FDA 510(k) Decisions During January, 2008  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K082475 11/07/2008 REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 MEDTRONIC INC. DEBBIE KIDDER
K073296 01/09/2008 TEMPXN28 3M ESPE AG DENTAL PRODUCTS DESI W SOEGIARTO
K073395 01/17/2008 GILB-2, GLASS IONOMER PROTECTIVE COATING 3M ESPE DENTAL PRODUCTS KAREN O'MALLEY
K072653 01/24/2008 3VISEON/SURGERY 3MENSIO MEDICAL IMAGING BV CARL THOMAS
K072174 01/25/2008 INSUCOZI INSULIN VIAL COVER 41 INDUSTRIES LLC DANIEL LAFAVER
K082734 11/13/2008 A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR A & D ENGINEERING, INC. JERRY WANG
K082714 11/19/2008 AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5 AALTO SCIENTIFIC LTD. BRANDON J PEREZ
K082762 11/12/2008 AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE AARDVARK MEDICAL
K071788 01/11/2008 AVIATOR INSULIN PUMP ABBOTT DIABETES CARE INC. SARAH HARRINGTON
K081975 11/26/2008 RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT) ABBOTT DIABETES CARE INC. ARUL STERLIN
K073202 01/30/2008 ARDIS SPACER ABBOTT SPINE, INC. MARITZA ELIAS
K072798 01/31/2008 VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER ABBOTT VASCULAR-VASCULAR SOLUTIONS DANIELLE M TAYLOR
K073530 01/31/2008 ACCIN ANTERIOR CERVICAL PLATE SYSTEM ACCELERATED INNOVATION, LLC MICHAEL KVITNITSKY
K073068 01/10/2008 ACCIN HIP SYSTEM ACCELERATED INNOVATION, LLC MICHAEL KVITNITSKY
K072252 01/30/2008 VEINOPLUS NEUROMUSCULAR STIMULATOR ADREM TECHNOLOGY SARL NORMAN F ESTRIN
K073233 01/28/2008 ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS ADVANCED BIO-SURFACES, INC. PHILIP B JARVI
K080503 11/12/2008 SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING ADVANCED MEDICAL SOLUTIONS LIMITED CLAIRE RYAN
K082392 11/13/2008 EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR ADVANCED STERILIZATION PRODUCTS JOSEPH ASCENZI, PH.D.
K073719 01/29/2008 ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE ADVANCED SURGICAL CONCEPTS MARY MCNAMARA-CULLINANE
K082991 11/20/2008 BIOLOX DELTA CERAMIC FEMORAL HEAD AESCULAP IMPLANT SYSTEMS, INC. KATHY A RACOSKY
K073573 01/30/2008 WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM AGAMATRIX CONNIE HERTEL
K080013 01/17/2008 REGISTRATION AND FUSION AGFA HEALTHCARE CORPORATION TOM HOLBROOK
K081062 11/07/2008 AIRSONNETT AIRSHOWER AIR 3 AIRSONETT, INC. CONSTANCE G BUNDY
K073171 01/31/2008 RESUSCITATION TIMER, MODEL L770-CPR ALLIED HEALTHCARE PRODUCTS, INC. WAYNE KARCHER
K070514 01/30/2008 ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPROACH, EXTRACTION KIT, PRECURVED EXTRACTIO ALN IMPLANTS CHIRURGICAUX DAVE PARENTE
K072887 01/25/2008 G-TRAINER MEDICAL ALTER-G, INC. GLEN MANGSETH
K082284 11/20/2008 AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM ALVEOLUS, INC TONY ALEXANDER
K082861 11/25/2008 AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561 AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. ALEXANDER B HENDERSON SR.
K072596 01/24/2008 LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500 AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. ALEXANDER B HENDERSON
K073505 01/09/2008 MODIFICATION TO VALEO VBR AMEDICA CORP. ADAM HERDER
K073430 01/29/2008 VALEO PEDICLE SCREW SPINAL SYSTEM AMEDICA CORP. JUSTIN EGGLETON
K082730 11/26/2008 AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE AMERICAN MEDICAL SYSTEMS, INC. MONA INMAN
K073703 01/30/2008 AMS MINIARC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. BRAD ONSTAD
K082266 11/07/2008 DIGITAL CLINICAL THERMOMETER MODEL V9XX AMPEROR-ELECTRONIC(SZ) CO., LTD LARRY YANG
K073464 01/23/2008 ANGIODYNAMICS, INC., NEVERTOUCH II 400UM FIBER AND VENACURE PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K073672 01/24/2008 SKATER BILIARY CATHETER ANGIOTECH TRUDY ESTRIDGE
K082457 11/10/2008 MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) ANSELL HEALTHCARE PRODUCTS, INC. CYNTHIA A INGRAM
K082575 11/25/2008 ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES APATECH LTD. CANDACE F CEDERMAN
K081979 11/06/2008 ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE APATECH LTD. CANDACE F CEDERMAN
K080467 11/25/2008 BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC, APPLIED DNA TECHNOLOGIES, INC. FENG YU-LEE
K073452 01/11/2008 MODIFICATION TO: ARAGON SURGICAL LAPCAP ARAGON SURGICAL INC. ALAN CURTIS
K073632 01/10/2008 INTUITION, MODEL 0170 ARCOMA AB BENGT-HUGO JOHANSSON
K081011 11/07/2008 AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45 AREX USA ELLEN HOKANSON
K073451 01/15/2008 PRESSURE INJECTABLE PICC ARROW INTERNATIONAL, INC. KEVIN LENTZ
K071456 01/17/2008 ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT ARTHREX, INC. MARIELA CABARCAS
K082980 11/05/2008 ARTHROCARE ARTHROWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K070945 01/09/2008 ASAHI PTCA GUIDE WIRE ASAHI INTECC CO., LTD. YOSHI TERAI
K083146 11/21/2008 ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000 ASAHI INTECC CO., LTD. YOSHI TERAI
K080294 11/04/2008 ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT ASTORIA-PACIFIC,INC. JASON REYNOLDS
K073014 01/23/2008 INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN AUTOGENOMICS, INCORPORATED EVELYN G LOPEZ
K083189 11/21/2008 STERI-LUB LUBRICATION GEL AVAIL MEDICAL PRODUCTS, INC. PATRICIA A GOEREE
K081940 11/18/2008 AVALON ELITE VASCULAR ACCESS KIT AVALON LABORATORIES, LLC LEE WIRTH
K072754 01/25/2008 AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE AXENIC DENTAL, INC. JOSEPH T SOBOTA
K072760 01/29/2008 SOLCART B B. BRAUN MEDIZINTECHNOLOGIE GMBH TRACY MADDOCK
K072875 01/22/2008 NIO 5MP DISPLAY, MODEL E5620 BARCOVIEW, MEDICAL IMAGING SYSTEMS NEIL PHILLIPS
K082538 11/20/2008 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST BECTON, DICKINSON & CO. MONICA E GIGUERE
K073433 01/14/2008 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML BECTON, DICKINSON & CO. VICKI K WHITLEY
K072825 01/14/2008 FINGERTIP PULSE OXIMETER, MODEL MD300I BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. DIANA HONG
K082125 11/21/2008 N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT BEST GLOVE, INC NEIL DOW
K083148 11/07/2008 TELECTRODE WET GEL ECG ELECTRODE BIO PROTECH, INC. KEVIN HAN
K082011 11/28/2008 MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K073080 01/24/2008 QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 BIO-RAD LABORATORIES MARIA ZEBALLOS
K082381 11/14/2008 GENEX BIOCOMPOSITES LTD. SIMON FITZER
K073663 01/30/2008 GELSPRAY WOUND DRESSING BIOCURE, INC. JOHN GREENBAUM
K072647 01/25/2008 GLYCERIN & PARABEN FREE ASTROGLIDE BIOFILM, INC. ROBERT DE ARMOND
K081818 11/13/2008 BIOLOK MICRO-LOK IMPLANT SYSTEM BIOHORIZONS IMPLANT SYSTEMS, INC. MICHAEL DAVIS
K083069 11/13/2008 EZLASE 10W BIOLASE TECHNOLOGY, INC. IOANA RIZOIU
K071734 01/25/2008 WATERLASE MD DERM BIOLASE TECHNOLOGY, INC. IOANA RIZOIU
K072779 01/24/2008 CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 BIOLITEC, INC. JONATHAN S KAHAN
K073406 01/23/2008 VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE BIOMERIEUX, INC. NANCY WEAVER
K072363 01/31/2008 NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX BIOMET 3I, INC. DIANA TAYLOR
K072879 01/14/2008 INNERVUE DIAGNOSTIC SCOPE SYSTEM BIOMET ORTHOPEDICS, INC. SUSAN ALEXANDER
K082432 11/21/2008 CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM BIOPTICS, INC. PATRICIA WADE
K082933 11/03/2008 PASSEO-35 PTA CATHETER BIOTRONIK, INC. JON BRUMBAUGH
K073318 01/16/2008 BIPORE BALLOON DILATION CATHETER BIPORE, INC. KEITH PALUCH
K072124 01/18/2008 BLACK AND BLACK ELECTROSURGICAL CUTTING AND COAGULATION FORCEPS AND ELECTRODES BLACK & BLACK SURGICAL, INC. NORMAN M BLACK, III
K073654 01/24/2008 BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR BLACKSTONE MEDICAL, INC. WHITNEY G TORNING
K082253 11/25/2008 BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT BODYSTAT LTD. I. J. MEEUWSEN
K082971 11/13/2008 BONART ART-L5 LED CORDLESS CURING LIGHT BONART CO. LTD. ERIC L ONG
K072862 01/22/2008 BOSTON-BAND CRANIAL REMODLING ORTHOSIS BOSTON BRACE INTL., INC. JAMES H WYNNE
K082568 11/17/2008 SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE BOVIE MEDICAL RICHARD A KOZLOFF
K073018 01/23/2008 STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT BRAINLAB AG RAINER BIRKENBACH
K082508 11/21/2008 FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD BRANAN MEDICAL CORPORATION RAPHAEL WONG
K073082 01/09/2008 CPS COURIER GUIDEWIRE BRIVANT, LTD. TOMAS FUREY
K073090 01/15/2008 RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F; JUGULAR/SUBCLAVAIN DELIVERY KIT, MODEL RF-320J C.R. BARD, INC. GENEVIEVE BALUTOWSKI
K073472 01/09/2008 VACCESS PTA BALLOON DILATATION CATHETER C.R. BARD, INC. JENNIFER LOGVIN
K083139 11/25/2008 VIPERSPHERE PTA BALLOON CATHETER CARDIOVASCULAR SYSTEMS, INC. DAVID BROOKE
K073038 01/11/2008 CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B CAREMATIX INC. SUKHWANT KHANUJA
K073539 01/31/2008 PROVISA CEM CAVEX HOLLAND B.V. RICHARD WOORTMAN
K072652 01/18/2008 ENTERAL FEEDING SPIKE ADAPTER CEDIC S.R.L. GIANCARLO GAGLIARDONI
K081088 11/06/2008 MYRAY SKYVIEW CEFLA S.C. BERTHOIN CLAUDE
K072662 01/16/2008 CHEETAH RELIANT, CHEETAH ACTIVE CHEETAH MEDICAL INC. BENNY ARAZY
K071631 01/18/2008 NICOM ELECTRODES CHEETAH MEDICAL INC. RHONA SHANKER
K072777 01/24/2008 CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES CIBA VISION CORPORATION MARTINA HEIM
K082628 11/20/2008 CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 CIRCLE CARDIOVASCULAR IMAGING INC. SHIRANTHA SAMARAPPULI
K081858 11/05/2008 RETCAM 3 OPHTHALMIC IMAGING SYSTEM CLARITY MEDICAL SYSTEMS GARY A SEEGER
K073336 01/04/2008 CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 CODMAN & SHURTLEFF, INC. EMILY E VALERIO
K072790 01/11/2008 CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008 CONFLUENT SURGICAL,INC VIRGINIA VETTER
K073481 01/07/2008 THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES CONMED LINVATEC JOY LOVETT
K082641 11/10/2008 FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL CONTEC MEDICAL SYSTEM CO., LTD. DIANA HONG
K073496 01/23/2008 OPTILITE HOLMIUM LASER FIBERS COOK UROLOGICAL, INC. CINDY FOOTE
K082066 11/07/2008 TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER COOK UROLOGICAL, INC. CINDY FOOTE
K063223 01/23/2008 MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS COOPERSURGICAL, INC. JOSEPH AZARY
K071736 01/04/2008 AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS COOPERVISION, INC. JACK P DOUGLAS
K082322 11/14/2008 AIR ASSISTED SPRAYER, MODELS: AIRSPRAYUS01 AND AIRSPRAYUS COVIDIEN VIRGINIA VETTER
K082454 11/07/2008 MICROMYST APPLICATOR, MODEL 20-5000 COVIDIEN VIRGINIA VETTER
K072687 11/25/2008 VALLEYLAB MICROWAVE ABLATION GENERATOR COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON PHILIP E AKE
K082619 11/07/2008 SILS PORT, MODELS SILSPT5, SILSPT12 COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES ROBERT ZOTT
K062970 01/22/2008 I-PAD CU MEDICAL SYSTEMS, INC. ELAINE DUNCAN
K083321 11/26/2008 CARDIO-VIEW CURLVIEW IGT, LLC
K071883 01/23/2008 IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2 CYDEN LIMITED MICHAEL KIERNAN
K080121 01/31/2008 CYNOSURE SMARTLIPO MULTIWAVLENGTH LASER CYNOSURE, INC. GEORGE CHO
K072381 01/30/2008 SOFTPAP CERVICAL CELL COLLECTOR CYTOCORE, INC. RICHARD DOMANIK
K072219 01/18/2008 CYTOPHIL TISSUE MARKER CYTOPHIL INC GREG JOHNSON
K082606 11/10/2008 COMMISSIONING DATA MANAGEMENT SYSTEM (CDMS) D3 RADIATION PLANNING NABIL ADNANI
K073587 01/18/2008 DERMAPAL WITH DIGITAL TIMER DAAVLIN DISTRIBUTING CO. TARA MANSUR
K073055 01/03/2008 DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 DADE BEHRING, INC. VICTOR M CARRIO
K073701 01/28/2008 DANE TECHNOLOGIES WHEELCHAIR MOVER, MODEL WM 2000 DANE TECHNOLOGIES OLIVER PITTENGER
K073707 01/30/2008 GE DATEX-OHMEDA AISYS DATEX-OHMEDA, INC. DAN KOSEDNAR
K073242 01/03/2008 PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400 DELPHI MEDICAL SYSTEMS GILBERT ROQUE
K081287 11/21/2008 SAPPHIRE PLASMA ARC DENTAL CURING LIGHT DEN-MAT HOLDINGS, LLC ALAN MATTHEWS
K073101 01/17/2008 AURAVENEER CEMENT DENALI CORPORATION JAN G STANNARD
K073218 01/07/2008 MTA ADVANCED MATERIAL DENTSPLY INTERNTIONAL HELEN LEWIS
K082974 11/07/2008 MYSTIQUE MB CERAMIC BRACKETS DENTSPLY INTERNTIONAL HELEN LEWIS
K073173 01/23/2008 SELF-ADHESIVE RESIN CEMENT DENTSPLY INTERNTIONAL HELEN LEWIS
K072989 01/28/2008 AXIS SYSTEM DENTSPLY INTL., INC. HELEN LEWIS
K072762 01/22/2008 DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM DEPALT INC. RAJEEV PATEL
K082282 11/07/2008 HEALIX TI ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON CO. KRISTINE CHRISTO
K073412 01/17/2008 GRYPHON BR AND HEALIX BR ANCHORS DEPUY MITEK, A JOHNSON & JOHNSON COMPANY RUTH FORSTADT
K073413 01/30/2008 DEPUY ASR 300 ACETABULAR CUP SYSTEM DEPUY ORTHOPAEDICS, INC. DAWN SINCLAIR
K073676 01/29/2008 DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K072963 01/09/2008 DEPUY PINNACLE ALTRX ACETABULAR LINERS DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K082500 11/18/2008 DEPUY SIGMA CR-F FEMORAL COMPONENT DEPUY ORTHOPAEDICS, INC. NANCY FRIDDLE
K073529 01/24/2008 DEPUY SIGMA PS FEMORAL COMPONENTS DEPUY ORTHOPAEDICS, INC. NANCY FRIDDLE
K082128 11/14/2008 DEPUY SPINE LATERAL CAGE SYSTEM DEPUY SPINE DENISE DUCHENE
K073649 01/25/2008 BENGAL STACKABLE CAGE SYSTEM DEPUY SPINE, INC. SHARON SLAROWICZ
K072385 01/11/2008 HEARTEVENT, MODEL AT DIAGNOSTIC DEVICES PTY LTD HARRY PLATT
K073390 11/21/2008 DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS DIASORIN, INC. MARI MEYER
K082050 11/03/2008 LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM DIASORIN, INC. CAROL A DEPOUW
K081685 11/18/2008 LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG DIASORIN, INC. CAROL A DEPOUW
K081687 11/10/2008 LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG DIASORIN, INC. CAROL A DEPOUW
K072395 01/03/2008 DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS DIAZYME LABORATORIES CHARLES YU
K082763 11/12/2008 DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B DIAZYME LABORATORIES ABHIJIT DATTA
K072469 01/03/2008 DIGIFLO CONCENTRATOR ANALYZER DIGIFLO, INC. MIKE STERN
K072292 01/07/2008 NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS DIMA ITALIA SRL LEWIS WARD
K082512 11/07/2008 INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER DIMENSIONAL DOSING SYSTEMS, INC. EJ SMITH
K073503 01/23/2008 VERSA LITE DIOMEDICS, INC. GARY MOCNIK
K072002 01/31/2008 FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 DRAEGER MEDICAL AG & CO. KG KATHY ANDERSON
K082600 11/26/2008 OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082) DRAEGER MEDICAL B.V. JOYCE KILROY
K082888 11/26/2008 INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 DRAEGER MEDICAL SYSTEMS, INC. PRADEEP GUPTA
K073113 01/03/2008 INFINITY PICCO POD, MODEL MS16734 DRAEGER MEDICAL SYSTEMS, INC. GENCI OMARI
K062534 01/29/2008 ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE DRG INTL., INC. GARY LEHNUS
K080064 01/23/2008 FLAATZ 750 DRTECH CORP. BEOM-JIN MOON
K082261 11/06/2008 DXRAD MODELS DX800 OR DX808 DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS DXRAD SOLUTIONS LTD. DANIEL KAMM
K080036 01/16/2008 PORTABLE ECSCOPE 12I DYANSYS, INC. SRINI NAGESHWAR
K082187 11/13/2008 BIOMET ANTERIOR LUMBAR PLATE EBI, L.P. VIVIAN KELLY MS, RAC
K082369 11/07/2008 CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR EDAN INSTRUMENTS, INC. WILLIAM STERN
K082602 11/26/2008 FETAL & MATERNAL MONITOR, MODEL F6, F9 EDAN INSTRUMENTS, INC. WILLIAM STERN
K073559 01/31/2008 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II EDWARDS LIFESCIENCES RESEARCH MEDICAL JOHN W NICHOLSON
K080075 01/28/2008 MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM ELITE SURGICAL SUPPLIES (PTY) LTD. CHARISE DE BARROS
K073687 01/09/2008 HABIB LAPAROSCOPIC HEXABLATE EMCISION, LTD. NAGY HABIB
K072634 11/19/2008 EMG TRITON -COMP,MODEL NCA01-XXX SERIES EMG TECHNOLOGY CO., LTD. SALLY CHUANG
K082844 11/25/2008 BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE ENCORE MEDICAL, L.P. TEFFANY HUTTO
K072888 01/10/2008 REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED) ENCORE MEDICAL, L.P. TIFFANY HUTTO
K073267 01/30/2008 ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM ENDIUS, INC. REGINA WAGNER
K082339 11/20/2008 ENABLER-P SUPPORT CATHETER ENDOCROSS, LTD. JOHN J SMITH
K082655 11/25/2008 ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 ENVITEC-WISMAR GMBH STEPHEN GORSKI
K080049 01/23/2008 VASCUVIEW ULTRASOUND SYSTEM ESCALON MEDICAL CORP. MARK WALLACE
K082579 11/20/2008 EVERCROSS .035 OTW PTA DILATATION CATHETER EV3 INC. DAVID WORRELL
K072590 01/04/2008 INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM EVENT MEDICAL, INC. ROBERT LUNDBERG
K080278 11/28/2008 TABATABA COTESTER FIM MEDICAL DANIEL KAMM
K071104 01/14/2008 ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM FLIER'S QUALITY WATER SYSTEMS INC JAMES FLIER
K073289 01/11/2008 MICROSHEATH XL CATHETERS FLOWCARDIA, INC. DUSTIN MICHAELS
K072114 01/28/2008 IMPULSE 6000D/7000DP FLUKE BIOMEDICAL COLLEEN BOSWELL
K072870 01/14/2008 MICROWAVE TISSUE COAGULATION SYSTEM (MTCS) FOUNDRY NEWCO X, INC. GREGORY MATHISON
K080649 11/25/2008 POGO SCREW FXDEVICES RICH LIPSCHUTZ
K082740 11/26/2008 GC AADVA ZR DISK GC AMERICA, INC. MARK HEISS
K082434 11/14/2008 GDLS-200 GC AMERICA, INC. MARK HEISS
K082540 11/28/2008 GE ENTROPY SENSOR GE HEALTHCARE JOEL C KENT
K083018 11/14/2008 CENTRICITY PACS WEB DIAGNOSTIC GE HEALTHCARE DYNAMIC IMAGING SOLUTIONS JILLIAN M REED
K073625 01/25/2008 MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM GE HEALTHCARE SYSTEMS INFORMATION TECHNOLOGIES MARGARET MUCHA
K080124 01/31/2008 VENTRI 1.1 GE MEDICAL SYSTEMS F.I. HAIFA LAURENCE BIGIO
K073462 01/11/2008 MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES JOEL KENT
K082851 11/19/2008 MULTLINK CABLE AND LEADWIRE SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MATTHIAS BUERGER
K072664 11/21/2008 GE LUNAR FEMUR STRENGTH SOFTWARE GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA JAMES RASKOB
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