FDA 510(k) Decisions During March, 2008  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K073324 03/13/2008 MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R MEDTRONIC INC. BECKY HANNACK
K072163 03/06/2008 HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5 3A HEALTH CARE S.R.L. MAUREEN O'CONNELL
K080514 03/26/2008 PECD-01 AND PECD QUICK-01 3M ESPE AG DENTAL PRODUCTS DESI W SOEGIARTO
K080133 03/13/2008 MOUNTABLE ENDOSCOPIC BLADE A.M. SURGICAL, INC. VINCENT PASCALE
K072411 03/20/2008 AAP BONE PLATES AND SCREW IMPLANTS AAP IMPLANTATE AG MARC SEEGERS
K080101 03/25/2008 AAP CANNULATED SCREW AND DARCO HEADED SCREW AAP IMPLANTATE AG MARC SEEGERS
K071525 03/19/2008 ACTIVATED ASPARTATE AMINOTRANSFERASE ABBOTT LABORATORIES LINDA MORRIS
K080264 03/26/2008 MODIFICATION TO: FOX PLUS PTA CATHETER ABBOTT VASCULAR-VASCULAR SOLUTIONS IVALEE COHEN
K073276 03/05/2008 IONTOPHORESIS SYSTEM ACCLARENT, INC. KERI YEN
K073041 03/11/2008 RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER ACCLARENT, INC. KERI YEN
K072891 03/19/2008 SINUS SPACER ACCLARENT, INC. KERI YEN
K073343 03/13/2008 ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX ACE SURGICAL SUPPLY CO., INC. J. EDWARD CARCHIDI
K080500 03/13/2008 MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 ACUMEN MEDICAL, INC. KEVIN MACDONALD
K071120 03/13/2008 AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999 AEMED, INC. RALPH JUGO
K072816 03/03/2008 NIOX MINO AEROCRINE AB JOEL SLOMOFF
K073227 03/20/2008 SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300 AIIA COMMUNICATION INC. DANIEL KAMM
K072185 03/27/2008 AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000 AIRISTAR TECHNOLOGIES, LLC DANIEL KAMM
K070965 03/05/2008 ALICIA MENSTRUAL CUP ALICIA INTERNATIONAL PTY LTD. TOM STONE
K072214 03/06/2008 PORTABLE VENTILATOR, MODEL EPV-100 ALLIED HEALTHCARE PRODUCTS, INC. WAYNE KARCHER
K080318 03/07/2008 ALMA LASER NIR MODULE ALMA LASERS LTD. TATIANA EPSTEIN
K073553 03/05/2008 CAMLOG IMPLANT SYSTEM ABUTMENTS ALTATEC GMBH LINDA K SCHULZ
K071242 03/06/2008 DBEST ONE STEP OCCULT BLOOD TEST KITS AMERITEK USA, INC. K.C. YEE
K073526 03/12/2008 AMICAS VISION SERIES PACS, MODEL 5.5 AMICAS, INC. PATRICE NEDELEC
K070800 03/06/2008 LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM ANSELL HEALTHCARE PRODUCTS LLC LON D MCILVAIN
K073265 03/14/2008 APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM APIERON, INC. RICHARD LOTTI
K073034 03/14/2008 AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419) APPLIED MEDICAL TECHNOLOGY, INC. BRIAN BAKER
K080482 03/20/2008 ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01 ARTHROCARE CORP. VALERIE DEFIESTA-NG
K080610 03/31/2008 ARTHROCARE ORTHOWAND SURGICAL DEVICE ARTHROCARE CORP. VALERIE DEFIESTA-NG
K073605 03/11/2008 ATRICURE COOLRAIL LINEAR PEN ATRICURE, INC. ALISON GRIMALDI
K072686 03/17/2008 AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS AXIS-SHIELD DIAGNOSTICS, LTD. CLAIRE DORA
K073538 03/12/2008 DUAL CHAMBER TPN CONTAINER B. BRAUN MEDICAL, INC. TRACY MADDOCK
K073023 03/12/2008 STERILS SINGLE-USE I/A HANDPIECES BAUSCH & LOMB, INC. NED LUCE
K080494 03/04/2008 BAXANO ULTRA LOW PROFILE RONGEUR BAXANO, INC. SHARON ROCKWELL
K080166 03/19/2008 ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545 BECKMAN COULTER, INC. JEFFREY L KOLL
K073589 03/05/2008 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS BECTON, DICKINSON & CO. MONICA GIGUERE
K073262 03/26/2008 BELLA BEEKLEY CORP. MARTINE M BOUTTE
K073299 03/05/2008 BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE BETELCARE SDN BHD KENG BENG SIAH
K071666 03/12/2008 SLENDERTONE ENERVIVE, MODEL 561 BIO-MEDICAL RESEARCH CORP. ANNE-MARIE KEENAN
K080471 03/05/2008 RADIO BIOAQUACARE BIOARTIFICIAL GEL TECHNOLOGIES (BAGTECH) INC JONATHAN KAHAN
K072036 03/19/2008 ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01 BIOKIT S.A. JOAN GUIXER
K073345 03/07/2008 CERTAIN CONTOURED MARGIN CERAMIC ABUTMENT BIOMET 3I, INC. PRISCILLA CARO
K073637 03/20/2008 PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS BIOMET MANUFACTURING CORP. ELIZABETH WRAY
K080204 03/20/2008 VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS BIOMET, INC. GARY BAKER
K072321 03/25/2008 BIOFLEX BIOSPINE CO., LTD. JUSTIN EGGLETON
K072329 03/25/2008 SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED BIOTRONIK, INC. JON BRUMBAUGH
K080394 03/13/2008 BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM BLACKSTONE MEDICAL, INC. WHITNEY G TORNING
K080407 03/13/2008 BLACKSTONE SFS PARALLEL ROD CONNECTORS BLACKSTONE MEDICAL, INC. WHITNEY G TORNING
K073713 03/28/2008 BLUE SKY BIO DENTAL IMPLANT SYSTEM BLUE SKY BIO, LLC MICHELE VOVOLKA
K073623 03/13/2008 ATLANTIS 018 PERIPHERAL IMAGING CATHETER BOSTON SCIENTIFIC CORP. EMILLY TOJIMA
K080272 03/11/2008 ATLANTIS PVIMAGING CATHETER, MODEL H749364560 BOSTON SCIENTIFIC CORP. JANICE BROWN
K072719 03/07/2008 CONVOY ADVANCED DELIVERY SHEATH BOSTON SCIENTIFIC CORP. CINDY MORROW
K070310 03/31/2008 B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM BRAHMS AKTIENGESELLSCHAFT JONAS LEICHTNER
K080170 03/25/2008 AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP) C.R. BARD, INC. SKIP RIMER
K080154 03/20/2008 ACUITY UNIVERSAL CUTTER CARDIAC PACEMAKERS, INC. KATHLEEN VITTUM
K080076 03/14/2008 RX DC X-RAY UNIT CEFLA S.C.R.L. CLAUDE BERTOIN
K073475 03/10/2008 SYSTEM PLUS CONTINENTAL DENTAL LABORATORY KAREEN CHAMBERLAIN
K071763 03/07/2008 AMADEUS ADAPTIVE COMPRESSION THERAPY CONVATEC MARILYN KONICKY
K073391 03/21/2008 SURGISIS BIODESIGN TISSUE GRAFT COOK BIOTECH, INC. MARY A FADERAN
K073627 03/04/2008 FLEXOR EVAC ASPIRATION CATHETER COOK, INC. KAREN BRADBURN
K073164 03/05/2008 IVS TUNNELLER DEVICES COVIDIEN UK MANUFACTURING LTD SHARON ALEXANDER
K080406 03/10/2008 IPULSE, MODEL I400 CYDEN LIMITED MICHEAL KIERNAN
K073604 03/13/2008 DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD DADE BEHRING, INC. YUK-TING LEWIS
K071694 03/20/2008 COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX DAIKEN MEDICAL CO, LTD. FUMIAK KANAI
K080207 03/12/2008 DANYANG HUAYI K2 AND K7 WHEELCHAIRS DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD NORMAN F ESTRIN
K073075 03/31/2008 FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K080203 03/26/2008 MTA ROOT CANAL SEALER DENTSPLY INTERNTIONAL HELEN LEWIS
K072730 03/27/2008 FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS DENTSPLY INTL. HELEN LEWIS
K080352 03/12/2008 MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KRISTINE CHRISTO
K073260 03/13/2008 LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109 DEVICE PARTNERS INTERNATIONAL MONICA E DOUGHERTY
K073118 03/05/2008 PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM DIAGNOSTIC DEVICES INC. ERICA LI
K073488 03/07/2008 DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX DIAZYME LABORATORIES CHARLES YU
K063443 03/11/2008 DRAEGER ALCOTEST 6510 DRAGER SAFETY EVE DAMIANO
K070855 03/20/2008 SLEEP QUALITY DYNADX CORPORATION EJ SMITH
K080087 03/11/2008 SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR EDAN INSTRUMENTS, INC. WILLIAM STERN
K080422 03/10/2008 5 MEGAPIXEL MONOCHROME LCD MONITOR, MODEL RADIFORCE GS520 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K080457 03/20/2008 COLOR LCD MONITOR, MODEL RADIFORCE RX211 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K080423 03/11/2008 INTEGRE, MODEL LP581 ELLEX MEDICAL PTY. LTD. KEVIN HOWARD
K080717 03/27/2008 HABIB HEXABLATE 10 EMCISION, LTD. NAGY HABIB
K071869 03/07/2008 TENS/IF 14 EMSI CHERITA JAMES
K080402 03/28/2008 ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38 ENCORE MEDICAL, L.P. TEFFANY HUTTO
K080258 03/10/2008 MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM ENDIUS, INC. REGINA WAGNER
K073709 03/11/2008 MODIFICATION TO VIEWMATE SYSTEM EP MEDSYSTEMS LARRY PICCIANO
K073507 03/05/2008 ANCHORAGE ACCESS KIT EPITEK, INC. WERNER HAMPL
K073484 03/10/2008 ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432 ETHICON ENDO-SURGERY, INC. RENEE L ROWE
K072301 03/18/2008 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05 EV3 INC. DAVID WORRELL
K073339 03/03/2008 BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR FENWAL, INC. TAMMY DAVIS
K073706 03/31/2008 RESPIRATORY HUMIDIFIER, MODEL MR850 FISHER & PAYKEL HEALTHCARE, LTD. ADELE BINDON
K070355 03/04/2008 FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILY FOTONA D.D. STOJAN TROST
K072425 03/10/2008 JNE IMPLANT SYSTEM GC AMERICA, INC. CARL JENKINS
K061907 03/27/2008 MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES GE HEALTHCARE JOEL C KENT
K080157 03/24/2008 DASH 2500 PATIENT MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES SHARON UNTZ
K073062 03/10/2008 OMNI-VUE SYSTEM GENESIS DIGITAL IMAGING, INC. CARL ALLETTO
K073636 03/13/2008 TINNITUS SOUND GENERATOR MODULE GN RESOUND A/S LARS HAGANDER
K073064 03/11/2008 GRAFTYS BCP GRAFTYS ANTHONY LE NAOUR
K080025 03/19/2008 LED.L, LED.M, LED.G, LED.B GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD CHARLIE MACK
K080066 03/05/2008 VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR) GX CORPORATION SDN BHD FOO KHON PU
K080560 03/18/2008 HENKE SASS WOLF OF AMERICA ARTHROSCOPE HENKE SASS WOLF OF AMERICA, INC. LYNETTE HOWARD
K072256 03/12/2008 HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL HILL LABORATORIES CO. BRADY ALLER
K072369 03/21/2008 EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM HMD BIOMEDICAL LLC MERRELL SHYE
K072847 03/28/2008 APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS HOLOGIC, INC. BRYAN COWELL
K071779 03/05/2008 ABX PENTRA URINE CAL HORIBA ABX OLIVIER DUCAMP
K080667 03/19/2008 VARIAX DISTAL RADIUS TORX SCREWS HOWMEDICA OSTEONICS CORP. DANIELLE HILLMAN
K080322 03/05/2008 HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200 HYCOR BIOMEDICAL, INC. P. NARAYAN NAYAK
K080184 03/26/2008 DISTAL HUMERAL PLATES WITH ANGULAR STABILITY I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH AL LIPPINOCOTT
K073161 03/07/2008 REPLUS DENTAL IMPLANTS (HA) IMPLANT DIRECT LLC THOMAS GOTTENBOS
K072944 03/05/2008 QUANTA LITE CCP3.1 IGG/IGA ELISA INOVA DIAGNOSTICS, INC. RUFUS BURLINGAME
K080280 03/14/2008 SUB-TALAR LOK, MODEL 7-11 MM INSTRATEK, INC. JEFF SEAVEY
K080291 03/19/2008 INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER INTUITIVE SURGICAL, INC. KAREN UYESUGI
K080155 03/06/2008 MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM INTUITIVE SURGICAL, INC. MICHAEL H YRAMATEGUI
K073485 03/03/2008 VISTAKON (NARAFILCON) A SOFT CONTACT LENS JOHNSON & JOHNSON VISION CARE, INC. ROSALIND B WILLIAMS
K080302 03/24/2008 CAYMAN BUTTRESS PLATE SYSTEM K2M, INC. RICHARD WOODS
K073519 03/28/2008 QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 KENSEY NASH CORP. CINDY VARUGHESE
K073008 03/11/2008 KFH ENERGY, MODEL: E1 KINGFISHER HEALTHCARE NV NEIL R ARMSTRONG
K080661 03/24/2008 MODELS TENS 7000, EMS 7500 AND TWIN STIM KOALATY PRODUCTS, INC. JAY MANSOUR
K080010 03/14/2008 NOCC HYDROPHILIC WOUND DRESSING KYTOGENICS, INC MARINA ZAZANIS
K073552 03/05/2008 LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY LABORIE MEDICAL TECHNOLOGIES, CORP BARBARA MORNET
K080508 03/21/2008 MANDREL GUIDEWIRES OR M-WIRE LAKE REGION MEDICAL KAREN MORTENSEN
K073274 03/17/2008 SPINAL SPHERE SYSTEM LIFE SPINE REBECCA M BROOKS
K073506 03/07/2008 LUMINEX LX 100/200 INSTRUMENT LUMINEX CORP. NANCY KRUNIC
K072421 03/06/2008 K-Y BRAND YOURS+MINE MCNEIL-PPC, INC. NADER FOTOUHI
K080391 03/18/2008 DRIVE SOLSTICE OXYGEN CONCENTRATOR MEDICAL DEPOT ARTHUR WARD
K073476 03/07/2008 COMPACT AUTO-SAFETY INJECTOR (CASI) MEDICAL HOUSE (ASI) LIMITED ROSE Y GUANG
K063175 03/14/2008 IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION) MEDICAL TECHNOLOGY SYSTEMS, INC. ELLIS K NAM
K073156 03/04/2008 QPLAQUE MR MEDIS MEDICAL IMAGING SYSTEMS, B.V. J.I. HOLLANDER
K073718 03/19/2008 MEDLINE GASTROSTOMY TUBE MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K071244 03/05/2008 MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K073255 03/24/2008 XPS 3000 SYSTEM MEDTRONIC XOMED, INC. DAVID GUZEK
K063157 03/10/2008 MERRIES K-PHATE BONE GRAFT SUBSTITUTE MERRIES INTERNATIONAL INC. SOPHIA LEE
K072197 03/12/2008 POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR METACURE SURGICAL GLOVES SDN BHD AZMAN ISMAIL
K073401 03/14/2008 EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 MICROMEDICS, INC. TOM LOPAC
K080393 03/13/2008 MODIFICATION TO REBOUND HRD MINNESOTA MEDICAL DEVELOPMENT, INC. JULIE BULVER
K072793 03/04/2008 LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688 MOELLER MEDICAL GMBH & CO. KG BILL KELLEY
K073176 03/19/2008 KANTERON DICOM STATION (KDS), MODEL 3.0 MONICA VEYTIA MONICA VEYTIA
K080035 03/03/2008 LED CURING LIGHT MONITEX INDUSTRIAL CO., LTD. SHU-LUNG WANG
K073647 03/03/2008 MINITAPE EXTRA URETHRAL SLING MPATHY MEDICAL DEVICES, LTD. LOUIS J MAZZARESE
K073699 03/26/2008 MCT-DIABETES MYCARE TEAM, INC. DIANE MANDELL HORWITZ
K073652 03/20/2008 ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE NAKAMURA MAGNIFIER CO., LTD. CHARLIE ITO
K073671 03/26/2008 PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE NDO SURGICAL, INC. JOHN J VOZELLA
K072116 03/20/2008 SAVANNAH LUMBAR PERCUTANEOUS STABILIZATION SYSTEM NEUROSPINE INNOVATIONS AND SOLUTIONS RICHARD JANSEN
K080540 03/13/2008 NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0 NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YANFANG
K073455 03/25/2008 E-VAC NEW LEAF MEDICAL, INC. RICHARD T NOCK
K073550 03/28/2008 PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION NIHON KOHDEN AMERICA, INC. JACK COGGAN
K080228 03/27/2008 ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH NOVAMIN TECHNOLOGY, INC. ROBERT G ROTHFRITZ
K080340 03/05/2008 COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG NOVARTIS NUTRITION CORP. THOMAS A DOLD
K073278 03/28/2008 SPINOUS PROCESS PLATE SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K073293 03/19/2008 DURETTE IMPLANT OCULO PLASTIK, INC. JEAN-FRANCOIS DURETTE
K072957 03/18/2008 EVIS EXERA II 180 SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K071254 03/25/2008 SMALL INTESTINAL VIDEOSCOPE SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K073714 03/19/2008 TRAUMACAD VERSION 2.0 ORTHOCRAT, LTD. GEORGE J HATTUB
K073624 03/20/2008 MODULAR FOOT SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. DEREK LEWIS
K070184 03/24/2008 DENTAL IMPLANT, DENTAL ABUTMENT, ABUTMENT SCREW, COVER SCREW, HEALING ABUTMENT OSPOL AB LENNART CARLSSON
K073247 03/07/2008 US/SS/GS SYSTEM OSSTEM IMPLANT CO LTD MINJOO KIM
K080387 03/07/2008 HU II / HS II FIXTURE SYSTEM OSSTEM IMPLANT CO.,LTD MIN JOO KIM
K073405 03/03/2008 PLEXUR M OSTEOTECH, INC. CHRISTOPHER TALBOT
K073363 03/20/2008 THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300 PALADIN BIOMEDICAL CORPORATION ROBERT BICKFORD
K073583 03/26/2008 MODIFICATION TO PALOMAR LUX1540 HANDPIECE PALOMAR MEDICAL PRODUCTS, INC. SHARON TIMBERLAKE
K080098 03/10/2008 MRJ EXTENDED PARAMED SRL MICHAEL A DOUGLAS
K073698 03/19/2008 SECURE PARKELL, INC. DANIEL R SCHECHTER
K072481 03/07/2008 JET PORT PLUS HP CATHETER SYSTEM PFM MEDICAL, INC SALVADORE PALOMARES
K080461 03/13/2008 STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 PHILIPS MEDICAL SYSTEMS ZETY BILLARD
K080495 03/24/2008 SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3 PHILIPS MEDICAL SYSTEMS MARY KRUITWAGEN
K080120 03/10/2008 HFO SHOULDER COIL PHILIPS MEDICAL SYSTEMS MR FINLAND CATHERINE CONNELL
K080548 03/27/2008 HD7 DIAGNOSTIC ULTRASOUND SYSTEM PHILLIPS MEDICAL SYSTEMS NANCY BURKE
K073659 03/05/2008 XTRAC ULTRA 2, MODEL AL10000 PHOTO MEDEX, INC. JEFF LEVATTER
K072459 03/03/2008 OMNILUX NEW-U PHOTO THERAPEUTICS, INC. SUE DARCY
K080504 03/20/2008 PIONEER LOWTOP SPINAL ROD SYSTEM PIONEER SURGICAL TECHNOLOGY JONATHAN M GILBERT
K080518 03/20/2008 PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM PIONEER SURGICAL TECHNOLOGY JONATHAN M GILBERT
K073638 03/20/2008 SWIFT LT RESMED LTD. DAVID D'CRUZ
K072723 03/20/2008 RESPIRONICS GOLOX RESPIRONICS, INC. ZITA A YURKO
K073111 03/27/2008 PORTRAIT PSR, MODEL 745915 RHYTEC INCORPORATED ROBERT ZOLETTI
K073544 03/05/2008 PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES RJ MEDICAL, INC. JIM INNES
K063684 03/21/2008 COBAS LITHIUM ROCHE DIAGNOSTICS CORP. THERESA AMBROSE BUSH
K080183 03/25/2008 CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 ROCHE DIAGNOSTICS CORP. DIMITRIS DEMIRTZOGLOU
K073277 03/06/2008 ROCHE-CREACTIVE PROTEIN (LATEX) ROCHE DIAGNOSTICS CORP. KERWIN L KAUFMAN
K073342 03/26/2008 SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW SALVIN DENTAL SPECIALTIES, INC. ROBERT SALVIN
K080171 03/06/2008 SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012 SANARUS MEDICAL, INC. LISA HENRY
K080698 03/31/2008 GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP SENORX, INC. EBEN GORDON
K072406 03/21/2008 NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS) SGMP CO., LTD. JANNA P TUCKER
K072400 03/27/2008 NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES SGMP CO., LTD. JANNA P TUCKER
K072403 03/27/2008 NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS) SGMP CO., LTD. JANNA P TUCKER
K073705 03/24/2008 MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE SHANDONG QIAOPAI GROUP CO., LTD MARK JOB
K072739 03/21/2008 JIERUI SYRINGES AND NEEDLES SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. DIANA HONG
K080640 03/21/2008 M5 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K073674 03/24/2008 BONE FIXATION WIRE (KIRSCHNER WIRE) SIGNAL MEDICAL CORP. LOUIS A SERAFIN
K080349 03/10/2008 KIMBA MINI SIGNUS MEDIZINTECHNIK GMBH ALAN ALEXANDER
K073635 03/19/2008 SBI SR MTP TOE IMPLANT SMALL BONE INNOVATIONS INC. JEFFREY ZIGLER
K072212 03/07/2008 JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE SMITH & NEPHEW, INC. DAVID HENLEY
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