510kDecisions.com

FDA 510(k) Decisions During November, 2007  

FDA 510(k) Number Decision Date Device Name Applicant Contact
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
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
K072313 11/02/2007 AMPLATZER TORQVUE DELIVERY SYSTEM AGA MEDICAL CORP. PATRICIA A LAFORTE
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
K072022 11/19/2007 VALEO PEDICLE SCREW SPINAL SYSTEM AMEDICA CORP. JUSTIN EGGLETON
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
K071413 11/09/2007 HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM ARTHROSURFACE, INC. DAWN J WILSON
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
K072247 11/08/2007 STERICAN HYPODERMIC NEEDLES B. BRAUN MEDICAL, INC. CHRISTINE FORD
K063245 11/28/2007 ELUTIA COATED CLOSED SURGICAL WOUND DRAIN BACTERIN INTERNATIONAL INC. JOSEPH M AZARY
K072576 11/06/2007 CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K070691 11/20/2007 BBL CHROMAGAR 0157 BECTON, DICKINSON & CO. DENNIS R MERTZ
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
K072082 11/05/2007 GUMEASE DENTAL MOUTHPIECE BIOMEDEVICE LTD. BRICE L YODER
K073146 11/21/2007 PADNET+ BIOMEDIX, INC. WILLIAM ROGERS
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
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
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
K071957 11/08/2007 PINNACLE PELVIC FLOOR REPAIR KITS BOSTON SCIENTIFIC CORP. MICHELLE BERRY
K071365 11/06/2007 AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE C.R. BARD, INC. MICHELLE R GUDITH
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
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
K072260 11/27/2007 NUFACE, MODEL NU-4003 CAROL COLE COMPANY HOWARD ASHER
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
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
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
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
K072868 11/05/2007 ACCOLADE II LASER CYNOSURE, INC. GEORGE CHO
K071224 11/13/2007 DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR DADE BEHRING, INC. LORRAINE H PIESTRAK
K072807 11/21/2007 I LIGHT DENT'N CO ALAN DONALD
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
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
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
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
K070569 11/08/2007 SM INTERNAL./EXTERNAL IMPLANT SYSTEM DIO DEPARTMENT DSI, INC. KENNY LIM
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
K072383 11/29/2007 HABIB ENDOBLATE EMCISION, LTD. NAGY HABIB
K072946 11/16/2007 HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM EMPI SANDRA WALROD
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
K063050 11/19/2007 CAP PLUS ETEX CORP. FRANCES A FLORENCE
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
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
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
K072952 11/16/2007 GE ECHOPAC GENERAL ELECTRIC CO. ALLEN SCHUH
K071388 11/06/2007 GENTIAN CYSTATIN C IMMUNOASSAY GENTIAN AS RONALD G LEONARDI
K073182 11/28/2007 GYN DISPOSABLES TENACULUM 356T GYN-DISPOSABLES, INC. JAMES K PATTERSON
K070513 11/26/2007 HAMILTON-G5 HAMILTON MEDICAL AG JOERG SCHNEIDER
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
K063852 11/09/2007 ACCESSA CHOLESTEROL PANEL HOME ACCESS HEALTH CORP. KAREN L HANSON
K072115 11/30/2007 ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H HORIBA ABX OLIVIER DUCAMP
K072446 11/29/2007 MOBIL-O-GRAPH NG 24 H ABP-CONTROL I.E.M. GMBH GUENTER GINSBERG
K072867 11/21/2007 IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K IMIX ADR FINLAND OY JAMES TAYLOR
K072101 11/19/2007 RIGI-FIX HIP STEM SYSTEM IMPLANTS INTL. LTD. MOHAN EMMANUEL
K072822 11/26/2007 FUNHALER, MODEL V-201E INFAMED LTD. JOHN GREENBAUM
K073060 11/29/2007 CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR INNOVA VISION INC. JENNIFER REICH
K071921 11/16/2007 INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS) INNOVASIS, INC. WARREN DANSIE
K072650 11/28/2007 IST ANTERIOR CERVICAL PLATE SYSTEM INNOVATIVE SPINAL TECHNOLOGIES INC GINA YEH
K073134 11/16/2007 A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I INVACARE CORPORATION CARROLL MARTIN
K071265 11/30/2007 SMARTCHECK INR SYSTEM INVERNESS MEDICAL INNOVATIONS, INC. LESLEY MOORE
K072874 11/16/2007 LBS-127-16 BREAST ARRAY COIL INVIVO JEFF WILKINSON
K072873 11/16/2007 LBS-63-16 BREAST ARRAY COIL INVIVO JEFF WILKINSON
K072325 11/30/2007 BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205 JAWON MEDICAL CO., LTD. HL JUNG
K072216 11/09/2007 KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 KAPP SURGICAL INSTRUMENT, INC. ALBERT N SANTILLI
K071955 11/01/2007 WIM-PC, MODEL 1010 KARMEL SONIX YORAM LEVY
K072250 11/09/2007 SUPERCABLE GRIP AND PLATE SYSTEM KINAMED, INC. VINEET K SARIN
K070270 11/05/2007 PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 KIRCHNER & WILHELM GMBH + CO.KG NATALYA VALERIO
K072795 11/27/2007 MODELS EMS 5.0, EMS 5.1 KOALATY PRODUCTS, INC. JEFF LENOIR
K070550 11/06/2007 AUSCO ES-3100 KORATEK COMPANY, LTD. PAUL SUMNER
K072135 11/07/2007 KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. HEATHER VIELE
K072580 11/05/2007 JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23 LANG DENTAL MFG. CO., INC. CHAH SHEN
K062931 11/28/2007 IMPLUS IMPLANT SYSTEM LEADER ITALIA S.R.L. HENRY J VOGELSTEIN
K073104 11/16/2007 SKINTACT AND VARIOUS OTHER TRADENAMES LEONHARD LANG GMBH ELAINE DUNCAN
K072241 11/09/2007 PRIMACONNEX CAD/CAM ABUTMENT SYSTEM LIFECORE BIOMEDICAL, INC. JUDITH MEDLOCK-HAYES
K073032 11/16/2007 PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS LIFECORE BIOMEDICAL, INC. JUDITH MEDLOCK-HAYES
K072681 11/02/2007 BLOODSTOP HEMOSTATIC GAUZE; IX HEMOSTATIC GAUZE LIFESCIENCE PLUS, INC. AUDRY VITALE
K072048 11/16/2007 LUMACARE MODEL LC-122M NON-COHERENT LIGHT SOURCE AND MODEL LUM-P FIBRE OPTIC PROBE LYNTON LASERS LIMITED ANDREW JOHN BERRY
K071802 11/09/2007 TESLA GUARD, MODEL EFT G04 MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN GMBH ROBERT N CLARK
K072509 11/26/2007 PRO-PICC, BASIC TRAY; LONG WIRE TRAY; BASIC NURSING TRAY; FULL NURSING TRAY MEDCOMP JEAN CALLOW
K071610 11/05/2007 MEDIAID PULSE OXIMETER M30 AND M34 MEDIAID INC. JAYESH PATEL
K072053 11/06/2007 SMARTBLOCK PAIN PUMP MEDICAL FLOW SYSTEMS LTD MARK DOLLINGER
K070669 11/01/2007 IOL INJECTOR SET MEDICEL AG GEORGE MYERS
K073323 11/29/2007 SA-3000P MEDICORE CO., LTD. YOO BYUNG-KUK
K072972 11/06/2007 MEDSTREAMING MEDICAL OFFICE SOFTWARE MEDSTREAMING, LLC KARLA PATTEN
K071655 11/21/2007 REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538 MEDTRONIC INC. MICHELLE NIVALA
K071641 11/21/2007 REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539) MEDTRONIC INC. MICHELLE NIVALA
K071813 11/09/2007 MASTERGRAFT PUTTY MEDTRONIC SOFAMOR DANEK CHRISTINE SCIFERT
K071416 11/01/2007 PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. CHRISTINE SCIFERT
K062264 11/08/2007 COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM MEDTRONIC VASCULAR DAVID W GARCIA
K072372 11/21/2007 PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE MEGO AFEK AHAVA STEIN
K073140 11/21/2007 VITALOGIK MODEL 4000/4500 MENNEN MEDICAL LTD. IFAT OREN
K071657 11/15/2007 TRU FLU MERIDIAN BIOSCIENCE, INC. SUSAN ROLIH
K072556 11/20/2007 HEMOSTASIS VALVE MERIT MEDICAL SYSTEMS, INC. SHIRLEY HYINK
K073035 11/20/2007 PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS MERIT MEDICAL SYSTEMS, INC. SHIRLEY HYINK
K063733 11/14/2007 RESOLVE BILIARY DRAINAGE CATHETER MERIT MEDICAL SYSTEMS, INC. AMY MCKINNEY
K072740 11/19/2007 MONDEAL EXTREMITY BONE FIXATION SYSTEM MONDEAL MEDICAL SYSTEMS GMBH JAY EVANS
K071579 11/20/2007 PEF TUBE N.M. BEALE CO. INC. PAMELA PAPINEAU
K073236 11/30/2007 NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE NEOCOIL BRIAN BROWN
K073181 11/21/2007 NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL NEOCOIL, LLC BRIAN BROWN
K072984 11/14/2007 SATURN 9000-550 NEW MEDICAL CO., LTD. YOUNG-HOON SHIN
K072983 11/13/2007 SATURN 9000-750 NEW MEDICAL CO., LTD. YOUNG-HOON SHIN
K072710 11/08/2007 NEXFIX COMPRESSION PIN NEXA ORTHOPEDICS, INC. COREY WILSON-WIRTH
K072843 11/29/2007 YG-125T AND YG-135T NASAL ADAPTER NIHON KOHDEN AMERICA, INC. JACK COGGAN
K071815 11/28/2007 NOVEON, MODEL LS1100-01-0968 NOMIR MEDICAL TECHNOLOGIES, INC. RICHARD BURTT
K073099 11/20/2007 FMRI HARDWARE SYSTEM NORDICNEUROLAB CONSTANCE G BUNDY
K071588 11/26/2007 DISPENSER DP 20 NOUVAG AG ERICH FORSTER
K071619 11/09/2007 SPY FLUORESCENT IMAGING SYSTEM NOVADAQ TECHNOLOGIES, INC. ALLISON MANNERS
K072643 11/16/2007 CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US OLYMPUS CORPORATION FUMIAKI KANAI
K073100 11/30/2007 INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S OSCOR INC. MILA DOSKOCIL
K072896 11/06/2007 GS FIXTURE SYSTEM OSSTEM IMPLANT CO.,LTD KIM M JOO
K072033 11/13/2007 OTODYNAMICS OTOPORT OTODYNAMICS, LTD. CHRISTINA NORRIS
K071768 11/05/2007 ERBIUM FRACTIONAL HANDPIECE PALOMAR MEDICAL PRODUCTS, INC. SHARON TIMBERLAKE
K072982 11/29/2007 PARI HYDRATE V PARI INNOVATIVE MANUFACTURERS, INC. MIKE JUDGE
K072480 11/21/2007 GENERATION 8 SE ADHESIVE PENTRON CLINICAL TECHNOLOGIES GREG MARCEAU
K072391 11/19/2007 PFM PICC PFM MEDICAL, INC SALVADORE PALOMARES
K072661 11/20/2007 IMMUNOCAP THYRLOBULIN IMMUNOCAP PHADIA US INC. MARTIN R MANN
K072769 11/14/2007 ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS POSSIS MEDICAL, INC. MIKE BURNSIDE
K062658 11/26/2007 PRIMUS A1CARE ASSAY PRIMUS CORP. BRITT EINSPAHR
K062575 11/26/2007 MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP PRINCETON BIOMEDITECH CORP. KYUNG-AH KIM
K072846 11/26/2007 CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 R & D SYSTEMS, INC. NANCY C RING
K072268 11/20/2007 HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S R & D SYSTEMS, INC. NANCY C RING
K072780 11/26/2007 MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR RALCO S.R.L. DANIEL KAMM
K072479 11/09/2007 FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD RAPID INJECTION SYSTEMS CORP. SOL SOROCA
K071051 11/02/2007 FRAXEL III SR LASER SYSTEM AND ACCESSORIES RELIANT TECHNOLOGIES, INC. HEATHER MACFALLS
K072827 11/26/2007 RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE REMEL, INC. ANDRE HSIUNG
K072194 11/29/2007 RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 RENU MEDICAL, INC. BRUCE PIERSON
K072398 11/21/2007 RT300-S AND RT300-SP FES CYCLE ERGOMETER RESTORATIVE THERAPIES INC. ANDREW BARRISKILL
K072554 11/14/2007 ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES SABLE INDUSTRIES, INC. KEVIN RANDALL
K072030 11/19/2007 IMPLANT CENTER SATELEC-ACTEON GROUP STEVE SALESKY
K072463 11/29/2007 SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM SATYRNE MEDICAL SCOTT LOVALD
K072134 11/02/2007 SCHICK COMPUTED ORAL RADIOLOGY SYSTEM SCHICK TECHNOLOGIES, INC. DANIEL MITCHELL
K072639 11/19/2007 YUYUAN LATEX EXAMINATION GLOVE, POWDERED SHANDONG YUYUAN LATEX GLOVES COMPANY LTD. JESSIE SUN
K072346 11/29/2007 PM-7000 PATIENT MONITOR SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K072794 11/05/2007 IMMULITE 2500 OM-MA, MODEL L5KOP SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS MAYA MAHUE-GIANGRECO
K070799 11/01/2007 MODULARIS VARIOSTAR SIEMENS MEDICAL SOLUTIONS USA INC. KIM RENDON
K072786 11/13/2007 ACUSON S2000 ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. SHELLY PEARCE
K071228 11/21/2007 FIDELITY 200 CARDIAC EVENT RECORDER SIGNALIFE, INC. WILLIAM MATTHEWS
K072818 11/19/2007 PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS SMITH & NEPHEW, INC. DAVID HENLEY
K062607 11/09/2007 POLYGRAFT BGS SMITH & NEPHEW, INC. DEANA BOUSHELL
K072858 11/20/2007 TC-PLUS PRIMARY KNEE SYSTEM SMITH & NEPHEW, INC. RISHI SINHA
K072419 11/09/2007 ADVANTIV SAFETY I.V. CATHETER SMITHS MEDICAL ASD, INC. BARBARA LAW
K072482 11/29/2007 HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY SMITHS MEDICAL ASD, INC. BRIAN FARIAS
K072783 11/30/2007 SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SMITHS MEDICAL ASD, INC. BRIAN FARIAS
K071958 11/21/2007 THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS SMITHS MEDICAL ASD, INC. CHRISTINE LLOYD
K072059 11/01/2007 GRIPPER MICRO NEEDLE SMITHS MEDICAL MD, INC. BRIAN L HAUGSTAD
K072912 11/16/2007 SOPRO 225 DUAL HALOGEN LIGHT SOURCE SOPRO STEVE SALESKY
K071161 11/16/2007 ENDOSSEOUS DENTAL IMPLANT SYSTEM SOUTHERN IMPLANTS, INC. GRETA M HOLS
K071724 11/09/2007 LUCENT SPINAL ELEMENTS, INC. KERRI DIMARTINO
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