FDA 510(k) Decisions During February, 2007  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K073284 12/14/2007 AIR-FLOW MASTER STANDARD (EMS SA) ELECTRO MEDICAL SYSTEMS SUSAN M BONAPACE
K063023 02/23/2007 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870 3M COMPANY DIANNE GIBBS
K072697 12/20/2007 3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES 3T MEDICAL SYSTEMS, LLC ROBERT P EATON
K072637 12/11/2007 DIVO A2D IMAGING LLC DON WAUCHOPE
K062554 02/06/2007 STARCLOSE HEX-HUB DILATOR ABBOTT VASCULAR INC. Daun Putnam
K070225 12/13/2007 SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE ABIOMED, INC. ROBERT T KUNG
K072354 12/07/2007 GUIDEWIRE, MODEL G-V220-3527S AND OTHERS ACCELLENT INC. KARL STEINECK
K072836 12/27/2007 CHOLESTRAK HDL CHOLESTEROL HOME TEST ACCUTECH, LLC. Gary Lehnus
K063418 02/02/2007 ACON DIGITAL THERMOMETER PROBE COVERS ACON LABORATORIES, INC. JINN-NAN LIN, PH.D
K070028 02/08/2007 CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER ACTHERM, INC. RICHARD HSIEH
K070197 02/23/2007 ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY ACUMEN MEDICAL, INC. Marybeth Gamber
K062961 02/08/2007 MICROLUX TRANSILLUMINATOR ADDENT, INC. JOSHUA FRIEDMAN
K071537 12/18/2007 STERRAD 100NX TEST PACK ADVANCED STERILIZATION PRODUCTS REUBEN LAWSON
K073170 12/03/2007 R-PORT II LAPAROSCOPIC ACCESS DEVICE ADVANCED SURGICAL CONCEPTS MARY MCNAMARA-CULLINANE
K062012 02/09/2007 S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM AESCULAP, INC. LISA M BOYLE
K070238 02/28/2007 AMPLATZER RELIANT CATHETER DELIVERY SYSTEM AGA MEDICAL CORP. DAVID D COX
K062694 02/06/2007 MAMMAPRINT AGENDIA BV GUILDO BRINK
DEN070009 02/06/2007 MAMMAPRINT AGENDIA BV GUILDO BRINK
K073271 12/05/2007 ORTHOGON AGFA HEALTHCARE CORPORATION TOM HOLBROOK
K070722 12/14/2007 PLASMAIR, MODEL T2006 AIRINSPACE B.V. WADE TETSUKA
K063617 02/08/2007 EUSOL-C AL.CHI.MI.A GEORGE MYERS
K061467 02/15/2007 EXSEPT WC WOUND CLEANSER ALCAVIS INTERNATIONAL, INC. GARY J MISHKIN
K071236 12/12/2007 ALCON MULTI-PURPOSE SOLUTION ALCON, INC. KIM B KRACKE
K071697 12/03/2007 NEURONAV SYSTEM AND NEURONAV DRIVE ALPHA OMEGA LTD. BAHEEJ DANIAL
K070161 02/15/2007 QUATTRO CATHETER MODEL IC4593 ALSIUS CORP. KENNETH A COLLINS
K063511 02/02/2007 CERAMILL ZI AMANN GIRRBACH AMERICA, INC. DANIEL KAMM
K071164 12/07/2007 LIFE+CEL BATTERY AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. ALEX HENDERSON
K073125 12/05/2007 VALEO VBR AMEDICA CORP. ADAM HERDER
K063713 02/22/2007 AMS SMART SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. BRAD ONSTAD
K063716 12/28/2007 AEROSOL SYSTEM AMICI, INC. MICHAEL BONO
K070873 12/19/2007 AMSURE BLADDER IRRIGATION SET AMSINO INTL., INC. YI CHEN
K072375 12/13/2007 SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET ANGIODYNAMICS, INC. BRIAN KUNST
K071746 12/13/2007 DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES ANSELL HEALTHCARE PRODUCTS, LLC CYNTHIA A INGRAM
K071671 12/28/2007 SCANSCOPE XT SYSTEM APERIO TECHNOLOGIES PERRY JOHNSTON
K070088 02/16/2007 ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM APEX BIOTECHNOLOGY CORP. THOMAS Y.S. SHEN
K062799 02/06/2007 GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM APEX BIOTECHNOLOGY CORP. BRUCE A MACFARLANE
K072883 12/10/2007 ICE-SENSE ARBEL MEDICAL LTD. ZVI LADIN
K071616 12/19/2007 ARC SURGICAL BIOTRAK PIN SYSTEM ARC SURGICAL LLC. ED BOEHMER
K070069 02/05/2007 ZIPPREP ELECTRODE ASPECT MEDICAL SYSTEMS, INC. VIKRAM VERMA
K061445 02/01/2007 SURGIMESH WN ASPIDE MEDICAL HOWARD M HOLSTEIN
K062197 02/28/2007 ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT ATLANTIS COMPONENTS, INC. BETSY A BROWN
K062069 02/14/2007 ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANT ATLANTIS COMPONENTS, INC. BETSY A BROWN
K063205 02/26/2007 ATLAS SPINE VERTEBRAL BODY REPLACEMENT ATLAS SPINE LLC FLOYD G LARSON
K060564 02/07/2007 INFINITI SYSTEM AUTOGENOMICS, INC EVELYN LOPEZ
K072137 12/07/2007 AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB AVITA CORPORATION JENNIFER REICH
K073205 12/19/2007 NIO 5MP, MODEL MDNG-5121 BARCOVIEW, MEDICAL IMAGING SYSTEMS NEIL PHILLIPS
K063696 02/27/2007 COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163 BAXTERHEALTHCARE, INC. JEME WALLACE
K063845 12/07/2007 ADVIA CHEMISTRY TOTAL BILIRUBIN_2 BAYER HEALTHCARE, LLC PHILIP LIU
K072478 12/19/2007 BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K071026 12/20/2007 BD GENEOHM STAPHSR ASSAY BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC) RAYMOND BOULE
K070144 02/01/2007 INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS BECKMAN COULTER, INC. TYLER J FOUTCH
K063824 02/14/2007 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM (GN) 0.5-64UG/ML BECTON, DICKINSON & CO. JANINE MATLAK
K063811 02/09/2007 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/ML BECTON, DICKINSON & CO. JANINE MATLAK
K063704 02/20/2007 BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101 BEKS INCORPORATED JILL CREASY
K073360 12/19/2007 PROPLATE BIO PROTECH, INC. E.J. Smith
K072553 12/14/2007 SYSTEM-ARMS, MODEL 390,E60 BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K072835 12/11/2007 LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK BIO-RAD, DIAGNOSTICS GRP. SUZANNE PARSONS
K072721 12/11/2007 LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC BIO-RAD, DIAGNOSTICS GRP. ELIZABETH PLATT
K072068 12/21/2007 BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS BIOARTIFICIAL GEL TECHNOLOGIES (BAGTECH) INC JONATHAN KAHAN
K062756 02/20/2007 PATHIAM IMAGING SOFTWARE FOR HER2/NEU BIOIMAGENE, INC. ANNA LONGWELL
K072078 12/19/2007 QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 BIOKIT S.A. JOAN GUIXER
K071210 12/19/2007 MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 BIOMEDICAL DIAGNOSTICS (BMD) SA COURIVAUD CHRISTELLE
K070458 12/21/2007 MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 BIOMEDICAL DIAGNOSTICS (BMD) SA COURIVAUD CHRISTELLE
K072138 12/21/2007 VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 BIOMERIEUX, INC. NIKITA S MAPP
K063243 12/14/2007 VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448 BIOMERIEUX, INC. NIKITA S MAPP
K073083 12/10/2007 VITEK 2 GRAM NEGATIVE PIPERACILLIN BIOMERIEUX, INC. Nancy Weaver
K072642 12/20/2007 BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS BIOMET 3I, INC. DIANA TAYLOR
K063614 02/20/2007 ALTRA FX HIP SYSTEM BIOMET MANUFACTURING CORP. BECKY EARL
K063570 02/27/2007 BIOMET TIBIAL LOCKING NAIL SYSTEM BIOMET MANUFACTURING CORP. BECKY EARL
K072804 12/12/2007 COMPREHENSIVE RS SHOULDER SYSTEM BIOMET MANUFACTURING CORP. PATRICIA S BERES
K063515 02/02/2007 TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE BIOMET MANUFACTURING, INC. SUSAN ALEXANDER
K072330 12/06/2007 CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM BIOMET, INC. PAULA DEMING
K062567 02/16/2007 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM BIONIME CORPORATION SUSAN D GOLDSTEIN-FALK
K072344 12/03/2007 APL MEDICAL SYSTEM BIOS S.R.L. ALDO CASALINO
K072892 12/07/2007 TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 BIOSITE INCORPORATED FIL V BUENVIAJE
K062603 02/15/2007 BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230 BIOSPACE CORPORATION LIMITED DANIEL KAMM
K073230 12/20/2007 MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS BIOTRONIK, INC. Jon Brumbaugh
K072765 12/12/2007 PASSEO 18 BIOTRONIK, INC. Jon Brumbaugh
K072577 12/05/2007 BISICO IMPRESSION SILICONES & ALGINATES BISICO GMBH & CO KG DAGMAR MAESER
K071930 12/18/2007 ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C BLUE CROSS BIO-MEDICAL CO., LTD. HILDA HONG YANG
K061919 02/05/2007 VERSATILE 1 EZCARE WOUND VACUUM SYSTEM BLUE SKY MEDICAL GROUP INCORPORATED JASPER BENKE
K072476 12/14/2007 THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT Boston Scientific Corporation VIRGINIA CARR
K063236 02/16/2007 BETA-POWDER BRAINBASE CORPORATION SATOSHI NOAKE
K063777 02/23/2007 ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE BRIGHT ELEMENT SDN BHD SEOW LAW AUDIE
K073199 12/21/2007 3M ESPE LAVA CHAIRSIDE ORAL SCANNER BRONTES TECHNOLOGIES JOHN GREENBAUM
K072453 12/03/2007 CRY-AC TRACKER, MODEL(S) B-700T, AND B-800T BRYMILL CORP. STEPHEN WILLIAMS
K063839 02/08/2007 POSITIONER C-RAD POSITIONING AB BENGT ERIC ROSTH
K063118 02/13/2007 BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE C.R. BARD, INC. SUSAN SCOTT
K070582 12/07/2007 BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS C.R. BARD, INC. SKIP RIMER
K070558 12/07/2007 BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS C.R. BARD, INC. SKIP RIMER
K073423 12/19/2007 MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER C.R. BARD, INC. SUSAN D SCOTT
K070025 02/01/2007 C.T.M. MOBILITY SCOOTER, MODEL HS-310 C.T.M. HOMECARE PRODUCT, INC. LINDA J BOVARD
K073226 12/07/2007 CINCH KNOTLESS FIXATION IMPLANT SYSTEM C2M MEDICAL, INC. GABRIELE G NIEDERAUER
K063800 02/05/2007 CANDELA FLUORESCENT PULSED LIGHT SYSTEM CANDELA CORP. JEFFREY ROBERTS
K071995 12/18/2007 CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K073123 12/06/2007 CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150 CARDICA, INC. ISKRA MRAKOVIC
K073304 12/20/2007 CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES CARDICA, INC. ISKRA MRAKOVIC
K072105 12/28/2007 ALARIS SYSTEM WITH MMS, MODEL 8XXX CARDINAL HEALTH 303, INC. STACY L LEWIS
K070268 02/23/2007 SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X CARDINAL HEALTH 303, INC. STACY L LEWIS
K071400 12/14/2007 SMARTSITE STOPCOCK CARDINAL HEALTH, ALARIS PRODUCTS STACY L LEWIS
K072558 12/05/2007 CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005 CARDIONET, INC JACK GAIKWAD
K072473 12/10/2007 CHASE MR SYSTEM CHASE MEDICAL, LP DAVID M HERNON
K062952 02/21/2007 C300 SERIES AIR NEBULIZER COMPRESSOR CHOICE SMART HEALTH CARE CO. LTD. JANICE MA
K072621 12/13/2007 ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR CINCINNATI SUB-ZERO PRODUCTS, INC FATMA ALI
K071706 12/20/2007 ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) CLINICAL DATA, INC. WYNN STOCKING
K063114 02/09/2007 DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES COEUR, INC. DEBRA F MANNING
K062200 02/13/2007 COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS COLLAGEN MATRIX, INC. PEGGY HANSON
K061516 02/06/2007 STAODYN MAX PRESET, MODEL 4470 COMPEX TECHNOLOGIES, INC. CARL BEAURLINE
K072796 12/18/2007 MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044 CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K073009 12/07/2007 ONEPORT SURGICAL TROCAR SYSTEM CONMED CORPORATION BRIAN KILLORAN
K073378 12/28/2007 ADVANCE 18LP PTA DILATATION CATHETER COOK, INC. NATHAN SIMON
K072625 12/13/2007 TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) COOK, INC. KAREN BRADBURN
K063349 02/16/2007 CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR CORMATRIX CARDIOVASCULAR, INC. KIT CARIQUITAN
K063626 02/08/2007 DURAFLEX COSMETIC DENTAL MATERIALS INC ROBERT BOWERS
K072537 12/18/2007 CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM CREASPINE SAS CYNTHIA J.M NOLTE
K062977 02/28/2007 CRITIVIEW, MODEL CRV3 CRITISENSE LTD. PAUL DRYDEN
K072518 12/20/2007 CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS) CRS MEDICAL DIAGNOSTICS INC. DANIEL KAMM
K070357 12/28/2007 FLEXCATH STEERABLE SHEATH & DILATOR CRYOCATH TECHNOLOGIES, INC. FRED MILDER
K072651 12/07/2007 CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM CSA MEDICAL, INC. JENNIFER CARTLEDGE
K072866 12/13/2007 ISSYS LP SPINAL FIXATION SYSTEM CUSTOM SPINE, INC. SAAD ATTIYAH
K072484 12/27/2007 CYNOSURE YAG FAMILY LASER CYNOSURE, INC. GEORGE CHO
K073394 12/12/2007 SMARTLIPO LASER CYNOSURE, INC. GEORGE CHO
K072587 12/10/2007 CYTORI AFT SYSTEM CYTORI THERAPEUTICS, INC. KENNETH KLEINHENZ
K063754 02/23/2007 DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632 DADE BEHRING, INC. PAMELA A JURGA
K063608 02/23/2007 DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K072965 12/21/2007 DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K063425 02/15/2007 DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K072717 12/12/2007 DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210 DADE BEHRING, INC. HELEN M LEE
K063655 02/15/2007 DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K063564 02/08/2007 MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CHLORAMPHENICOL (4-16 UG/ML) DADE BEHRING, INC. ROBERT EUSEBIO
K062894 02/08/2007 INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0 DAILYCARE BIOMEDICAL INC DANIEL J CHANG
K062569 02/14/2007 SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING DATASCOPE CORP. SUSAN MANDY
K062098 02/05/2007 SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX DATASCOPE CORP. KATHLEEN KRAMER
K070297 02/05/2007 CLEARVIEW DENTAL HANDPIECE LUBRICATOR AND LUBRICANT DENTAL AIR SOLUTIONS OF NC, INC. THOMAS FEE
K073117 12/19/2007 DENTIN DESENSITIZER AGENT DENTSPLY INTL., INC. HELEN LEWIS
K072832 12/14/2007 ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K062250 02/02/2007 DELTA XTEND REVERSE SHOULDER SYSTEM DEPUY ORTHOPAEDICS, INC. NATALIE S HECK
K063686 12/20/2007 DEPUY LPS DISTAL FEMORAL COMPONENT DEPUY ORTHOPAEDICS, INC. REBECCA LENNARD
K063652 02/01/2007 GLOBAL AP POROUS COATED HUMERAL STEM DEPUY ORTHOPAEDICS, INC. REBECCA LENNARD
K073126 12/06/2007 EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. CHRISTOPHER KLACZYK
K062339 02/05/2007 DERMOTHERAP GUN DERMOEQUIPOS S.R.L. BENNY ARAZY
K072599 12/20/2007 PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 DIADEXUS, INC. ROBERT WOLFERT PH.D
K061820 02/26/2007 DIASORIN LIAISON VZV IGG DIASORIN, INC. Mari Meyer
K071375 12/21/2007 MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE) DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. JONATHAN S KAHAN
K071679 12/17/2007 METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. YAEL RUBIN
K073518 12/20/2007 FLASHLITE REBEL* DISCUS DENTAL, INC. VIVIAN LAI
K070189 02/21/2007 ACCU-CHEK ULTRAFLEX INFUSION SET DISETRONIC MEDICAL SYSTEMS AG MIKE FLIS
K062388 02/22/2007 ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM DOCUSYS GORDON J PETERS
K061379 02/16/2007 INFINITY TELESMART TELEMETRY SYSTEM Draeger Medical Systems, Inc. THOMAS M MCINTOSH
K071562 12/11/2007 D3 HEMATOLOGY ANALYZER, MODEL D3 DREW SCIENTIFIC, INC. ROGER BOURREE
K072146 12/18/2007 EMS PIEZON MASTER SURGERY E.M.S. ELECTRO MEDICAL SYSTEMS S.A. SUSAN BONAPACE
K073221 12/28/2007 CADENCE II EDAN INSTRUMENTS, INC. WILLIAM STERN
K073340 12/19/2007 COLOR LCD MONITOR, FLEXSCAN MX300W EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K070122 02/08/2007 MONOCHROME LCD MONITOR, MODEL RADIFORCE GX320 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K070131 02/15/2007 RADIFORCE GX220 AND GS220 MONOCHROME LCD MONITORS EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K072159 12/27/2007 SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER EL.EN. ELECTRONIC ENGINEERING SPA ANDREA TOZZI
K072154 12/14/2007 FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM ENCORE MEDICAL, L.P. TEFFANY HUTTO
K072840 12/07/2007 ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM ENDIUS, INC. CHRISTINE KUNTZ-NASSIF
K070246 02/16/2007 DOWN PAK ENDO TWINN B.V. F.M. VERHOEVEN
K060846 12/03/2007 THERAPEUTIC MASSAGE COMPANION ENDURANCE THERAPEUTICS BRAD BREZDEN
K072890 12/10/2007 STASILON FR ENTEGRION, INC. E.S. ESKRIDGE, JR.
K073399 12/21/2007 TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE ENVISIONEERING, LLC. DAVID KENNEDY
K070053 12/03/2007 EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2 EPS BIO TECHNOLOGY CORP. Y.C. LEI
K072231 12/26/2007 THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE) ESM TECHNOLOGIES, LLC. CLIFF TRIBUS
K072555 12/13/2007 EDTA PLUS ESSENTIAL DENTAL SYSTEMS, INC. BRIAN RASIMICK
K063856 02/06/2007 EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM ESSENTIAL DENTAL SYSTEMS, INC. SUSAN D GOLDSTEIN-FALK
K072475 12/21/2007 BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION) ETAC SVERIGE AB IAN GORDON
K062869 02/26/2007 CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G ETHICON ENDO-SURGERY, LLC DENNIS HAHN
K063562 02/26/2007 GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS ETHICON, INC. PATRICE NAGODA
K070789 12/31/2007 EUROIMMUN ANTI-CCP ELISA EUROIMMUN US LLC KATHRYN KOHL
K063569 02/23/2007 EQUINOXE REVERSE SHOULDER SYSTEM EXACTECH, INC. AMNON TALMOR
K061497 02/23/2007 SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML EXCELSIOR MEDICAL CORP. JOHN TALARICO
K073251 12/14/2007 HYALOMATRIX PA FIDIA ADVANCED BIOPOLYMERS SRL SHARON A SEGAL
K063111 02/01/2007 FINOMETER MODEL-2 WITH ACCESSORIES FINAPRES MEDICAL SYSTEMS BV GERAD J LANGEWOUTERS
K072776 12/07/2007 THE CROSSER SYSTEM FLOWCARDIA, INC. Dustin Michaels
K062543 02/01/2007 HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G FOCUS DIAGNOSTICS, INC. MICHEAL J WAGNER,ESQ.
K063642 12/13/2007 FD EMS, MODEL # D-FJ30E FUJI DYNAMICS LIMITED IRENE CHEUNG
K063183 02/15/2007 PRISMA M10 PRE SET GAMBRO RENAL PRODUCTS, INC. JEFFREY R SHIDEMAN
K070319 02/26/2007 GC FUJI IX GP EXTRA GC AMERICA, INC. TERRY L JORITZ-LYONS
K062580 12/21/2007 GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784) GE HEALTHCARE JOEL KENT
K072976 12/20/2007 MODEL 250CX SERIES MATERNAL/FETAL MONITOR GE HEALTHCARE AGATA SMIEJA
K073408 12/19/2007 GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA NICOLE LANDREVILLE
K073297 12/18/2007 GE LOGIQ P6 GENERAL ELECTRIC CO. ALLEN SCHUH
K071781 12/19/2007 PF4 IGG GENETIC TESTING INSTITUTE SUZETTE C CHANCE
K070280 02/23/2007 CARDIODAY, VERSION 2.0 GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG ROMIL RAMBHIA
K073172 12/13/2007 BEACON STABILIZATION SYSTEM GLOBUS MEDICAL INC. KELLY J BAKER
K071187 12/20/2007 MICROFUSE BONE VOID FILLER GLOBUS MEDICAL, INC. KELLY J BAKER
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K071886 12/27/2007 SELF SEAL STERILIZATION POUCH SHANGHAI JIANZHONG MEDICAL PACKAGING CO., LTD. LONGFU SONG
K062893 02/05/2007 KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LTD. ZHAO J YU
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K070322 02/27/2007 SYNGO DYNAMICS, VERSION 6.0 SIEMENS MEDICAL SOLUTIONS USA, INC. SIEGLINDE NINA WEST
K071730 12/20/2007 STUDIODOP VICORDER SKIDMORE MEDICAL, LIMITED DAVID W WAGNER
K070236 02/21/2007 SBI LATERAL RADIO CAPITELLUM SMALL BONE INNOVATIONS, INC. ROBERT HOEHN
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K070266 02/22/2007 560 HIGH DEFINITION CAMERA SYSTEM SMITH & NEPHEW, INC. JANICE HASELTON
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K063126 02/02/2007 DANA DIABECARE IIS SOOIL DEVELOPMENT CO., LTD. JEREMY KIM
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K071818 12/20/2007 ENSITE FUSION DYNAMIC REGISTRATION TOOL ST. JUDE MEDICAL KAREN J MCKELVEY
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K070199 02/23/2007 RETIC-CHEX LINEARITY FOR BC Streck KERRIE OETTER
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K070219 02/07/2007 SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM SUNI MEDICAL IMAGING, INC. DAVID STARK
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K062753 02/08/2007 FORSURE DISPOSABLE SYRINGE WITH NEEDLE, MODEL 1CC, 3C, 5CC, 10CC, 20CC, 50CC SURGIMED, INC. FERNANDO LAVOI
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K072791 12/26/2007 ORACLE SPACER, OPAL SPACER SYNTHES SPINE STACEY BONNELL
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K071712 12/04/2007 LEUKO EZ VUE TECHLAB INC., CORPORATE RESEARCH CENTER CHARLES PENNINGTON
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K072180 12/18/2007 VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM VISION-SCIENCES, INC. PAMELA PAPINEAU
K061775 02/23/2007 WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR WAKO CHEMICALS, USA, INC. LORI CREASY
K063386 02/09/2007 LORENZ ORTHODONTIC ANCHORAGE SYSTEM WALTER LORENZ SURGICAL, INC. KIM REED
K072009 12/14/2007 WEINMANNCOMPACT, MODEL WM 27380; WEINMANNCLICK2, MODEL WM 27340 WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG ECKHARDT ALBERS
K070060 12/18/2007 WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE) WELCH ALLYN, INC. JOHN SAWYER
K072168 12/19/2007 OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412 WELL-LIFE HEALTHCARE LIMITED JENNY HSIEH
K063660 02/07/2007 OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407 WELL-LIFE HEALTHCARE LIMITED JENNY HSIEH
K070128 02/15/2007 CO2 EASY Westmed, Inc. DALE BICKLEY
K063840 02/06/2007 XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION WITT BIOMEDICAL CORP JAMES LUKER
K070149 02/23/2007 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES WUXI SHENZHOU PLASTIC PRODUCTS CO., LTD. CHU XIAOAN
K070145 02/28/2007 POWDERED VINYL PATIENT EXAMINATION GLOVES WUXI SHENZHOU PLASTIC PRODUCTS CO., LTD. CHU XIAOAN
K072377 12/14/2007 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVE, WHITE COLOR XUZHOU FULL SUN MEDICAL PRODUCTS LTD. HSUN-HUI HUANG
K072314 12/12/2007 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR XUZHOU FULL SUN MEDICAL PRODUCTS LTD. HSUN- HUI HUANG
K071122 12/12/2007 DISPOSABLE POWDERED VINYL EXAM GLOVE, YELLOW COLOR XUZHOU FULL SUN MEDICAL PRODUCTS LTD. HSUN-HUI HUANG
K072878 12/03/2007 MODIFICATION TO: LOCATOR IMPLANT ANCHOR ZEST ANCHORS, INC. RICHARD OVERTON
K071219 12/06/2007 ATHENA MULTI-LYTE GBM TEST SYSTEM ZEUS SCIENTIFIC, INC. EWA NADOLCZAK
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K070008 02/08/2007 POWDERED VINYL PATIENT EXAMINATION GLOVES ZIBO HENGDE PLASTIC & RUBBER PRODUCTS CO., LTD. CHU XIAOAN
K063523 02/16/2007 ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11, 13, 16; ZOP37A10, 11, 13, 16; ZOP47S10, 11, 13, 16; ZOP4 ZIMMER DENTAL INC. ERIN MCVEY
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