FDA 510(k) Applications Received During October, 2008

FDA 510(k) Number Submission Date Device Name Applicant Contact
K082985 10/07/2008 A-DEC 334/335 DELIVERY SYSTEM A-DEC, INC. THOMAS H LOUISELL
K083111 10/21/2008 IMPELLA 5.0 CATHETER FAMILY ABIOMED, INC. WILLIAM BOLT
K083103 10/20/2008 ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B ACRYMED, INC. BRUCE GIBBINS
K083144 10/23/2008 ACUMED CLAVICLE SCREW SYSTEM ACUMED LLC ALYSSA THOMAS
K082993 10/07/2008 SURGISEAL TOPICAL SKIN ADHESIVE ADHEZION BIOMEDICAL RICHARD G JONES
K083074 10/15/2008 AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT ADVANDX, INC. PAULA E BULGER
K083186 10/29/2008 AESCULAP HYDROLIFT VBR SYSTEM AESCULAP IMPLANT SYSTEM, INC. MATHEW M HULL
K082991 10/07/2008 BIOLOX DELTA CERAMIC FEMORAL HEAD AESCULAP IMPLANT SYSTEMS, INC. KATHY A RACOSKY
K083004 10/08/2008 MILI (MINIMALLY INVASIVE LUMBAR IMPLANT) SYSTEM AESCULAP IMPLANT SYSTEMS, INC. Lisa Boyle
K083214 10/31/2008 AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100 AGA MEDICAL CORP. DIANE CARROLL
K083221 10/31/2008 AIDERA DIASEND AIDERA AB ANDERS SONESSON
K083040 10/14/2008 S-TEST C-REACTIVE PROTEIN (CRP) ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. DENNIS TASCHEK
K082965 10/03/2008 DS-A BLOOD GLUCOSE MONITORING SYSTEM ALLIANCE INTERNATIONAL CO., LTD. Ke-Min Jen
K082956 10/03/2008 ALPHA ORTHOPAEDICS AT2 SYSTEM ALPHA ORTHOPAEDICS GINA TO
K083102 10/20/2008 REFINE LIFT SYSTEM ALURE MEDICAL INC. JASPER BENKE
K083142 10/23/2008 PICASSO LASER SYSTEM AMD LASERS, LLC MAUREEN O'CONNELL
K083133 10/23/2008 SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS ANDOVER HEALTHCARE INC. VALERIE GUNN
DEN080009 10/29/2008 AIRPURGE ANESTHESIA SAFETY PRODUCTS, LLC IHSAN A HADDAD
K082968 10/06/2008 APNEICARE CONNECTION CENTER/INTERNET ANALYSIS APNEICARE, LLC PAUL DRYDEN
K082951 10/03/2008 IMMERSION HYDROBATH ARJO HOSPITAL EQUIPMENT AB TRACI GIOVENCO
K082999 10/08/2008 ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART ARTHREX, INC. NANCY HOFT
K083007 10/08/2008 PROWICK ARTHREX, INC. SALLY FOUST
K082980 10/06/2008 ARTHROCARE ARTHROWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K083127 10/21/2008 ASAHI CORSAIR MICROCATHETER ASAHI INTECC CO., LTD. YOSHI TERAI
K083145 10/23/2008 ASAHI GUIDE WIRE EXTENSION, MODEL AG149000 ASAHI INTECC CO., LTD. YOSHI TERAI
K083146 10/23/2008 ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000 ASAHI INTECC CO., LTD. YOSHI TERAI
K083189 10/29/2008 STERI-LUB LUBRICATION GEL AVAIL MEDICAL PRODUCTS, INC. PATRICIA A GOEREE
K083180 10/28/2008 THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM AVANTIS MEDICAL SYSTEMS, INC. AMRITA SETHI
K082944 10/02/2008 CRYSTALSERT CRYSTALENS DELIVERY SYSTEM BAUSCH & LOMB, INC. DAVID THOMAS
K083066 10/15/2008 CHROMOPHARE E 778 AND E 558 BERCHTOLD HOLDING GMBH SILKE GORAL
K083148 10/24/2008 TELECTRODE WET GEL ECG ELECTRODE BIO PROTECH, INC. KEVIN HAN
K083105 10/20/2008 KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411 BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K083164 10/27/2008 SYSTEM-ARMS, MODELS 390, X60 BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K082927 10/01/2008 BIOEMG III BIO-RESEARCH ASSOCIATES, INC. JOHN RADKE
K083091 10/17/2008 LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES BIOCOMPATIBLES U.K. LIMITED JOHN GREENBAUM
K082953 10/03/2008 ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01 BIOKIT S.A. JOAN GUIXER
K082938 10/02/2008 EZLASE BIOLASE TECHNOLOGY, INC. IOANA RIZOIU
K083069 10/15/2008 EZLASE 10W BIOLASE TECHNOLOGY, INC. IOANA RIZOIU
K082941 10/02/2008 BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215 BIOMERIX CORPORATION CHRISTINA L KICHULA
K083070 10/15/2008 TOGGLELOC SYSTEM BIOMET SPORTS MEDICINE ROBERT FRIDDLE
K082996 10/08/2008 BIOLOX DELTA OPTION CERAMIC HEADS BIOMET, INC. PATRICIA SANDBORN BERES
K083006 10/08/2008 BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER BIOPSY SCIENCES, LLC SHARON ROCKWELL
K083178 10/28/2008 SOLAS ANATOMIX SPINAL SYSTEM BIOTECHNI AMERICA SPINE GROUP, INC. DANIEL R BAKER
K082933 10/01/2008 PASSEO-35 PTA CATHETER BIOTRONIK, INC. Jon Brumbaugh
K082935 10/01/2008 VISION WIRE CORONARY GUIDEWIRE BIOTRONIK, INC. Jon Brumbaugh
K082971 10/06/2008 BONART ART-L5 LED CORDLESS CURING LIGHT BONART CO. LTD. ERIC L ONG
K082928 10/01/2008 STRAIGHT FIRE HOLMIUM LASER FIBER BOSTON SCIENTIFIC CORP. LAUREN B ANDERSON
K082982 10/06/2008 BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BREATHE TECHNOLOGIES, INC. CRAIG COOMBS
K083094 10/17/2008 STREAMER POLYMER GUIDEWIRE BRIVANT, LTD. TOMAS FUREY
K083185 10/29/2008 CADI SMARTSENSE VITAL SIGNS AND WIRELESS TEMPERATURE MONITORI NG SYSTEM, MODEL S1 CADI SCIENTIFIC PTE.LTD STEPHEN H GORSKI
K083174 10/27/2008 HEALTHEPOD CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K082981 10/06/2008 DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT CARDIOVASCULAR SYSTEMS, INC. DAVID D BROOKE
K083139 10/23/2008 VIPERSPHERE PTA BALLOON CATHETER CARDIOVASCULAR SYSTEMS, INC. David Brooke
K082930 10/01/2008 CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE CARDIVA MEDICAL, INC. KIT CARIQUITAN
K083140 10/23/2008 COMPEX SPORT PLUS CHATTANOOGA GROUP MICHAEL TREAS
K083093 10/17/2008 CHEETAH RELIANT CHEETAH MEDICAL INC. Rhona Shanker
K083216 10/31/2008 CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES CIBA VISION CORPORATION MARTINA HEIM
K083024 10/09/2008 HYLATOPIC EMOLLIENT FOAM COLLEGIUM PHARMACEUTICAL INCORPORATED RONALD M GURGE
K083161 10/27/2008 ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100) CONMED LINVATEC SUE DAUTERMAN
K082939 10/02/2008 COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 COOK UROLOGICAL, INC. CINDY FOOTE
K083210 10/31/2008 CORFLO ANTI IV ENTERAL FEEDING TUBE CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
K083121 10/22/2008 NEO MAPCATH SENSOR STYLET CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
K082966 10/06/2008 PB 540 VENTILATOR COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC. TINA O'BRIEN
K083106 10/20/2008 CRYOVALVE SG PULMONARY VALVE AND CONDUIT CRYOLIFE, INC. JOHN D FERROS
K083182 10/28/2008 DATACOM DC PACS DATACOM TECHNOLOGY CORP. JEN KE-MIN
K083201 10/30/2008 ZMATCH BLOCK DENTAIM CO., LTD. DAESUCK CHUN
K082974 10/06/2008 MYSTIQUE MB CERAMIC BRACKETS DENTSPLY INTERNTIONAL HELEN LEWIS
K082973 10/06/2008 STER-MATE STERILE LAVAGE KIT DENTSPLY INTERNTIONAL HELEN LEWIS
K083107 10/20/2008 MODIFICATION TO DEPUY NEUFLEX PIP FINGER DEPUY ORTHOPAEDICS, INC. JANET G JOHNSON
K082942 10/02/2008 MODFICATION TO: EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. FRANK JURCZAK
K083059 10/14/2008 AIR SONIC SCALER DPM USA CORP. GEORGE ECHEVERRI
K083050 10/14/2008 EVITE XL DRAEGER MEDICAL AG & CO. KG JOYCE KILROY
K083191 10/29/2008 DETLOGIX ANNULOPLASTY RING, MODEL: 5100 EDWARDS LIFESCIENCES, LLC. MARTIN A KAUFMAN
K083008 10/08/2008 COOLSKIN ELBIO CO., LTD JAY MANSOUR
K083061 10/14/2008 ELLEX INNOVATIVE IMAGING EYE CUBED V4 ELLEX, INC. TOM DAVIS
K083030 10/10/2008 TENS-EMS-14 EMSI CHERITA JAMES
K083099 10/20/2008 EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008 EPS BIO TECHNOLOGY CORP. Y. C LEI
K082955 10/03/2008 ETHICON ENDO-SURGERY ARTICULATING HOOK KNIFE, MODEL IN4505 ETHICON ENDO-SURGERY, INC. GLENDA C MARSH
K083052 10/14/2008 EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) EUROIMMUN US INC KATHRYN KOHL
K083053 10/14/2008 EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG) EUROIMMUN US INC KATHRYN KOHL
K082934 10/01/2008 EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM EXTREMITY MEDICAL LLC JAMY GANNOE
K083151 10/24/2008 EXTREMITY MEDICAL SUTURE ANCHOR EXTREMITY MEDICAL LLC JAMY GANNOE
K083358 10/14/2008 LUBRICANO-ULTRASOUND FARCO PHARMA GMBH SETH A MAILHOT
K083122 10/22/2008 HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041 FISHER & PAYKEL HEALTHCARE, LTD. STEPHANIE COSTE
K083034 10/10/2008 FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F FOTONA D.D. STOJAN TROST
K083158 10/24/2008 EXALIS, SOFTWARE VERSION 1.15 GAMBRO, INC. KAE MILLER
K083018 10/09/2008 CENTRICITY PACS WEB DIAGNOSTIC GE HEALTHCARE DYNAMIC IMAGING SOLUTIONS JILLIAN M REED
K083098 10/17/2008 NAVIGATOR APPLICATIONS SUITE GE HEALTHCARE FINLAND OY ADRIENNE LENZ
K083147 10/24/2008 DISCOVERY MR450 GE MEDICAL SYSTEMS, LLC YUAN MA
K082960 10/03/2008 GE XTREME INJECTOR OPTION GE MEDICAL SYSTEMS, LLC STEVEN KACHELMEYER
K083156 10/24/2008 NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE GIGA-DRIVE SDN, BHD IAN NG TZE CHEU
K083131 10/23/2008 MEDOS HILITE RESERVOIR, MODEL: 4030 GISH BIOMEDICAL, INC. JANET PEETS
K083013 10/09/2008 PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001 GYRUS ACMI, INC. GRAHAM A.L. BAILLIE
K083157 10/24/2008 HS AMICA H.S HOSPITAL SERVICE S.P.A. LUCIO IMPROTA
K083183 10/28/2008 AKLARUS PHOTOTHERAPY SYSTEM HILL LABORATORIES CO. BRADY ALLER
K083086 10/16/2008 ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150) HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K083153 10/24/2008 ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007 HOLLISTER, INC. CHRIS STUKEL
K083049 10/14/2008 TORNADO ROTATABEL SNARE AND POLYP CATCHER HORIZONS INTL. CORP. RAFIC SALEH
K083019 10/09/2008 GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE HOSPIRA, INC. Yuliya Matlin
K083137 10/23/2008 NEURO III-SV IMRIS, INC. THOMAS M TSAKERIS
K083215 10/31/2008 INCISIVE FAMILY OF INPULSE ND:YAG LASERS INCISIVE, LLC. ANN WORDEN
K083192 10/29/2008 INCLUSIVE TITANIUM ABUTMENT BLANKS INCLUSIVE DENTAL SOLUTIONS KEITH D ALLRED
K082990 10/07/2008 INFINITT XELIS INFINITT CO., LTD. TRISTAN CHOI
K082943 10/02/2008 IROOT BP, MODEL IRBP 4609 INNOVATIVE BIOCERAMIX INC. QUANZU YANG
K083115 10/21/2008 MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000 INTEL CORP. TAE-WOONG KOO
K083081 10/16/2008 MODIFICATION TO SECURACATH, MODEL: SPK01 INTERRAD MEDICAL, INC. Sew-Wah Tay
K082987 10/07/2008 HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL INVIVO ANDREW ADAMS
K083058 10/14/2008 IBA PROTON THERAPY SYSTEM - PROTEUS 235 ION BEAM APPLICATIONS S.A. JOHN B REISS
K082925 10/01/2008 XENON-100 SCB LIGHT SOURCE, MODEL 20132620 KARL STORZ ENDOSCOPY-AMERICA, INC. MONIKA CAMPBELL
K082922 10/01/2008 FREEWAY AND RAILRUNNER GUIDEWIRES LAKE REGION MFG., INC. DEEP PAL
K083195 10/29/2008 MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN LANG DENTAL MFG. CO., INC. CHAH M SHEN
K083206 10/31/2008 LOUSEBUSTER LARADA SCIENCES PHIL TRIOLO
K083203 10/30/2008 HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM LASEROPTEK CO. LTD. PHILLIP CHEON
K082947 10/02/2008 LENSX 550 LASER SYSTEM LENSX LASERS, INC. Judy Gordon
K083017 10/09/2008 LEVO C3 LEVO AG THOMAS RABER
K082923 10/01/2008 PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C LIFE-TECH, INC. JEFF KASOFF
K083171 10/27/2008 INTROL CF PANEL I CONTROL, MODEL: G106 MAINE MOLECULAR QUALITY CONTROLS, INC. JOAN GORDON
K083116 10/21/2008 VERSAFIT CUP DOUBLE MOBILITY SYSTEM MEDACTA INTERNATIONAL, SA NATALIE J KENNEL
K083123 10/22/2008 MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES MEDART A/S OLAV BALLE-PETERSON
K082969 10/06/2008 LUMINEX INFRARED LAMP SYSTEM MEDICAL LASER SYSTEMS INC MIKI KOLTON
K082967 10/06/2008 MORTARA STRESS ECHO BED MEDICAL POSITIONING, INC. CAROL WHITE
K082988 10/07/2008 MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT MEDIVATORS REPROCESSING SYSTEMS LYNN LUEDERS
K083179 10/28/2008 MEDILED PHOTOTHERAPY LAMP MEDIX I.C.S.A. J. HARVEY KNAUSS
K083076 10/16/2008 STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K083026 10/10/2008 CLYDESDALE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK LEE GRANT
K083071 10/15/2008 VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK MELISA LANSKY
K083124 10/22/2008 NIM 3.0 MEDTRONIC XOMED, INC. JAYME WILSON
K083063 10/14/2008 BIS INTERFACE FOR VITALOGIK PATIENT MONITORS MENNEN MEDICAL LTD. IFAT OREN
K083056 10/14/2008 NEO-STAT CO2 MERCURY MEDICAL PAUL DRYDEN
K083016 10/09/2008 ACTHYDERM MICROLAB AMERICAS INC E J SMITH
K082977 10/06/2008 BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP MK BIO, INC Jane Zhang
K083082 10/16/2008 MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS MOOR INSTRUMENTS LTD. XIABING HUANG
K082946 10/02/2008 MORTARA ELI 350 ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC. CHARLES MORREALE
K083112 10/21/2008 PRIMADO NAKANISHI, INC. KEITH A BARRITT
K083088 10/16/2008 VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST NANOSPHERE, INC GREGORY W SHIPP
K083154 10/24/2008 NEWDEAL HALLU LOCK PLATE SYSTEM NEWDEAL SAS JUDITH O'GRADY
K083205 10/30/2008 NOBELACTIVE 8.5 MM & 18.0 MM NOBEL BIOCARE AB HERBERT CRANE
K083100 10/20/2008 GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP NOBEL BIOCARE USA, LLC HERBERT CRANE
K083042 10/14/2008 WOUND FLUSH, STERILE WATER & NORMAL SALINE NURSE ASSIST, INC. DENICE GALLAGHER
K083028 10/10/2008 MODIFICATION TO: NUVASIVE SPHERX II SYSTEM NUVASIVE, INC. HAN FAN
K083184 10/28/2008 TEARLAB OSMOLARITY SYSTEM OCUSENSE, INC. JANICE M HOGAN
K083155 10/24/2008 HD CAMERA HEAD OTV-S7PROH-HD-L08E OLYMPUS MEDICAL SYSTEMS CORPORATION STACY A KLUESNER
K083173 10/27/2008 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM ORTHO-CLINICAL DIAGNOSTICS LEAH VAN DE WATER
K082950 10/03/2008 STARBAND ORTHOMERICA PRODUCTS, INC. ALAN T SANDIFER
K082945 10/02/2008 STARLIGHT ORTHOMERICA PRODUCTS, INC. ALAN T SANDIFER
K082949 10/02/2008 ORTHOPEDIATRICS BONE SCREWS ORTHOPEDIATRICS, CORP. GARY BARNETT
K083033 10/10/2008 VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE ORTHOVITA, INC. DEBORAH L JACKSON
K083067 10/15/2008 MS SYSTEM OSSTEM IMPLANT CO.,LTD MINJOO KIM
K083077 10/16/2008 ULC SPINAL PEDICLE SCREW SYSTEM OTIS BIOTECH CO., LTD JISUK YOO
K083012 10/09/2008 PAPCONE OTTO BOCK PUR LIFE SCIENCE GMBH CHRISTIAN SCHULTE
K083057 10/14/2008 I-MAX TOUCH OWANDY CLAUDE D BERTHOIN
K083165 10/27/2008 PALOMAR ASPIRE LASER PLATFORM PALOMAR MEDICAL PRODUCTS, INC. Sharon Timberlake
K083176 10/28/2008 PASTURE, MODELS: F550, A520 PASTURE PHARMA PTE LTD SARAH HASSAN
K083125 10/22/2008 NEURON SELECT CATHETER SIZE 070 PENUMBRA, INC. THERESA BRANDNER-ALLEN
K083130 10/23/2008 NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 PERKINELMER, INC. KAY A TAYLOR
K083117 10/22/2008 ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01 PHADIA US INC. MARTIN ROBERT MANN
K083188 10/29/2008 VARELISA RECOMBI ANA SCREEN, MODEL 12 596 PHADIA US INC. MARTIN R MANN
K082937 10/01/2008 LIFEPAK 15 MONITOR/DEFIBRILLATOR PHYSIO-CONTROL, INC. TERESA DAVIDSON
K083152 10/24/2008 EQUASHIELD SYSTEM PLASTMED, LTD. ELISSA BURG
K083087 10/16/2008 ECOCEL POLICHEM S.A. HARI NAGARADONA
K083048 10/14/2008 NEORAY DR 2520 DIGITAL IMAGING SYSTEM PORTAVISION MEDICAL LLC TERRY ANCAR
K082964 10/03/2008 PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5) PRISM CLINICAL IMAGING, INC. JAMES L REUSS
K083199 10/30/2008 CHARTIS CONSOLE PULMONX, INC. SUZON LOMMEL
K083160 10/27/2008 1.5T ATLAS SPEEDER HEAD-NECK COIL QUALITY ELECTRODYNAMICS
K083078 10/16/2008 QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200 QUANTA COMPUTER INC. JENNIFER REICH
K083079 10/16/2008 QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100 QUANTA COMPUTER INC. JENNIFER REICH
K083207 10/31/2008 ULTRAWAVE III EX 1320 QUANTA SYSTEM, S.P.A. ISABELLA CARRER
K083181 10/28/2008 QV-9000 UNIVERSAL SYSTEM QUANTUM MEDICAL IMAGING, LLC. MARK CAMIRAND
K082921 10/01/2008 RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 RAD SOURCE TECHNOLOGIES, INC. RANDOL E KIRK
K083029 10/10/2008 MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR RALCO S.R.L. DANIEL KAMM
K083051 10/14/2008 FLOWTAIN & FLOWTAIN LV RELIANCE ORTHODONTIC PRODUCTS, INC. PAULA WENDLAND
K083208 10/31/2008 SATURN ACTIVE LASER SYSTEM RESEARCH INSTRUMENTS LTD.
K082983 10/06/2008 RESSCAN-PRO RESMED LTD. DAVID D'CRUZ
K082979 10/06/2008 S8 ADVANCE RESMED LTD. DAVID D'CRUZ
K083193 10/29/2008 REVAC AUTO RETRACTABLE SAFETY SYRINGE REVOLUTIONS MEDICAL CORPORATION INC RICHARD THERIAULT
K082970 10/06/2008 MARVEL WHEELCHAIR, MODEL EDCAL01 ROGUE WHEELS INC KATHRYN RONALDS
K083062 10/14/2008 ROOT CANAL XR S & C POLYMER GMBH CHRISTIAN BOETTCHER
K083101 10/20/2008 PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES SABLE INDUSTRIES, INC. KEVIN RANDALL
K082995 10/08/2008 SMART DILATOR SAFESTITCH MEDICAL MARIO ARBESU
K083089 10/16/2008 NEWPORT SPINAL SYSTEM SEASPINE, INC. ETHEL BERNAL
K082926 10/01/2008 ZUMA, MODEL 55-XXXX/56-XXXX SEASPINE, INC. JEFF BRITTAN
K083163 10/27/2008 OMNI 2 OXYGEN SYSTEM SEQUAL TECHNOLOGIES, INC. BRIAN JARRELL
K083044 10/14/2008 HUBANG, MODEL HBL13/HBG12-S SHANGHAI HUBANG MEDICAL APPLIANCES CO., LTD. JUNNATA CHANG
K083129 10/22/2008 SHARPS COMPLIANCE CONTAINER SHARPS COMPLIANCE, INC. AL ALADWANI
K083043 10/14/2008 KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201 SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. DACHENG GONG
K083010 10/09/2008 SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. THOMAS KROENKE
K083001 10/08/2008 M5 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD TAN CHUANBIN
K082957 10/03/2008 NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGS SIAM SEMPERMED CORP. LTD. WILLIAM E HARRIS
K083035 10/14/2008 DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM SICEL TECHNOLOGIES, INC. SUZANNE SCHWALLER
K083159 10/27/2008 BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2 SIEMENS HEALTHCARE DIAGNOSTICS JANET M FOSE
K083175 10/28/2008 BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2 SIEMENS HEALTHCARE DIAGNOSTICS JANET M FOSE
K083114 10/21/2008 ACUSON P50 ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. SHEILA W PICKERING
K083149 10/24/2008 ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE SIEMENS MEDICAL SOLUTIONS USA, INC.
K083166 10/27/2008 SPECIALTY COILS FOR THE MAGNETOM ESSENZA SIEMENS MEDICAL SOLUTIONS USA, INC. ELIZABETH LAZARO
K083141 10/23/2008 SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM SIMPACT LLC MARK SCHENK
K083113 10/21/2008 ACTICOAT FLEX 7 DRESSING SMITH & NEPHEW, INC. TERRY MCMAHON
K083032 10/10/2008 PERI-LOC BONE PLATING AND SCREW SYSTEM SMITH & NEPHEW, INC. DAVID HENLEY
K083119 10/22/2008 PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 SMITHS MEDICAL ASD, INC. JOHN TULLETT
K083031 10/10/2008 PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT SMITHS MEDICAL ASD, INC. JOHN TULLETT
K083021 10/09/2008 APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR SORIN GROUP ITALIA S.R.L. BARRY SALL
K083209 10/31/2008 ACRYLIC HERBST SPLINT APPLIANCE SPECIALTY APPLIANCE WORKS, INC. CAROLYN THOMAS
K083167 10/27/2008 PHENIX CERVICAL INTERBODY DEVICE SPINAL DEVICES, LLC RICHARD JANSEN
K082992 10/07/2008 AXXION LIGHT GUIDE SPINAL ELEMENTS, INC. KERRI DIMARTINO
K083118 10/22/2008 SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE SPINAL USA JEFFREY JOHNSON
K083080 10/16/2008 IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM SQI DIAGNOSTICS SYSTEMS Kate Smith
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K082932 10/01/2008 CPS AIM SL SLITTABLE INNER CATHETER ST. JUDE MEDICAL COLLEEN CANAN
K083060 10/14/2008 REPROCESSED HARMONIC SCALPEL STERILMED, INC. DENNIS TOUSSAINT
K083097 10/17/2008 AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM STERIS Corporation JOHN R SCOVILLE
K083162 10/27/2008 STINGRAY ELECTROSURGICAL FORCEPS STINGRAY SURGICAL PRODUCTS, INC DANIEL KAMM
K083200 10/30/2008 X-CAL Streck ERIN JOHNSON
K083020 10/09/2008 STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYSTEM STRYKER CORP. KIMBERLY LANE
K083009 10/09/2008 ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000 Stryker Leibinger GmbH & Co. KG LILIAN ECKERT
K083109 10/20/2008 SUINSA DIAGNOSTIC X-RAY SYSTEM SUINSA DANIEL KAMM
K083211 10/31/2008 AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM SURGIQUEST, INC. KOUROSH AZARBARZIN
K083039 10/14/2008 VERITAS COLLAGEN MATRIX (DRY) SYNOVIS SURGICAL INNOVATIONS JODI JORGENSON
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K083002 10/08/2008 SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER SYSMEX AMERICA, INC. NINA GAMPERLING
K083096 10/17/2008 LATARJET CORTICAL SCREW SET T.A.G. MEDICAL PRODUCTS GEORGE J HATTUB
K083046 10/14/2008 FORA TELEHEALTH SYSTEM TaiDoc Technology Corporation Yuhua Chen
K083169 10/27/2008 EPTFE SLFTM SPIRAL VASCULAR GRAFT TAYSIDE FLOW TECHNOLOGIES LIMITED EDWIN LINDSAY
K083005 10/08/2008 NANGEL TEKNIMED SA J.D. WEBB
K083194 10/29/2008 VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550 TERUMO CARDIOVASCULAR SYSTEMS CORP. JUNKO KUROSAWA
K082997 10/08/2008 TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER TERUMO MEDICAL CORP. EILEEN DORSEY
K083073 10/15/2008 THEKEN ATOLL CERVICO-THORACIC SYSTEM THEKEN SPINE LLC DALE DAVISON
K083135 10/23/2008 MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002 THERMOGEAR, INC. WAYNE FIELDS, PHD
K082962 10/03/2008 TIVAMED COOLED RF SYSTEM, MODEL 78001 TIVAMED, INC. SHELLEY TRIMM
K083014 10/09/2008 ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K083218 10/31/2008 TC ENDO PORT TRANSCARDIAC THERAPEUTICS, INC. DAVID SMITH
K082954 10/03/2008 ENCAGE BIPOLAR RF PROBE TROD MEDICAL SA CELINE GARCIA
K082972 10/06/2008 KODAK 9500 TROPHY MARIE-PIERRE LABAT-CAMY
K083095 10/17/2008 SONIXTOUCH ULTRASOUND SYSTEM UltraSonix Medical Corporation CHAS YU
K082959 10/03/2008 PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS UNIMED MEDICAL SUPPLIES INC. LIMING XUE
K083190 10/29/2008 D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015 VASCULAR SOLUTIONS, INC. LISA GALLATIN
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K083150 10/24/2008 G-FORCE TENODESIS SCREW WRIGHT MEDICAL TECHNOLOGY, INC. KELLEN HILLS
K082963 10/03/2008 WU'S 4-WHEELED NEO SCOOTER, WT-M3A WU'S TECH CO., LTD. JEN KEN-MIN
K083202 10/30/2008 COMBOCARE 2000 XANACARE TECHNOLOGIES, LLC ROBERT N CLARK
K083015 10/09/2008 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES ZIBO GOLDENLINE PLASTIC PRODUCT CO., LTD JOHN ZHAO
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K083084 10/16/2008 CT BRAIN PERFUSION FOR ZIOSTATION ZIOSOFT, INC. RICHARD BALL


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