FDA 510(k) Decisions During August, 2005  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K043015 08/15/2005 3L SURGICAL DRAPES 3L MEDICAL PRODUCTS CO., LTD. GEORGE SU
K052128 08/16/2005 3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER 3M COMPANY CYNTHIA LAMANRUCCIOLA
K051657 08/30/2005 A-DEC SELF-CONTAINED WATER SYSTEM A-DEC, INC. TOM LOUISELL
K051802 08/09/2005 FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM ABBOTT DIABETES CARE INC. KIMBERLEY KLINE
K051327 08/03/2005 ABBOTT AXSYM B12 ABBOTT LABORATORIES MARGARET PROCHNIAK
K051962 08/25/2005 ULTRA HDL ABBOTT LABORATORIES LINDA MORRIS
K052072 08/29/2005 THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES ABBOTT SPINE, INC. NOAH BARTSCH
K052198 08/31/2005 RELIEVA SINUS BALLOON INFLATION DEVICE ACCLARENT, INC. SU-MIEN CHONG
K051231 08/05/2005 VERIFYNOW-P2Y12 ASSAY ACCUMETRICS, INC. BARBARA STEVENS
K051941 08/09/2005 CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM ACCURAY, INC. ANNE SCHLAGENHAFT
K052044 08/16/2005 ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL ACMI CORPORATION TERRENCE E SULLIVAN
K050468 08/31/2005 TRIABSORB COMPOSITE SCREW ADVANCED BIOMATERIALS PATRICK JANIN
K051643 08/19/2005 STERRAD STERILIZER CYCLESURE TEST PACK ADVANCED STERILIZATION PRODUCTS JOSEPH M ASCENZI
K052251 08/31/2005 DRYSTAR MODEL 5500 AGFA CORPORATION JEFF JEDLICKA
K052062 08/25/2005 ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES ALLIANCE MEDICAL CORP. MOIRA BARTON
K052064 08/25/2005 ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES ALLIANCE MEDICAL CORP. MOIRA BARTON
K052065 08/22/2005 ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES ALLIANCE MEDICAL CORP. MOIRA BARTON
K051529 08/04/2005 AMBU NEUROLINE GROUND AMBU, INC. SANJAY PARIKH
K051485 08/03/2005 AMS PELVIC FLOOR REPAIR SYSTEM AMERICAN MEDICAL SYSTEMS, INC. ELSA LINKE
K051042 08/05/2005 METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000 ANGIOMETRX INC. TIM VERSPAGEN
K052136 08/25/2005 GR17 DIGITAL DETECTOR ANRAD CORP. DONALD J SHERRATT
K051793 08/17/2005 ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE) ANSELL HEALTHCARE PRODUCTS, LLC CYNTHIA A INGRAM
K050969 08/18/2005 INCLOSE SURGICAL MESH SYSTEM ANULEX TECHNOLOGIES, INC TIM MILLER
K051639 08/02/2005 AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM AS SOFTWARE, INC. KIM A NATHANSON
K052022 08/25/2005 ASAHI PTCA GUIDE WIRE FIELDER ASAHI INTECC CO., LTD. YOSHI TERAI
K050320 08/15/2005 FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT ASCENDIA MEDTECH AB JANE B CAMPBELL
K051413 08/29/2005 ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100 AVENT AMERICA, INC. RICHARD MORRONEY
K051135 08/11/2005 AXIOM NVP8500 AXIOM WORLDWIDE, INC. JAMES J GIBSON
K050798 08/15/2005 ECLIPSE NEUROLOGICAL WORKSTATION AXON SYSTEMS, INC. HOWARD BAILIN
K051983 08/05/2005 MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR AXYA MEDICAL, INC. HOWARD SCHRAYER
K052006 08/03/2005 POWDER-FREE VINYL EXAM GLOVES BAODING GUANZHONG GLOVE CO., LTD. MARY ANN DOUCETTE
K051902 08/11/2005 NIO 2MP-21" BARCOVIEW LIEVEN DE WANDEL
K051901 08/17/2005 NIO 3MP-21" BARCOVIEW LIEVEN DE WANDEL
K052236 08/23/2005 BARD ATLAS PTA BALLOON DILATATION CATHETER BARD PERIPHERAL VASCULAR, INC. GENEVIEVE BALUTOWSKI
K052114 08/25/2005 BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP BARD PERIPHERAL VASCULAR, INC. DENNIS SALZMANN
K051370 08/12/2005 STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K051619 08/01/2005 LIPOPROTEIN FOR MULTIPLE ANALYTES BAYER HEALTHCARE, LLC ANDERS HOLLE
K052082 08/19/2005 FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 BECKMAN COULTER, INC. CAROLYN ANDERSON
K051122 08/01/2005 ITAG MHC TETRAMER CMV ASSAY BECKMAN COULTER, INC. MARA CALER
K051689 08/05/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - DAPTOMYCIN 0.125 - 32 UG/ML BECTON, DICKINSON & CO. MONICA GIGUERE
K052066 08/26/2005 CEEGRAPH/SLEEPSCAN NETLINK TRAVELER BIO-LOGIC SYSTEMS CORP. NORMAN E BRUNNER
K052053 08/09/2005 LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK BIO-RAD SUZANNE S PARSONS
K051816 08/26/2005 LUMIWAVE 1X4 INFRARED THERAPY DEVICE BIOCARE SYSTEMS, INC. CLAY ANSELMO
K050170 08/26/2005 FORTOSS VITAL BONE GRAFT SUBSTITUTE BIOCOMPOSITES LTD. SIMON FITZER
K050613 08/16/2005 QUANTIA BETA-2 MICROGLOBULIN BIOKIT S.A. JOAN GUIXER
K050493 08/16/2005 QUANTIA IGE BIOKIT S.A. JOAN GUIXER
K050824 08/10/2005 100W CERALAS D 980 LASER SYSTEM, MODEL D100 BIOLITEC, INC. JONATHAN S KAHAN
K050182 08/09/2005 Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM BIOMEDIX, INC. JUDY S CHEN
K051849 08/16/2005 VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. NANCY WEAVER
K051479 08/10/2005 RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS BIOMET MANUFACTURING, INC. GARY BAKER
K051570 08/05/2005 AVL HINGE KNEE SYSTEM BIOMET, INC. PATRICIA SANDBORN BERES
K051496 08/04/2005 COBALT BONE CEMENT BIOMET, INC. LONNIE WITHAM
K051532 08/03/2005 COBALT G HV BONE CEMENT BIOMET, INC. LONNIE WITHAM
K043547 08/05/2005 COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM BIOMET, INC. GARY BAKER
K051385 08/05/2005 EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE BIOMET, INC. PATRICIA SANDBORN BERES
K050222 08/16/2005 VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS BIOMET, INC. GARY BAKER
K050971 08/16/2005 BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS) BIOVALVE TECHNOLOGIES, INC. SCOTT HUIE
K051985 08/17/2005 BIOVALVE MINI-JECT NEEDLEFREE INJECTOR BIOVALVE TECHNOLOGIES, INC. SCOTT HUIE
K050840 08/16/2005 MODIFICATION TO DUET SYSTEM BIOVIEW LTD. DORIT WINITZ
K051999 08/22/2005 BISCOVER LED BISCO, INC. BENJAMIN LICHTENWALNER
K052194 08/24/2005 SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR BOSTON SCIENTIFIC CORP. ALLYSON BARFORD
K052038 08/16/2005 PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM BOSTON SCIENTIFIC CORPORATION RENUKA KRISHNAN
K051819 08/15/2005 C CHANGE SOLUTION WARMER C CHANGE SURGICAL LLC ROBERT KELLY
K051748 08/12/2005 HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS C.R. BARD, INC. MICHAELA RIVKOWICH
K050558 08/29/2005 MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F C.R. BARD, INC. KAREN HUTCHISON
K051649 08/02/2005 VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0 CAMTRONICS MEDICAL SYSTEMS STEVE KRUEGER
K052035 08/31/2005 CANADY PLASMA PROBES CANADY TECHNOLOGY, LLC JEROME CANADY
K050994 08/03/2005 AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM CARDINAL HEALTH SHARON NICHOLS
K051853 08/22/2005 CARDIOSTREAM SONOAIM CARDIOSTREAM, LLC IAN P GORDON
K050250 08/10/2005 AQUIFY MULTIPURPOSE SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K051038 08/12/2005 506 PATIENT MONITOR CIRITICARE SYSTEMS, INC. ALEX KAPLAN
K051533 08/11/2005 I-STOP CL MEDICAL VINCENT GORIA
K043034 08/04/2005 OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS COLLAGEN MATRIX, INC. PEGGY HANSEN
K051660 08/04/2005 DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM COLTENE/WHALEDENT INC. LORETTA MOONEY
K052045 08/24/2005 ACCESS BREAST COIL CONFIRMA, INC. PATRICIA A MILBANK
K052036 08/25/2005 ATB ADVANCE PTA DILATATION CATHETER COOK, INC. KAREN BRADBURN
K051785 08/23/2005 FORMULA 418 BILIARY STENT COOK, INC. KAREN BRADBURN
K050764 08/24/2005 UNIGLIDE UNICONDYLAR KNEE PROSTHESIS CORIN U.S.A. JOEL BATTS
K051405 08/31/2005 REGENSIS PERICARDIAL PATCH CORMATRIX CARDIOVASCULAR, INC. PUNAM GOLLAMUDI
K050889 08/26/2005 FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH CRS MEDICAL DIAGNOSTICS INC. JOSEPH M MATTANO
K051916 08/05/2005 POLAR CATH PERIPHERAL DILATATION SYSTEM CRYOVASCULAR SYSTEMS, INC. ELAINE APLAON
K051305 08/18/2005 CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5 CS MEDICAL LLC BEN CHEMELLI
K051131 08/15/2005 VCS S3T CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER/CHC CHANG WAN LAN
K051597 08/17/2005 STRATUS CS D-DIMER DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K051897 08/12/2005 TRIO MONITOR DATASCOPE CORP. SUSAN E MANDY
K051177 08/29/2005 PVC AND SILICONE MANUAL RESUSCITATORS DAVID MEDICAL PRODUCTS CO.,LTD DAVID LU
K051848 08/11/2005 SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079 DAVOL INC., SUB. C.R. BARD, INC. LUCINDA L FOX
K051960 08/19/2005 CARDIONAVIGATOR + DEL MAR REYNOLDS MEDICAL, LTD. GEORGE MYERS
K050851 08/19/2005 DELTA PUNCTUM PLUG DELTA LIFE SCIENCE, INC. GEORGE W MURRAY
K052097 08/12/2005 CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE DENTSPLY INTERNATIONAL HELEN LEWIS
K051989 08/05/2005 GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE DEPUY MITEK, A JOHNSON & JOHNSON COMPANY DENISE LUCIANO
K040627 08/05/2005 DEPUY ASR MODULAR ACETABULAR CUP SYSTEM DEPUY ORTHOPAEDICS, INC. NATALIE HECK
K051296 08/26/2005 SIJF CANNULATED SCREW SYSTEM DEPUY SPINE, INC. SHARON STAROWICZ
K051786 08/15/2005 MELIDE FIBEROPTIC LIGHT DESIGNS FOR VISION, INC. CYNTHIA J M. NOLTE
K050827 08/22/2005 NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE) DIALYSIS SOLUTIONS, INC. MARCY MACDONALD
K051996 08/18/2005 DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30 DIOMED, LTD. TIM PHIPPS
K052090 08/05/2005 SPLASH! IMPRESSION MATERIAL DEVICE DISCUS DENTAL INC. SUZANNE RIDGWAY
K051014 08/09/2005 SILENT PARTNER SERIES OSA APPLIANCES DREAMWRX DENTAL LABORATORY NICOLAAS BESSELING
K050234 08/25/2005 REMOTE CARE E.CARE SOLUTIONS, INC. CONSTANCE G BUNDY
K051273 08/19/2005 DIVAS DUAL PLEASURE MALE LATEX CONDOM EAGLE TWE, INC. BILL TAFFS
K050446 08/09/2005 BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE PETER S REICHERTZ
K052132 08/24/2005 MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM EDWARDS LIFESCIENCES, LLC. KEVIN DRISKO
K052071 08/16/2005 MODIFICATION TO LYSUS INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K051932 08/12/2005 ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 ELEKTA, INC PETER STEGAGNO
K051420 08/15/2005 HABIB 4X EMCISION, LTD. NAGY HABIB
K052086 08/31/2005 ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER ENCORE MEDICAL, INC. CHRISTIE SHUMAKER
K051860 08/22/2005 FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 EPIMED INTERNATIONAL, INC. CHRISTOPHER LAKE
K051171 08/26/2005 STINGRAY EPIDURAL CATHETER CONNECTOR EPIMED INTERNATIONAL, INC. CHRISTOPHER LAKE
K052077 08/16/2005 G-SCAN CERVICAL SPINE COIL ESAOTE, S.P.A. CARRI GRAHAM
K051301 08/30/2005 PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES ETHICON ENDO-SURGERY, INC. KIMBERLY MCCOY
K051732 08/09/2005 ENDOSCOPIC APPLICATOR ETHICON INC. PETER CECCHINI
K052111 08/17/2005 XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382 EXCEL TECH. LTD. NICOLE LANDREVILLE
K050927 08/01/2005 RT019 INSPIRATORY/EXPIRATORY FILTER FISHER & PAYKEL HEALTHCARE, LTD. RENETA MONEY
K052058 08/22/2005 MODIFICATION TO: TITANIUM TELEGRAPH HUMERAL NAIL FOURNITURES HOSPITALIERES INDUSTRIE CHRISTINE QUENDEZ
K051522 08/17/2005 SILBRONCHO DOUBLE LUMEN TUBE FUJI SYSTEMS CORP. PAUL E DRYDEN
K050575 08/15/2005 FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM FUTUMEDS SDN BHD LEONG PEI PING
K051427 08/22/2005 GC FUJI FIL LC GC AMERICA, INC. TERRY L JORITZ
K052145 08/23/2005 DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES GE HEALTHCARE JOEL KENT
K051883 08/05/2005 DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES. GE HEALTHCARE JOEL KENT
K051967 08/09/2005 REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS GE HEALTHCARE JOHN L SCHMIDT
K051855 08/02/2005 VENTRI GE MEDICAL SYSTEMS F.I. HAIFA ELI WERNER
K052157 08/25/2005 INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ GE MEDICAL SYSTEMS, LLC LARRY A KROGER
K052039 08/11/2005 GE OEC ALTITUDE GE OEC MEDICAL SYSTEMS SUSAN SCHMIDT
K043224 08/09/2005 GEN-PROBE APTIMA COMBO 2 ASSAY GEN-PROBE, INC. ALAN MADERAZO
K051666 08/23/2005 GAV - GENERAL ANAESTHETIC VAPORIZER GENERAL ANAESTHETIC SERVICES LIMITED ANDREW JW WALL
K051606 08/12/2005 GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING GISH BIOMEDICAL, INC. J. HARVEY KNAUSS
K052069 08/17/2005 PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES GLOBUS MEDICAL INC. KELLY J BAKER
K052166 08/18/2005 MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM GUIDANT CORPORATION JULIA ANASTAS
K052165 08/16/2005 RX ACCUNET EMBOLIC PROTECTION SYSTEM GUIDANT CORPORATION JULIA ANASTAS
K051777 08/12/2005 NITRILE POWDER FREE EXAMINATION GLOVES (BLUE) HARTALEGA SDN BHD KUAN KAM HON
K052052 08/24/2005 HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5 HOSPIRA, INC. PATRICIA MELERSKI
K052037 08/05/2005 MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP VIVIAN KELLY
K051380 08/30/2005 TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM HOWMEDICA OSTEONICS CORP TIFFANI ROGERS
K051642 08/22/2005 FR.O.H. CALCANEUS REPAIR SYSTEM I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH AL LIPPINCOTT
K052011 08/10/2005 PILONPLATE WITH ANGULAR STABILITY I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH AL LIPPINCOTT
K051437 08/03/2005 CML 1000 ICU MEDICAL, INC. JIM COOMBES
K051980 08/19/2005 DVT SCANNER IMAGING SCIENCES INTL., INC. DAVID W COWAN
K050465 08/04/2005 IMMUNALYSIS COCAINE ELISA FOR HAIR IMMUNALYSIS CORPORATION MICHAEL VINCENT
K051715 08/02/2005 STARPACS DENTAL INFINITT CO., LTD. CARL ALLETTO
K051285 08/02/2005 GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM INFOPIA CO., LTD BYEONG WOO BAE
K051362 08/04/2005 INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000 INION OY HANNA MARTILA
K051129 08/12/2005 DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR INNOVA VISION INC. JENNIFER REICH
K052060 08/31/2005 OPTI-AMP DC-POWERED INTELLIGENT HEARING SYSTEMS EDWARD MISKIEL
K051917 08/08/2005 DIVER C.E. CATHETER INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. STEPHANIE K ISGRIGG ROBINSON
K050399 08/26/2005 MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160 INVIVO RESEARCH, INC. NEIL BATTISTE
K051918 08/17/2005 RESOLVE OPEN BACK HALO RINGS JEROME MEDICAL BERNIE TATRO
K051814 08/04/2005 JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET JMS NORTH AMERICA CORP. CHONG SWEE CHEAU
K051900 08/12/2005 ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR JOHNSON & JOHNSON VISION CARE, INC. SUSAN MORRIS
K051827 08/12/2005 JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE JOIMAX GMBH KARIN GASTINEAU
K050657 08/08/2005 MONDEAL CONTOUR HO SYSTEM KAPP SURGICAL INSTRUMENT, INC. ALBERT SANTILLI
K050655 08/08/2005 MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005 KAPP SURGICAL INSTRUMENT, INC. ALBERT SANTILLI
K051972 08/15/2005 KARL STORZ TRANS-NASAL ESOPHAGOSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC. YVONNE FERNANDEZ
K051505 08/11/2005 SCB/STERIS OR-LIGHT INTERFACE BOX KARL STORZ ENDOSCOPY-AMERICA, INC. PAUL S LEE
K030146 08/03/2005 KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ KAVO AMERICA J0HN R FRANZ
K042394 08/02/2005 DIAGNODENT PERIO TIP (ACCESSORY) KAVO AMERICA CORPORATION DANIEL KAMM
K051586 08/04/2005 VIEWSEND MEDICAL SYSTEM KENEI CO., LTD. JENNIFER LI
K043259 08/15/2005 BIOBLANKET SURGICAL MESH KENSEY NASH CORP. DEBORAH RACIOPPI
K050984 08/11/2005 BIOPLANT KERR DENTAL MATERIALS CENTER COLLEEN BOSWELL
K051236 08/22/2005 RESORB-X SF KLS-MARTIN L.P. JENNIFER DAMATO
K051796 08/09/2005 CLEARFIL TRI-S BOND SINGLE DOSE KURARAY MEDICAL KURASHIKI PLANT SATOSHI YAMAGUCHI
K051473 08/31/2005 LEARDO, AVANTICARE ELECTRICAL SCOOTERSM3021 LERADO CHINA LIMITED JEN KE-MIN
K052080 08/25/2005 MATRYX INTERFERENCE SCREW LINVATEC BIOMATERIALS, INC. TUIJA ANNALA
K052129 08/30/2005 LUMENIS 1000 INTEGRATED SLIT LAMP LUMENIS, INC. KAREN L BAKER
K051567 08/23/2005 APTUS TITANIUM OSTEOSYNTHESIS SYSTEM MEDARTIS, INC. FLOYD G LARSON
K051946 08/22/2005 MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM MEDARTIS, INC. FLOYD G LARSON
K051700 08/15/2005 OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR MEDCHANNEL, LLC FREDERICK TOBIA
K051930 08/16/2005 DRUG ACCESS SPIKE MEDEGEN MEDICAL MANUFACTURING SERVICES SALVADORE F PALOMARES
K051939 08/01/2005 MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR MEDEGEN MEDICAL MANUFACTURING SYSTEM TIM TRUITT
K051421 08/30/2005 INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR MEDICAL DEVICE TECHNOLOGIES, INC. KRISTINE LIBERACKI
K051809 08/15/2005 EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM MEDICAL INSIGHT A/S GARY J ALLSEBROOK
K051378 08/03/2005 POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) MEDLINE JENNIFER MASON
K051302 08/15/2005 EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K052180 08/23/2005 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K052187 08/22/2005 MODIFICATION TO: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K052054 08/16/2005 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K052144 08/31/2005 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K051846 08/05/2005 7F SHERPA NX GUIDE CATHETER MEDTRONIC VASCULAR FRED L BOUCHER
K050421 08/31/2005 MS 4/5 HEMATOLOGY ANALYZER MELET SCHLOESING LABORATORIES USA JACKIE COLEMAN
K050430 08/04/2005 MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR MERITS HEALTH PRODUCTS CO., LTD. LEE LEICHTER
K051618 08/02/2005 SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64 MIDWEST R.F. LLC. DAVID M PETERSON
K051445 08/22/2005 MILLIKEN SILVER WOUND DRESSINGS MILLIKEN CHEMICAL MARY MCNAMARA-CULLINANE
K050896 08/24/2005 H12+ HOLTER RECORDER MORTARA INSTRUMENT, INC. HARLAN L VAN MATRE
K052200 08/19/2005 TEM 3000 HEAD COIL MR INSTRUMENTS INC. MARK WATSON
K052067 08/29/2005 DOPPLER GUIDED PROCTOSCOPE, MODEL 500H MULTIGON INDUSTRIES, INC. WILLIAM STERN
K051352 08/11/2005 OXIMAX NPB-40 HANDHELD PULSE OXIMETER NELLCOR PURITAN BENNETT, INC. SARAH HARRINGTON
K052246 08/22/2005 MODIFICATION TO EN-BLOC BIOPSY SYSTEM NEOTHERMIA CORPORATION DAVID JACOBS
K051434 08/09/2005 COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV NEW STAR LASERS, INC. DONALD V JOHNSON
K051406 08/01/2005 OSTEOCURE RESORBABLE BEAD KIT NEXA ORTHOPEDICS, INC. LOUISE M FOCHT
K050336 08/24/2005 OPD-STATION SOFTWARE NIDEK, INC. CAROL PATTERSON
K051178 08/17/2005 MEE-1000A NEUROMASTER NIHON KOHDEN AMERICA, INC. SERRAH NAMINI
K051574 08/26/2005 NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE NIPRO MEDICAL CORP. KAELYN HADLEY
K042915 08/31/2005 O'MY NATURAL LUBRICANT, O'MY NATURAL FLAVORED LUBRICANT O'MY PRODUCTS INCORPORATED ROB LOGAN
K051889 08/30/2005 CAREVENT CA AND DRA O-TWO MEDICAL TECHNOLOGIES, INC. AMMAR AL-DOJAILY
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