FDA 510(k) Decisions During January, 2007  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K062027 01/19/2007 A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR A & D ENGINEERING, INC. JERRY WANG
K070984 11/01/2007 THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS ABBOTT DIABETES CARE INC. MARIA E TREJO
K072672 11/28/2007 SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES ABBOTT SPINE, INC. DAVID PADGETT
K063782 01/19/2007 ACCIN UNI-KNEE SYSTEM ACCIN CORPORATION MICHAEL KVITNITSKY
K072019 11/05/2007 AKITA2 APIXNEB ACTIVAERO AMERICA, INC. PAUL DRYDEN
K072309 11/19/2007 MICROLUX/BLU ADDENT, INC. JOSHUA FRIEDMAN, DDS
K072850 11/21/2007 MRI SYSTEM, MODEL MAGFINDER II / AI 3200 ADVANCED IMAGING LABORATORY STEPHEN T MLCOCH
K071385 11/29/2007 STERRAD 100NX STERILIZER ADVANCED STERILIZATION PRODUCTS REUBEN LAWSON
K072359 11/08/2007 AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C AEARO COMPANY ANN L PHILLIPS
K062009 01/17/2007 AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T AESCULAP, INC. MATTHEW M HULL
K072313 11/02/2007 AMPLATZER TORQVUE DELIVERY SYSTEM AGA MEDICAL CORP. PATRICIA A LAFORTE
K063409 01/12/2007 LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 AGAMATRIX CONNIE HERTEL
K063285 01/12/2007 RELIANCE CI PROCESS INDICATOR ALBERT BROWNE LTD. CYNTHIA J.M. NOLTE
K062624 11/05/2007 NEXT GENERATION LASER ALCON LABORATORIES TERRY J DAGNON
K071165 11/07/2007 ISCALERT SENSOR SYSTEM ALERTIS MEDICAL AS CONSTANCE G BUNDY
K072659 11/15/2007 RAD VISION, MODELS E AND EU ALMANA MEDICAL IMAGING DANIEL KAMM
K071890 11/09/2007 ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC. MARY STANNERS
K063829 01/22/2007 THERMOGARD THERMAL REGULATION SYSTEM ALSIUS CORP. KENNETH A COLLINS
K062511 01/31/2007 AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX ALVEOLUS, INC. DONALD CANAL
K072022 11/19/2007 VALEO PEDICLE SCREW SPINAL SYSTEM AMEDICA CORP. JUSTIN EGGLETON
K062907 01/09/2007 ALEXIS WOUND RETRACTOR APPLIED MEDICAL RESOURCES CHERYL BLAKE
K062544 01/03/2007 AR1000 ULTRASONIC WOUND THERAPY SYSTEM AROBELLA MEDICAL, LLC ALLISON SCOTT
K063058 01/03/2007 ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS ARTHREX, INC. NANCY HOFT
K072378 11/09/2007 PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626 ARTHREX, INC. ANN WATERHOUSE
K070874 11/02/2007 ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006; ACCESSORIES FOR MR GENERATOR ARTHRO KINETICS INC. JAMES HOBBS
K063370 01/12/2007 CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY ARTHROSURFACE, INC. DAWN J WILSON
K071413 11/09/2007 HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM ARTHROSURFACE, INC. DAWN J WILSON
K063819 01/26/2007 ASAHI PTCA GUIDE WIRE, FIELDER FC ASAHI INTECC CO., LTD. YOSHI TERAI
K062497 01/31/2007 REPROCESSED TROCARS ASCENT HEALTHCARE SOLUTIONS ELIZABETH RENKIN
K073010 11/07/2007 ROYALE AE 9036 LSP INJECTOR ASICO LLC RAVI NALLAKRISHNAN
K072286 11/20/2007 BIS EEG VISTA MONITOR SYSTEM AND BISX ASPECT MEDICAL SYSTEMS, INC. VIKRAM VERMA
K072483 11/16/2007 ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTS ATLANTIS COMPONENTS, INC. BETSY A BROWN
K063630 01/26/2007 ATRICURE ABLATION SYSTEM ATRICURE, INC. ELSA C ABRUZZO
K062996 01/12/2007 DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES AXON SYSTEMS, INC. HOWARD BAILIN
K063470 01/05/2007 AYCAN WORKSTATION OSIRIX AYCAN DIGITALSYSTEME GMBH CARL ALLETTO
K062363 01/17/2007 BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM B&W TEK, INC. SEAN WANG
K072247 11/08/2007 STERICAN HYPODERMIC NEEDLES B. BRAUN MEDICAL, INC. CHRISTINE FORD
K063217 01/12/2007 VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL) B. BRAUN MEDICAL, INC. PAUL O'CONNELL
K063245 11/28/2007 ELUTIA COATED CLOSED SURGICAL WOUND DRAIN BACTERIN INTERNATIONAL INC. JOSEPH M AZARY
DEN060006 01/30/2007 COMPUTERIZED LABOR MONITORING SYSTEM BARNEV, LTD. ARAVA HACOHEN
K060028 01/30/2007 COMPUTERIZED LABOR MONITORING SYSTEM BARNEV, LTD. ARAVA HACOHEN
K072576 11/06/2007 CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K052973 01/25/2007 IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K BAXTER HEALTHCARE CORP. JOHN MANARIK
K062937 01/08/2007 TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K063573 01/11/2007 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTAZIDIME (GN) 0.5-64 UG/ML BECTON DICKINSON & CO. VICKI KENNEDY WHITLEY
K070691 11/20/2007 BBL CHROMAGAR 0157 BECTON, DICKINSON & CO. DENNIS R MERTZ
K063300 01/29/2007 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFPODOXIME (GN) 0.125-8UG/ML BECTON, DICKINSON & CO. VICKI K WHITLEY
K063196 01/23/2007 LANDLEX, MODEL S403X BESTEAM TECHNOLOGY INC. JUNNATA CHANG
K072666 11/05/2007 BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM BIO COMPRESSION SYSTEMS, INC. JAMES JOCHEN ROGERS
K072306 11/15/2007 BIOXTRA MOISTURIZING GEL BIO-X HEALTHCARE S.A. EMALEE MURPHY
K063666 01/25/2007 SHARPS CONTAINER, MODEL 039-413 BIODEX MEDICAL SYSTEMS, INC. CLYDE SCHLEIN
K060818 01/23/2007 ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01 BIOKIT S.A. JOAN GUIXER
K061898 01/26/2007 EZLASE BIOLASE TECHNOLOGY, INC. IOANA M RIZOIU
K072082 11/05/2007 GUMEASE DENTAL MOUTHPIECE BIOMEDEVICE LTD. BRICE L YODER
K073146 11/21/2007 PADNET+ BIOMEDIX, INC. WILLIAM ROGERS
K063597 01/19/2007 VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. JOLYN TENLLADO
K063623 01/11/2007 VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. JOLYN TENLLADO
K072695 11/16/2007 VITEK 2 GRAM POSITIVE TIGECYCLINE BIOMERIEUX, INC. JOLYN TENLLADO
K073102 11/27/2007 BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS BIOMET MANUFACTURING CORP. BECKY EARL
K070015 11/30/2007 COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT BIOMET MANUFACTURING CORP. GARY E BAKER, MS RAC
K062998 01/19/2007 COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG) BIOMET MANUFACTURING CORP. JING XIE
K063732 01/18/2007 MICROPLASTY TIBIAL TRAYS BIOMET MANUFACTURING CORP. BECKY EARL
K072336 11/05/2007 REGENEREX POROUS TITANIUM SLEEVE AUGMENTS BIOMET MANUFACTURING CORP. BECKY EARL
K072848 11/02/2007 ACTIVASCREW BIORETEC LTD MARI RUOTSALAINEN
K072202 11/19/2007 CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01) BIOSENSE WEBSTER, INC. NATALIE BENNINGTON
K062530 01/29/2007 TRIAGE PROTEIN C TEST BIOSITE INCORPORATED FIL V BUENVIAJE
K062318 01/03/2007 BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML BIOTOP TECHNOLOGY CO., LTD. LYDIA LEE
K061602 01/23/2007 DUET SYSTEM BIOVIEW LTD. DORIT WINITZ
K063780 01/19/2007 ACE BOND SE BISCO, INC. BENJAMIN LICHTENWALNER
K072436 11/01/2007 MEGA SPINE SYSTEM BK MEDITECH CO., LTD. HENRY YANG
K072049 11/29/2007 CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS BMEYE B.V. JACQUELINE EMERY
K062289 01/03/2007 BONART ART-L3 LED CURING LIGHT BONART CO. LTD. ERIC L ONG
K071957 11/08/2007 PINNACLE PELVIC FLOOR REPAIR KITS BOSTON SCIENTIFIC CORP. MICHELLE BERRY
K062358 01/17/2007 MODIFICATION TO VECTORVISION TRAUMA BRAINLAB, AG RAINER BIRKENBACH
K063476 01/22/2007 BREAS ISLEEP 20I BREAS MEDICAL AB KARL-JOHAN HOLM
K063018 01/22/2007 GLASS LOSS OF RESISTANCE SYRINGE BUSSE HOSPITAL DISPOSABLES, INC. MUHAMAD ANSARI
K071365 11/06/2007 AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE C.R. BARD, INC. MICHELLE R GUDITH
K063377 01/25/2007 POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER C.R. BARD, INC. MICHAELA RIVKOWICH
K072215 11/01/2007 TITANIUM POWERPORT ISP IMPLANTED PORT C.R. BARD, INC. SUSAN D SCOTT
K072549 11/14/2007 TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER C.R. BARD, INC. SUSAN D SCOTT
K063632 01/05/2007 X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER C.R. BARD, INC. TERRI MORRIS
K063717 01/23/2007 CF-1 CANON, INC. SHEILA DRISCOLL
K063644 01/11/2007 CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM CARDICA, INC. TIFFINI LALUDE
K072133 11/20/2007 AVAFLEX VERTEBRAL AUGMENTATION NEEDLE CARDINAL HEALTH, INC. SHARON NICHOLS
K072748 11/09/2007 MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM CARDIOVASCULAR SYSTEMS, INC. JOHN CARLINE
K063378 01/26/2007 CIRRUS HD-OCT, MODEL 4000 CARL ZEISS MEDITEC INC JUDITH A BRIMACOMBE
K072260 11/27/2007 NUFACE, MODEL NU-4003 CAROL COLE COMPANY HOWARD ASHER
K062503 01/19/2007 CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT CATACHEM, INC. LUIS P LEON
K072245 11/08/2007 EMULATE ADVANCED CAVEX HOLLAND B.V. RICHARD WOORTMAN
K073054 11/27/2007 MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER CAYENNE MEDICAL, INC. DAVID J COLLETTE
K072960 11/08/2007 CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET CDP, LTD. DORON DAVID
K070093 01/24/2007 OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE CEREMED INC. TADEUSZ WELLISZ M.D.
K070968 11/15/2007 CHOY COMPRESSION FRAME CHOY MEDICAL TECHNOLOGIES, INC. JONATHAN S KAHAN
K073016 11/09/2007 TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT CHURCH & DWIGHT CO., INC. STEPHEN C KOLAKOWSKY
K073180 11/19/2007 SMARTSPONGE PLUS SYSTEM CLEARCOUNT MEDICAL SOLUTIONS, INC. JEFF WOLFGONG
K073124 11/16/2007 COLLIMARE "COLLIMATOR FAMILY" COLLIMARE, LLC HOWARD C THOMAS
K072808 11/09/2007 SPEEDICATH COMPACT COLOPLAST CORP. REBEKA STOLTMAN
K072604 11/16/2007 DUO TEMP COLTENE/WHALEDENT AG HENRY J VOGELSTEIN
K073013 11/21/2007 CTU676 DEVICE COMPRESSION TECHNOLOGIES UNLIMITED, INC. DOUGLASS HALE
K063774 01/24/2007 MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6 CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K062046 01/19/2007 MODIFIED MERCI RETRIEVER, MODEL 90050 CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K072698 11/16/2007 CONFIDANT 2.5 CONFIDANT INC. DANIEL R PLONSKI
K072586 11/08/2007 CONFORMIS UNI-CONDYLAR KNEE SYSTEM CONFORMIS, INC. S. MICHAEL SHARP
K062082 01/25/2007 CONMED ABC DISSECTING BLADE ELECTRODE, MODEL 139330; BLUNT NEEDLE ELECTRODE, MODEL 139331 CONMED CORPORATION SHAWN RIEDEL
K063326 01/31/2007 CONMED LINVATEC 24K IRRIGATION SYSTEM CONMED LINVATEC SUE F DAUTERMAN
K072521 11/20/2007 COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH COOK UROLOGICAL, INC. CINDY FOOTE
K072724 11/09/2007 CXI SUPPORT CATHETER COOK, INC. KAREN BRADBURN
K072240 11/08/2007 GUNTHER TULIP VENA CAVA FILTER COOK, INC. MOLLY BUSENBARK
K070690 11/16/2007 THE LIFE VESSEL COTTONWOOD VESSEL CORPORATION MIKI KOLTON
K073122 11/21/2007 MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR DEBORA STAPLETON
K061430 01/12/2007 SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR CUSTOM ULTRASONICS LAWRENCE F MUSCARELLA
K072868 11/05/2007 ACCOLADE II LASER CYNOSURE, INC. GEORGE CHO
K070063 01/30/2007 YAG MIR II LASER CYNOSURE, INC. GEORGE CHO
K063235 01/24/2007 CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT CYTORI THERAPEUTICS, INC. KENNETH K KLEINHENZ
K063621 01/17/2007 3 SERIES PHOTOTHERAPY CABINET DAAVLIN CO. TARA MANSUR
K063610 01/11/2007 DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K063272 01/26/2007 DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K063351 01/22/2007 DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K063508 01/23/2007 DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN DADE BEHRING, INC. HELEN M LEE
K063322 01/24/2007 DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K071224 11/13/2007 DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR DADE BEHRING, INC. LORRAINE H PIESTRAK
K063525 01/05/2007 DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM DATASCOPE CORP. NANCY COHEN
K062099 01/25/2007 PHASE 3, MODEL DT-1 DATREND SYSTEMS, INC. RON EVANS
K062397 01/25/2007 SENTINEL DEL MAR REYNOLDS MEDICAL, LTD. GEORGE MYERS
K072807 11/21/2007 I LIGHT DENT'N CO ALAN DONALD
K063483 01/23/2007 DEN TEK NIGHTGUARD DENTEK ORAL CARE, INC. JEFFREY SHAPIRO
K070228 11/20/2007 IMPLANTIUM PROSTHETICS DENTIUM CO., LTD. CATHRYN N CAMBRIA
K072522 11/16/2007 THERMOFORM SHEET MATERIALS AND ACCESSORIES DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K070019 01/26/2007 CARRARA VOLUMIA DENTSPLY INTL. HELEN LEWIS
K072423 11/07/2007 4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY. DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K063509 01/04/2007 DEPUY PEAK FX HIP PLATE DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K071059 11/09/2007 DEPUY SPA POROUS COATED PROXIMAL SLEEVE DEPUY ORTHOPAEDICS, INC. KATHY HARRIS
K071927 11/21/2007 MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT DEPUY SPINE, A JOHNSON & JOHNSON COMPANY SHARON STAROWICZ
K063741 01/17/2007 EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. CHRISTOPHER KLACZYK
K072956 11/07/2007 MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY DERMA SCIENCES, INC. MARY MCNAMARA-CULLINANE
K071202 11/30/2007 DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS) DERMAPORT, INC GARY SYRING
K063208 01/19/2007 MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 DIAGNOSTIC CHEMICALS LTD. DEBBIE M MURRAY
K070569 11/08/2007 SM INTERNAL./EXTERNAL IMPLANT SYSTEM DIO DEPARTMENT DSI, INC. KENNY LIM
K063828 01/25/2007 DIOMED DELTA 25 DIOMED, LTD. TIM PHIPPS
K062176 01/10/2007 RELIEF ACP ORAL CARE GEL DISCUS DENTAL INC. STEVEN L ZIEMBA
K072532 11/02/2007 TRUEPIX LCD MEDICAL DISPLAY MONITOR, MODELS TX-5M, TX-3M, TX-2M DOOYANG SYSTEMS INC DANIEL KAMM
K073021 11/06/2007 MULTI-SPECT EAGLE HEART IMAGING, LLC JOHN KOSS
K070375 11/15/2007 EARLYSENSE ES-16 SYSTEM EARLYSENSE LTD. DORIT WINITZ
K063846 01/26/2007 EIGEN DSA 2000 EIGEN NATALIE J KENNEL
K063797 01/25/2007 GEODESIC EEG SYSTEM 300 ELECTRICAL GEODESICS, INCORPORATED LINDA J BOVARD
K063151 01/09/2007 HUMAPEN LUXURA HD ELI LILLY AND CO. LEEANN CHAMBERS
K072383 11/29/2007 HABIB ENDOBLATE EMCISION, LTD. NAGY HABIB
K072946 11/16/2007 HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM EMPI SANDRA WALROD
K061650 01/22/2007 SELECT TENS, MODEL 4600S EMPI CARL BEAURLINE
K063406 01/08/2007 ENCORE KNEE SYSTEM IFU ENCORE MEDICAL, L.P. TEFFANY HUTTO
K062354 01/26/2007 VECTRA GENISYS VMS FR ENCORE MEDICAL, L.P. MICHAEL TREAS
K072919 11/02/2007 VENDYS, MODEL 6000 B B/C ENDOTHELIX, INC. DOUG BLAKELY
K072248 11/09/2007 VIAPEEL PEELABLE INTRODUCER ENPATH MEDICAL, INC. PATRICE STROMBERG
K072470 11/16/2007 BIOELAST 5-0 SUTURE, MODEL 500100 ENTRIGUE SURGICAL, INC. GABRIELE NIEDERAUER
K062712 01/26/2007 ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094 ERBE USA, INC. JOHN TARTAL
K063050 11/19/2007 CAP PLUS ETEX CORP. FRANCES A FLORENCE
K063192 01/30/2007 HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP ETHICON ENDO-SURGERY, LLC ELIZABETH MILLER, MST
K062892 01/22/2007 EUKARE EUMED BIOTECHNOLOGY CO., LTD. KE-MIN JEN
K063785 01/19/2007 SPIDERFX EMBOLIC PROTECTION DEVICE EV3 INC DAVID WORRELL
K071624 11/27/2007 EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR EVERLIFE MEDICAL EQUIPMENT CO., LTD. JEN KE-MIN
K072641 11/01/2007 DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4. FAMIDOC TECHNOLOGY CO., LTD STEELJIN
K060272 01/12/2007 LOCOBASE WOUND AND SKIN EMULSION FERNDALE LABORATORIES, INC. RICHARD A HAMER
K062868 01/19/2007 THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02 FLOWCARDIA INC DUSTIN MICHAELS
K071826 11/09/2007 THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910 FOX HOLLOW TECHNOLOGIES SRIDEVI SHESHADRI
K072755 11/16/2007 GALEMED CPAP MASK GALEMED CORP. PAUL DRYDEN
K063290 01/30/2007 GAMBRO QUICKSET BLOODLINES GAMBRO RENAL PRODUCTS THOMAS B DOWELL
K061782 01/04/2007 GAMBRO POSICLEAR GAMBRO SERVICES, INC. JEFFERY R SHIDEMAN
K070643 11/02/2007 PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35 GAMBRO, INC. THOMAS B DOWELL
K072986 11/20/2007 INTEGRADWEB PACS SYSTEM GE HEALTHCARE JILLIAN M REED
K073203 11/29/2007 CARESCAPE V100 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES KAREN RUSSELL
K072502 11/19/2007 MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES PATRICIA TAIGE
K072998 11/01/2007 IDEAL SOFTWARE OPTION FOR GE MR SCANNERS GE MEDICAL SYSTEMS, LLC MARK M STAUFFER
K062675 01/04/2007 GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES GEMORE TECHNOLOGY CO., LTD. TONY C.S. CHANG
K063451 01/22/2007 GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 GEN-PROBE, INC. E. JOSEPH MCMULLEN
K063664 01/25/2007 GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 GEN-PROBE, INC. E. JOSEPH MCMULLEN
K072952 11/16/2007 GE ECHOPAC GENERAL ELECTRIC CO. ALLEN SCHUH
K063429 01/17/2007 GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200 GENERIC MEDICAL DEVICE, INC. MONICA MONTANEZ
K063121 01/11/2007 PORTABLE X-RAY SYSTEM, MODEL PORT-X II GENORAY CO., LTD. CHARLIE MACK
K071388 11/06/2007 GENTIAN CYSTATIN C IMMUNOASSAY GENTIAN AS RONALD G LEONARDI
K063739 01/17/2007 SEPRAMESH, MODEL 5959-1214 GENZYME CORPORATION MATTHEW HIBBERT
K063589 01/31/2007 GSO BONE FIXATION FASTENERS GOLD STANDARD ORTHOPAEDICS LLC DAVID BAUGHMAN
K073182 11/28/2007 GYN DISPOSABLES TENACULUM 356T GYN-DISPOSABLES, INC. JAMES K PATTERSON
K062604 01/31/2007 RAPIDTEG TEG-ACT TEST HAEMOSCOPE CORP. ELI COHEN
K070513 11/26/2007 HAMILTON-G5 HAMILTON MEDICAL AG JOERG SCHNEIDER
K070061 01/31/2007 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT HAYES MEDICAL, INC. LUKE ROSE
K071875 11/05/2007 V-CATH POLY PICC HDC CORP. EARL SMART
K072593 11/15/2007 A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE HEALTHSTATS INTERNATIONAL PTE. LTD. STEPHEN GORSKI
K072778 11/19/2007 BRIO ACUPUNCTURE NEEDLES HELIO MEDICAL SUPPLIES, INC. YUKUO HSU
K063524 01/23/2007 POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR) HL RUBBER INDUSTRIES SDN BHD KENNY HOE
K063852 11/09/2007 ACCESSA CHOLESTEROL PANEL HOME ACCESS HEALTH CORP. KAREN L HANSON
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