FDA 510(k) Decisions During October, 2006  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K062292 10/25/2006 UNICEM 3M ESPE DENTAL PRODUCTS SABINE KRISCHER
K062305 10/18/2006 CLARITY MODIFIED CERAMIC BRACKETS 3M UNITEK L MARLYN SCHEFF
K062668 10/16/2006 AUDIT MICROCV IMMUNOASSAY LINEARITY SET AALTO SCIENTIFIC LTD. ALAN VEKICH
K062337 10/05/2006 MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR AARON MEDICAL INDUSTRIES RICHARD A KOZLOFF
K062843 10/17/2006 FOX SV PTA CATHETER ABBOTT LABORATORIES KATHRYN MARCHEL
K063078 10/24/2006 MICROENDOSCOPE ACCLARENT, INC. DEBBIE COGAN
K062967 10/30/2006 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM ACCURAY, INC. ANNE SCHLAGENHAFT
K061232 10/06/2006 ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006 ACRYMED, INC. BRUCE GIBBINS
K061661 10/18/2006 STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20 ADVANCED INFUSION, INC. JAMES CHRISTENSEN
K062686 10/05/2006 UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM ADVANCED SPINE TECHNOLOGY, INC. J.D. WEBB
K061899 10/26/2006 EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM ADVANCED STERILIZATION PRODUCTS JOSEPH M ASCENZI
K062461 10/25/2006 C. ALBICANS PNA FISH ADVANDX, INC. Amy Aulwes
K062742 10/13/2006 CR 85-X AGFA CORPORATION JUDITH HARBOUR
K062143 10/24/2006 KOZY COMFORT INFANT POSITIONER ALFRED E MANN INST. FOR BIOMEDICAL ENGINEERING ARMAN H NADERSHAHI
K062080 10/18/2006 RESUSCITATION TIMER, MODEL L770-CPR ALLIED HEALTHCARE PRODUCTS, INC. WAYNE KARCHER
K053550 10/25/2006 AMBU BLUE SENSOR NEO AND NEO X AMBU A/S SANJAY PARIKH
K052944 10/25/2006 AMBU WHITE SENSOR CFM, CFL AMBU A/S SANJAY PARIKH
K062477 10/27/2006 AMICAS VISION SERIES PACS, MODEL 4.3 AMICAS, INC. PATRICE JC NEDELEC
K062609 10/06/2006 MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER ANGIODYNAMICS, INC. TERI JUCKETT
K062157 10/13/2006 CONFORM APEX DENTAL MATERIALS, INC. CHRIS KULTON
K061651 10/20/2006 FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 APPLE MEDICAL CORP. JOHN C PULFORD
K061005 10/04/2006 ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS APPLIED DNA TECHNOLOGIES, INC. Feng-Yu Lee
K053590 10/06/2006 SILVERLON CA (CALCIUM ALGINATE) ARGENTUM MEDICAL, LLC. WILLIAM A CLEMNTI
K061863 10/19/2006 ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY ARTHREX, INC. ANN WATERHOUSE
K061925 10/31/2006 MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS ARTHREX, INC. SALLY FOUST
K062244 10/02/2006 OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR ARTHROCARE CORP. LAURA KASPEROWICZ
K061984 10/05/2006 TREASURE ASAHI INTECC CO., LTD. YOSHI TERAI
K062861 10/31/2006 ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM ASCENSION ORTHOPEDICS, INC. GLEN NEALLY
K053585 10/11/2006 VANGUARD REPROCESSED SUTURE PASSER ASCENT HEALTHCARE SOLUTIONS MOIRA BARTON
K060158 10/13/2006 NET-2000 MICROCURRENT STIMULATOR AURI-STIM MEDICAL, INC. LEWIS WARD
K062700 10/26/2006 INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM B. BRAUN MEDICAL, INC. SCOTT PEASE
K062699 10/26/2006 PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM B. BRAUN MEDICAL, INC. SCOTT PEASE
K062887 10/26/2006 MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F BARD PERIPHERAL VASCULAR GENEVIEVE BALUTOWSKI
K062079 10/19/2006 XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210 BAXTER HEALTHCARE CORPORATION DAVID E CURTIN
K060538 10/10/2006 BEAVERITE BODY FAT SCALES, MODELS 8901, 8903, 8905, 8909, 8911, 8915, 9563 AND 9568 BEAVERITE INTERNATIONAL LIMITED PATSY J TRISLER
K052223 10/06/2006 ACCESS EPO ASSAY BECKMAN COULTER, INC. LYNN WEIST
K062516 10/05/2006 ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) BECKMAN COULTER, INC. TYLER FOUTCH
K061616 10/04/2006 COULTER LH 780 HEMATOLOGY ANALYZER BECKMAN COULTER, INC. NANCY NADLER
K062680 10/05/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN (GN) 1-128 UG/ML BECTON, DICKINSON & CO. VICKI L KENNEDY
K062687 10/24/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANATE (GN) 1/2 - 128/2UG/ML BECTON, DICKINSON & CO. JANINE MATLAK
K062774 10/19/2006 BELMONT BUDDY PLUS FLUID WARMER BELMONT INSTRUMENT CORP. URAIWAN P LABADINI
K062730 10/05/2006 NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS BIOGREEN MEDICAL SDN. BHD. SRI MAHENDRA SATHIACAMA
K062830 10/20/2006 BIOLUCENT APPLICATOR KIT BIOLUCENT, INC. DAVE CAMPBELL
K063002 10/31/2006 ALTRA PRESS-FIT HIP SYSTEM BIOMET MANUFACTURING CORP. GARY BAKER
K062995 10/31/2006 M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT BIOMET MANUFACTURING CORP. PATRICIA S BERES
K061681 10/19/2006 REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT BIOMET MANUFACTURING CORP. LESTER F PADILLA
K063107 10/27/2006 3DNET SUITE BIOTRONICS3D, LTD. HARALAMBOS HATZAKIS
K060756 10/30/2006 MEDLOG, MODEL 1-0-10 BMC GESELLSCHAFT FUR MEDIZINTECHNIK MBH ANGELIKA M BERGER
K062387 10/05/2006 SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM BOSTON SCIENTIFIC ANGIE BYLAND
K062202 10/20/2006 OCCLUSION BALLOON BOSTON SCIENTIFIC CORP. CHRISTINE M CAMERON
K062832 10/20/2006 VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138 C.R. BARD, INC. GLENN NORTON
K061428 10/16/2006 PMP4 APPLICATION CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K061046 10/12/2006 CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001 CARDIOMEMS, INC. CAROL VIERLING
K062808 10/13/2006 LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT CATCH INCORPORATED Cindy Green
K063037 10/18/2006 CENTARISONE RIS/PACS CENTARISONE, LLC SCOTT SHANNON
K062476 10/31/2006 CERAGEM RH1 AUTOMATIC THERMAL MASSAGER CERAGEM INTERNATIONAL, INC. SUSAN ONEL
K060927 10/06/2006 CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES CERES MEDICAL SYSTEMS, L.L.C. CORRINE BONFIGLIO
K062240 10/16/2006 CAREVENT CHIEF MEDICAL LLC SCOTT HORN
K062016 10/27/2006 RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES CHOICE SMART HEALTH CARE CO. LTD. JANICE MA
K062015 10/31/2006 CHRONOS VISION EYE TRACKING DEVICE (C-ETD) CHRONOS VISION MAUREEN O'CONNELL
K062916 10/23/2006 CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3 CLINIQA CORPORATION CAROL RUGGIERO
K061876 10/16/2006 CODMAN VPV SYSTEM, MODEL 82-3192 Codman & Shurtleff, Inc. SUSAN KAGAN
K062846 10/13/2006 COLLAGEN DENTAL MEMBRANE III COLLAGEN MATRIX, INC. PEGGY HANSON
K062881 10/11/2006 COLLAGEN DENTAL MENBRANE - CONFORMABLE II COLLAGEN MATRIX, INC. PEGGY HANSEN
K052229 10/13/2006 COLOPLAST OSTOMY ROD, MODEL 12814 COLOPLAST CORP. ELIZABETH BOOTS
K063032 10/16/2006 COMFORT SCOOTER, MODEL LY-EW415 COMFORT ORTHOPEDIC CO. LTD. Ke-Min Jen
K062215 10/16/2006 CONFIDANT 2.0 CONFIDANT INC. DANIEL R PLONSKI
K052992 10/16/2006 CONMED LINVATEC INSTRUMENT STERILIZATION TRAY CONMED LINVATEC ELIZABETH PAUL
K062697 10/13/2006 SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT COOK BIOTECH, INC. MARY A FADERAN
K062320 10/02/2006 SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 COOK BIOTECH, INC. MARY A FADERAN
K062729 10/10/2006 SURGISIS RVP RECTO-VAGINAL FISTULA PLUG COOK BIOTECH, INC. DANIEL J DILLON
K062696 10/13/2006 SURGISIS, SURGISIS ES COOK BIOTECH, INC. MARY A FADERAN
K062438 10/27/2006 BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 COOK OB/GYN CINDY RUMPLE
K053538 10/10/2006 MODIFICATION TO PHYTACARE ALGINATE HYDROGEL WOUND FILLER CURAPHARM, INC. THOMAS M HNAT
K062321 10/31/2006 SMARTLIPO ND:YAG LASER CYNOSURE, INC. GEORGE CHO
K062035 10/04/2006 DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K062927 10/12/2006 MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML) DADE BEHRING, INC. MAY MORISHIMA
K063064 10/26/2006 MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML) DADE BEHRING, INC. MAUREEN MENDE
K063053 10/26/2006 MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) DADE BEHRING, INC. SHANNON POPSON
K062375 10/26/2006 MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML) DADE BEHRING, INC. MAUREEN MENDE
K063065 10/27/2006 MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML) DADE BEHRING, INC. MAUREEN MENDE
K062923 10/13/2006 MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML) DADE BEHRING, INC. LIBBY WARRINER
K062777 10/10/2006 MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN DADE BEHRING, INC. MAUREEN MENDE
K062773 10/13/2006 MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN DADE BEHRING, INC. LIBBY WARRINER
K062705 10/20/2006 SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID DADE BEHRING, INC. ROBERT EUSEBIO
K062103 10/25/2006 DARCO FORCE TITANIUM COMPRESSION SCREW DARCO INTERNATIONAL, INC. MARK S COOPER
K061754 10/23/2006 BARD COMPOSITE L/P MESH DAVOL INC., SUB. C.R. BARD, INC. GAIL DOW
K062732 10/25/2006 TOMAS PIN 6 MM DENTAURUM CHARLES R BELL
K060836 10/27/2006 VISTADENT OC - VERSION 4 DENTSPLY INTL., INC. HELEN LEWIS
K062301 10/13/2006 DEPUY LPS PROXIMAL TIBIAL COMPONENT DEPUY ORTHOPAEDICS, INC. NANCY FRIDDLE
K062148 10/24/2006 DEPUY PINNACLE ALTRX ACETABULAR CUP LINER DEPUY ORTHOPAEDICS, INC. ANNE M SCHULER
K062352 10/19/2006 FRS SCREW DEPUY ORTHOPAEDICS, INC. REBECCA LENNARD
K062495 10/13/2006 HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM DEPUY SPINE, INC. MELANIE ARCHER
K060653 10/24/2006 THERMACLEAR DERMACARE, INC. HEIDI STARK
K062959 10/16/2006 DMS 300-2, 300-3 AND 300-4 DIAGNOSTIC MONITORING SOFTWARE WILLIAM PARSONS
K060204 10/18/2006 LIAISON EA IGG DIASORIN, INC. DAVID M IKEDA
K062032 10/05/2006 ACCUSOFT, ACCUSOFT XL DIREX SYSTEMS CORP. LARISA GERSHTEIN
K062147 10/20/2006 INTEGRA SL DIREX SYSTEMS CORP. LARISA GERSHTEIN
K062267 10/31/2006 OXYLOG 3000 DRAGER MEDICAL B.V. BRYAN OVERTON
K062895 10/13/2006 XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV F CARLETON
K061878 10/24/2006 ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC E SURGICAL, LLC LEWIS WARD
K061996 10/03/2006 SANDMAN POCKET EB NEURO, S.P.A. CARRI GRAHAM
K062685 10/06/2006 EBI ARAY SPINAL SYSTEM EBI, L.P. DEBRA BING
K062494 10/19/2006 EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM EBI, L.P. DEBRA BING
K062810 10/17/2006 SOLITAIRE ANTERIOR SPINAL SYSTEM EBI, L.P. DEBRA BING
K062716 10/27/2006 ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400 ECO-RX, INC. CONSTANCE R BROWN, ESQ.
K062054 10/06/2006 5 MEGAPIXEL MONOCHROME LCD MONITOR, RADIFORCE GS510 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K060781 10/03/2006 MEDICAL COMPRESSOR, MODELS DK50 D AND DM EKOM S.R.O. ESTHER SALTZ
K062743 10/31/2006 UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0 ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM) JEFFREY CHERN
K062888 10/24/2006 MIDDLE WHEEL DRIVE POWER CHAIR, CWD01 EMG TECHNOLOGY CO., LTD. Ke-Min Jen
K063113 10/27/2006 EP-WORKMATE EP MEDSYSTEMS LARRY PICCIANO
K062598 10/31/2006 IMT.LAB SOFTWARE ESAOTE EUROPE B.V. CARRI GRAHAM
K061614 10/06/2006 TERRAQUANT MQ2000 V. 5 AND HANDYRX MQ2007 LASERS ESCADA INTERNATIONAL, INC. MARY MCNAMARA-CULLINANE
K062209 10/10/2006 BASX BLADELESS TROCAR ETHICON ENDO-SURGERY, LLC DENNIS HAHN
K061804 10/06/2006 ZERION ALPHA, ; ZERION BETA ETKON INTERNATIONAL GMBH MATTHIAS ZITZMANN
K061408 10/05/2006 EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT EUROIMMUN US LLC KATHRYN KOHL
K062549 10/04/2006 XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238 EXCEL TECH. LTD. NICOLE LANDREVILLE
K061188 10/23/2006 SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM FOXHOLLOW TECHNOLOGIES, INC. MELISSA S MURPHY
K062090 10/18/2006 PRISMA SYSTEM R03.10A GAMBRO RENAL PRODUCTS THOMAS B DOWELL
K061413 10/13/2006 APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM GEN-PROBE, INC. BRIAN J SHEA
K061509 10/04/2006 TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 GEN-PROBE, INC. BRIAN J SHEA
K062312 10/16/2006 AXIOM PULSED LIGHT SYSTEM GENERAL PROJECT S.R.L. CORNELIA DAMSKY
K061417 10/10/2006 GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910 GENICON GARY HABERLAND
K062786 10/18/2006 MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD. SHOSHANA FRIEDMAN
K062010 10/27/2006 RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES GLOBAL TREASURE INDUSTRIES LTD. JANICE MA
K061234 10/30/2006 GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM GLUCOPLUS INC JEFFREY FLEISHMAN
K062672 10/24/2006 GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES Grace Medical, Inc. JEFF COBB
K061153 10/27/2006 GYNESONICS EC6 TRANSDUCER GYNESONICS, INC. JESSICA GROSSMAN, MD
K062801 10/04/2006 SMARTSUCTION SOLO DEVICE HAEMONETICS CORP. GABRIEL J MURACA
K061070 10/13/2006 HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR HANSEN MEDICAL, INC. NINA PELED
K060669 10/13/2006 MEDRELIEF ST SERIES, MODELS RT-50, ST-100, ST 150, ST-200, ST-300 HEALTHONICS, INC. JAMES W KRONBERG
K063191 10/31/2006 HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT HEIDELBERG ENGINEERING GERHARD ZINSER
K062556 10/05/2006 ECHELON SHOULDER COIL HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLEWAITE
K062180 10/02/2006 ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP HORIBA ABX TIM LAWTON
K061585 10/05/2006 OPTICATH CENTRAL VENOUS OXIMETRY CATHETER HOSPIRA, INC. NICOHL WILDING
K062498 10/25/2006 PROFYLE SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K062113 10/03/2006 SOLAR REUNION FRACTURE STEM HOWMEDICA OSTEONICS CORP. FRANCISCO HARO
K062634 10/06/2006 ORTHOXP IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K051436 10/13/2006 PRE' VAGINAL LUBRICANT INGFERTLITY, LLC DENNIS CLIFTON
K062617 10/04/2006 MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM INION LTD. KATI MARTINEN
K061746 10/02/2006 COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID INNOCOLL PHARMACEUTICALS AARON WYSE
K062361 10/23/2006 INNOVACON HCG UKTRA TEST DEVICE INNOVACON, INC. EDWARD TUNG
K061842 10/18/2006 QUANTA LITE PBC SCREEN IGG/IGA ELISA INOVA DIAGNOSTICS, INC. GARY L NORMAN
K062665 10/24/2006 INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS INOVEL LLC WILLIAM WAWRZYNIAK
K062129 10/20/2006 P.0004 IMPLANTS INSTITUT STRAUMANN AG ELAINE ALAN
K062068 10/27/2006 INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0 INTELWAVE, LLC ALEXANDER RIFTINE
K062809 10/18/2006 ADMIRAL XTREME PTA CATHETER INVATEC INNOVATIVE TECHNOLOGIES David Worrell
K062735 10/27/2006 TUTU 7, MODEL IV-T22 INVISIBLE TECHNOLOGY CO., LTD. Allison Scott
K062767 10/13/2006 CTL-63 AND CTL-128 SPINE ARRAY COILS INVIVO CORPORATION THOMAS SCHUBERT
K062144 10/12/2006 ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810 INVIVO CORPORATION RUSTY KELLY
K061549 10/18/2006 AMNIOSTAT-FLM-PG IRVINE SCIENTIFIC SALES CO., INC. WENDELL LEE, PHARM. D
K061679 10/13/2006 WALLACE ARTIFICIAL INSEMINATION CATHETER IRVINE SCIENTIFIC SALES CO., INC. WENDELL LEE
K062520 10/11/2006 POWDERED VINYL PATIENT EXAMINATION GLOVES JIANGSU JAYSUN GLOVE CO., LTD. CHU XIAOAN
K062311 10/04/2006 KARMA MANUAL WHEELCHAIR, MODEL BUDGET 800 KARMA MEDICAL PRODUCTS CO., LTD. Ke-Min Jen
K062309 10/10/2006 KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105 KARMA MEDICAL PRODUCTS CO., LTD. Ke-Min Jen
K062227 10/04/2006 V.A.C. THERAPY SYSTEM KCI USA, INC. (KINETIC CONCEPTS, INC.) MARGARET MARSH
K062870 10/20/2006 TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 KENSEY NASH CORP. ROBIN M FATZINGER
K062519 10/19/2006 NEXUS 3 KERR CORPORATION COLLEEN BOSWELL
K062660 10/24/2006 CATALYSY KI MOBILITY LLC DOUGLAS MUNSEY
K061465 10/05/2006 KMI CEMENT RESTRICTOR IMPLANT KINETIKOS MEDICAL, INC. JOHN G SPAMPINATO
K062570 10/31/2006 PATIENT CONTOURED MESH (PCM) KLS-MARTIN L.P. JENNIFER DAMATO
K060414 10/23/2006 KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE KMI KOLSTER METHODS, INC. JEFFREY A KOLSTER
K060458 10/12/2006 MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR LANGFORD IC SYSTEMS, INC. JIMMIE T JOHNSTON
K062831 10/19/2006 MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM LIFE SPINE ERIN MALLOY
K063024 10/30/2006 LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. MARIE LIN
K060070 10/12/2006 INTROL CF PANEL I CONTROL MAINE MOLECULAR QUALITY CONTROLS, INC. JOAN GORDON
DEN060007 10/12/2006 INTROL CF PANEL I CONTROL MAINE MOLECULAR QUALITY CONTROLS, INC. JOAN GORDON
K062864 10/18/2006 MASTALEX -MRSA, MODEL RST501 MAST GROUP LTD. BARBARA A LEE
K063047 10/19/2006 MEDHOT MTI 2000 THERMAL IMAGING SYSTEM MEDHOT THERMAL IMAGING, INC. SID MATHUR
K062136 10/06/2006 PASS 2 SPINAL SYSTEM MEDICREA J.D. WEBB
K061145 10/02/2006 SPERMSLOW MEDICULT A/S RONALD G LEONARDI
K062386 10/05/2006 QANGIO CT MEDIS MEDICAL IMAGING SYSTEMS, B.V. J.I. HOLLANDER
K062295 10/20/2006 IRI INTEGRATED RETINAL IMAGER MEDIVISION MEDICAL IMAGING, LTD. AHAVA STEIN
K060772 10/16/2006 MANUEL SAFTEY SYRINGE PARTS 1 & 2 MEDSAFE ASA NILS GUNNARSSON
K060615 10/25/2006 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K062727 10/11/2006 CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE MEDTRONIC VASCULAR SCOTT CANDY
K061416 10/25/2006 SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74 MEDTRONIC VASCULAR MICHELLE NIVALA
K062421 10/10/2006 MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER MENTOR CORPORATION NICOLA SELLEY
K062490 10/27/2006 VISAGE PACS/CS, RELEASE VERSION 4.1 MERCURY COMPUTER SYSTEMS, INC RICHARD GLASHEEN
K062302 10/06/2006 MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM MILLICORE AB ROSINA ROBINSON
K050197 10/06/2006 MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 MINITUBE OF AMERICA, INC FREDERICK T RIKKERS
K062471 10/26/2006 ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF MISONIX, INC. RONALD R MANNA
K062663 10/11/2006 MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS MOLDEX/METRIC, INC. WILLIAM WAWRZYNIAK
K062138 10/05/2006 POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE MOLNLYCKE HEALTH CARE, INC. STEVE DOWDLEY
K061700 10/26/2006 NEOTRACT ANCHOR NEOTRACT, INC. KEVIN MACDONALD
K062860 10/27/2006 MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YANFANG
K062779 10/05/2006 DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP) NEW WAVE SURGICAL CORPORATION SID MATHUR
K061359 10/18/2006 DENSHIELD TREATMENT FOR SENSITIVE TEETH NOVAMIN TECHNOLOGY, INC. DAVID C GREENSPAN
K062456 10/16/2006 NOVASPINE POWERED SUCTION PUMP PRO-1 NOVASPINE LLC DINA L WEISSMAN
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