FDA 510(k) Applications Received During December, 2008

FDA 510(k) Number Submission Date Device Name Applicant Contact
K083672 12/11/2008 P.D SOFTWARE .DECIMAL, INC. DANIEL BENNETT
K083903 12/29/2008 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200 3M COMPANY JIZHONG JIN
K083610 12/08/2008 FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE 3M COMPANY SCOTT ERICKSON
K083894 12/30/2008 ALIF SPINAL TRUSS INTERBODY FUSION DEVICE 4-WEB SPINE, LLC RICHARD JANSEN
K083645 12/22/2008 RADSTAR "FAMILY", MODELS: RADSTAR 4343 & VARIATIONS 5 STAR MEDICAL, INC. TERRY L ANCAR
K083809 12/22/2008 CREATININE ABBOTT LABORATORIES LINDA MORRIS
K083713 12/15/2008 .035 LOC GUIDE WIRE EXTENSION ABBOTT VASCULAR NADINE SMITH
K083706 12/15/2008 HI-TORQUE VERSACORE GUIDE WIRE ABBOTT VASCULAR NADINE SMITH
K083732 12/16/2008 TAD AND TAD II TAPERED GUIDE WIRES ABBOTT VASCULAR NADINE SMITH
K083574 12/03/2008 RELIEVA STRATUS MICROFLOW SPACER ACCLARENT, INC. KERI YEN
K083377 12/10/2008 ACCUPEN ACCUTOME ULTRASOUND, INC. BRIAN T.S. BARRETT
K083855 12/24/2008 MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59 ACUMEN MEDICAL, INC. KEVIN MACDONALD
K083626 12/08/2008 DISTRACTABLE WAVE CAGE ADVANCED MEDICAL TECHNOLOGY, INC. J.D. WEBB
K083915 12/30/2008 ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC ADVANCED TECHNOLOGY LASER CO., LTD. DIANA HONG
K083918 12/30/2008 ATL CO2 MEDICAL LASER SYSTEMS, MODELS ATL-150 AND ATL-250 ADVANCED TECHNOLOGY LASER CO., LTD. DIANA HONG
K083772 12/18/2008 COLUMBUS REVISION KNEE SYSTEM AESCULAP IMPLANT SYSTEM, INC. LISA M BOYLE
K083730 12/16/2008 ISOLAZ AESTHERA CORPORATION PAMELA M BUCKMAN
K083761 12/22/2008 ALATECH POWDER FREE LATEX EXAMINATION GLOVE ALATECH HEALTHCARE, LLC. NEIL ANDERSON
K083628 12/08/2008 GLUCODR AUTO SYSTEM ALL MEDICUS CO., LTD MARGARET KIM
K083812 12/22/2008 REFRESH OPTIVE LENS COMFORT REWETTING DROPS ALLERGAN, INC. BEVERLEY D VENUTI
K083826 12/23/2008 LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM ALLEZ SPINE, LLC HARTMUT LOCH
K083507 12/01/2008 BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS ALLIED HEALTHCARE PRODUCTS, INC. WAYNE KARCHER
K083625 12/08/2008 AERO DV TRACHEOBRONCHIAL STENT SYSTEM ALVEOLUS, INC TONY ALEXANDER
K083549 12/01/2008 ABT GLUCOSE CONTROL SOLUTION AMERICAN BIOLOGICAL TECHNOLOGIES, INC. JOHN GORMLEY
K083686 12/12/2008 BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES ANHUI KANGDA MEDICAL PRODUCTS CO., LTD. BIAN WEI QIANG
K083687 12/12/2008 BAIXIN INTRAVASCULAR ADMINISTRATION SET ANHUI KANGDA MEDICAL PRODUCTS CO., LTD. BIAN WEI QIANG
K083729 12/16/2008 HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN ANIARA DIAGNOSTICA ,LLC OLA ANDERSON
K083656 12/23/2008 APEX MEDICAL XT AUTO CPAP 9S-005200 APEX MEDICAL CORP. ALAN CHANG
K083617 12/08/2008 APIERON INSIGHT ENO SYSTEM APIERON, INC. NINA PELED
K083638 12/09/2008 FIXATION TROCARS APPLIED MEDICAL RESOURCES CORP.
K082951 12/30/2008 IMMERSION HYDROBATH ARJO HOSPITAL EQUIPMENT AB TRACI GIOVENCO
K083799 12/22/2008 TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00 ARK DIAGNOSTICS,INC JOHNNY VALDEZ
K083707 12/15/2008 ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE ARTHREX, INC. SALLY FOUST
K083904 12/29/2008 ASAHI SUOH PTCA GUIDE WIRE ASAHI INTECC CO., LTD. YOSHI TERAI
K083858 12/29/2008 BOND BONE AUGMA BIOMATERIALS, LTD. DAVID J COLLETTE
K083868 12/29/2008 ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 AXIS-SHIELD DIAGNOSTICS, LTD. CLAIRE DORA
K083667 12/11/2008 NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 B-K MEDICAL APS LARS OKSBY HANSEN
K083757 12/17/2008 BPZ02 MULTIPURPOSE SOLUTION BAUSCH & LOMB, INC. GLENN A DAVIES, O.D.
K083778 12/19/2008 XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210 BAXTER HEALTHCARE CORPORATION DIANE RENNPFERD
K083718 12/15/2008 BEAU RX SCAR CARE GEL BEAU RX SOLUTIONS, LLC. THOMAS L MCGRAW
K083867 12/29/2008 ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND BECKMAN COULTER, INC. TYLER FOUTCH
K083572 12/03/2008 BD BACTEC PLUS AEROBIC/F BLOOD CULTURE MEDIUM BECTON, DICKINSON & CO. DENNIS MERTZ
K083720 12/15/2008 OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K BIEN-AIR SURGERY SA HUGUES FROIDEVAUX
K083744 12/16/2008 BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 BINAX, INC. ANNE JEPSON
K083681 12/12/2008 BIOLAND BLOOD PRESSURE MONITOR BIOLAND TECHNOLOGY LTD. DAVID LEE
K083595 12/05/2008 EZLASE BIOLASE TECHNOLOGY, INC. IOANA RIZOUI
K083927 12/31/2008 WATERLASE MD BIOLASE TECHNOLOGY, INC. IOANNA RIZOU
K083682 12/11/2008 180W CERELAS D 980NM DIODE LASER, MODEL D180 BIOLITEC, INC. JONATHAN S KAHAN
K083827 12/23/2008 ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES BIOMET MANUFACTURING CORP. GARY BAKER
K083674 12/11/2008 PK-141 PATIENT CABLE BIOTRONIK, INC. JON BRUMBAUGH
K083715 12/15/2008 BELTBEAT WF-400 BONUS COMMUNICACIONES SRL BENNY ARAZY
K083627 12/09/2008 WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540 BOSTON SCIENTIFIC CORPORATION MARYBETH GAMBER
K083727 12/15/2008 STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012 BRIDGEPOINT MEDICAL JILL MUNSINGER
K083869 12/29/2008 BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI BTLOCK SRL ESTHER BATTILANA
K083839 12/23/2008 AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM C.R. BARD, INC. TERRI MORRIS
K083657 12/10/2008 CONQUEST PTA BALLOON DILATATION CATHETER C.R. BARD, INC. GENEVIEVE BALUTOWSKI
K083675 12/11/2008 POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER C.R. BARD, INC. JESSICA AGNELLO
K083722 12/15/2008 ASCEND CALDERA MEDICAL, INC. MARA KORSUNSKY
K083673 12/11/2008 CARESTREAM PACS, MODEL CARESTREAM PACS VII CARESTREAM HEALTH, INC. LINDA STEWART
K083892 12/29/2008 FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030) CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K083612 12/05/2008 APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K083607 12/05/2008 APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K083876 12/29/2008 SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT CENDRES & METAUX SA PETER W FLEETWOOD
K083640 12/09/2008 DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D CHOONGWAE MEDICAL CORP. CHARLIE MACK
K083716 12/15/2008 FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) CHURCH & DWIGHT CO., INC. STEPHEN C KOLAKOWSKY
K083596 12/05/2008 REEKROSS FAMILY OR OTW PTA CATHETERS CLEARSTREAM TECHNOLOGIES, LTD. FIONA N MHULLAIN
K083783 12/19/2008 VF LIQUIGEL COAPT SYSTEMS, INC. LOUIS-PIERRE MARCOUX
K083895 12/29/2008 CODMAN ISOCOOL BIPOLAR FORCEPS CODMAN & SHURTLEFF, INC. EMILY E VALERIO
K083742 12/16/2008 SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX COLLAGEN MATRIX, INC. PEGGY HANSEN
K083770 12/18/2008 COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM COLOPLAST A/S JANELL A COLLEY
K083624 12/08/2008 POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES COMFORT RUBBER GLOVES IND. SDN. BHD. TAN K BENG
K083677 12/11/2008 PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 COMMWELL LTD. JONATHAN KAHAN
K083785 12/19/2008 VITALA CONTINENCE CONTROL DEVICE CONVATEC MARILYN KONICKY
K083814 12/22/2008 OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 CORDIS CORP., A JOHNSON & JOHNSON CO. KAREN WILK
K083776 12/19/2008 CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
K083791 12/19/2008 CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
K083786 12/19/2008 CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
K083519 12/02/2008 AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES FRANK GIANELLI
K083693 12/12/2008 PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840 COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC. KIM BLOOM
K083748 12/17/2008 IPULSE, MODEL: I150 CYDEN LIMITED MICHAEL KIERNAN
K083795 12/22/2008 CYNOSURE SMARTLIPO MPX LASER CYNOSURE, INC. GEORGE CHO
K083586 12/09/2008 I-FIX SYSTEM DENTIS CO. LTD. JUNG BAE BANG
K083841 12/24/2008 ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K083805 12/22/2008 ANKYLOS C/X DENTAL IMPLANT SYSTEM DENTSPLY INTL., INC. HELEN LEWIS
K083789 12/23/2008 ACE FISCHER EXTERNAL FIXATION SYSTEM DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K083642 12/09/2008 DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS DEPUY ORTHOPAEDICS, INC. DAWN SINCLAIR
K083843 12/24/2008 LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K083649 12/09/2008 CARDIUS 3 X-ACT DIGIRAD CORP. JOEL TUCKEY
K083769 12/18/2008 MODIFICATION TO URESTA PESSARY EASTMED INC. ROSHANA AHMED
K083821 12/22/2008 VITAL SIGNS MONITOR EDAN INSTRUMENTS, INC. WILLIAM STERN
K083623 12/08/2008 CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100 EDWARDS LIFESCIENCES, LLC. ERICA WALTERS
K083648 12/09/2008 GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL EFRATGO, LTD. HI TECH BIO-SURGICAL GEORGE J HATTUB
K083629 12/08/2008 SMOOTHSHAPES ELEME MEDICAL, INC. MICHAIL PANKRATOV
K083555 12/02/2008 PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION EMSOMA CO., LTD. WEONBUM LEE
K083651 12/09/2008 REVELATION STEM, MODEL 427-21/42-080/180 ENCORE MEDICAL, L.P. TEFFANY HUTTO
K083788 12/19/2008 ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR ENDO OPTIKS, INC. DONALD R WATSON
K083833 12/23/2008 ENABLER-P CATHETER, 1000 PART NUMBER:1160 ENDOCROSS, LTD. JOHN SMITH
K083608 12/08/2008 ERBE HYBRID KNIFE ERBE USA, INC. JOHN TARTAL
K083452 12/01/2008 ERBE MODEL VIO 300 D WITH ACCESSORIES ERBE USA, INC. JULIE STEPHENS
K083882 12/29/2008 MYLABFIVE ESAOTE EUROPE B.V. JAMIE AUSTIN
K083850 12/24/2008 EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS EUROIMMUN US INC KATHRYN KOHL
K083615 12/08/2008 EUROIMMUN ANTI BP 180-4X ELISA (IGG) EUROIMMUN US INC KATHRYN KOHL
K083669 12/11/2008 OBI EUROTEKNIKA EMMANUEL MONTINI
K083670 12/11/2008 UNIVERSAL, AESTHETICA, NATEA, NATURA EUROTEKNIKA EMMANUEL MONTINI
K083793 12/22/2008 STEERABLE GUIDE CATHETER EVALVE INC KARUNA VELUSAMY
K083870 12/29/2008 EXSALT SD7 WOUND DRESSING EXCITON TECHNOLOGIES INC. SANDRA REIS
K083825 12/22/2008 EOI SPINAL SYSTEM EXPANDING ORTHOPEDICS, INC. JANICE M HOGAN
K083690 12/12/2008 FEMVUE(TM) CATHETER SYSTEM FEMASYS INC. MARC FINCH
K083832 12/23/2008 ZEST NASAL MASK FISHER & PAYKEL HEALTHCARE, LTD. TINA MASON
K083889 12/29/2008 FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY FOTONA D.D. STOJAN TROST
K083697 12/15/2008 FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M FUKUDA DENSHI USA, INC. DOUG BLAKELY
K083750 12/17/2008 CAPNOSTAT / CAPNOFLEX CO2 SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES ROBERT L CASARSA
K083639 12/09/2008 MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES LARRY LEPLEY
K083683 12/12/2008 ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC GENESEE BIOMEDICAL, INC. JOHN T.M. WRIGHT
K083752 12/17/2008 GLUSEAL 90, MODEL GLU9010 GLUSTITCH, INC. DON BLACKLOCK
K083717 12/15/2008 POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK GX CORPORATION SDN BHD FOO KHON PU
K082690 12/03/2008 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD. CHU XIAOAN
K082691 12/03/2008 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD. CHU XIAOAN
K083652 12/09/2008 IBOND TOTAL ETCH HERAEUS KULZER GMBH CHERYL ZIMMERMAN
K083552 12/18/2008 MAXMORESPINE TOM STICK HOOGLAND SPINE PRODUCTS GMBH BORIS MIKLITZ
K083899 12/29/2008 REVLITE Q-SWITCHED ND:YAG LASER SYSTEM HOYA CONBIO, INC LIZA BURNS
K083824 12/24/2008 HUMANSCAN M5S-D ULTRASOUND TRANSDUCER HUMANSCAN COMPANY, LTD. GARY ALLSEBROOK
K083591 12/04/2008 IKOENGELO, VERSION 2 IKOETECH, LLC. HUIMIN CHAO
K083728 12/16/2008 INVISION SYSTEM INNEROPTIC TECHNOLOGY, INC CAROLINE GREEN
K083908 12/30/2008 BLACK NITRILE EXAMINATION GLOVES INNOVATIVE GLOVES CO; LTD RAJEEV K SOOD
K083879 12/29/2008 INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500) INNOVISION A/S H. CARL JENKINS
K083861 12/30/2008 TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE INTERACOUSTICS AS HANNE NIELSEN
K083751 12/17/2008 INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100 INVACARE CORPORATION CARROLL MARTIN
K083919 12/31/2008 AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. STEVE CAMP
K083590 12/08/2008 ISKRA MEDICAL GREEN IRF PRESTIGE ISKRA MEDICAL, D.O.O. MOJCA VALJAVEC
K083854 12/24/2008 CARDIAC TRIGGER, MODEL: CTM300 IVY BIOMEDICAL SYSTEMS, INC. DICK LISTRO
K083753 12/17/2008 SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500, FULLY FUZZY AUTO DIGITAL UPPER ARM BLOOD PRESSU K-JUMP HEALTH CO., LTD. JASON CHENG
K083701 12/15/2008 PANASIL INITIAL CONTACT AND PANASIL TRAY KETTENBACH GMBH & CO KG KRISTI KISTNER
K083609 12/08/2008 KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE KFX MEDICAL GAYLE HIROTA
K083801 12/22/2008 BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 KHN SOLUTIONS, LLC DANIEL KAMM
K083815 12/22/2008 LANX FUSION SYSTEM LANX, INC. ALAN BURKHOLDER
K083581 12/08/2008 LANX SPINAL FIXATION SYSTEM LANX, INC. ANDREW LAMBORNE
K083822 12/22/2008 LASER TOUCHONE LASER HEALTH TECHNOLOGIES, LLC PATSY TRISLER
K083253 12/15/2008 LOTUS II PULSED ER: YAG LASER SYSTEM LASEROPTEK CO. LTD. PHILLIP CHEON
K083909 12/30/2008 SPINAL INJECTION SYSTEM LAURIMED LLC SEVRINA CIUCCI
K083857 12/24/2008 LDR SPINE ROI-C IMPLANT LDR SPINE USA NOAH BARTSCH
K083580 12/03/2008 ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301 LED INTELLECTUAL PROPERTIES, LLC ROBERT T WAGNER
K083865 12/29/2008 PILOT SPINAL SYSTEM LIFE SPINE REBECCA M BROOKS
K083560 12/02/2008 EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X LIGHTHOUSE TECHNICAL INNOVATIONS, INC. JEAN ASQUITH
K083733 12/16/2008 LUME 2 SYSTEM, MODEL GA0005000 LUMENIS, LTD. FRANCES HARRISON
K083845 12/24/2008 XTAG CF60 KIT V2 LUMINEX MOLECULAR DIAGNOSTICS, INC. GLORIA LEE
K083846 12/24/2008 XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 LUMINEX MOLECULAR DIAGNOSTICS, INC. GLORIA LEE
K083891 12/29/2008 VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 MAINE STANDARDS CO. HOLLY CRESSMAN
K083644 12/09/2008 MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP MAKO SURGICAL CORP. WILLIAM TAPIA
K083684 12/12/2008 ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX MANUFACTURING & RESEARCH, INC. SUZANNE DEW
K083794 12/22/2008 MECC SET WITH BIOLINE COATING MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K083622 12/08/2008 LNCS OXIMETRY SENSORS MASIMO CORPORATION MARGUERITE THOMLINSON
K083719 12/15/2008 LNCS OXIMETRY SENSORS MASIMO CORPORATION MARGUERITE THOMLINSON
K083872 12/29/2008 IMNS MEDACTA NAVIGATION SYSTEM MEDACTA INTERNATIONAL, SA NATLIE J KENNEL
K083558 12/02/2008 MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C MEDACTA INTERNATIONAL, SA NATALIE J KENNEL
K083862 12/29/2008 MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM MEDAPPS, INC. KENT DICKS
K083765 12/18/2008 MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL MEDEGEN MEDICAL MANUFACTURING SERVICES MATTHEW FRIED
K083802 12/22/2008 SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025 MEDI-GLOBE CORPORATION SCOTT KARLER
K083658 12/10/2008 PACS PLUS 5TH EDITION MEDICAL STANDARD CO., LTD. BRANDON CHOI
K083803 12/29/2008 FIXIT HEADREST CLAMP SYSTEM MEDICON, E.G. JOACHIM SCHMID
K083810 12/23/2008 PASS LP SPINAL SYSTEM MEDICREA TECHNOLOGIES J.D. WEBB
K083792 12/19/2008 WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055 MEDSHAPE SOLUTIONS JACK GRIFFIS
K083735 12/16/2008 ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS MEDTECHS, LLC MEGHAN ATH
K083702 12/15/2008 TRACH-ASSIST MERGENET MEDICAL PAUL DRYDEN
K083576 12/03/2008 MISER CONTRAST MANAGEMENT SYSTEM MERIT MEDICAL SYSTEMS, INC. STEPHANIE ERSKINE
K083016 12/16/2008 ACTHYDERM MICROLAB AMERICAS INC E J SMITH
K083691 12/15/2008 BONEVUE MICROMRI, INC. RICHARD ELRATH
K082565 12/02/2008 MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200 MICROSURGEON, INC. DUDLEY HARRIS
K083922 12/31/2008 MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00 MICRUS ENDOVASCULAR CORPORATION PATRICK LEE
K083646 12/09/2008 MICRUS MICROCOLI SYSTEM, "DELTAPLUSH", MODELS CPL, DPL MICRUS ENDOVASCULAR CORPORATION PATRICK LEE
K083659 12/10/2008 SILVER WOUND PAD MILLIKEN & CO. MARY MCNAMARA-CULLINANE
K083796 12/22/2008 MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT MILTEX, INC. JENNIFER J BOSLEY
K083754 12/23/2008 MINI LAP ELECTROCAUTERY INSTRUMENTS MINI LAP TECHNOLOGIES INC. JOSEPH AZARY
K083685 12/12/2008 ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285 MRI MANUFACTURING AND RESEARCH, INC. SUZANNE DEW
K083840 12/24/2008 MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE MSI MEDSERV INTERNATIONAL DEUTSCHLAND GMBH CHRISTINE STROBEL
K083662 12/31/2008 CRITICOOL MTRE ADVANCED TECHNOLOGY LTD. IFAT OREN
K083916 12/30/2008 LCD3090WQXI OR MD304MC 29.8 INCH DIAGNOSTIC IMAGING LCD MONITOR, MODEL L307TD NEC DISPLAY SOLUTIONS, LTD. ANGUS HSU
K083907 12/30/2008 MD212MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR-L217TG NEC DISPLAY SOLUTIONS, LTD. ANGUS HSU
K083561 12/02/2008 NEOSS PROACTIVE IMPLANT NEOSS, LTD. CHERITA JAMES
K083603 12/09/2008 I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL NEURO KINETICS JOE ARGYROS
K083818 12/22/2008 UNIVERSAL ELECTRODES NEUROMETRIX, INC. RAINER MAAS
K083877 12/29/2008 FLYING DIAGNOSTIC ULTRASOUND SYSTEM NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YANFANG
K083578 12/03/2008 NORAS CPC MULTIFUNCTIONAL COIL NORAS MRI PRODUCTS GMBH ZAHED SEDIGHIANI
K083583 12/04/2008 XPRESSE INJECTION SYSTEM NORDSON EFD JEFF PEMBROKE
DEN080015 12/24/2008 NUCLEUS-X PTV CATHETER NUMED, INC. NICHELLE LAFLESH
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