| 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 |
| K083323 |
12/02/2008 |
NUVO VERDE LED LIGHTING SYSTEM |
NUVO, INC. |
CURT V SCHAAFF |
| K083594 |
12/22/2008 |
EZ HSG CATHETER.FOAMSEAL CATHETER |
OBG PRODUCTS |
AL MUZZAMMEL |
| K083491 |
12/02/2008 |
NEUROSCAPE |
OLEA MEDICAL |
NEAL KOLBER |
| K083680 |
12/12/2008 |
VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258 |
ORTHO-CLINICAL DIAGNOSTICS, INC. |
MARLENE A HANNA |
| K083726 |
12/15/2008 |
PEDINAIL INTRAMEDULLARY NAILING SYSTEM |
ORTHOPEDIATRICS, CORP. |
GARY BARNETT |
| K083830 |
12/23/2008 |
OSCAR BONE RESECTOR |
ORTHOSONICS, LTD. |
MICHAEL J YOUNG |
| K083633 |
12/08/2008 |
HS II SHORT FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
MINJOO KIM |
| K083618 |
12/09/2008 |
PACS SCAN |
PACSGEAR, INC. |
IAN GORDON |
| K083745 |
12/17/2008 |
THE IC-PRO SYSTEM, MODEL VERSION 3.2 |
PAIEON, INC. |
SHAHAR MANDELBOIM |
| K083900 |
12/29/2008 |
ERBIUM FRACTIONAL HANDPIECE |
PALOMAR MEDICAL PRODUCTS, INC. |
SHARON TIMBERLAKE |
| K083619 |
12/08/2008 |
PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020 |
PARCUS MEDICAL, LLC |
BARTON BRACY |
| K083616 |
12/16/2008 |
PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS |
PATHOLASE, INC |
ANNE WORDEN |
| K083837 |
12/23/2008 |
JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
BRIAN CLEARY |
| K083842 |
12/24/2008 |
ROTEM DELTA THROMBOELASTOMETRY SYSTEM |
PENTAPHARM GMBH |
VOLKER JOACHIM FRIEMERT |
| K083873 |
12/29/2008 |
PICC (CT RATED AND NON-RATED) |
PFM MEDICAL, INC |
SALVADORE PALOMARES |
| K083740 |
12/16/2008 |
MAMMODIAGNOST VU |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
LYNN HARMER |
| K083663 |
12/10/2008 |
PACP |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN GILBERT |
| K083692 |
12/12/2008 |
HEM-AVERT PERIANAL STABILIZER |
PLEXUS BIOMEDICAL INC. |
DAVID BLURTON |
| K083621 |
12/16/2008 |
MEDPOR CUSTOMIZED SURGICAL IMPLANT |
POREX SURGICAL, INC. |
JERRI L MANN |
| K083695 |
12/15/2008 |
TRAXODENT |
PREMIER DENTAL PRODUCTS CO. |
VINCENT D'ALESSANDRO |
| K083746 |
12/17/2008 |
BIOSIGN FLU A+B |
PRINCETON BIOMEDITECH CORP. |
KYUNG-AH KIM |
| K083688 |
12/22/2008 |
PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR |
PULMONETIC SYSTEMS, INC. |
ROBERT C SAMEC |
| K083883 |
12/29/2008 |
CHARTIS CATHETER |
PULMONX, INC. |
ROBERTA HINES |
| K083199 |
12/03/2008 |
CHARTIS CONSOLE |
PULMONX, INC. |
SUZON LOMMEL |
| K083571 |
12/03/2008 |
ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR |
PURNABINA SDN BHD |
ROBERT HILL |
| K083749 |
12/31/2008 |
CARDIOVIEW32 REVIEW MODULE |
QRS DIAGNOSTIC, LLC. |
MARY KAY JENSEN |
| K083613 |
12/08/2008 |
QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY |
QUANTA SYSTEM, S.P.A. |
ISABELLA CARRER |
| K083931 |
12/05/2008 |
SYNTHETIC POWDER-FREE EXAM VINYL GLOVES, YELLOW/WHITE |
QUANTUM CO., LTD. |
LIJUAN WANG |
| K083600 |
12/05/2008 |
VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED) |
QUANTUM CO., LTD. |
LIJUAN WANG |
| K083878 |
12/29/2008 |
LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA |
R2 DIAGNOSTICS, INC. |
MARC D GOLDFORD |
| K083763 |
12/18/2008 |
ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN |
R4 VASCULAR, INC. |
LAURIE LEWANDOWSKI |
| K083856 |
12/24/2008 |
INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT SET, MODELS: FG0018, FG0026 |
RELIEVANT MEDSYSTEMS, INC. |
MARK SMUTKA |
| K083575 |
12/03/2008 |
APNEALINK PLUS, MODEL: 22328 |
RESMED GERMANY INC. |
DAVID D'CRUZ |
| K083816 |
12/22/2008 |
RES TRAXX ONLINE, MODEL: R14 |
RESMED LTD. |
DAVID D'CRUZ |
| K083874 |
12/29/2008 |
GALAXY |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ANDREW P ZELTWANGER |
| K083721 |
12/15/2008 |
MODIFICATION TO ZENIEVA |
RIVER'S EDGE PHARMACEUTICALS, LLC |
SANDRA R KIRCUS |
| K083655 |
12/10/2008 |
ELECSYS TOXO IGG CALCHECK |
ROCHE DIAGNOSTICS |
KELLY FRENCH |
| K083764 |
12/18/2008 |
AMPHETAMINES II |
ROCHE DIAGNOSTICS CORP. |
MICHELLE NEFF |
| K083847 |
12/24/2008 |
MARVEL PEDIATRIC WHEELCHAIR |
ROGUE WHEELCHAIRS INC |
KATHRYN RONALDS |
| K083766 |
12/22/2008 |
PHOGLASS CEM |
S & C POLYMER GMBH |
CHRISTIAN BOETTCHER |
| K083901 |
12/29/2008 |
NAVI ROOT |
S-DENTI CO., LTD. |
KEVIN WALLS |
| K083556 |
12/02/2008 |
MODIFICATION TO AUTO-BAND LIGATOR |
SCANDIMED INTERNATIONAL |
STEPHEN M PAGE |
| K083553 |
12/18/2008 |
NASO-LARYNGO-PHARYNGOSCOPE |
SCHOELLY IMAGING, INC. |
F. DAVID ROTHKOPF |
| K083756 |
12/17/2008 |
GUARDIAN 150 ELECTRODE |
SELECTIVE MED COMPONENTS, INC. |
JAY MANSOUR |
| K083602 |
12/05/2008 |
KAPPA LIGHT CHAINS |
SENTINEL CH. SPA |
YANGTSE PORTELLES |
| K083601 |
12/05/2008 |
LAMBDA LIGHT CHAINS |
SENTINEL CH. SPA |
YANGTSE PORTELLES |
| K083755 |
12/17/2008 |
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS |
SIAM SEMPERMED CORP. LTD. |
WILLIAM E HARRIS |
| K083844 |
12/24/2008 |
ADVIA CENTAUR TSH3-ULTRA METHOD |
SIEMENS HEALTHCARE DIAGNOSTICS |
ERNEST JOSEPH |
| K083906 |
12/30/2008 |
ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487 |
SIEMENS HEALTHCARE DIAGNOSTICS |
KIRA GORDON |
| K083462 |
12/15/2008 |
DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350 |
SIEMENS HEALTHCARE DIAGNOSTICS |
HELEN M LEE |
| K083579 |
12/04/2008 |
DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360 |
SIEMENS HEALTHCARE DIAGNOSTICS |
VICTOR M CARRIO |
| K083853 |
12/24/2008 |
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT |
SIEMENS HEALTHCARE DIAGNOSTICS |
CLARE SANTULLI |
| K083852 |
12/24/2008 |
BIOGRAPH 16 TRUE POINT SYSTEMS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALAINE MEDIO |
| K083569 |
12/09/2008 |
SURGYBONE |
SILFRADENT S.R.L. |
CLAUDE D BERTHOIN |
| K083886 |
12/29/2008 |
SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004 |
SIMPLER ONE STOP |
HAROLD BERGMAN |
| K083635 |
12/08/2008 |
SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW |
SMITH & NEPHEW ENDOSCOPY, INC. |
CHRISTINA FLORES |
| K083762 |
12/18/2008 |
BIOLOX DELTA CERAMIC FEMORAL HEADS |
SMITH & NEPHEW, INC. |
MANDY COE |
| K083565 |
12/03/2008 |
PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0 |
SMITH & NEPHEW, INC. |
GINO ROUSS |
| K083566 |
12/03/2008 |
R3 CONSTRAINED LINER, CONSTRAINED LINER |
SMITH & NEPHEW, INC. |
JASON SELLS |
| K083641 |
12/09/2008 |
BIVONA TRACHEOSTOMY TUBES |
SMITHS MEDICAL ASD, INC. |
DANIEL COATES |
| K083787 |
12/19/2008 |
BCI WW1000 PULSE OXIMETER, MODEL WW1000 |
SMITHS MEDICAL PM, INC. |
DONALD ALEXANDER |
| K083705 |
12/15/2008 |
BCI WW1020 PULSE OXIMETER, MODEL WW1020 |
SMITHS MEDICAL PM, INC. |
DONALD ALEXANDER |
| K083557 |
12/02/2008 |
BCI WW1030 PULSE OXIMETER |
SMITHS MEDICAL PM, INC. |
DONALD ALEXANDER |
| K083597 |
12/08/2008 |
SONOWAND INVITE |
SONOWAND AS |
CONSTANCE G BUNDY |
| K083743 |
12/16/2008 |
CAPSURE PS SYSTEM |
SPINE WAVE, INC. |
ROAIDA RIZKALLAH |
| K083835 |
12/23/2008 |
ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR |
ST. JUDE MEDICAL |
WILLIAM MCKELVEY |
| K083577 |
12/12/2008 |
HARMONIE SYSTEM |
STELLATE SYSTEMS |
GOLDY SINGH |
| K083636 |
12/09/2008 |
REPROCESSED EXTERNAL FIXATION DEVICE |
STERILMED, INC. |
GARRETT AHLBORG |
| K083643 |
12/09/2008 |
VERIFY 275F GRAVITY INDICATORS |
STERIS CORPORATION |
JOHN ROBERT SCOVILLE, JR. |
| K083665 |
12/10/2008 |
VERIFY SCBI 275F 3-10 |
STERIS CORPORATION |
JOHN ROBERT SCOVILLE, JR. |
| K083650 |
12/09/2008 |
EMU-GRAPH 4 EMULATOR, MODEL CI 144 |
STERITEC PRODUCTS, INC. |
LINDA NELSON |
| K083550 |
12/01/2008 |
STRAUMANN DENTAL IMPLANT SYSTEM |
STRAUMANN USA |
ELAINE ALAN |
| K083926 |
12/31/2008 |
CD4 COUNT |
STRECK |
KERRIE OETTER |
| K083661 |
12/10/2008 |
AVS TL PEEK SPACERS |
STRYKER CORP. |
KIMBERLY LANE |
| K083562 |
12/02/2008 |
STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM |
STRYKER CORP. |
KIMBERLY LANE |
| K083917 |
12/30/2008 |
X-RAY, TOMOGRAPHY, COMPUTED, DENTAL |
SUNI MEDICAL IMAGING, INC. |
AL BETTENCOURT |
| K083781 |
12/19/2008 |
EEA HEMORRHOID STAPLER & ACCESSORIES |
SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN |
FRANK GIANELLI |
| K083582 |
12/04/2008 |
SIGN HIP CONSTRUCT (SHC), MODEL: 701 |
SURGICAL IMPLANT GENERATION NETWORK (SIGN) |
DOUGLAS J DONNELLY |
| K083817 |
12/22/2008 |
M. DIOR BRAND |
SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD. |
CHU XIAOAN |
| K083694 |
12/12/2008 |
SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES |
SYNTHES (USA) |
SHERI L MUSGUNG |
| K083573 |
12/04/2008 |
SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES |
SYNTHES (USA) |
KARL J NITTINGER |
| K083664 |
12/10/2008 |
FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245 |
TAIDOC TECHNOLOGY CORPORATION |
YUHUA CHEN |
| K083570 |
12/03/2008 |
U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM |
TAIDOC TECHNOLOGY CORPORATION |
SOPHIE LIN |
| K083614 |
12/08/2008 |
SONOLITH I-SYS LITHOTRIPER |
TECHNOMED MEDICAL SYSTEMS, SA |
LYNETTE L HOWARD |
| K083898 |
12/29/2008 |
SURGIMEND |
TEI BIOSCIENCES INC. |
KENNETH JAMES |
| K083630 |
12/31/2008 |
CLUE MEDICAL AND CLUE MEDICAL BASIC |
TELOVITAL GMBH TELEMEDIZIN |
CHERITA JAMES |
| K083747 |
12/17/2008 |
TERUMO PALL AL3X ARTERIAL FILTER |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
| K083834 |
12/23/2008 |
TERUMO PALL AL6X ARTERIAL FILTER |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
EILEEN DORSEY |
| K083620 |
12/08/2008 |
SOMNOLYZER 24X7 |
THE SIESTA GROUP NORTH AMERICA |
ZVI LADIN |
| K083863 |
12/29/2008 |
THEKEN ATOLL OCT SPINAL SYSTEM |
THEKEN SPINE LLC |
DALE DAVISON |
| K083710 |
12/15/2008 |
RETRACTOR LITE |
THOMAS SURGICAL INSTRUMENTS, INC. |
STEPHANIE A ZALUCHA |
| K083714 |
12/15/2008 |
ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD) |
TITAN SPINE, LLC |
RICHARD JANSEN |
| K083828 |
12/23/2008 |
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT |
TRANSOMA |
LISA STONE |
| K083606 |
12/05/2008 |
SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K083912 |
12/30/2008 |
TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS |
TREU-INSTRUMENTE GMBH |
FRANZ MENEAN |
| K083896 |
12/29/2008 |
DESTINY MAX COAGULATION ANALYZER |
TRINITY BIOTECH |
BONNIE B DEJOY |
| K083647 |
12/09/2008 |
VALO, MODEL 5919 |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
| K083679 |
12/11/2008 |
UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 |
UROVAL |
SHARON IVERSON |
| K083784 |
12/19/2008 |
PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER, |
VASCULAR SOLUTIONS, INC. |
CHARMAINE SUTTON |
| K083820 |
12/30/2008 |
VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C |
VASOMEDICAL, INC. |
MELISSA PURPURA |
| K083920 |
12/31/2008 |
FLOWPICC CATHETER |
VASONOVA INC. |
KIM TOMPKINS |
| K083910 |
12/30/2008 |
VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER |
VIDISTAR, LLC |
CRAIG WALKER |
| K083725 |
12/16/2008 |
RADPRO ION |
VIRTUAL IMAGING, INC. |
DANIEL KAMM |
| K083767 |
12/18/2008 |
VIRULITE COLD SORE MACHINE |
VIRULITE LLC |
BEKY PINE |
| K083811 |
12/30/2008 |
W&H HANDPIECE "ANESTO", MODEL: RA-5 |
W & H DENTALWERK BUERMOOS GMBH |
JOHANN G SCHARL |
| K083724 |
12/15/2008 |
WIENER LAB. URINE STRIP 10 AND 11 |
WIENER LABORATORIOS S.A.I.C. |
VIVINA CETOLA |
| K083409 |
12/10/2008 |
POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL |
WRP ASIA PACIFIC SDN. BHD. |
KIRK PENNER |
| K083410 |
12/10/2008 |
POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM |
WRP ASIA PACIFIC SDN. BHD. |
KIRK PENNER |
| K083305 |
12/10/2008 |
POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM |
WRP ASIA PACIFIC SDN. BHD. |
KIRK PENNER |
| K083408 |
12/10/2008 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
WRP ASIA PACIFIC SDN. BHD. |
KIRK PENNER |
| K083637 |
12/09/2008 |
CALIX SPINAL IMPLANT SYSTEM |
X-SPINE SYSTEMS, INC. |
DAVID KIRSCHMAN |
| K083734 |
12/17/2008 |
AXXENT SURFACE APPLICATOR, MODEL 710257 |
XOFT, INC. |
STEVE LIN |
| K083823 |
12/22/2008 |
SECURIAN TISSUE REINFORCEMENT MATRIX |
XYLOS CORPORATION |
JOYCE ELKINS |
| K083739 |
12/16/2008 |
HYDRORISE AND HYDROSYSTEM |
ZHERMACK S.P.A. |
GERALD W SHIPPS |
| K083015 |
12/02/2008 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZIBO GOLDENLINE PLASTIC PRODUCT CO., LTD |
JOHN ZHAO |
| K083654 |
12/10/2008 |
ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM) |
ZIMMER, INC. |
ANTHONY FRANCALANCIA |
