FDA 510(k) Decisions During April, 2006  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K060684 04/24/2006 ADPER PROMPT, ADPER PROMPT L-POP 3M ESPE AG DENTAL PRODUCTS SABINE KRISCHER
K060768 04/21/2006 PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS ABBOTT DIABETES CARE INC. MARIA E TREJO
K060466 04/21/2006 ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K053481 04/14/2006 KELO-COTE SPRAY ADVANCED BIO-TECHNOLOGIES, INC. STEVEN CHERNOFF
K060366 04/07/2006 THE AMO OPHTHALMIC SURGICAL SYSTEM ADVANCED MEDICAL OPTICS, INC. TONI ELLIOTT
K060492 04/07/2006 AESCULAP CRANIOFACIAL PLATE AND SCREW AESCULAP, INC. MATTHEW M HULL
K053187 04/27/2006 AMPLATZER NOODLEWIRE GUIDEWIRE AGA MEDICAL CORP. PATRICIA A LAFORET
K053117 04/10/2006 EZ-OX PLUS AIR LIQUIDE HEALTHCARE AMERICA ANGIE BEYER
K060761 04/28/2006 BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS Akers Biosciences, Inc. BARBARA A BAGBY
K060145 04/14/2006 FDS INTIMATE AND INTIMATE WARMING LUBRICANT ALBERTO-CULVER USA, INC. RICK MAIN
K051438 04/04/2006 VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM) ALLIANCE MEDICAL, INC. MOIRA BARTON
K052527 04/12/2006 NEUROPROBES ALPHA OMEGA ENGINEERING, LTD. SHLOMO PUNDAK
K060308 04/26/2006 COOLGARD 3000 ALSIUS CORP. KENNETH A COLLINS
K060314 04/06/2006 ROTATING GAMMA SYSTEM. GAMMA ART-6000 AMERICAN RADIOSURGERY, INC. DAN OLIVIER
K060382 04/19/2006 FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1 AMERIFLO CORP. MATTHEW THIE
K053407 04/05/2006 OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M ANALYTICAL INDUSTRIES, INC. PATRICK J PRINDIBLE
K060887 04/28/2006 ANGIODYNAMIC, INC. MORPHEUS CT PICC AND PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K060629 04/07/2006 GELPORT BLUNT TIP TROCAR SYSTEM APPLIED MEDICAL RESOURCES CORP. CHERYL BLAKE
K060800 04/07/2006 SEEKER/SPARK ULTRASOUND SYSTEM Ardent Sound, Inc. PAUL JAEGER
K060865 04/24/2006 BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 ARIZANT HEALTHCARE INC. DAVID WESTLIN
K060309 04/06/2006 AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES ARROW INTL., INC. KAREN PROVENCHER
K053543 04/03/2006 ARTHREX ARTHOERESIS IMPLANT ARTHREX, INC. ANN WATERHOUSE
K060823 04/10/2006 ARTHROCARE WANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K060461 04/28/2006 V-505 INFA WARMER ATOM MEDICAL INC MARY STANIEWICZ
K053589 04/13/2006 LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING BARD ACCESS SYSTEMS, INC. MICHAELA RIVKOWICH
K060733 04/24/2006 SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION GLOVES MDL 1362-10 TO 1362-44 BARRIERMED, INC. VICTOR RAGUCCI
K060169 04/21/2006 BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERATOR, BARRX COAGULATION CATHETER, MODELS 2200-115A, 1520F BARRX MEDICAL, INCORPORATED VIORICA FILIMON
K060470 04/12/2006 ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080 BAYER HEALTHCARE ROGER SONNEMBURG
K053612 04/26/2006 DRI-STAT ACID PHOSPHATASE REAGENT BECKMAN COULTER, INC. ERI HIRUMI
K060774 04/21/2006 FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 BECKMAN COULTER, INC. CAROLYN ANDERSON
K060935 04/28/2006 SYNCHRON SYSTEMS CREATININE (CREA) REAGENT BECKMAN COULTER, INC. ANNETTE HELLIE
K060217 04/12/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN-0.125-8 AND CIPROFLOXACIN-0.25 - 4 UG/ML BECTON DICKINSON & CO. MONICA E GIGUERE
K060447 04/26/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -NITROFURANTOIN (GN) 8-512 UG/ML, TRIMETHOPRIM-SULFAMETHOXAZOLE (GN) BECTON DICKINSON & CO. MONICA E GIGUERE
K060444 04/12/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) , CEFTRIAXONE (GN), CEFOTAXIME (GN), 0.5-64 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K060257 04/14/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN - 0.5-64 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K052457 04/13/2006 PICSI SPERM SELECTION DEVICE BIOCOAT, INC. JAMES B JOHNSTON
K060815 04/18/2006 JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT BIOFORM MEDICAL, INC. JAMES S MILLER
K052996 04/28/2006 POROUS TITANIUM ACETABULAR SHELLS BIOMET MANUFACTURING CORP. ALLISON KOSKEY
K060807 04/24/2006 SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM BIOTRONIK, INC. Jon Brumbaugh
K060655 04/04/2006 SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H BIOTRONIK, INC. Jon Brumbaugh
K051984 04/10/2006 FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300 BOSTON SCIENTIFIC CORP. DEBBIE MCINTIRE
K060947 04/19/2006 SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020 BOSTON SCIENTIFIC CORP. ROBERT Z PHILLIPS
K060960 04/12/2006 BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER Boston Scientific Corporation SARA L COON
K060959 04/12/2006 SYMMETRY BALLOON DILATATION CATHETER Boston Scientific Corporation ANGELA BYLAND
K060658 04/10/2006 BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR) BRIGHTWAY HOLDINGS SDN. BHD. G. BASKARAN
K052843 04/17/2006 BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE BUSSE HOSPITAL DISPOSABLES, INC. MUHAMAD ANSARI
K060962 04/19/2006 ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100 BYRNE MEDICAL, INC. J. HARVEY KNAUSS
K052322 04/10/2006 BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 1175104, 1175105 C.R. BARD, INC. ROBIN DRAGO
K060636 04/19/2006 PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE C.R. BARD, INC. JULIE J BASSETT
K060341 04/14/2006 SHERLOCK TIP LOCATION SYSTEM (TLS) C.R. BARD, INC. LYNN M KIRCHOFF
K060703 04/04/2006 PMP4 BP PRO BLOOD PRESSURE MONITOR CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K060167 04/19/2006 ATRIA 3100, ATRIA 6100 CARDIAC SCIENCE CORPORATION CHERYL SHEA
K053263 04/25/2006 CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003 CARDIONET, INC JACK GAIKWAD
K060866 04/28/2006 PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS CARMEL PHARMA AB. KJELL ANDREASSON
K060089 04/27/2006 TULIP DISPOSABLE CANNULAS CELL BIO-SYSTEMS, INC. CHRISTINE EMANUEL
K052643 04/11/2006 EPICERAM CERAGENIX CORPORATION CARL GENBERG
K050826 04/10/2006 FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS CETRO AMERICA MAYA CIANCIOLO
K060828 04/19/2006 MODIFICATION TO ENDOTINE RIBBON COAPT SYSTEMS, INC. LINDA RUEDY
K050674 04/25/2006 PHYSIOGLOVE ES COMMWELL LTD. JONATHAN S KAHN
K060570 04/13/2006 HEMOGLOBIN ALC CONTROL COMPASS BIOSCIENCE CARTER GRANDJEAN
K061021 04/28/2006 ENTAKE STANDARD AND SAFETY PEG SYSTEM CONMED CORP. BETH A ZIS
K060717 04/25/2006 NURSE ASSISTANT 1.7 O.R. CONTROL SYSTEM CONMED INTEGRATED SYSTEMS (CMIS) C. JEFF LIPPS
K060714 04/06/2006 HI-FI ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR CONMED LINVATEC ELIZABETH PAUL
K060877 04/27/2006 PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX CORDIS CORP. KAREN WILK
K060302 04/11/2006 INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED CORDIS EUROPA, N.V. HARM HOVINGA
K053415 04/25/2006 LESIONPOINT RF CANNULA COSMAN MEDICAL, INC. MICHAEL ARNOLD
K060804 04/18/2006 COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSING COVALON TECHNOLOGIES LTD. JACQUES LEMMETTI
K060555 04/21/2006 SPRAYGENIX CRYO ABLATION SYSTEM CRYMED TECHNOLOGIES, INC. TIM ASKEW
K051842 04/14/2006 GREEN LOVE MALE CONTRACEPTIVE (CONDOM) CUPID CONDOM, LTD. K.K. GOYAL
K060878 04/13/2006 GELITA-SPON ABSORBABLE GELATIN SPONGE, USP CURAMEDICAL, BV WILLIAM GREENROSE
K060628 04/06/2006 DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR DADE BEHRING, INC. GEORGE M PLUMMER
K053577 04/14/2006 DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT DADE BEHRING, INC. GEORGE M PLUMMER
K060385 04/06/2006 EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT DADE BEHRING, INC. YUK-TING LEWIS
K060548 04/06/2006 STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK DADE BEHRING, INC. PAMELA A JURGA
K060654 04/28/2006 DSI PINS AND WIRES DELTA SURGICAL INSTRUMENTS, INC. DANDENIA ZABAT
K060359 04/14/2006 ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 DENKA SEIKEN CO., LTD. TOSHIMI MATSUNAGA
K060377 04/26/2006 DR DISPOSABLE PROPHY ANGLE MODEL H310 DENTAL RESOURCES BRYAN NICHOLS
K060640 04/24/2006 DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM DENTAMERICA ERIC HUANG
K060837 04/10/2006 IN-OVATION C DENTSPLY INTERNATIONAL HELEN LEWIS
K060696 04/14/2006 ACCLAIM TOTAL ELBOW SYSTEM DEPUY ORTHOPAEDICS, INC. NATALIE S HECK
K060139 04/28/2006 CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 DIAGNOSTIC CHEMICALS LTD. PENNY WHITE
K060140 04/24/2006 CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250 DIAGNOSTIC CHEMICALS LTD. PENNY WHITE
K060929 04/28/2006 IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6 DIAGNOSTIC PRODUCTS CORPORATION DEBORAH L MORRIS
K050913 04/04/2006 DICK'S FORMALWEAR MALE LATEX CONDOM DICK'S FORMALWEAR INC. CURT STRENK
K060039 04/12/2006 INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS Draeger Medical Systems, Inc. KAREN IORIO
K060223 04/12/2006 INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM Draeger Medical Systems, Inc. KAREN A IORIO
K060254 04/04/2006 MODIFICATION TO INFINITY EXPLORER Draeger Medical Systems, Inc. KAREN A IORIO
K052611 04/26/2006 ECP HEALTH SYSTEM, MODEL 2005 ECP HEALTH INC. SHAMON HUANG
K060660 04/25/2006 EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER EDWARDS LIFESCIENCES, LLC. PAULA A TORRIANNI
K060093 04/28/2006 PRESEP OLIGON OXIMETRY CATHETERS EDWARDS LIFESCIENCES, LLC. JASON SMITH
K060845 04/25/2006 MONOCHROME LCD MONITOR, RADIFORCE MODEL GS310 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K060231 04/13/2006 CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK ELCAM MEDICAL A.C.A.L. TALI HAZAN
K053563 04/07/2006 HUMAPEN MEMOIR ELI LILLY AND COMPANY LEEANN CHAMBERS
K060683 04/18/2006 ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM ENDIUS, INC. CHRISTINE KUNTZ-NASSIF
K060990 04/26/2006 ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM ENDIUS, INC. CHRISTINE KUNTZ-NASSIF
K053078 04/27/2006 ERGOSELECT 100 K/P, ERGOSELECT 200 K/P ERGOLINE GMBH HAIKO BELL
K060317 04/28/2006 ANTHOGYR CONTRA ANGLES AND HANDPIECES EST. ANTHOGYR ERIC GENEVE
K060245 04/07/2006 HARMONIC SCALPEL BLADES AND SHEARS ETHICON ENDO-SURGERY, INC. ELIZABETH MILLER
K060778 04/28/2006 SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWDER FREE EVER LIGHT PLASTIC PRODUCTS CO., LTD. KATHY LIU
K053386 04/21/2006 XLTEK EMU40 EEG HEADBOX, MODEL PK1072 EXCEL TECH. LTD. NICOLE LANDREVILLE
K060044 04/06/2006 ACUTE CARE FACE MASK, MODEL RT040 FISHER & PAYKEL HEALTHCARE, LTD. BRETT WHISTON
K060390 04/27/2006 SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA GALIL MEDICAL LTD. JONATHAN S KAHN
K060195 04/24/2006 GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE GAMBRO RENAL PRODUCTS THOMAS B DOWELL
K060779 04/05/2006 ADVANCE VESSEL ANALYSIS II GE HEALTHCARE LARRY A KROGER
K053121 04/05/2006 TRAM MODULE GE HEALTHCARE JOEL KENT
K060661 04/07/2006 MACTRODE 3 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES KAREN RUSSELL
K053356 04/19/2006 MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES RONALD N BLASKI
K060052 04/19/2006 GE LIGHTSPEED XTRA CT SCANNER SYSTEM GE MEDICAL SYSTEMS, LLC GLEN E SABIN
K060222 04/28/2006 LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP GEMORE TECHNOLOGY CO., LTD. BODEN S.P. LAI
K050007 04/26/2006 PHICAL TEST GENOVA DIAGNOSTICS PATRICK HANAWAY
DEN060001 04/26/2006 PHICAL TEST GENOVA DIAGNOSTICS PATRICK HANAWAY
K053497 04/14/2006 GUAVA EZCD4 SYSTEM GUAVA TECHNOLOGIES, INC. LAWRENCE F BRUDER
K053459 04/12/2006 OMNILINK .035 BILIARY STENT SYSTEM GUIDANT CORPORATION SYLVIA HERNANDEZ
K052420 04/06/2006 G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM GYNOVA, LLC DON GUINAN
K060864 04/28/2006 MULTIDIRECTIONAL THREADED PEG HAND INNOVATIONS, LLC. NATALIE S HECK
K060635 04/28/2006 CONSENSUS ACETABULAR SHELL SYSTEM HAYES MEDICAL, INC. LUKE ROSE
K060729 04/12/2006 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168FV HEALTH & LIFE CO., LTD. ALEX KOU
K060835 04/21/2006 HL888SF HEALTH & LIFE CO., LTD. ALEX KOU
K060843 04/20/2006 MODIFICATION TO HEALTH BUDDY APPLIANCE HEALTH HERO NETWORK, INC. ROBIN BUSH
K060315 04/07/2006 HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM HEALTHSTATS INTERNATIONAL PTE. LTD. STEPHEN GORSKI
K060834 04/19/2006 PROBEAT WITH MGCS HITACHI, LTD. JONATHAN S KAHN
K060111 04/24/2006 IVA (MXA II SOFTWARE OPTION) HOLOGIC, INC. JEANETTE SCHIER-PUGSLEY
K060147 04/28/2006 POWDER FREE NITRILE EXAMINATION GLOVES, BLUE HONGYE PLASTIC PRODUCTS CO., LTD. MICKY LIN
K060806 04/21/2006 HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088 HOSPIRA, INC. PATRICIA MELERSKI
K060921 04/13/2006 S2 RECON NAIL SYSTEM HOWMEDICA OSTEONICS CORP. FRANCISCO HARO
K060798 04/12/2006 STRYKER PLATING SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K060613 04/21/2006 VARIAX LOCKING PLATE SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K052319 04/04/2006 IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7 IMPEDIMED PTY LTD. NEVILLE BERTWISTLE
K051419 04/27/2006 INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1 INDITHERM MEDICAL M.W. (ANDY) ANDERSON
K060688 04/13/2006 HEMOSIL SYNTHASIL INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K060413 04/27/2006 INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE INTACT MEDICAL CORPORATION DAVID JACOBS
K060014 04/03/2006 INTELIFUSE, INC., WARMSYSTEM WITH STIMULINKS INTELIFUSE, INC. SHARON ROCKWELL
K060391 04/10/2006 INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182 INTUITIVE SURGICAL, INC. MICHAEL J HYRAMATEGUI
K060695 04/11/2006 IBA PROTON THERAPY SYSTEM - PROTEUS 235 ION BEAM APPLICATIONS S.A. JOHN B REISS
K060757 04/19/2006 INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER IRVINE BIOMEDICAL, INC. DENNIS HONG
K060168 04/24/2006 VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT IRVINE SCIENTIFIC SALES CO., INC. WENDELL LEE
K060365 04/17/2006 APEXCAL IVOCLAR VIVADENT, INC. DONNA M HARTNETT
K060618 04/12/2006 CIDEX ACTIVATED DIALDEHYDE SOLUTION JOHNSON & JOHNSON CO. JOSEPH M ASCENZI
K060016 04/25/2006 THROMCAT THROMBECTOMY CATHETER SYSTEM KENSEY NASH CORP. JENNIFER J BOSLEY
K060472 04/28/2006 PREMISE FLOWABLE KERR CORPORATION COLLEEN BOSWELL
K060177 04/18/2006 KLS MARTIN RIGID FIXATION - STERILE KLS MARTIN L.P. JENNIFER DAMATO
K060462 04/24/2006 NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2) LAB VISION CORP. GRACE CHANG
K050094 04/20/2006 LADY COMP USA LADY COMP USA MICHAEL CARTAIN
K060920 04/27/2006 VELSCOPE LED MEDICAL DIAGNOSTICS INC. DAVID C MORGAN
K060533 04/14/2006 LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM LENSTEC, INC. LUIS RUIZ
K050989 04/06/2006 AWQ-104 LHASA OMS, INC. MARK W SHEEHAN
K060706 04/28/2006 LIBERTY NORMAL GLUCOSE CONTROL SOLUTION LIBERTY HEALTHCARE GROUP, INC. JOHN C GORMLEY
K052929 04/26/2006 PREFTEST PROFESSIONAL SUITE LIMESTONE TECHNOLOGIES INC. NANCY RUTH
K050988 04/06/2006 OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. MARIE LIN
K060260 04/10/2006 MICROPOWER HAND PIECE HIGH SPEED DRILL LINVATEC CORP. ELIZABETH PAUL
K060270 04/10/2006 MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL LINVATEC CORP. ELIZABETH PAUL
K053628 04/07/2006 LIGHTSHEER DUET LASER SYSTEM LUMENIS, INC. Connie Hoy
K053568 04/17/2006 BILISOFT PHOTOTHERAPY SYSTEM LUMITEX, INC. JEFF WILLIAMS
K060119 04/12/2006 MCKINLEY SATURATION CATHETER MCKINLEY MEDICAL LLC JOHN CHAPPELL
K060166 04/21/2006 OHMEGA MEDICAL MEASUREMENT SYSTEMS,B.V. K. OGINK-SOMHORST
K060680 04/11/2006 ATRILAZE SURGICAL ABLATION SYSTEM MEDICALCV, INC. DENNY STEGER
K060719 04/14/2006 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK EDWARD S CHIN
K060697 04/11/2006 TRAVEL PAL (MM-111B) /MEGA MOTION MEGA MOTION, INC. MARK CALOMINO
K053354 04/13/2006 INTERMEZZO PLUS FIXTURE MEGAGEN CO., LTD. DAE CHANG
K053353 04/19/2006 RESCUE IMPLANT SYSTEM MEGAGEN CO., LTD. DAE CHANG
K060625 04/20/2006 NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR MICRO THERAPEUTICS, INC. FLORIN TRUUVERT
K053265 04/28/2006 MICRUS GUIDE WIRE, WATUSI 0.014 MICRUS ENDOVASCULAR CORPORATION MARGARET WEBBER
K060566 04/05/2006 MINXRAY, MODELS HFP24 AND HFP40 MIKASA X-RAY CO., LTD. DANIEL KAMM
K060646 04/21/2006 BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 MONITEX INDUSTRIAL CO., LTD. Ke-Min Jen
K060840 04/07/2006 SVIEW MRI CARDIAC SERVICES, INCORPORATED S. SCOTT HUBER
K060679 04/21/2006 SURTRAK IMPLANTATION KIT NORTH AMERICAN SCIENTIFIC, INC. LEIGH SPOTTEN
K053478 04/05/2006 ENDOSSEOUS DENTAL IMPLANT SYSTEM NORTHERN IMPLANTS, LLC GRETA M HOLS
K060345 04/28/2006 NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS NOVA BIOMEDICAL CORP. PAUL W MACDONALD
K060432 04/04/2006 NOVABONE POROUS-BONE GRAFT SCAFFOLD NovaBone Products, LLC DAVID M GAISSER
K060225 04/12/2006 NUVASIVE SPHERX SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K060193 04/10/2006 MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2 OCEANIC MEDICAL PRODUCTS, INC. HOWARD M HOLSTEIN
K060064 04/10/2006 STETHOFLUX ODVI ARMELLE LAPRELLE
K053306 04/19/2006 IVIEW ONDEMANDSOFT IAN P GORDON
K060577 04/28/2006 ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS ORTHO DEVELOPMENT CORP. WILLIAM J GRIFFIN
K060940 04/24/2006 VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III Ortho-Clinical Diagnostics, Inc. MARLENE HANNA
K060650 04/06/2006 VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702 Ortho-Clinical Diagnostics, Inc. MICHAEL M BYRNE
K060336 04/28/2006 NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002 ORTHOSOFT, INC. CHRISTOPHER MCLEAN
K051798 04/07/2006 OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEM OSTEOMED L.P. DAWN T HOLDERMAN
K060357 04/05/2006 TREK S NEBULIZER COMPRESSOR PARI INNOVATIVE MANUFACTURERS, INC. MICHAEL JUDGE
K053491 04/27/2006 PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F PENUMBRA, INC. THERESA BRANDNER-ALLEN
K060579 04/20/2006 COMFORT/IO IONTOPHORESIS ELECTRODES PEPIN MFG., INC. Gary Syring
K060749 04/04/2006 XPERCT PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. LYNN HARMER
K060941 04/19/2006 CAAS MRV VERSION 3.0 PIE MEDICAL IMAGING B.V. CARL M BEAURLINE
K061018 04/28/2006 PLANAR DOME EX LINE MODEL DOME E2C PLANAR SYSTEMS, INC. CRAIG HARSHMAN
K060617 04/05/2006 PTS PANELS HDL CHOLESTEROL TEST STRIPS POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
K053542 04/10/2006 SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM PRAXIM SA RANDY VEALE
K060282 04/10/2006 TOTAL KNEE SURGETICS NAVIGATION SYSTEM PRAXIM SA RANDY VEALE
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