| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K083610 |
12/17/2008 |
FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE |
3M COMPANY |
SCOTT ERICKSON |
| K082985 |
12/17/2008 |
A-DEC 334/335 DELIVERY SYSTEM |
A-DEC, INC. |
THOMAS H LOUISELL |
| K081697 |
12/04/2008 |
THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 |
ACCESS SCIENTIFIC, INC. |
ALBERT MISAJON |
| K082993 |
12/19/2008 |
SURGISEAL TOPICAL SKIN ADHESIVE |
ADHEZION BIOMEDICAL |
RICHARD G JONES |
| K081751 |
12/19/2008 |
ADIN DENTAL IMPLANTS SYSTEM |
ADIN DENTAL IMPLANTS SYSTEM LTD |
BENNY ARAZY |
| K081309 |
12/19/2008 |
E.COLI/P. AERUGINOSA PNA FISH |
ADVANDX, INC. |
HENRIK STENDER |
| K081960 |
12/17/2008 |
INVISALIGN SYSTEM |
ALIGN TECHNOLOGY |
SANGEETA SACHDEVA |
| K071849 |
12/04/2008 |
ALLOFUSE GEL AND PUTTY |
ALLOSOURCE, INC. |
PAMELA VETTER |
| K083254 |
12/19/2008 |
ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM |
ALOKA CO., LTD. |
RICHARD CEHOVSKY |
| K082956 |
12/18/2008 |
ALPHA ORTHOPAEDICS AT2 SYSTEM |
ALPHA ORTHOPAEDICS |
GINA TO |
| K082898 |
12/19/2008 |
AMEDICA DRUG SCREEN TEST CUP |
AMEDICA BIOTECH, INC. |
Jeff Chen |
| K083549 |
12/22/2008 |
ABT GLUCOSE CONTROL SOLUTION |
AMERICAN BIOLOGICAL TECHNOLOGIES, INC. |
JOHN GORMLEY |
| K082387 |
12/04/2008 |
APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM |
AMERICAN MEDICAL SYSTEMS |
SARAH PETERSON |
| K082677 |
12/23/2008 |
AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE |
AMERICAN MEDICAL SYSTEMS, INC. |
MONA INMAN |
| K082180 |
12/17/2008 |
PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440 |
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS |
LINDA K SCHULZ |
| K082729 |
12/19/2008 |
RIMCLOSE BONE ANCHOR |
ANULEX TECHNOLOGIES, INC |
RACHEL KENNEDY |
| K082114 |
12/19/2008 |
ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00 |
APOLLO ENDOSURGERY, INC. |
DENNIS MCWILLIAMS |
| K083638 |
12/23/2008 |
FIXATION TROCARS |
APPLIED MEDICAL RESOURCES CORP. |
|
| K083370 |
12/12/2008 |
D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006 |
ARTEGRAFT, INC. |
LAURENCE A POTTER |
| K082999 |
12/30/2008 |
ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART |
ARTHREX, INC. |
NANCY HOFT |
| K083306 |
12/10/2008 |
MODIFICATION TO ARTHROCARE ARTHROWANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K081551 |
12/24/2008 |
TWIN NEUROTRAC-III |
ASTRO-MED, INC. |
ALFREDO BUSTAMANTE |
| K082749 |
12/04/2008 |
OMNI-TIGHT |
BASIC DENTAL IMPLANT SYSTEMS, INC. |
DAN BLACKLOCK |
| K081920 |
12/19/2008 |
BD GENEOHM CDIFF ASSAY |
BD DIAGNOSTICS (GENEOHM SCIENCES, INC.) |
RAYMOND BOULE |
| K081930 |
12/19/2008 |
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM |
BECKMAN COULTER, INC. |
LOURDES COBA |
| K083572 |
12/24/2008 |
BD BACTEC PLUS AEROBIC/F BLOOD CULTURE MEDIUM |
BECTON, DICKINSON & CO. |
DENNIS MERTZ |
| K082913 |
12/05/2008 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML |
BECTON, DICKINSON & CO. |
VICKI K WHITLEY |
| K081824 |
12/11/2008 |
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY |
BECTON, DICKINSON & CO. |
KATHRYN B CARR |
| K081825 |
12/11/2008 |
BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY |
BECTON, DICKINSON & CO. |
KATHRYN B CARR |
| K081522 |
12/05/2008 |
BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY |
BIO NUCLEAR DIAGNOSTICS, INC. |
SURENDER CHOUDHRY |
| K083164 |
12/16/2008 |
SYSTEM-ARMS, MODELS 390, X60 |
BIO-MEDICAL RESEARCH, LTD. |
ANNE-MARIE KEENAN |
| K081498 |
12/17/2008 |
TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205 |
BIOCOMFORT DIAGNOSTICS GMBH & CO. KG |
Martin Gabler |
| K083091 |
12/24/2008 |
LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES |
BIOCOMPATIBLES U.K. LIMITED |
JOHN GREENBAUM |
| K082953 |
12/22/2008 |
ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01 |
BIOKIT S.A. |
JOAN GUIXER |
| K082938 |
12/22/2008 |
EZLASE |
BIOLASE TECHNOLOGY, INC. |
IOANA RIZOIU |
| K082225 |
12/03/2008 |
15W CERALAS D 1470NM DIODE LASER, MODEL D1470 |
BIOLITEC, INC. |
JONATHAN S KAHAN |
| K080766 |
12/23/2008 |
VIDAS RUB IGG |
BIOMERIEUX, INC. |
NIKITA S MAPP |
| K083070 |
12/16/2008 |
TOGGLELOC SYSTEM |
BIOMET SPORTS MEDICINE |
ROBERT FRIDDLE |
| K082008 |
12/11/2008 |
BIONET BM3PLUS PATIENT MONITOR |
BIONET CO., LTD. |
YINGCHAO XIAO |
| K082705 |
12/15/2008 |
BIOPRO BIPOLAR HEAD, MODELS 18130-18152 |
BIOPRO, INC. |
DAVID MRAK |
| K082935 |
12/04/2008 |
VISION WIRE CORONARY GUIDEWIRE |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K082652 |
12/30/2008 |
BITTAR ZIRCONIA BLOCKS |
BITTAR ZIRCONIA BLOCK, LLC |
STUART R GOLDMAN |
| K083355 |
12/29/2008 |
WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553 |
BLAIREX LABORATORIES, INC. |
CAREY BOTTOM |
| K081739 |
12/03/2008 |
2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT |
BOSTON SCIENTIFIC CORP. |
Marybeth Gamber |
| K082297 |
12/09/2008 |
BUSSE SURGICAL DRAPE |
BUSSE HOSPITAL DISPOSABLES, INC. |
MUHAMAD ANSARI |
| K082094 |
12/17/2008 |
BARD PTFE (TEFLON) COATED GUIDE WIRES |
C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION |
DEBORAH L HERRINGTON |
| K083657 |
12/24/2008 |
CONQUEST PTA BALLOON DILATATION CATHETER |
C.R. BARD, INC. |
GENEVIEVE BALUTOWSKI |
| K081855 |
12/19/2008 |
IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) |
CANADA, INC. |
FEDERICO FORERO |
| K082090 |
12/12/2008 |
9131 DEFIBRILLATION ELECTRODES |
CARDIAC SCIENCE CORPORATION |
BEVERLY MAGRANE |
| K082539 |
12/02/2008 |
MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT |
CARDINAL HEALTH GERMANY 234 GMBH |
THOMAS RUST |
| K072964 |
12/30/2008 |
NICOLET CORTICAL STIMULATOR |
CARDINAL HEALTH, INC. |
Gary Syring |
| K083673 |
12/30/2008 |
CARESTREAM PACS, MODEL CARESTREAM PACS VII |
CARESTREAM HEALTH, INC. |
LINDA STEWART |
| K082829 |
12/22/2008 |
AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS) |
CARLETON LIFE SUPPORT SYSTEMS INC. |
GARY BYRD |
| K080558 |
12/05/2008 |
STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS |
CASE MEDICAL, INC. |
TANIA LUPU |
| K080595 |
12/05/2008 |
CELLAVISION DM96 WITH THE BODY FLUID APPLICATION |
CELLAVISION AB |
CONSTANCE G BUNDY |
| K073417 |
12/15/2008 |
EMBOZENE MICROSPHERES |
CELONOVA BIOSCIENCES, INC. |
THOMAS A GORDY |
| K083093 |
12/15/2008 |
CHEETAH RELIANT |
CHEETAH MEDICAL INC. |
Rhona Shanker |
| K081768 |
12/23/2008 |
COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES |
COOK INCORPORATED |
SUSANNE GALIN |
| K081060 |
12/24/2008 |
FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 |
CORE ESSENCE ORTHOPAEDICS, LLC |
SHAWN T HUXEL |
| K083210 |
12/29/2008 |
CORFLO ANTI IV ENTERAL FEEDING TUBE |
CORPAK MEDSYSTEMS |
STEPHANIE WASIELEWSKI |
| K083379 |
12/12/2008 |
CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE |
CYNOSURE, INC. |
GEORGE CHO |
| K082731 |
12/17/2008 |
ML24000 UVA-1 PHOTOTHERAPY CABINET |
DAAVLIN DISTRIBUTING CO. |
TARA MANSUR |
| K073681 |
12/09/2008 |
NANOBEAM 940, MODEL 940-900-02 |
DAVARAY, INC. |
DAVID J ARNDT |
| K083400 |
12/11/2008 |
CUSTOM COMFORT NIGHTGUARD |
DENTEK ORAL CARE, INC. |
HOWARD M HOLSTEIN |
| K082408 |
12/03/2008 |
LEDEX, MODEL: WL-070 |
DENTMATE TECHNOLOGY CO., LTD. |
CHENG-FENG CHOU |
| K082643 |
12/19/2008 |
3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
ZHENG LIU |
| K083364 |
12/11/2008 |
2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424 |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K082585 |
12/04/2008 |
DEPUY ASPHERE M-SPEC HEAD |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
| K082715 |
12/18/2008 |
DEPUY GLOBAL AP CTA HUMERAL HEAD |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
| K081746 |
12/23/2008 |
D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT |
DIAGNOSTIC HYBRIDS, INC. |
GAIL R GOODRUM |
| K081928 |
12/23/2008 |
D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT |
DIAGNOSTIC HYBRIDS, INC. |
GAIL R GOODRUM |
| K082248 |
12/12/2008 |
STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER |
DIAGNOSTICA STAGO, INC. |
UMBERTO V PARROTTA |
| K082049 |
12/05/2008 |
LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV |
DIASORIN, INC. |
CAROL A DEPOUW |
| K080485 |
12/04/2008 |
ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS |
DIASYS DIAGNOSTICS SYSTEMS GMBH |
STEPHANIE KLEIN |
| K082001 |
12/05/2008 |
DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B |
DIAZYME LABORATORIES |
Abhijit Datta |
| K082904 |
12/17/2008 |
STASYS MOTION CORRECTION SOFTWARE |
DIGIRAD CORP. |
Joel Tuckey |
| K083050 |
12/29/2008 |
EVITE XL |
DRAEGER MEDICAL AG & CO. KG |
JOYCE KILROY |
| K082308 |
12/09/2008 |
MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR |
EDWARDS LIFESCIENCES, LLC. |
JASON SMITH |
| K082421 |
12/17/2008 |
HEARTSUITE HEMODYNAMICS 7.10 |
EMAGEON INC. |
|
| K083555 |
12/16/2008 |
PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION |
EMSOMA CO., LTD. |
WEONBUM LEE |
| K082233 |
12/18/2008 |
VIKY |
ENDOCONTROL |
CARINE HUGUEL |
| K082380 |
12/03/2008 |
VICARDIO 12B |
ENERGY-LAB TECHNOLOGIES GMBH |
GEORGE MYERS |
| K083452 |
12/31/2008 |
ERBE MODEL VIO 300 D WITH ACCESSORIES |
ERBE USA, INC. |
JULIE STEPHENS |
| K082893 |
12/05/2008 |
PRAGER SHELL |
ESI, INC. |
GEORGE MYERS |
| K082278 |
12/16/2008 |
MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS |
ETHICON ENDO-SUGERY, LLC |
CAROL HUBBARD |
| K082854 |
12/04/2008 |
NANOCORSS .014 OTW PTA DILATATION CATHETER |
EV3 INC. |
David Worrell |
| K083392 |
12/17/2008 |
NOVATION 12/14 CEMENTED FEMORAL STEMS |
EXACTECH, INC. |
GRAHAM L CUTHBERT |
| K082837 |
12/18/2008 |
STERILE FIELD SALINE PRE-FILLED SYRINGE(S) |
EXCELSIOR MEDICAL CORP. |
JOHN LINFANTE |
| K081990 |
12/05/2008 |
LUBRICANO STERILE GEL |
FARCO PHARMA GMBH |
SETH A MAILHOT |
| K071573 |
12/09/2008 |
RUGALIFT, MODEL# V.2.1 |
FATROTEK S.R.L. |
FRANSICO PELUSO |
| K083347 |
12/24/2008 |
IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS |
FLUKE BIOMEDICAL |
COLLEEN BOSWELL |
| K083542 |
12/29/2008 |
FRESENIUS STERILE STAY SAFE CAP |
FRESENIUS MEDICAL CARE NORTH AMERICA |
JANET KAY |
| K083504 |
12/12/2008 |
GE DISCOVERY NM/CT 570C |
GE MEDICAL SYSTEMS F.I. HAIFA |
LAURENCE BIGIO |
| K082676 |
12/18/2008 |
GENADYNE A4 WOUND VACUUM SYSTEM |
GENADYNE BIOTECHNOLOGIES, INC. |
CHIEN-MING GOH |
| K082210 |
12/16/2008 |
TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 |
GENZYME DIAGNOSTICS P.E.I. INC. |
PENNY J WHITE |
| K083272 |
12/16/2008 |
SKINCLEAR Q-SWITCHED ND:YAG LASER |
GLOBAL USA DISTRIBUTION, LLC. |
MATT MAKOUSKY |
| K083232 |
12/24/2008 |
MODIFICATION TO:MICROFUSE BONE VOID FILLER |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
| K081929 |
12/16/2008 |
VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR |
GREINER BIO-ONE NORTH AMERICA, INC. |
Judi Smith |
| K083013 |
12/09/2008 |
PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001 |
GYRUS ACMI, INC. |
GRAHAM A.L. BAILLIE |
| K082591 |
12/05/2008 |
FLEXITIME BITE |
HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION |
CHERYL V ZIMMERMAN |
| K083086 |
12/05/2008 |
ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150) |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
| K083049 |
12/23/2008 |
TORNADO ROTATABEL SNARE AND POLYP CATCHER |
HORIZONS INTL. CORP. |
RAFIC SALEH |
| K081412 |
12/17/2008 |
PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE |
HOSPIRA, INC. |
DANIELA WEKSLER |
| K082892 |
12/29/2008 |
REJUVENATE MONOLITHIC HIP SYSTEM |
HOWMEDICA OSTEONICS CORP |
DENISE DAUGERT |
| K083437 |
12/18/2008 |
MODIFICATION TO T2 RECON NAIL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
AVITAL MERL-MARGULIES |
| K083591 |
12/29/2008 |
IKOENGELO, VERSION 2 |
IKOETECH, LLC. |
HUIMIN CHAO |
| K071526 |
12/10/2008 |
UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV |
IMPACT INSTRUMENTATION, INC. |
LESLIE H SHERMAN |
| K083137 |
12/16/2008 |
NEURO III-SV |
IMRIS, INC. |
THOMAS M TSAKERIS |
| K082020 |
12/24/2008 |
ENVISION BLOOD GLUCOSE TEST SYSTEM |
INFOPIA CO., LTD |
MARIA F GRIFFIN |
| K081788 |
12/17/2008 |
INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200 |
INNOCHIPS TECHNOLOGY CO., LTD. |
BRANDON CHOI |
| K082384 |
12/08/2008 |
HAV-LOK BUNION CORRECTION SYSTEM |
INSTRATEK, INC. |
Jeff Seavey |
| K082859 |
12/19/2008 |
HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K081635 |
12/04/2008 |
INTEGRA MESHED BILAYER WOUND MATRIX |
INTEGRA LIFESCIENCES CORP. |
DIANA M BORDON |
| K082795 |
12/12/2008 |
SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT |
INTERVENTIONAL SPINE, INC. |
CAROL EMERSON |
| K081207 |
12/19/2008 |
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE |
INTUITIVE SURGICAL, INC. |
JERRY TSUTSUMI |
| K080740 |
12/31/2008 |
CLEARVIEW ENDOSCOPE COVER |
INVOTEC INTERNATIONAL, INC. |
JEFFREY L AULL |
| K082416 |
12/12/2008 |
IBA PROTON THERAPY SYSTEM- PROTEUS 235 |
ION BEAM APPLICATIONS S.A. |
JOHN REISS |
| K070541 |
12/11/2008 |
IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II |
IVIVI TECHNOLOGIES, INC. |
ANDRE DIMINO |
| K082911 |
12/19/2008 |
SMOOTHCOOL HR SYSTEM |
JEISYS MEDICAL, INC. |
Kevin Walls |
| K080542 |
12/15/2008 |
DISTRAX |
JOHN W. KING |
EMILY B ROSSITER |
| K082769 |
12/11/2008 |
MESA AND RANGE SPINAL SYSTEMS |
K2M, INC. |
RICHARD W WOODS |
| K082925 |
12/18/2008 |
XENON-100 SCB LIGHT SOURCE, MODEL 20132620 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
MONIKA CAMPBELL |
| K082509 |
12/15/2008 |
EOS SPINAL SYSTEM |
KOREA BONE BANK CO., LTD |
JUNG BAE BANG |
| K082922 |
12/09/2008 |
FREEWAY AND RAILRUNNER GUIDEWIRES |
LAKE REGION MFG., INC. |
DEEP PAL |
| K082590 |
12/17/2008 |
SYMPHONY METER REMOTE |
LIFESCAN, INC. |
MARTHA MURARI |
| K083560 |
12/11/2008 |
EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X |
LIGHTHOUSE TECHNICAL INNOVATIONS, INC. |
JEAN ASQUITH |
| K081008 |
12/22/2008 |
BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS |
Lin-Zhi International, Inc. |
MARIE LIN |
| K081848 |
12/04/2008 |
LIPOSE FAT TRANSFER SYSTEM |
LIPOSE CORP. |
ALAN CURTIS |
| K082460 |
12/15/2008 |
CENEFOM PVA SURGICAL SPEAR |
LONGTEK SCIENTIFIC CO., LTD. |
JOSEPH J CHANG |
| K082809 |
12/18/2008 |
ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM |
LUMENIS, INC. |
FRANCES E HARRISON |
| K083171 |
12/16/2008 |
INTROL CF PANEL I CONTROL, MODEL: G106 |
MAINE MOLECULAR QUALITY CONTROLS, INC. |
JOAN GORDON |
| K082700 |
12/09/2008 |
TEMPORARY COLD.V AND SELF-CURE DENTINE |
MAJOR PRODOTTI DENTARI S.P.A. |
MONICA FUNAI |
| K082725 |
12/17/2008 |
GRAFTGUARD PRESSURE CONTROLLING SYRINGE |
MAQUET CARDIOVASCULAR, LLC |
CHRISTINA L ROWE |
| K082818 |
12/23/2008 |
SUBCUTANEOUS NEEDLE INFUSION SET |
MARCAL MEDICAL, INC. |
ARTHUR WARD |
| K082792 |
12/29/2008 |
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS |
MEDACTA INTERNATIONAL, SA |
NATALIE J KENNEL |
| K083472 |
12/09/2008 |
MEDEGEN PRESSURE RATED EXTENSION SETS |
MEDEGEN INC. |
TIM L TRUITT |
| K083765 |
12/30/2008 |
MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL |
MEDEGEN MEDICAL MANUFACTURING SERVICES |
MATTHEW FRIED |
| K080810 |
12/10/2008 |
EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT |
MEDICA CORP. |
Photios Makris |
| K082472 |
12/30/2008 |
VIROCULT, MODEL MW950 |
MEDICAL WIRE & EQUIPMENT COMPANY (BATH) LTD |
DAVID ELLIS |
| K083308 |
12/10/2008 |
PASS LP SPINAL SYSTEM |
MEDICREA TECHNOLOGIES |
J.D. WEBB |
| K080172 |
12/18/2008 |
BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216 |
MEDICULT A/S |
RONALD G LEONARDI |
| K081355 |
12/18/2008 |
BIOFLEX LD-R100 TREATMENT HEAD |
MEDITECH INTERNATIONAL, INC. |
FRED KAHN |
| K080428 |
12/09/2008 |
ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY |
MEDTRONIC INC. |
MARLENE PETERSON |
| K082670 |
12/04/2008 |
MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET |
MEDTRONIC INC. |
BETH CLAAS |
| K083026 |
12/29/2008 |
CLYDESDALE SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
LEE GRANT |
| K080741 |
12/16/2008 |
MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE |
MEGADYNE MEDICAL PRODUCTS, INC. |
RONDA K MAGNESON |
| K083063 |
12/16/2008 |
BIS INTERFACE FOR VITALOGIK PATIENT MONITORS |
MENNEN MEDICAL LTD. |
IFAT OREN |
| K081962 |
12/29/2008 |
LAPEX BCS |
MERIDIAN CO., LTD. |
DANIEL KAMM |
| K082613 |
12/30/2008 |
MERIT MICROCATHETER |
MERIT MEDICAL SYSTEMS, INC. |
MICHAELA RIVKOWICH |
| K083576 |
12/23/2008 |
MISER CONTRAST MANAGEMENT SYSTEM |
MERIT MEDICAL SYSTEMS, INC. |
STEPHANIE ERSKINE |
| K082385 |
12/11/2008 |
CHAPERON GUIDING CATHETER |
MICROVENTION, INC. |
FLORIN TRUUVERT |
| K083343 |
12/04/2008 |
HEADWAY 17 MICROCATHETER |
MICROVENTION, INC. |
|
| K072562 |
12/04/2008 |
MICROWARE BONE PLATES AND BONE SCREWS |
MICROWARE PRECISION CO., LTD. |
HARRISON DU |
| K082766 |
12/17/2008 |
MODIFICATION TO MINISPIR, SPIROLAB III |
MIR MEDICAL INTL. RESEARCH SRL |
SIMON FOWLER |
| K080458 |
12/17/2008 |
MIS CREST WIDENER |
MIS - IMPLANT TECHNOLOGIES LTD. |
IMAN KHORSHID |
| K082946 |
12/29/2008 |
MORTARA ELI 350 ELECTROCARDIOGRAPH |
MORTARA INSTRUMENT, INC. |
CHARLES MORREALE |
| K082203 |
12/30/2008 |
NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025 |
NCONTACT SURGICAL, INC. |
JANE RICUPERO |
| K083538 |
12/16/2008 |
NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 |
NEURONETICS |
JUDY P WAYS |
| K072831 |
12/12/2008 |
FROG |
NEWBY-COOMBS, LLC |
KARLA COOMBS |
| K082724 |
12/16/2008 |
NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM |
NEWPORT MEDICAL INSTRUMENTS, INC. |
DIANA RODRIGUEZ |
| K082566 |
12/03/2008 |
MARK 5 NUVO LITE OCSI AND STD |
NIDEK MEDICAL PRODUCTS, INC. |
JENNIFER MCWILLIAMS |
| K083271 |
12/24/2008 |
BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY |
NIHON KOHDEN AMERICA, INC. |
JACK COGGAN |
| K081972 |
12/11/2008 |
BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES |
NITRITEX (M) SDN. BHD. |
DEREK WATTS |
| K081971 |
12/23/2008 |
BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES |
NITRITEX (M) SDN. BHD. |
DEREK WATTS |
| K083476 |
12/22/2008 |
NOVEON MODEL LS1100-03 |
NOMIR MEDICAL TECHNOLOGIES, INC. |
RICHARD F BURTT |
| K081861 |
12/04/2008 |
HOLTER LX ANALYSIS |
NORTH EAST MONITORING INC. |
JOSEPH AZARY |
| K082672 |
12/09/2008 |
NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT |
NovaBone Products, LLC |
DAVID M GALSSER |
| K082878 |
12/30/2008 |
NEVONI CLASSIC, MODEL 6600-PO |
NSR COMERCIO E REPRESENTACOES LTDA |
POLLY SCHERMAN |
| K083042 |
12/18/2008 |
WOUND FLUSH, STERILE WATER & NORMAL SALINE |
NURSE ASSIST, INC. |
DENICE GALLAGHER |
| K081173 |
12/23/2008 |
ENDOSCOPIC CO2 REGULATION UNIT UCR |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K083335 |
12/15/2008 |
MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM |
OMNISONICS MEDICAL TECHNOLOGIES |
ANNE M KULIS |
| K083173 |
12/22/2008 |
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM |
ORTHO-CLINICAL DIAGNOSTICS |
LEAH VAN DE WATER |
| K082574 |
12/08/2008 |
MAXTORQUE MINI CANNULATED SCREW SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
DEREK LEWIS |
| K082950 |
12/05/2008 |
STARBAND |
ORTHOMERICA PRODUCTS, INC. |
ALAN T SANDIFER |
| K081786 |
12/02/2008 |
ZIOCERA & CONVERTIBLE SYSTEM |
OSSTEM IMPLANT CO LTD |
MINJOO KIM |
| K080149 |
12/18/2008 |
HEATER BASE, MODEL PMH7000 |
PACIFIC MEDICO CO., LTD. |
YOSHIMO TOYAMA |
| K081073 |
12/05/2008 |
HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F |
PAUSCH LLC |
JUSTIN TICE |
| K082786 |
12/03/2008 |
PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES |
PEAK SURGICAL, INC. |
GRACE CARLSON |
| K083413 |
12/18/2008 |
COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM |
PHILIPS MEDICAL SYSTEMS |
TERESA SCHMIDT |
| K083498 |
12/17/2008 |
PHILIPS MODEL MX 16 SLICE CT SYSTEM |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
MICHAEL CHILBERT |
| K080794 |
12/17/2008 |
POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
POLYVUE DISTRIBUTION, INC. |
GAROLD L EDWARDS |
| K082382 |
12/12/2008 |
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 |
POSSIS MEDICAL, INC. |
MARK STENOIEN |
| K083527 |
12/18/2008 |
INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
| K082302 |
12/09/2008 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM |
PT. MEDISAFE TECHNOLOGIES |
ANIL TANEJA |
| K081592 |
12/03/2008 |
POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES |
QUALITY GALLANT SDN. BHD. |
SEAH BEE HOON |
| K083613 |
12/23/2008 |
QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY |
QUANTA SYSTEM, S.P.A. |
ISABELLA CARRER |
| K081095 |
12/12/2008 |
PROLITE III TOWER AND PR AND HR HANDPIECE |
QUANTEL S.A. |
MICHAEL JOHNSON |
| K080455 |
12/31/2008 |
RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050 |
QUANTRX BIOMEDICAL CORPORATION |
NATALIE J KENNEL |
| K082631 |
12/17/2008 |
THROMBO TEK PSE, MODEL 90-480 |
R2 DIAGNOSTICS, INC. |
MARC D GOLDFORD |
| K082423 |
12/03/2008 |
NO!NO! SKIN |
RADIANCY (ISRAEL) LTD. |
ZVI LADIN |
| K083029 |
12/05/2008 |
MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR |
RALCO S.R.L. |
DANIEL KAMM |
| K082079 |
12/18/2008 |
REGEN COLLAGEN SCAFFOLD (CS) |
REGEN BIOLOGICS, INC. |
JOHN DICHIARA |
| K082603 |
12/12/2008 |
TRIMIRA OCS 3000 |
REMICALM, LLC |
DAVID B JONES |
| K082448 |
12/10/2008 |
DISPOSABLE VINYL SYNTHETIC EXAMINATION GLOVES, POWDERED |
RICH MOUNTAIN MEDICAL PRODUCTS, INC. |
MICHELLE SHIH |
| K072617 |
12/05/2008 |
ELECSYS RUBELLA IGG IMMUNOASSAY |
ROCHE DIAGNOSTICS CORP. |
THERESA A BUSH |
| K082970 |
12/12/2008 |
MARVEL WHEELCHAIR, MODEL EDCAL01 |
ROGUE WHEELS INC |
KATHRYN RONALDS |
| K082902 |
12/10/2008 |
RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES |
RZ MEDIZINTECHNIK GMBH |
ANGELIKA SCHERP |
| K082116 |
12/17/2008 |
HEMOSTASYL PASTE |
SATELEC |
RICK ROSATI |
| K082208 |
12/01/2008 |
DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER |
SCIVOLUTIONS, INC. |
ARTHUR WARD |
| K082926 |
12/22/2008 |
ZUMA, MODEL 55-XXXX/56-XXXX |
SEASPINE, INC. |
JEFF BRITTAN |
| K082755 |
12/15/2008 |
SEDAT FLAMINGO |
SEDAT |
CHARLES COUSIN |
| K083044 |
12/12/2008 |
HUBANG, MODEL HBL13/HBG12-S |
SHANGHAI HUBANG MEDICAL APPLIANCES CO., LTD. |
JUNNATA CHANG |
| K083129 |
12/15/2008 |
SHARPS COMPLIANCE CONTAINER |
SHARPS COMPLIANCE, INC. |
AL ALADWANI |
| K083505 |
12/12/2008 |
DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
TAN CHAUNBIN |
| K082224 |
12/15/2008 |
DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC |
SHIMADZU MEDICAL SYSTEMS |
DON KARLE |
| K082744 |
12/11/2008 |
BEAUTIBOND |
SHOFU DENTAL CORP. |
DAVID P MORAIS |
| K071474 |
12/10/2008 |
DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426 |
SIEMENS HEALTHCARE DIAGNOSTICS |
GEORGE M PLUMMER |
| K082503 |
12/19/2008 |
DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL |
SIEMENS HEALTHCARE DIAGNOSTICS |
ANNA MARIE KATHLEEN ENNIS |
| K081148 |
12/22/2008 |
SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
SHEILA PICKERING |
| K081977 |
12/01/2008 |
PROSIT WOUND TREATMENT DEVICE |
SILVERLEAF MEDICAL PRODUCTS, INC. |
JEFFRY SKIBA |
| K083344 |
12/23/2008 |
HELIODENT PLUS |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
| K082783 |
12/17/2008 |
CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE |
SMITHS MEDICAL MD, INC. |
PHIL NEURURER |
| K082344 |
12/17/2008 |
STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO) |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
| K082651 |
12/22/2008 |
ENDOSSEOUS DENTAL IMPLANT SYSTEM |
SOUTHERN IMPLANTS, INC. |
GRETA M HOLS |
| K082580 |
12/08/2008 |
SPECTRA GUIDEWIRE INTRODUCER NEEDLE |
SPECTRA MEDICAL DEVICES, INC. |
AGUSTIN TURRIZA |
| K082559 |
12/11/2008 |
SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER |
SPECTRANETICS CORP. |
MICHAEL K HANDLEY |
| K082561 |
12/10/2008 |
SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS |
SPECTRANETICS CORP. |
MICHAEL K HANDLEY |
| K083230 |
12/03/2008 |
MERCURY SPINAL SYSTEM |
SPINAL ELEMENTS, INC. |
KERRI DIMARTINO |
| K083353 |
12/11/2008 |
CAPSURE(R) PS SYSTEM |
SPINE WAVE, INC. |
ROAIDA RIZKALLAH |
| K081165 |
12/17/2008 |
ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM |
SPINEART |
FRANCK PENNESI |
| K083402 |
12/15/2008 |
AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323 |
ST. JUDE MEDICAL |
MAC MCKEEN |
| K081645 |
12/09/2008 |
AGILIS NXT STEERABLE INTRODUCER, MODEL G408324 |
ST. JUDE MEDICAL |
MAC MCKEEN |
| K082932 |
12/12/2008 |
CPS AIM SL SLITTABLE INNER CATHETER |
ST. JUDE MEDICAL |
COLLEEN CANAN |
| K081814 |
12/17/2008 |
REPROCESSED ENT SHAVERS |
STERILMED, INC. |
JOSHUA CLARIN |
| K082435 |
12/30/2008 |
AMSCO EVOLUTION MEDIUM STEAM STERILIZER |
STERIS Corporation |
ROBERT F SULLIVAN |
| K082765 |
12/18/2008 |
ASTOFLO PLUS |
STIHLER ELECTRONIC GMBH |
STEPHEN T MLCOCH |
| K082758 |
12/19/2008 |
PRISMAFLO II |
STIHLER ELECTRONIC GMBH |
STEPHEN T MLCOCH |
| K082813 |
12/19/2008 |
STRYKER LED LIGHTSOURCE |
STRYKER CORP. |
DESIREE CRISOLO |
| K082451 |
12/16/2008 |
STRYKER VIDEOSCOPE |
Stryker Endoscopy |
DESIREE CRISOLO |
| K082010 |
12/29/2008 |
STRYKER DISPOSABLE CRANIAL PERFORATOR BIT |
STRYKER IRELAND LTD., INSTRUMENTS DIVISION |
COLETTE O'CONNOR |
| K083109 |
12/04/2008 |
SUINSA DIAGNOSTIC X-RAY SYSTEM |
SUINSA |
DANIEL KAMM |
| K083249 |
12/23/2008 |
QUICKIE RHYTHM |
SUNRISE MEDICAL HHG, INC. |
JAMES W LEWIS |
| K082535 |
12/01/2008 |
COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE |
SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN |
TIM M LOHNES |
| K083211 |
12/15/2008 |
AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM |
SURGIQUEST, INC. |
KOUROSH AZARBARZIN |
| K082671 |
12/11/2008 |
HERCULITE ULTRA |
SYBRON DENTAL SPECIALTIES |
Wendy Garman |
| K082625 |
12/17/2008 |
SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES |
SYNTHES (USA) |
KARL J NITTINGER |
| K083213 |
12/30/2008 |
SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K082914 |
12/11/2008 |
CLAMPFIX |
SYNTHES SPINE |
JASON LIPMAN |
| K081715 |
12/17/2008 |
FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM |
TaiDoc Technology Corporation |
Yuhua Chen |
| K082169 |
12/04/2008 |
PRO GLUCOSE TEST STRIP |
TaiDoc Technology Corporation |
Yuhua Chen |
| K083299 |
12/10/2008 |
TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THERMOMETERS & FORA IR16/17 EAR THERMOMETER |
TaiDoc Technology Corporation |
JEFF WANG |
| K083440 |
12/12/2008 |
PRIMATRIX DERMAL REPAIR SCAFFOLD |
TEI BIOSCIENCES INC. |
KENNETH JAMES |
| K083301 |
12/18/2008 |
X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
JUNKO KUROSAWA |
| K082637 |
12/22/2008 |
CRANIAL PERFORATOR |
THE ANSPACH EFFORT, INC. |
JIM BANIC |
| K082086 |
12/19/2008 |
KEY RING ALCOHOL BREATHALYZER |
THE ASHLEY COLLECTION, INC. |
ROBERT GOLDY |
| K081827 |
12/19/2008 |
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K080499 |
12/08/2008 |
MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 |
THE MAGSTIM COMPANY LTD. |
ANWEN EVANS |
| K082909 |
12/23/2008 |
RSVP HALF SPHERE PHANTOM, MODEL DDP010 |
THE PHANTOM LABORATORY, INC. |
JOSHUA R LEVY |
| K081083 |
12/19/2008 |
CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS |
Thermo Fisher Scientific |
JACK ROGERS |
| K082962 |
12/04/2008 |
TIVAMED COOLED RF SYSTEM, MODEL 78001 |
TIVAMED, INC. |
SHELLEY TRIMM |
| K081608 |
12/19/2008 |
PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS) |
TOBY ORTHOPAEDICS, LLC |
AL WEISENBORN |
| K083348 |
12/23/2008 |
IMAGE-ARENA APPLICATIONS |
TOMTEC IMAGING SYSTEMS, GMBH |
INGE SCHEIDT |
| K083282 |
12/12/2008 |
MODEL TSX-301B AQUILION CT SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K082972 |
12/05/2008 |
KODAK 9500 |
TROPHY |
MARIE-PIERRE LABAT-CAMY |
| K081852 |
12/12/2008 |
TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11 |
TRULY INSTRUMENT LIMITED |
YANG JIANHAO |
| K083434 |
12/23/2008 |
TT1 GENERAL PURPOSE COIL |
TURSIOP TECHNOLOGIES LLC |
|
| K083454 |
12/04/2008 |
NUOVOCATH |
U.S. SAFETY SYRINGES CO., INC. |
CHRISTINE SMITH |
| K082546 |
12/02/2008 |
REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91) |
UNIMED MEDICAL SUPPLIES INC. |
DON MELNIKOFF |
| K082424 |
12/16/2008 |
UNITED U2 TOTAL KNEE SYSTEM |
UNITED ORTHOPEDIC CORP. |
RUDY CHEN |
| K083535 |
12/15/2008 |
HEARTRAK SMART ECAT |
UNIVERSAL MEDICAL, INC. |
JOYCE W DEAN |
| K082701 |
12/18/2008 |
URONIRS, MODEL 2000 |
URODYNAMIX TECHNOLOGIES LTD |
ANDRE KINDSVATER |
| K082801 |
12/22/2008 |
PHANTOM PLUS CAGE SYSTEM |
US SPINE |
PETER HARRIS |
| K080022 |
12/09/2008 |
GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP |
VASCULAR SOLUTIONS, INC. |
DEBORAH NEYMARK |
| K082481 |
12/17/2008 |
FLOWPICC CATHETER |
VASONOVA INC. |
TINA CHENG |
| K082456 |
12/01/2008 |
VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600 |
VERATHON INCORPORATED |
RICHARD A ZEINE |
| K083293 |
12/05/2008 |
VIATRONIX V3D-CARDIAC, REVISION 1.0 |
VIATRONIX, INC. |
DONGQING CHEN |
| K082709 |
12/29/2008 |
VICOR PD2I ANALYZER, VERSION 2.1 |
VICOR TECHNOLOGIES, INC. |
JULES MITCHEL |
| K082269 |
12/12/2008 |
VISAGE PACS, VERSION 6.0/CS 3.1 |
VISAGE IMAGING, INC. |
STEFAN STROWICH |
| K082355 |
12/15/2008 |
VISIONSENSE STEREOSCOPIC VISION SYSTEM |
VISIONSENSE, LTD. |
GERARD J PRUD'HOMME |
| K082607 |
12/05/2008 |
MRI-PLAQUE VIEW, VERSION 1.1.2003 |
VPDIAGNOSTICS, INC |
MICHAEL HARTMANN |
| K082673 |
12/12/2008 |
CONSERVE PRESSFIT FEMORAL COMPONENT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
THERESA LEISTER |
| K083202 |
12/15/2008 |
COMBOCARE 2000 |
XANACARE TECHNOLOGIES, LLC |
ROBERT N CLARK |
| K082630 |
12/19/2008 |
VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES |
ZEFON INTL. |
SCOTT RYAN |
| K083474 |
12/23/2008 |
ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT |
ZIMMER DENTAL INC. |
WILLIAM FISHER |
| K082639 |
12/19/2008 |
ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS |
ZIMMER DENTAL INC. |
WILLIAM FISHER |
| K082770 |
12/11/2008 |
ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL |
ZIMMER, INC. |
DANIEL J WILLIMAN |
| K082527 |
12/18/2008 |
ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS |
ZIMMER, INC. |
ANTHONY FRANCALANCIA |
| K083084 |
12/19/2008 |
CT BRAIN PERFUSION FOR ZIOSTATION |
ZIOSOFT, INC. |
RICHARD BALL |
| K080903 |
12/04/2008 |
ZOLL E SERIES WITH INTIBATION ASSIST OPTION |
ZOLL MEDICAL CORPORATION |
EILEEN M BOYLE |
| K081828 |
12/09/2008 |
ZOLL R SERIES BLS DEFIBRILLATOR |
ZOLL MEDICAL CORPORATION |
EILEEN M BOYLE |
