FDA 510(k) Decisions During December, 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
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
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
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
K073271 12/05/2007 ORTHOGON AGFA HEALTHCARE CORPORATION TOM HOLBROOK
K070722 12/14/2007 PLASMAIR, MODEL T2006 AIRINSPACE B.V. WADE TETSUKA
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
K071164 12/07/2007 LIFE+CEL BATTERY AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. ALEX HENDERSON
K073125 12/05/2007 VALEO VBR AMEDICA CORP. ADAM HERDER
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
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
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
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
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
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
K072804 12/12/2007 COMPREHENSIVE RS SHOULDER SYSTEM BIOMET MANUFACTURING CORP. PATRICIA S BERES
K072330 12/06/2007 CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM BIOMET, INC. PAULA DEMING
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
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
K072476 12/14/2007 THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT BOSTON SCIENTIFIC CORPORATION VIRGINIA CARR
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
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
K073226 12/07/2007 CINCH KNOTLESS FIXATION IMPLANT SYSTEM C2M MEDICAL, INC. GABRIELE G NIEDERAUER
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
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
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
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
K072537 12/18/2007 CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM CREASPINE SAS CYNTHIA J.M NOLTE
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
K072965 12/21/2007 DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K072717 12/12/2007 DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210 DADE BEHRING, INC. HELEN M LEE
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
K063686 12/20/2007 DEPUY LPS DISTAL FEMORAL COMPONENT DEPUY ORTHOPAEDICS, INC. REBECCA LENNARD
K073126 12/06/2007 EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. CHRISTOPHER KLACZYK
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
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
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
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
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
K072475 12/21/2007 BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION) ETAC SVERIGE AB IAN GORDON
K070789 12/31/2007 EUROIMMUN ANTI-CCP ELISA EUROIMMUN US LLC KATHRYN KOHL
K073251 12/14/2007 HYALOMATRIX PA FIDIA ADVANCED BIOPOLYMERS SRL SHARON A SEGAL
K072776 12/07/2007 THE CROSSER SYSTEM FLOWCARDIA, INC. DUSTIN MICHAELS
K063642 12/13/2007 FD EMS, MODEL # D-FJ30E FUJI DYNAMICS LIMITED IRENE CHEUNG
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
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
K072513 12/07/2007 DM-EMG GVP ELETTRONICA SRL JOHN ROMANO
K072594 12/13/2007 GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM GYRUS ACMI, INC. GRAHAM A BAILLIE
K073237 12/27/2007 REHASTIM & REHAMOVE HASOMED GMBH MATTHIAS WEBER
K073044 12/07/2007 HEARTWAY POWER MOBILITY SCOOTER, MODEL PT7 HEARTWAY MEDICAL PRODUCTS CO., LTD. KE-MIN JEN
K071150 12/12/2007 TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE HEINZ KURZ GMBH MEDIZINTECHNIK DAGMAR MAESER
K072690 12/07/2007 HEMAWAY SEAT HEMAWAY LLC ARCHIE ROSENBLUM
K073059 12/10/2007 PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM HITACHI, LTD., POWER SYSTEMS GROUP JONATHAN S KAHAN
K043617 12/21/2007 IMAGECHECKER CT CAD SOFTWARE SYSTEM HOLOGIC, INC. ARTHUR FRIEDMAN
K072631 12/20/2007 JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 IDAHO TECHNOLOGY, INC. BETH LINGENFELTER
K072547 12/19/2007 JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124 IDAHO TECHNOLOGY, INC. BETH LINGENFELTER
K073033 12/10/2007 LEGACY DENTAL IMPLANTS IMPLANT DIRECT LLC THOMAS GOTTENBOS
K073049 12/13/2007 SCREWPLUS DENTAL IMPLANTS (HA) IMPLANT DIRECT LLC THOMAS GOTTENBOS
K072660 12/12/2007 ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 IMTEC CORP. J. BRAD VANCE
K073367 12/27/2007 HEMOSIL FIBRINOGEN-C INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K072929 12/07/2007 LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030 INTEGRA LIFESCIENCES CORPORATION DARLENE M WELSH
K071928 12/12/2007 THE INVACARE FLYER, MODEL IPC 100 INVACARE CORP. CARROLL MARTIN
K072911 12/13/2007 ION MEDICAL BIPOLAR COAGULATION PEN ION MEDICAL, LLC KEITH HURON
K072640 12/21/2007 IRISPEC,CA/CB/CC IRIS DIAGNOSTICS GERALD HADDOCK
K070021 12/07/2007 ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0 JG MEDICAL PRODUCTS LLC WILLAIM STERN
K072788 12/26/2007 STORZ MODULITH LITHOTRIPTER SLX-F2-F180 KARL STORZ ENDOSCOPY-AMERICA, INC. CRYSTAL DIZOL
K071695 12/31/2007 KENSEY NASH MACROPORE SHIELD KENSEY NASH CORP. CINDY VARUGHESE
K072622 12/04/2007 STANDOUT 2 KERR CORP. WENDY GARMAN
K072764 12/20/2007 KLS MARTIN XTERNAL FIXATOR KLS MARTIN L.P. TOM FAUCETT
K072707 12/19/2007 PATIENT CONTOURED MESH-PEEK (PCM-P) KLS-MARTIN L.P. JENNIFER DAMATO
K070012 12/27/2007 POLYBONE KYUNGWON MEDICAL CO., LTD. JOO YEON LEE
K071905 12/28/2007 POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) LANX, LLC JANICE M HOGAN
K072995 12/18/2007 TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER LUMEN DEVELOPMENT AND MANUFACTURING, INC. CALVIN D OSTLER
K073436 12/28/2007 SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEM LUTRONIC CORPORATION MAUREEN O'CONNELL
K073248 12/12/2007 MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM MAKO SURGICAL CORP. WILLIAM F TAPIA
K072360 12/12/2007 K-Y BRAND INTRIGUE INTENSE WARMING SENSATION MCNEIL-PPC, INC. NADER FOTOUHU, PH.D.
K071878 12/07/2007 DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB MED-LECTRIC CORPORATION M. LEE GUNTER
K072550 12/07/2007 SIGHTSURE OPERATIONAL INDICATOR, MODEL SS301 MEDEVICE, INC. MICHELE H VOVOLKA
K072226 12/10/2007 IMPIX SPACER MEDICREA TECHNOLOGIES J.D. WEBB
K072511 12/13/2007 SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM MEDIMOP MEDICAL PROJECTS, LTD. ARI Y SOBEL
K072759 12/13/2007 VIAL2BAG MEDIMOP MEDICAL PROJECTS, LTD. ARI Y SOBEL
K072886 12/21/2007 MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T MEDRAD, INC. LISA M CASAVANT
K072328 12/21/2007 MEDTRADE PRODUCTS CELOX SOLBAG, ANTI - COAGULANT MEDTRADE PRODUCTS LTD. JONATHAN D RANFIELD
K071942 12/11/2007 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK MICHELLE WILLIS
K070356 12/18/2007 MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM MEDWAVES INCORPORATED TED ORMSBY
K073456 12/20/2007 T-QUEST SYSTEM MEDX, INC. MICHAEL HANUSHEWSKY
K071941 12/04/2007 MEMOMETAL BONE ANCHORS MEMOMETAL TECHNOLOGIES GILLES AUDIC
K072823 12/14/2007 MERILAS 532A MERIDIAN AG KEVIN WALLS
K072552 12/14/2007 MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE MERIT MEDICAL SYSTEMS, INC. WILLIAM D JORDAN
K073397 12/20/2007 MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50) MICROLIFE CORP. SUSAN D GOLDSTEIN-FALK
K073398 12/20/2007 MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100) MICROLIFE CORP. SUSAN D GOLDSTEIN-FALK
K073300 12/04/2007 MILESMAN PREMIUM MILESMAN S.L. NATALYA VALERIO
K072979 12/26/2007 SPIROBANK G MIR MEDICAL INTL. RESEARCH SRL SIMON FOWLER
K073448 12/20/2007 MEDICAL DISPLAY, MD205MG NEC DISPLAY SOLUTIONS, LTD. SHUICHI KINO
K070899 12/13/2007 PURITAN BENNETT LEGENDAIR XL2 NELLCOR PURITAN BENNETT JAMES BONDS
K071691 12/19/2007 DUAL SHOT ALPHA NEMOTO KYORINDO CO., LTD. MICHAEL HIEDA
K072997 12/19/2007 NEOMED URINARY CATHETER NEOMED, INC. PENNY NORTHCUTT
K071613 12/14/2007 AMIGO INSULIN PUMP NIPRO DIABETES SYSTEMS, INC. HARRY RUSSELL
K072570 12/28/2007 NOBELACTIVE MULTI UNIT ABUTMENT NOBEL BIOCARE AB HERBERT CRANE
K070857 12/28/2007 NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM NOBEL BIOCARE AB PHUONG NGUYEN SON
K072980 12/20/2007 NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS NOBEL BIOCARE AB KAM LEUNG
K073273 12/11/2007 EQUAL DOSE 1.0 NUCLETRON CORPORATION LISA DIMMICK
K073107 12/07/2007 VALENCIA SKIN APPLICATOR SET, MODEL: 189.701 NUCLETRON CORPORATION LISA] DIMMICK
K063304 12/21/2007 LIFE4C NUMEDIS, INC. MARY E FREDDO
K071795 12/04/2007 NUVASIVE COROENT SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K072937 12/28/2007 OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET OLSEN MEDICAL JOHN P WATERS
K073409 12/14/2007 OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM OMNIGUIDE, INC. DOUGLAS W WOODRUFF
K073045 12/18/2007 SAPPHIRE CERAMIC BRACKET ORTHO TECHNOLOGY, INC PAUL WILLIAMS
K073157 12/07/2007 VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 ORTHO-CLINICAL DIAGNOSTICS, INC. MARLENE HANNA
K072601 12/10/2007 OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT OSTEOSYMBIONICS, LLC CYNTHIA M BROGAN
K072670 12/13/2007 MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER PARI INNOVATIVE MANUFACTURERS, INC. JAMES MCINTIRE
K071063 12/20/2007 LINASYS PATHFINDER THERAPEUTICS, INC. JAMES D STEFANSIC
K072830 12/04/2007 RM BOND, MODEL J032 PENTRON CLINICAL TECHNOLOGIES GREG MOREAU
K072718 12/28/2007 PENUMBRA SYSTEM PENUMBRA, INC. THERESA BRANDNER-ALLEN
K073210 12/12/2007 MODIFICATION TO: T-PORT HP INFUSION PORT PFM MEDICAL, INC SALVADORE PALOMARES
K072393 12/07/2007 ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 PHADIA US INC. MARTIN R MANN
K070009 12/07/2007 AT HOME DRUG TEST MODELS, 9308T AND 9308X PHAMATECH INC. CARL MONGIOVI
K070098 12/07/2007 QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC PHAMATECH INC. CARL MONGIOVI
K072813 12/28/2007 EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG) PHASEIN AB DAVID WEISSBURG
K071885 12/20/2007 ANTIMICROBIAL AND SINGLE-PATIENT CUFFS PHILIPS MEDICAL SYSTEMS PETER SCHIPELLITI
K072376 12/12/2007 PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS PLAYTEX PRODUCTS, INC. KEITH EDGETT
K070757 12/04/2007 MICROPROTEIN REAGENT SET POINTE SCIENTIFIC, INC. RON JAMISON
K072766 12/11/2007 PVMED DDR 2520 DIGITAL IMAGING SYSTEM PORTAVISION MEDICAL IAN GORDEN
K073001 12/18/2007 IDRIVES, IDRIVEC, IDRIVEF POWER MEDICAL INTERVENTIONS, INC. BARBARA J WHITMAN
K073148 12/07/2007 IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS POWER MEDICAL INTERVENTIONS, INC. BARBARA J WHITMAN
K072267 12/10/2007 TOTAL HIP SURGETICS NAVIGATION SYSTEM PRAXIM SA JIHANE ZEMMOURI
K073220 12/19/2007 THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT PRESTIGE BRANDS, INC. KAREN A COSTA-STRACHAN
K072261 12/26/2007 FINESSE SYSTEM PRIMAEVA MEDICAL, INC. SEVRINA CIUCCI
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K072756 12/19/2007 NON-IV ADAPTER FOR INFANT NG TUBE PROMEDIC, INC. PAUL DRYDEN
K072528 12/28/2007 ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES PROSURG, INC. ASHVIN DESAI
K072264 12/06/2007 FASTPACK HCG IMMUNOASSAY QUALIGEN, INC. MICHAEL S POIRIER
K073066 12/26/2007 308 DERMATOLOGICAL EXCIMER SYSTEM QUANTEL MEDICAL, INC. GEORGE MYERS
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K072940 12/13/2007 MIRAGE MICRO RESMED LTD. DAVID D'CRUZ
K072450 12/12/2007 ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000 RESPIRONICS CALIFORNIA, INC. MARA CALER
K072588 12/18/2007 PERFORMAX SE TOTAL FACE MASK RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP ZITA YURKO
K072592 12/19/2007 PERFORMAX TOTAL FACE MASK RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP ZITA YURKO
K072996 12/27/2007 REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM RESPIRONICS, INC. ZITA A YURKO
K072654 12/14/2007 PATIENT SAFE SYRINGE RETRACTABLE TECHNOLOGIES, INC. RHONDA WELLS
K071093 12/06/2007 SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202 SAN SHIH ELECTRICAL ENTERPRISE CO., LTD. KE-MIN JEN
K072374 12/07/2007 COMPASS SCANDITRONIX WELLHOFER GMBH MARTIN AROLD
K072466 12/19/2007 STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 SCICAN LTD. TERESA BOYCE
K073043 12/14/2007 SET PP SDI LTD. RAY CAHILL
K072605 12/20/2007 MALIBU SPINAL SYSTEM SEASPINE, INC. ETHEL BERNAL
K070486 12/21/2007 CAPILLARYS URINE (PN 2012) SEBIA, INC. KAREN ANDERSON
K073127 12/20/2007 BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. DIANA HONG
K071353 12/14/2007 FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C SHANGHAI FOSHION MEDICAL INSTRUMENTS CO., LTD. WILLIAM MCLAIN
K071886 12/27/2007 SELF SEAL STERILIZATION POUCH SHANGHAI JIANZHONG MEDICAL PACKAGING CO., LTD. LONGFU SONG
K073193 12/20/2007 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD CHU XIAOAN
K073373 12/18/2007 SYNGO VOLUME PERFUSION-CT BODY SIEMENS AG, MEDICAL SOLUTIONS RALF HOFMANN
K072676 12/18/2007 ACUSON X300 ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. MARTINA VOGT
K072485 12/27/2007 ARTISTE MV SA SIEMENS MEDICAL SOLUTIONS USA, INC. ERIK RODRIGUEZ
K071730 12/20/2007 STUDIODOP VICORDER SKIDMORE MEDICAL, LIMITED DAVID W WAGNER
K073040 12/13/2007 SMH FLEX "S" SMH BIOMATERIAL AG ASHLEY TRUITT
K072785 12/10/2007 TWINFIX FT PK SMITH & NEPHEW INC., ENDOSCOPY DIVISION DEANA BOUSHELL
K073175 12/20/2007 JOURNEY UNICONDYLAR FEMORAL IMPLANT SMITH & NEPHEW, INC. MARLON RIDLEY
K073325 12/20/2007 LEGION POROUS PRIMARY SMITH & NEPHEW, INC. RISHI SINHA
K072531 12/06/2007 LEGION STEM WITH HOLES SMITH & NEPHEW, INC. MEGAN BEVILL
K072657 12/14/2007 POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS SMITHS MEDICAL MD, INC. BRIAN HAUGSTAD
K072951 12/19/2007 PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES SOFRADIM PRODUCTION SHARON ALEXANDER
K073196 12/19/2007 MASTER-VU SONOMED, INC. GEORGE MYERS
K070783 12/13/2007 SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR SOPRO STEVE SALESKY
K073350 12/19/2007 SCANORA 3D SOREDEX PALODEX GROUP OY JOUNI ONNELA
K072750 12/04/2007 SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066 SPECTRANETICS CORP. MICHAEL K HANDLEY
K073348 12/26/2007 LUCENT MAGNUM SPINAL ELEMENTS, INC. KERRI DIMARTINO
K072961 12/19/2007 LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) SRA DEVELOPMENTS, LTD. MICHAEL J.R. YOUNG
K071818 12/20/2007 ENSITE FUSION DYNAMIC REGISTRATION TOOL ST. JUDE MEDICAL KAREN J MCKELVEY
K072510 12/11/2007 VERIFY V-PRO CHEMICAL INDICATOR, VERSIONS 1 AND 2 STERIS CORPORATION JOHN ROBERT SCOVILLE
K073151 12/06/2007 MANTIS SPINAL SYSTEM STRYKER CORP. CURTIS TRUESDALE
K072271 12/18/2007 STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE STRYKER CORP. BECKY DITTY
K072118 12/07/2007 STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT STRYKER CORP. JEAN SHEPPARD
K071482 12/20/2007 STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 SYNERGETICS, INC DAN REGAN
K072758 12/18/2007 SYNTHES (USA) 2.0MM TITANIUM T-PLATE SYNTHES (USA) ANDREA M TASKER
K073186 12/17/2007 SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM SYNTHES (USA) KARL J NITTINGER
K072791 12/26/2007 ORACLE SPACER, OPAL SPACER SYNTHES SPINE STACEY BONNELL
K073372 12/07/2007 ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI) SYSTEMSONE THOMAS ARTHUR
K072784 12/21/2007 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK TD-4227 BLOOD GLUCOSE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION ERICA LI
K072273 12/20/2007 BELMONT QUOLIS 5000 SERIES DENTAL UNIT TAKARA BELMONT USA, INC. ROBERT SCHIFF
K071712 12/04/2007 LEUKO EZ VUE TECHLAB INC., CORPORATE RESEARCH CENTER CHARLES PENNINGTON
K071349 12/12/2007 NEUROSIGN LARYNGEAL ELECTRODES THE MAGSTIM COMPANY LTD. ANWEN EVANS
K072407 12/21/2007 BODYFORM THORACIC FIXATION SYSTEM THEKEN SPINE LLC DALE DAVISON
K070824 12/03/2007 CREATININE (ENZYMATIC) THERMO FISHER SCIENTIFIC OY PAIVI SORMUNEN
K073141 12/05/2007 SPI ART ABUTMENT THOMMEN MEDICAL, AG FLOYD G LARSON
K072649 12/06/2007 SPI SYSTEM DENTAL IMPLANTS THOMMEN MEDICAL, AG LINDA K SCHULZ
K073272 12/11/2007 WORKSTATIONONE BREAST IMAGING WORKSTATION THREE PALM SOFTWARE, LLC HEIDI D ZHANG
K072746 12/04/2007 E-1 ESTHETIC COMPOSITE SYSTEM TOKUYAMA DENTAL CORPORATION KEITH A BARRITT
K073259 12/20/2007 XIDF-100A/B1 IMAGE PROCESSOR TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K073147 12/03/2007 SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 TRANSOMA MEDICAL LISA STONE
K071876 12/17/2007 CROSS.BONE TRIMED, INC. KELLI ANDERSON
K073020 12/19/2007 ECLIPSE TREATMENT PLANNING SYSTEM VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K073264 12/07/2007 D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005 VASCULAR SOLUTIONS, INC. JAMES CHAPMAN
K072810 12/19/2007 PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010 VASCULAR SOLUTIONS, INC. DORALIE POGANSKI
K073400 12/20/2007 VARICATH PERIPHERAL INFUSION CATHETER VEINRX INC. GREGORY MATHISON
K072180 12/18/2007 VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM VISION-SCIENCES, INC. PAMELA PAPINEAU
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
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
K073005 12/12/2007 ELITE GLASS ZHERMACK S.P.A. GERALD W SHIPPS


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