FDA 510(k) Applications Received During August, 2006

FDA 510(k) Number Submission Date Device Name Applicant Contact
K062493 08/25/2006 LAVA SOFTWARE 3M ESPE AG DENTAL PRODUCTS SABINE KRISCHER
K062292 08/07/2006 UNICEM 3M ESPE DENTAL PRODUCTS SABINE KRISCHER
K062305 08/08/2006 CLARITY MODIFIED CERAMIC BRACKETS 3M UNITEK L MARLYN SCHEFF
K062337 08/10/2006 MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR AARON MEDICAL INDUSTRIES RICHARD A KOZLOFF
K062505 08/31/2006 NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES ABBOTT SPINE, INC. NOAH BARTSCH
K062554 08/31/2006 STARCLOSE HEX-HUB DILATOR ABBOTT VASCULAR INC. DAUN PUTNAM
K062458 08/23/2006 ETHMOID SINUS SPACER ACCLARENT, INC. DEBBIE COGAN
K062514 08/29/2006 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM ACCURAY INCORPORATED ANNE SCHLAGENHAFT
K062331 08/10/2006 HIGHPAK-12 AD ELEKTRONIK GMBH GREGORY J MATHISON
K062298 08/08/2006 APOLLO GAMMA CAMERA SYSTEM ADAC LABORATORIES ANNIE WRIGHT
K062461 08/31/2006 C. ALBICANS PNA FISH ADVANDX, INC. AMY AULWES
K062510 08/28/2006 AESCULAP STERILCONTAINER SYSTEM AESCULAP MATTHEW M HULL
K062406 08/18/2006 AESCULAP NEURO PATTIES AESCULAP, INC. LISA M BOYLE
K062413 08/17/2006 AESCULAP PNEUMATIC KERRISON AESCULAP, INC. KATHY A RACOSKY
K062327 08/10/2006 MODIFICATION TO S4 SPINAL SYSTEM AESCULAP, INC. LISA M BOYLE
K062217 08/03/2006 AESKULSKA BETA2-GLYCO-A AESKU, INC DAVID BELL
K062434 08/21/2006 ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528 AGAMATRIX CONNIE HERTEL
K062223 08/02/2006 AGFA MODEL CR30-X AGFA CORPORATION PATRICK J LYNCH
K062390 08/22/2006 CRYSTALVIEW R200 ALARA, INC. DIANE M KING
K062504 08/28/2006 CERAMAX ALPHADENT CO., LTD. NOH HAK
K062371 08/22/2006 PREVIEW ANTERIOR CERVICAL PLATE SYSTEM ALPHASPINE, INC. MIKE ENSIGN
K062332 08/10/2006 ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION ALTAIRE PHARMACEUTICALS, INC. MARTIN DALSING
K062511 08/31/2006 AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX ALVEOLUS, INC. DONALD CANAL
K062477 08/24/2006 AMICAS VISION SERIES PACS, MODEL 4.3 AMICAS, INC. PATRICE JC NEDELEC
K062212 08/01/2006 SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S ANACAPA TECHNOLOGIES, INC. ILA DOSHI
K062307 08/08/2006 XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS ANULEX TECHNOLOGIES, INC TIMOTHY MILLER
K062544 08/31/2006 AR1000 ULTRASONIC WOUND THERAPY SYSTEM AROBELLA MEDICAL, LLC ALLISON SCOTT
K062365 08/14/2006 ARTHREX ASPIRATE KIT ARTHREX, INC. SALLY FOUST
K062244 08/03/2006 OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR ARTHROCARE CORP. LAURA KASPEROWICZ
K062525 08/29/2006 REPROCESSED LIGASURE VESSEL SEALER/DIVIDER ASCENT HEALTHCARE SOLUTIONS MOIRA BARTON
K062497 08/31/2006 REPROCESSED TROCARS ASCENT HEALTHCARE SOLUTIONS ELIZABETH RENKIN
K062197 08/01/2006 ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT ATLANTIS COMPONENTS, INC. BETSY A BROWN
K062277 08/07/2006 ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE ATLANTIS COMPONENTS, INC. FRANKLIN UYLEMAN
K062467 08/24/2006 AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10 AXIS-SHIELD DIAGNOSTICS, LTD. ERICA CONWAY
K062198 08/03/2006 SUNSPOTS PRE-GELLED SURFACE ELECTRODES AXON SYSTEMS, INC. HOWARD BAILIN
K062363 08/10/2006 BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM B&W TEK, INC. SEAN WANG
K062441 08/22/2006 BARRX HALO COAGULATION SYSTEM; GENERATOR, MODEL 90-9000; OUTPUT CABLE, MODEL 90-9010; FOOTSWITCH, MODEL 90-9020 BARRX MEDICAL, INCORPORATED JONATHAN S KAHAN
K062225 08/03/2006 HALO COAGULATION CATHETER BARRX MEDICAL, INCORPORATED VIORICA FILIMON
K062465 08/24/2006 ZYOPTIX XP EPI SEPARATOR SYSTEM BAUSCH & LOMB, INC. NED LUCE
K062457 08/23/2006 INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES BAXTER HEALTHCARE CORPORATION NANETTE HEDDEN
K062347 08/10/2006 ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM BAYER HEALTHCARE, LLC MARC HENN
K062516 08/28/2006 ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) BECKMAN COULTER, INC. TYLER FOUTCH
K062207 08/01/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64 UG/ML BECTON, DICKINSON & CO. VICKI L KENNEDY
K062206 08/01/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML BECTON, DICKINSON & CO. JANINE MATLAK
K062211 08/01/2006 BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM BIO-RAD LABORATORIES, INC. DAVID BHEND
K062213 08/01/2006 BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM BIO-RAD LABORATORIES, INC. DAVID BHEND
K062558 08/30/2006 MESOSFOL SURGICAL FILM BIOMET MANUFACTURING CORP. ERIKA MARTIN
K062567 08/31/2006 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM BIONIME CORPORATION SUSAN D GOLDSTEIN-FALK
K062530 08/29/2006 TRIAGE PROTEIN C TEST BIOSITE INCORPORATED FIL V BUENVIAJE
K062318 08/09/2006 BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML BIOTOP TECHNOLOGY CO., LTD. LYDIA LEE
K062289 08/09/2006 BONART ART-L3 LED CURING LIGHT BONART CO. LTD. ERIC L ONG
K062387 08/15/2006 SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM BOSTON SCIENTIFIC ANGIE BYLAND
K062202 08/01/2006 OCCLUSION BALLOON BOSTON SCIENTIFIC CORP. CHRISTINE M CAMERON
K062358 08/14/2006 MODIFICATION TO VECTORVISION TRAUMA BRAINLAB, AG RAINER BIRKENBACH
K062221 08/02/2006 CXDI-40EC CANON, INC. SHEILA DRISCOLL
K062340 08/11/2006 CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM CARDIO-OPTICS, INC. LARRY BLANKENSHIP
K062314 08/08/2006 HORUS LASER KERATOME CARL ZEISS MEDITEC AG KENT W JONES
K062503 08/31/2006 CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT CATACHEM, INC. LUIS P LEON
K062400 08/16/2006 IMPRESSIX, COLORCHANGE ALGINATE CAVEX HOLLAND B.V. RICHARD WOORTMAN
K062487 08/25/2006 APERFIX FEMORAL IMPLANT WITH INSERTER CAYENNE MEDICAL, INC. FLOYD LARSON
K062476 08/24/2006 CERAGEM RH1 AUTOMATIC THERMAL MASSAGER CERAGEM INTERNATIONAL, INC. SUSAN ONEL
K062280 08/07/2006 OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE CEREMED, INC. TADEUSZ WELLISZ
K062031 08/07/2006 CHASE CARDIAC ANALYSIS SYSTEM CHASE MEDICAL, LP DAVID M HERNON
K062240 08/02/2006 CAREVENT CHIEF MEDICAL LLC SCOTT HORN
K062262 08/09/2006 CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS CIBA VISION CORPORATION ALICIA M PLESNARSKI
K062200 08/03/2006 COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS COLLAGEN MATRIX, INC. PEGGY HANSON
K062215 08/15/2006 CONFIDANT 2.0 CONFIDANT INC. DANIEL R PLONSKI
K062082 08/17/2006 CONMED ABC DISSECTING BLADE ELECTRODE, MODEL 139330; BLUNT NEEDLE ELECTRODE, MODEL 139331 CONMED CORPORATION SHAWN RIEDEL
K062548 08/31/2006 MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES CONTAMAC LTD. MARTIN DALSING
K062320 08/09/2006 SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 COOK BIOTECH, INC. MARY A FADERAN
K062438 08/21/2006 BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 COOK OB/GYN CINDY RUMPLE
K062531 08/31/2006 ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE CORDIS CORP., A JOHNSON & JOHNSON CO. JOAN MARTIN
K062321 08/09/2006 SMARTLIPO ND:YAG LASER CYNOSURE, INC. GEORGE CHO
K062316 08/09/2006 DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE DADE BEHRING, INC. LORRAINE H PIESTRAK
K062334 08/10/2006 DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130 DADE BEHRING, INC. VICTOR M CARRIO
K062236 08/02/2006 DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE DADE BEHRING, INC. LORRAINE H PIESTRAK
K062199 08/01/2006 DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) DADE BEHRING, INC. VICTOR M CARRIO
K062276 08/07/2006 MICROSCAN MICROSTREP PLUS PANEL DADE BEHRING, INC. MAUREEN MENDE
K062293 08/07/2006 MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML) DADE BEHRING, INC. MAUREEN MENDE
K062290 08/17/2006 MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML) DADE BEHRING, INC. SHANNON POPSON
K062569 08/31/2006 SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING DATASCOPE CORP. SUSAN MANDY
K062397 08/16/2006 SENTINEL DEL MAR REYNOLDS MEDICAL, LTD. GEORGE MYERS
K062469 08/24/2006 VOYAGER 12 DEL MAR REYNOLDS MEDICAL, LTD. GEORGE MYERS
K062250 08/02/2006 DELTA XTEND REVERSE SHOULDER SYSTEM DEPUY ORTHOPAEDICS, INC. NATALIE S HECK
K062301 08/08/2006 DEPUY LPS PROXIMAL TIBIAL COMPONENT DEPUY ORTHOPAEDICS, INC. NANCY FRIDDLE
K062352 08/11/2006 FRS SCREW DEPUY ORTHOPAEDICS, INC. REBECCA LENNARD
K062495 08/25/2006 HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM DEPUY SPINE, INC. MELANIE ARCHER
K062196 08/01/2006 SFX SNAP-FIT CROSS CONNECTOR DEPUY SPINE, INC. MARY GRAY
K062339 08/10/2006 DERMOTHERAP GUN DERMOEQUIPOS S.R.L. BENNY ARAZY
K062538 08/29/2006 EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM DIACARE CORP. SID MATHUR
K062234 08/02/2006 MODIFICATION TO DIADEXUS PLAC TEST DIADEXUS, INC. ROBERT L WOLFERT
K062433 08/23/2006 DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM DIAMICS, INC. PETER GOMBRICH
K062473 08/24/2006 LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871 DIASORIN, INC. CAROL A DEPOUW
K062424 08/18/2006 CONFIDENCE EX HIGH VISCOSITY BONE CEMENT DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. JONATHAN S KAHAN
K062176 08/16/2006 RELIEF ACP ORAL CARE GEL DISCUS DENTAL INC. STEVEN L ZIEMBA
K062388 08/15/2006 ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM DOCUSYS GORDON J PETERS
K062364 08/15/2006 I-SCOPE 200 DONGJIN MEDICAL CO., LTD MIN-KANG KIM
K062267 08/04/2006 OXYLOG 3000 DRAGER MEDICAL B.V. BRYAN OVERTON
K062534 08/29/2006 ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE DRG INTL., INC. GARY LEHNUS
K062449 08/22/2006 EMPOWERMR INJECTOR SYSTEM, MODEL 9730 E-Z-EM, INC. ROBERT WILLIAMS
K062404 08/17/2006 TRANSEAR BONE CONDUCTION HEARING AID EAR TECHNOLOGY CORP. RICK GILBERT
K062494 08/25/2006 EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM EBI, L.P. DEBRA BING
K062429 08/21/2006 MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH EDWARDS LIFESCIENCES RESEARCH MEDICAL KAREN JONES
K062507 08/28/2006 MICRO-INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K062508 08/28/2006 NEUROWAVE MICRO-INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K062354 08/14/2006 VECTRA GENISYS VMS FR ENCORE MEDICAL, L.P. MICHAEL TREAS
K062209 08/01/2006 BASX BLADELESS TROCAR ETHICON ENDO-SURGERY, LLC DENNIS HAHN
K062201 08/01/2006 SPIDERX EMBOLIC PROTECTION DEVICE EV3 INC BRENDA JOHNSON
K062563 08/31/2006 FEMTEN CERVICAL TENACULUM FEM SUITE, L.L.C. CARL YOUNGMANN
K062484 08/25/2006 FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS FLAEM NUOVA S.P.A. MAUREEN O'CONNELL
K062543 08/30/2006 HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G FOCUS DIAGNOSTICS, INC. MICHEAL J WAGNER,ESQ.
K062389 08/16/2006 Z-BLOCK, MODELS 20/19, 40/19, 55/19 FOUNDATION MILLING CENTRE IAN P GORDON
K062576 08/31/2006 DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES GE HEALTHCARE JOEL KENT
K062580 08/31/2006 GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784) GE HEALTHCARE JOEL KENT
K062393 08/16/2006 GE VANTAGE PET NEURO SOFTWARE GE HEALTHCARE D. DUERSTELER
K062324 08/09/2006 MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN GE HEALTHCARE JOEL KENT
K062440 08/21/2006 GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 GEN-PROBE, INC. E JOSEPH MCMULLEN
K062312 08/09/2006 AXIOM PULSED LIGHT SYSTEM GENERAL PROJECT S.R.L. CORNELIA DAMSKY
K062407 08/17/2006 GATEWAY THORACOLUMBAR PLATE SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
K062385 08/15/2006 BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES GRACE MEDICAL, INC. JEFF COBB
K062245 08/07/2006 HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936 HARDY DIAGNOSTICS ANDRE HSIUNG
K062383 08/15/2006 UNISYN HA PLASMA MODULAR HIP HAYES MEDICAL, INC. LUKE ROSE
K062448 08/22/2006 LYRA ACUPUNCTURE NEEDLES HELIO MEDICAL SUPPLIES, INC. ERIC CHENG
K062515 08/31/2006 RETENTION FLOW OPAQUE HERAEUS KULZER GMBH CHERYL V ZIMMERMAN
K062256 08/04/2006 HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM HILL LABORATORIES CO. BRANDY ALTER
K062556 08/31/2006 ECHELON SHOULDER COIL HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLEWAITE
K062419 08/18/2006 TRIDENT LARGE DIAMETER ACETABULAR INSERTS HOWMEDICA OSTEONICS CORP TIFFANI ROGERS
K062498 08/25/2006 PROFYLE SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K062488 08/29/2006 IQ-SYSTEM PACS SYSTEM IMAGE INFORMATION SYSTEMS, LTD. CARL ALLETTO
K062417 08/18/2006 XPLORER 1100 IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K062405 08/17/2006 XPLORER 1590 IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K062432 08/21/2006 NANOTITE DENTAL IMPLANTS IMPLANT INNOVATIONS, INC. JACQUELYN A HUGHES
K062541 08/30/2006 CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS INNOVA VISION INC. JENNIFER REICH
K062361 08/14/2006 INNOVACON HCG UKTRA TEST DEVICE INNOVACON, INC. EDWARD TUNG
K062261 08/04/2006 FOAM RING PORT PROTECTOR INSPIRED IDEAS, INCORPORATED ALLISON SCOTT
K062431 08/21/2006 HEMOSIL LIQUID ANTITHROMBIN INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K062430 08/21/2006 HEMOSIL PROTEIN C INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K062353 08/14/2006 MOZAIK BONE REGENERATION MATRIX - PUTTY INTEGRA LIFESCIENCES CORPORATION DIANA M BORDON
K062402 08/17/2006 EASYSTAND EVOLV INVACARE CORP. RONALD CLINES
K062252 08/03/2006 MOLTENO3 IOP, INC. JASON MALECKA
K062369 08/14/2006 IRIDEX OCULIGHT TX IRIDEX CORP. JOHN JOSSY
K062259 08/04/2006 ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 ISCIENCE SURGICAL GRACE BARTOO
K062384 08/15/2006 CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE ISORAY, INC DAVID J SWANBERG
K062258 08/15/2006 GENESIS DIODE LASER IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K062218 08/01/2006 JAN MAO WHEELCHAIR, MODELS JMC612-FL318EPP AND JMC612-FL418EPP JAN MAO INDUSTRIES CO., LTD. KE-MIN JEN
K062462 08/24/2006 NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L JAWON MEDICAL CO., LTD. W. H PARK
K062522 08/28/2006 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES JIANGSU JAYSUN GLOVE CO., LTD. CHU XIAOAN
K062520 08/28/2006 POWDERED VINYL PATIENT EXAMINATION GLOVES JIANGSU JAYSUN GLOVE CO., LTD. CHU XIAOAN
K062439 08/21/2006 POWERTONE, MODEL PT-11 JOHARI DIGITAL HEALTHCARE, LTD. NISHA JOHARI
K062401 08/16/2006 MODIFICATION TO LUCAS JOLIFE AB HOWARD M HOLSTEIN
K062464 08/24/2006 MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES A LEE
K062311 08/08/2006 KARMA MANUAL WHEELCHAIR, MODEL BUDGET 800 KARMA MEDICAL PRODUCTS CO., LTD. KE-MIN JEN
K062309 08/08/2006 KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105 KARMA MEDICAL PRODUCTS CO., LTD. KE-MIN JEN
K062227 08/02/2006 V.A.C. THERAPY SYSTEM KCI USA, INC. (KINETIC CONCEPTS, INC.) MARGARET MARSH
K062412 08/17/2006 CRYOMATIC KEELER INSTRUMENTS, INC. EUGENE R VANARSDALE
K062275 08/07/2006 RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135 KERBEROS PROXIMAL SOLUTIONS, INC. TOM MASON
K062519 08/29/2006 NEXUS 3 KERR CORPORATION COLLEEN BOSWELL
K062453 08/22/2006 KINGLY STAR POWERED MUSCLE STIMULATOR, MODEL KS-138 KINGLY STAR INTL. TECHNOLOGY CO., LTD. JEN KE-MIN
K062570 08/31/2006 PATIENT CONTOURED MESH (PCM) KLS-MARTIN L.P. JENNIFER DAMATO
K062356 08/14/2006 KOWA NONMYD ALPHA-D KOWA CO. LTD. SATOHIKO TAKANASHI
K062382 08/24/2006 CLEARFIL DC BOND KURARAY MEDICAL INC. KOJI NISHIDA
K062410 08/24/2006 CLEARFIL ESTHETIC CEMENT & DC BOND KURARAY MEDICAL INC. KOJI NISHIDA
K062409 08/24/2006 K-ETCHANT GEL KURARAY MEDICAL INC. KOJI NISHIDA
K062559 08/30/2006 URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER LABORATOIRES URGO SOPHIE FORTIN
K062308 08/08/2006 LMT-KATH-S; LMT-KATH-I LICHER MEDIZINTECHNOLOGIE GMBH DIETER MUSHOFF
K062195 08/01/2006 MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. CINDY MORROW
K062242 08/02/2006 METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS LIN-ZHI INTERNATIONAL, INC. MARIE LIN
K062483 08/25/2006 MINI POWER CHAIR, MODEL MN 5000 LINE IND.(SHANGHAI) CO., LTD. SID MATHUR
DEN060007 08/14/2006 INTROL CF PANEL I CONTROL MAINE MOLECULAR QUALITY CONTROLS, INC. JOAN GORDON
K062501 08/25/2006 VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901 MAINE STANDARDS CO. HOLLY CRESSMAN
K062535 08/29/2006 K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING MCNEIL-PPC, INC. NADER FOTOUHI PH.D.
K062474 08/29/2006 SMITHWICK CAROTID SHUNT MCPHERSON ENTERPRISES, INC. WILLIAM MCPHERSON
K062377 08/25/2006 MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100 MEDAPPS, INC. KENT E DICKS
K062229 08/02/2006 CTC WORKSTATION, MODEL 2200 MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. JAMES M BENSON
K062482 08/24/2006 VENTED VIAL ADAPTER TRANSFER DEVICE MEDIMOP MEDICAL PROJECTS, LTD. ARI Y SOBEL
K062386 08/16/2006 QANGIO CT MEDIS MEDICAL IMAGING SYSTEMS, B.V. J.I. HOLLANDER
K062295 08/07/2006 IRI INTEGRATED RETINAL IMAGER MEDIVISION MEDICAL IMAGING, LTD. AHAVA STEIN
K062478 08/24/2006 CLAVIS MEDTRONIC A/S ANN-CHRISTINE PROVOOST
K062348 08/16/2006 TIMESH SELF DRILLING SCREW MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K062427 08/18/2006 VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK EDWARD CHIN
K062254 08/04/2006 AXIS FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. EDWARD CHIN
K062447 08/22/2006 TRAVERSE OCT SPINAL FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. ED CHIN
K062420 08/18/2006 5F SHERPA ACTIVE NX GUIDE CATHETER MEDTRONIC VASCULAR MARK PUOPOLO
K062264 08/04/2006 COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM MEDTRONIC VASCULAR JENNIFER HACKNEY
K062421 08/22/2006 MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER MENTOR CORPORATION NICOLA SELLEY
K062490 08/31/2006 VISAGE PACS/CS, RELEASE VERSION 4.1 MERCURY COMPUTER SYSTEMS, INC RICHARD GLASHEEN
K062546 08/31/2006 IMMUNOCARD STAT! EHEC, MODEL 751630 MERIDIAN BIOSCIENCE, INC. SUSAN ROLIH
K062355 08/14/2006 ENA CEM MICERIUM S.P.A. EUGENIO MICELI
K062367 08/14/2006 MINISCREWS ANCHORING SYSTEM, M.A.S. MICERIUM S.P.A. EUGENIO MICELI
K062302 08/08/2006 MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM MILLICORE AB ROSINA ROBINSON
K062524 08/31/2006 OCTAX LASER SHOT SYSTEM MINITUBE OF AMERICA, INC FREDERICK KIKKERS
K062230 08/03/2006 MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 MINRAD, INC. JOHN MCNEIRNEY
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