/2004 NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236 NOBEL BIOCARE UAS INC ELIZABETH J MASON
K033171 04/27/2004 NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING NORTHERN IMPLANTS, LLC GRETA HOLS
K030989 04/01/2004 OSTEOSORB TACK FIXATION SYSTEM NOVIACE CORPORATION ALBERT ENAYATI
K040543 04/01/2004 NUVASIVE NEUROVISION JJB SYSTEM NUVASIVE, INC. LAETITIA BERNARD
K033546 04/12/2004 NUVASIVE SPINAL SYSTEM NUVASIVE, INC. LAETITIA BERNARD
K040074 04/08/2004 ONEVIEW INTERFACE NXSTAGE MEDICAL, INC. NORMA LEMAY
K040068 04/16/2004 BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM OHMEDA MEDICAL ALBERTO F PROFUMO
K040692 04/08/2004 OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023 OLYMPUS AMERICA, INC. MICHAEL CAMPBELL
K040940 04/19/2004 BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM OLYMPUS CORPORATION TINA STEFFANIE-OAK
K033092 04/21/2004 THE GNATHOMETER ORTHO GNATHICS LLC KENNETH J POLK
K040569 04/07/2004 PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU OSCOR INC. MILA DOSKOCIL
K040545 04/22/2004 OTTER SAFETY SYRINGE OTTER (CHINA) TECHNOLOGY CO., LTD. ELAINE DUNCAN
K040738 04/30/2004 MOBILE OXYGEN STORAGE TANK (MOST) PACIFIC CONSOLIDATED INDUSTRIES LLP TARIK NAHEIRI
K030139 04/02/2004 THE CARDIOP-B SYSTEM PAIEON, INC. OMER BARLEV
K040081 04/01/2004 PALOMAR LUXV HANDPIECE PALOMAR MEDICAL TECHNOLOGIES, INC. MARCY MOORE
K040599 04/09/2004 PARKELL RESIN GLAZE PARKELL, INC. NELSON J GENDUSA
K020700 04/26/2004 PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY PEGASUS RESEARCH CORP. KENNETH G MILLER
K040772 04/05/2004 PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM PENNER MANUFACTURING, INC. VICKIE J BRADY
K030604 04/30/2004 PERFECT SAFETY SYRINGE PERFECT MEDICAL INDUSTRY CO., LTD. ERIC LUO
K040164 04/05/2004 K-Y BRAND WARMING JELLY PERSONAL LUBRICANT PERSONAL PRODUCTS COMPANY, DIV. OF MCNEIL-PPC, INC MARYLOU P CARLSON
K040340 04/28/2004 K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT PERSONAL PRODUCTS COMPANY, DIV. OF MCNEIL-PPC, INC MARYLOU (PANICO) CARLSON
K040917 04/29/2004 PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH HERBERT VAN DYK
K033017 04/07/2004 PHOENIX INFUSION CATHETER PHOENIX BIOMEDICAL COURTNEY SMITH
K040234 04/02/2004 LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM PHOTOMEDEX, INC. BOB ROSE
K040224 04/06/2004 CADIMPLANT PRAXIM INC CHRISTINE MEEHAN
K030747 04/22/2004 PRODOSE AAD SYSTEM PROFILE THERAPEUTICS PLC PAUL DRYDEN
K040607 04/22/2004 MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES PT. MEDISAFE TECHNOLOGIES ANIL TANEJA
K040540 04/29/2004 MODIFICATION TO LTV 1000 VENTILATOR PULMONETIC SYSTEMS, INC. ROBERT C SAMEC
K040236 04/20/2004 PULPDENT VLC RESIN CEMENT PULPDENT CORPORATION KENNETH J BERK
K040085 04/20/2004 PERSONAL WARMING LUBRICANT QUALIS, INC. MIKE PETERSON
K040276 04/30/2004 QUANTUM CEMENT RESTRICTOR QUANTUM ORTHOPEDICS JASON BLAIN
K040385 04/07/2004 MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900 QUEST MEDICAL, INC. KATHRYN J THOMPSON
K040008 04/29/2004 QUICKVUE ADVANCE PH AND AMINES GLL TEST QUIDEL CORP. JENNIFER S HANKARD
K040763 04/08/2004 RESECT MEDICAL INLINE BI-POLAR RF LINEAR COAGULATION DEVICE RESECT MEDICAL, INC. NANCY LINCE
K033914 04/22/2004 OXYGEN DIVERTER VALVE RESMED LTD. DAVID D'CRUZ
K040566 04/02/2004 RESMED HOSPITAL NASAL MASK RESMED LTD. DAVID D'CRUZ
K033630 04/21/2004 MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK RHEIN 83 SRL JOSEPH E GRASSO
K040711 04/02/2004 MESACUP TEST PR-3 RHIGENE, INC. NANCI DEXTER
K033163 04/27/2004 CAUTION CONDOMS RICHARD VAN HAUSSEN AMERICA, INC. RICHARD QUAISON
K040989 04/28/2004 RITA SYSTEMS RITA MEDICAL SYSTEMS DARRIN UECKER
K033485 04/20/2004 ENDOSCOUT ROBIN MEDICAL, INC. BENNY ARAZY
K040796 04/22/2004 ACCU-CHEK GO SYSTEM ROCHE DIAGNOSTICS CORP. SCOTT THIEL
K040264 04/02/2004 CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF ROCHE DIAGNOSTICS CORP. SHERRI L COENEN
K040396 04/22/2004 ULTRASONIC SCALER ELEGANCE MS-10 (25K) ROLENCE ENTEPRISE, INC. STERLING CHENG
K040808 04/28/2004 MINI L.E.D. OEM MODULE SATELEC JACKIE MASSE
K031557 04/14/2004 CARDIOVIT AT-102 SCHILLER AG MARKUS BUETLER
K040087 04/01/2004 RABBIT SCION INTERNATIONAL, INC. C. KENNETH FRENCH
K040925 04/28/2004 NORMAL AND HYPERGAMMA CONTROL SERUM SEBIA BOREK JANIK
K040706 04/08/2004 GEL MARK IV SENORX, INC. AMY BOUCLY
K040842 04/30/2004 SENORX BIOPSY DEVICE II SENORX, INC. AMY BOUCLY
K040665 04/02/2004 SOMATOM SENSATION 64 AND SENSATION CARDIAC SIEMENS MEDICAL SOLUTIONS USA, INC. NEALIE HARTMANN
K040161 04/30/2004 SONA PILLOW SLEEP DEVICES, INC. NAJEEB A ZUBERI
K040331 04/14/2004 SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS SMITH & NEPHEW, INC. DENISE LIMA
K022688 04/29/2004 VERSABOND AB BONE CEMENT SMITH & NEPHEW, INC. DAVID HENLEY
K040632 04/27/2004 SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000 SMITHS MEDICAL ASD, INC. VERNON TRIMBLE
K040998 04/29/2004 MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH SOFRADIM PRODUCTION MARY MCNAMARA-CULLINANE, RAC
K024186 04/01/2004 X-VIEW SOMETECH CORPORATION KI CHEOL HAN
K040668 04/13/2004 E-Z SCAN AB5500+ SONOMED, INC. GEORGE MYERS
K033755 04/29/2004 MINRAY SOREDEX PALODEX GROUP OY KAI LANER
K040804 04/28/2004 .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR SOUTHEASTERN RADIATION PRODUCTS, INC. RICHARD SWEAT
K040393 04/30/2004 RIVA LUTING SOUTHERN DENTAL INDUSTRIES, INC. SAMANTHA J CHEETHAM
K040330 04/12/2004 QUIESCENCE SPECTRAL VISUALIZATION & DEVELOPMENT, INC. DENNIS WOO
K040067 04/27/2004 CLIRPATH EXCIMER LASER CATHETER SPECTRANETICS CORP. ADRIAN ELFE
K040509 04/19/2004 ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40 SPIRE BIOMEDICAL INC DONALD FICKETT
K040185 04/27/2004 DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM SSL AMERICAS KATHLEEN J HARRIS
K040240 04/01/2004 STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) STELLARTECH RESEARCH CORP. JAMES R SANTOS
K040764 04/27/2004 STRYKER T4 HYTREL ZIPPER TOGA STRYKER CORP. JENNIFER MARS
K040369 04/01/2004 STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM STRYKER INSTRUMENTS JEAN W SHEPPARD
K032406 04/01/2004 STRYKER RF ELECTRODES AND CANNULAE STRYKER INSTRUMENTS NICOLE PETTY
K040261 04/16/2004 REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM STRYKER SPINE SIMONA VOIC
K031664 04/28/2004 ELEMENTS OBTURATION UNIT SYBRON ENDO/ANALYTIC COLLEEN BOSWELL
K040163 04/16/2004 MICROVASCULAR ANASTOMOTIC DEVICE SYNOVIS MICRO COMPANIES ALLIANCE, INC. DAISY P SIN
K040415 04/14/2004 PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT SYNOVIS SURGICAL INNOVATIONS ANGELA MALLERY
K040336 04/12/2004 SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM SYNTHES (USA) SHERI MUSGNUNG
K040762 04/12/2004 SYNTHES (USA) TIBIAL NAIL SYSTEM EX SYNTHES (USA) SHERI L MUSGNUNG
K040765 04/12/2004 SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS SYNTHES (USA) LISA M BOYLE
K040169 04/14/2004 SYNTHES MANDIBLE EXTERNAL FIXATOR SYNTHES (USA) SHERI L MUSGNUNG
K032534 04/01/2004 SYNTHES AFS SYNTHES SPINE JOHN WALSH
K031310 04/12/2004 TAI SHENG VARIOUS NEOX POWERED MUSCLE STIMULATOR TAI SHENG ELECTRICAL MACHINERY CO., LTD. JEN KE-MIN
K033157 04/08/2004 TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418 TANITA CORP. OF AMERICA RHODA LYNN VALERA
K040840 04/14/2004 TERATECH MODEL 10V5 SMART PROBE TERATECH CORP. CHARLES F HOTTINGER
K040186 04/15/2004 ANSPACH MRI SAFE SURGICAL DRILL SYSTEM THE ANSPACH EFFORT, INC. WILLIAM G CONETY
K032845 04/05/2004 EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 THE FIRST YEARS, INC. ROBIN C CONNOR
K040363 04/12/2004 CERAMIC TIPPED SKULL PIN THE JEROME GROUP, INC. RONALD KOWALSKI
K040469 04/30/2004 THE STRAUMANN ORTHO IMPLANT SYSTEM THE STRAUMANN CO. CAROLYN BITETTI
K040054 04/27/2004 "BACK IN ACTION" COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE THEODORE BARASH THEODORE BARASH
K040546 04/27/2004 IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS TOMTEC IMAGING SYSTEMS, GMBH RALF JANITZ
K031661 04/23/2004 5M MEDICAL FLAT PANEL DISPLAY, ME511L TOTOKU ELECTRIC CO., LTD MIKIO HASEGAWA
K040619 04/07/2004 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K040846 04/26/2004 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K022256 04/26/2004 SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN TUCKER & ASSOCIATES JANNA TUCKER
K033453 04/29/2004 KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING TYCO HEALTHCARE GAIL CHRISTIE
K040633 04/01/2004 CLICK-ON UNOMEDICAL A/S JOHN M LINDSKOG
K032601 04/01/2004 STRYKER INTERVENTIONAL PAIN RF GENERATOR VALLEY FORGE SCIENTIFIC CORP. JERRY MALIS
K031687 04/30/2004 VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES VANGUARD MEDICAL CONCEPTS, INC. HEATHER CRAWFORD
K040698 04/07/2004 MASTERSCREEN CPX AND OXYCON CPX VIASYS HEALTHCARE GMBH EDMOND CHU
K040126 04/19/2004 VIATRONIX V3D COLON, REVISION 1.3 VIATRONIX, INC. BAMAN PATTANAYAK
K040984 04/27/2004 VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE VISION-SCIENCES, INC. PAMELA PAPINEAU
K040215 04/15/2004 VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM VISION-SCIENCES, INC. PAMELA PAPINEAU
K040876 04/19/2004 ICONNECTION, VERSION 3.2.0.0 MEDICAL IMAGE PROCESSING SOFTWARE VITAL IMAGES, INC. TIMOTHY J KAPPERS
K040769 04/07/2004 STRUCTUR 2 SC VOCO GMBH GERALD W SHIPPS
K040707 04/16/2004 PACKAGING TRAY AND COMPONENTS VYGON US LLC COURTNEY SMITH
K033860 04/23/2004 AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR WAKO CHEMICALS, USA, INC. TONYA MALLORY
K040195 04/07/2004 CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM WITT BIOMEDICAL CORP ELFRIEDE PAGAN
K022828 04/02/2004 OSTEOSET DBM PELLETS, MODEL 8600-48XX WRIGHT MEDICAL TECHNOLOGY, INC. ROGER D BROWN
K040645 04/28/2004 DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI WRP ASIA PACIFIC SDN. BHD. TERENCE LIM
K040968 04/30/2004 WU'S 4-WHEELED NEO SCOOTER, MODEL WT-T4D WU'S TECH CO., LTD. KE-MIN JEN
K040528 04/15/2004 AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, MODEL AK-4000T YA HORNG ELECTRONIC CO., LTD. JEN KE-MIN
K040105 04/07/2004 YUE PFONG SAFETY SYRINGE (3ML) YUE PFONG INTERNATIONAL INDUSTRIAL CO., LTD. JENNIFER REICH
K033699 04/22/2004 LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586 ZEST ANCHORS, INC. FLOYD G LARSON
K040111 04/05/2004 ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K040828 04/19/2004 DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES ZIBO BORUI PLASTIC & RUBBER PRODUCTS CO., LTD. HUAN-CHUNG LI
K040727 04/23/2004 CRYO 5 ZIMMER ELEKTROMEDIZIN GMBH STEFAN LEINWEBER
K040803 04/29/2004 MS-30 FEMORAL STEM STANDARD AND LATERAL ZIMMER, INC. ROBERT WOLFARTH
K040593 04/12/2004 PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES ZIMMER, INC. LAURA D WILLIAMS
K040012 04/02/2004 WELL@HOME SYSTEM ZOE MEDICAL, INC. STEPHEN STAATS


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