| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K072733 |
02/15/2008 |
3M ESPE ADULT CROWN |
3M COMPANY |
SCOTT ERICKSON |
| K083610 |
12/17/2008 |
FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE |
3M COMPANY |
SCOTT ERICKSON |
| K072055 |
02/26/2008 |
LAVA FRAME, LAVA FRAME SHADE |
3M ESPE AG DENTAL PRODUCTS |
DESI W SOEGIARTO |
| K073697 |
02/15/2008 |
TRANSBOND SUPREME ADHESIVE |
3M UNITEK |
L. MARLYN SCHEFF |
| K082985 |
12/17/2008 |
A-DEC 334/335 DELIVERY SYSTEM |
A-DEC, INC. |
THOMAS H LOUISELL |
| K073322 |
02/22/2008 |
FOX 1-980, FOX Q-1064, FOX-Q-810 |
A.R.C. LASER GMBH |
KIRSTEN H PAULSON |
| K073120 |
02/29/2008 |
ACCIN PATELLOFEMORAL SYSTEM |
ACCELERATED INNOVATION, LLC |
MICHAEL KVITNITSKY |
| K073531 |
02/04/2008 |
ACCIN PEDICLE SCREW SYSTEM |
ACCELERATED INNOVATION, LLC |
MICHAEL KVITNITSKY |
| K081697 |
12/04/2008 |
THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 |
ACCESS SCIENTIFIC, INC. |
ALBERT MISAJON |
| K080074 |
02/14/2008 |
ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX |
ACE SURGICAL SUPPLY CO., INC. |
J. EDWARD CARCHIDI |
| 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 |
| K071532 |
02/19/2008 |
ALPHA INFUSION PUMP, MODEL A200, A450 |
ADVANCED INFUSION, INC. |
JAMES CHRISTENSEN |
| K081309 |
12/19/2008 |
E.COLI/P. AERUGINOSA PNA FISH |
ADVANDX, INC. |
HENRIK STENDER |
| K072993 |
02/08/2008 |
REUSABLE HEADREST WITH NASAL SEAL |
AEIOMED, INC. |
Gary Syring |
| K072899 |
02/06/2008 |
ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0 |
AESCULAP IMPLANT SYSTEMS, INC. |
MATTHEW M HULL |
| K081960 |
12/17/2008 |
INVISALIGN SYSTEM |
ALIGN TECHNOLOGY |
SANGEETA SACHDEVA |
| K071849 |
12/04/2008 |
ALLOFUSE GEL AND PUTTY |
ALLOSOURCE, INC. |
PAMELA VETTER |
| K080176 |
02/29/2008 |
ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM |
ALOKA CO., LTD. |
RICHARD CEHOVSKY |
| 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 |
| K080069 |
02/13/2008 |
DIMERTEST |
AMERICAN DIAGNOSTICA, INC. |
LEIGH AYRES |
| 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 |
| K080290 |
02/22/2008 |
XVIEWNET |
AMERICAN RADIOLOGIST NETWORK, INC. |
IAN GORDON |
| 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. |
|
| K073446 |
02/08/2008 |
GRIND GUARD |
ARCHTEK, INC. |
IAN P GORDON |
| K083370 |
12/12/2008 |
D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006 |
ARTEGRAFT, INC. |
LAURENCE A POTTER |
| K080111 |
02/13/2008 |
ARTHREX COMPRESSION STAPLE |
ARTHREX, INC. |
SALLY FOUST |
| K082999 |
12/30/2008 |
ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART |
ARTHREX, INC. |
NANCY HOFT |
| K073149 |
02/11/2008 |
MENISCAL CINCH |
ARTHREX, INC. |
SALLY FOUST |
| K080282 |
02/15/2008 |
ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00; |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| 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 |
| K073258 |
02/14/2008 |
ATLANTIS ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI + ABUTMENT |
ATLANTIS COMPONENTS, INC. |
BETSY A BROWN |
| K073540 |
02/29/2008 |
ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT |
ATLANTIS COMPONENTS, INC. |
BETSY A BROWN |
| K072409 |
02/12/2008 |
AFINION ACR AND ACR CONTROL |
AXIS-SHIELD POC AS |
JORUNN GREVIE LOLLAND |
| K073007 |
02/14/2008 |
CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL |
BARCOVIEW, MEDICAL IMAGING SYSTEMS |
NEIL PHILLIPS |
| K082749 |
12/04/2008 |
OMNI-TIGHT |
BASIC DENTAL IMPLANT SYSTEMS, INC. |
DAN BLACKLOCK |
| K073184 |
02/21/2008 |
BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS |
BAUSCH & LOMB, INC. |
DEBRA KETCHUM |
| 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 |
| K070259 |
02/21/2008 |
EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR |
BEDFONT SCIENTIFIC LTD. |
E.J. Smith |
| K072274 |
02/29/2008 |
MAJOR III BLOOD GLUCOSE MONITORING SYSTEM |
BESTGEN BIOTECH CORP. |
JEN KE-MIN |
| K081522 |
12/05/2008 |
BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY |
BIO NUCLEAR DIAGNOSTICS, INC. |
SURENDER CHOUDHRY |
| K073438 |
02/07/2008 |
PROSTIM 1000/2000 |
BIO PROTECH, INC. |
E.J. Smith |
| K073626 |
02/05/2008 |
BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM |
BIO-LOGIC SYSTEMS CORP. |
NICOHL WILDING |
| 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 |
| K073268 |
02/08/2008 |
BIOHORIZONS INTERNAL IMPLANT SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON GREER |
| K073282 |
02/15/2008 |
BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON GREER |
| 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 |
| K071363 |
02/12/2008 |
WATERLASE AND WATERLASE MD |
BIOLASE TECHNOLOGY, INC. |
IOANA RIZOU |
| K073063 |
02/27/2008 |
15W CERALAS D 1470NM DIODE LASER |
BIOLITEC, INC. |
JONATHAN S KAHAN |
| K082225 |
12/03/2008 |
15W CERALAS D 1470NM DIODE LASER, MODEL D1470 |
BIOLITEC, INC. |
JONATHAN S KAHAN |
| K073091 |
02/29/2008 |
VIDAS NT-PROBNP ASSAY, MODEL: 30 449 |
BIOMERIEUX, INC. |
NIKITA S MAPP |
| K080766 |
12/23/2008 |
VIDAS RUB IGG |
BIOMERIEUX, INC. |
NIKITA S MAPP |
| K080107 |
02/28/2008 |
VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM |
BIOMERIEUX, INC. |
Nancy Weaver |
| K070961 |
02/25/2008 |
BIOMERIX SURGICAL MESH, MODEL: RCR-01 |
BIOMERIX CORPORATION |
CHRISTINA L KICHULA |
| K083070 |
12/16/2008 |
TOGGLELOC SYSTEM |
BIOMET SPORTS MEDICINE |
ROBERT FRIDDLE |
| K082008 |
12/11/2008 |
BIONET BM3PLUS PATIENT MONITOR |
BIONET CO., LTD. |
YINGCHAO XIAO |
| K072054 |
02/28/2008 |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310 |
BIONIME CORPORATION |
SUSAN D GOLDSTEIN-FALK |
| 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 |
| K072123 |
02/01/2008 |
HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE |
BIOWAVE CORPORATION |
MARY MCNAMARA-CULLINANE |
| K073263 |
02/14/2008 |
PRO-V |
BISCO, INC. |
BENJAMIN LICHTENWALNER |
| K082652 |
12/30/2008 |
BITTAR ZIRCONIA BLOCKS |
BITTAR ZIRCONIA BLOCK, LLC |
STUART R GOLDMAN |
| K073420 |
02/14/2008 |
BLACKSTONE ASCENT MULTIAXIAL SCREWS |
BLACKSTONE MEDICAL, INC. |
WHITNEY G TORNING |
| 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 |
| K073266 |
02/27/2008 |
WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM |
BOSTON SCIENTIFIC CORP. |
NEIL KELLY |
| K071702 |
02/15/2008 |
BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 |
BREAS MEDICAL AB |
IBB JESSEN |
| 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 |
| K073686 |
02/27/2008 |
C.T.M. POWER CHAIR, MODEL HS-1500 |
C.T.M. HOMECARE PRODUCT, INC. |
LINDA J BOVARD |
| K081855 |
12/19/2008 |
IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) |
CANADA, INC. |
FEDERICO FORERO |
| K080333 |
02/22/2008 |
IMAGEGRID |
CANDELIS, INC. |
CARL ALLETTO |
| 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 |
| K073194 |
02/14/2008 |
CMRTOOLS AND PLUG-INS VENTRICULAR TOOLS & THALASSAEMIA TOOLS |
CARDIOVASCULAR IMAGING SOLUTIONS LTD. |
CARL THOMAS |
| 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 |
| K073036 |
02/25/2008 |
FORE-SIGHT, MC-2000 SERIES |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
| K080558 |
12/05/2008 |
STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS |
CASE MEDICAL, INC. |
TANIA LUPU |
| K073426 |
02/19/2008 |
APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM |
CAYENNE MEDICAL, INC. |
KERESHMEH SHAHRIARI |
| 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 |
| K073669 |
02/13/2008 |
ORIA NATURA SPACER |
CHOICE SPINE, LP |
KAREN E WARDEN |
| K073459 |
02/28/2008 |
CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES |
CIBA VISION CORPORATION |
ALICIA M PLESNARSKI |
| K072947 |
02/08/2008 |
SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS |
CLEARSTREAM TECHNOLOGIES, LTD. |
IAN P GORDON |
| K072851 |
02/20/2008 |
POLYSTAR 79 DENTURE BASE RESIN |
CMP INDUSTRIES LLC. |
DEVON O HOWE |
| K071663 |
02/15/2008 |
VF GEL PLUS |
COAPT SYSTEMS, INC. |
LINDA RUEDY |
| K073061 |
02/29/2008 |
THE PROXIVENT KIT |
COLL PARTNERS LTD. |
ELI M ORBACH |
| K071557 |
02/08/2008 |
COLLAWOUND HYDROGEL |
COLLAMATRIX CO., INC. |
DENNIS J.N. SEAH |
| K081768 |
12/23/2008 |
COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES |
COOK INCORPORATED |
SUSANNE GALIN |
| K073528 |
02/27/2008 |
VENA CAVA FILTER |
COOK INCORPORATED |
MOLLY BUSENBANK |
| K062798 |
02/06/2008 |
SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB |
CORDIS CORP. |
KAREN WILK |
| 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 |
| K073557 |
02/28/2008 |
EEG NEUROAMP, MODEL CS10137 |
CORSCIENCE GMBH & CO. KG |
CHRISTINE BAUMANN |
| K071148 |
02/06/2008 |
ATLAS IMPLANT SYSTEM |
COWELL MEDI CO., LTD. |
CHANG D KYU |
| K033484 |
02/07/2008 |
HUMAN HEART VALVE, CRYOVALVE SG |
CRYOLIFE, INC. |
DAVID M FRONK |
| K080006 |
02/28/2008 |
AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE |
CYNOSURE, INC. |
GEORGE CHO |
| 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 |
| K073072 |
02/21/2008 |
DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B |
DADE BEHRING, INC. |
PAMELA A JURGA |
| K073561 |
02/26/2008 |
DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR |
DADE BEHRING, INC. |
HELEN M LEE |
| K080114 |
02/15/2008 |
HUAYI H035 BASIC WHEELCHAIR |
DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD |
NORMAN F ESTRIN |
| 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 |
| K073067 |
02/15/2008 |
ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K073073 |
02/12/2008 |
ANKYLOS TEMPORARY ABUTMENT BALANCE |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| 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 |
| K073570 |
02/21/2008 |
DEPUY TRI-LOCK BONE PRESERVATION STEM |
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 |
| K072270 |
02/01/2008 |
DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) |
DIAZYME LABORATORIES |
CHARLES YU |
| 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 |
| K073163 |
02/28/2008 |
LIMITED ARTIFACT SKULL PIN, MODEL 0107 |
DINKLER SURGICAL DEVICES, INC. |
CHARLES E DINKLER II |
| K083050 |
12/29/2008 |
EVITE XL |
DRAEGER MEDICAL AG & CO. KG |
JOYCE KILROY |
| K072412 |
02/06/2008 |
OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500 |
DRAGER MEDICAL AG & CO. KGAA |
KATHY ANDERSON |
| K073331 |
02/19/2008 |
DVO EXTENDED ARTICULATION HUMERAL HEADS |
DVO EXTREMITY SOLUTIONS, LLC |
JEFF ONDRLA |
| K073116 |
02/28/2008 |
EBI INTERNAL IMPLANT SYSTEM |
EBI, INC. |
DANIEL KAMM |
| K082308 |
12/09/2008 |
MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR |
EDWARDS LIFESCIENCES, LLC. |
JASON SMITH |
| K071343 |
02/28/2008 |
ELLMAN NOBLE ALLOY ELECTRODES |
ELLMAN INTERNATIONAL, INC. |
JOSEPH AZARY |
| 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 |
| K073510 |
02/11/2008 |
ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM |
ENDIUS, INC. |
REGINA WAGNER |
| K082233 |
12/18/2008 |
VIKY |
ENDOCONTROL |
CARINE HUGUEL |
| K082380 |
12/03/2008 |
VICARDIO 12B |
ENERGY-LAB TECHNOLOGIES GMBH |
GEORGE MYERS |
| K080032 |
02/28/2008 |
ENVOYCEM, MODEL 1640 |
ENVOY MEDICAL CORPORATION |
BERNARD (BUD) HORWATH |
| K072005 |
02/07/2008 |
RK EPIDURAL NEEDLE |
EPIMED INTERNATIONAL |
KATIE ALEXANDER |
| K073096 |
02/07/2008 |
ANCHORAGE CLOSURE DEVICE |
EPITEK, INC. |
WERNER HAMPL |
| K083452 |
12/31/2008 |
ERBE MODEL VIO 300 D WITH ACCESSORIES |
ERBE USA, INC. |
JULIE STEPHENS |
| K080119 |
02/21/2008 |
CLEARSCAN |
ESI, INC. |
GEORGE MYERS |
| 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 |
| K073046 |
02/25/2008 |
ETHICON ENDO SURGERY ARTICULATING NEEDLE KNIFE, MODEL 2504 |
ETHICON ENDO-SURGERY, INC. |
GLENDA C MARSH |
| K082854 |
12/04/2008 |
NANOCORSS .014 OTW PTA DILATATION CATHETER |
EV3 INC. |
David Worrell |
| K073688 |
02/29/2008 |
EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW |
EXACTECH, INC. |
GRAHAM CUTHBERT |
| 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 |
| K071432 |
02/12/2008 |
SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE |
FOX HOLLOW TECHNOLOGIES |
MELISSA S MURPHY |
| K083542 |
12/29/2008 |
FRESENIUS STERILE STAY SAFE CAP |
FRESENIUS MEDICAL CARE NORTH AMERICA |
JANET KAY |
| K073650 |
02/06/2008 |
FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371 |
FUJIFILM MEDICAL SYSTEMS USA, INC. |
DANIEL KAMM |
| K072093 |
02/01/2008 |
PRISMAFLEX SYSTEM, VERSION 3.20 |
GAMBRO |
THOMAS B DOWELL |
| K072908 |
02/04/2008 |
PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY |
GAMBRO RENAL PRODUCTS |
FEI LAW |
| K072100 |
02/14/2008 |
GC AADVA ABUTMENT |
GC AMERICA, INC. |
H. CARL JENKINS |
| K073283 |
02/20/2008 |
GC GAM-100 |
GC AMERICA, INC. |
MARK HEISS |
| K073588 |
02/15/2008 |
GC MODELS OPA-100 AND JC-50 |
GC AMERICA, INC. |
MARK HEISS |
| K073138 |
02/26/2008 |
CARDIQ EXPRESS VERSION 2.0 |
GE MEDICAL SYSTEMS |
STEPHEN SLAVENS |
| K083504 |
12/12/2008 |
GE DISCOVERY NM/CT 570C |
GE MEDICAL SYSTEMS F.I. HAIFA |
LAURENCE BIGIO |
| K073153 |
02/26/2008 |
CARDIQ FUNCTION XPRESS |
GE MEDICAL SYSTEMS SCS |
|
| 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 |
| K073154 |
02/14/2008 |
FACTS HAND AND PINCH GRIP COMBO |
GLOBAL SERVICES GROUP, LLC |
RAY GAGNE |
| 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 |
| K080169 |
02/08/2008 |
HEARTSTRING III PROXIMAL SEAL SYSTEM |
GUIDANT CORPORATION, CARDIAC SURGERY |
ELIZABETH TRUJILLO |
| 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 |
| K071149 |
02/01/2008 |
HRI 6500, 6600 AND 6700 SERIES V2MASKS |
HANS RUDOLPH, INC. |
KEVIN RUDOLPH |
| K073576 |
02/22/2008 |
NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES |
HAROD ENTERPRISES, INC. |
NORRIS R HAROD |
| K080091 |
02/05/2008 |
MODIFICATION TO:HEALTH BUDDY APPLIANCE |
HEALTH HERO NETWORK, INC. |
ROBIN BUSH SAWAMURA |
| K073314 |
02/21/2008 |
HEANY INDUSTRIES INC DENTAL XIRCONIA |
HEANY INDUSTRIES INC |
COREY DUNN |
| K080421 |
02/29/2008 |
HEART SYNC, MODELS C-100 AND T-100 |
HEART SYNC LLC |
STEPHEN SHULMAN |
| K080242 |
02/27/2008 |
HEARTWAY POWER MOBILITY SCOOTER, PF7 |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
JEN KE-MIN |
| K073554 |
02/04/2008 |
NEUN |
HERAEUS KULZER GMBH |
CHERYL V ZIMMERMAN |
| 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 |
| K080062 |
02/11/2008 |
OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120 |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLEWAITE |
| 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 |
| K073527 |
02/14/2008 |
VARIAX ELBOW SYSTEM |
HOWMEDICA OSTEONICS CORP |
FRANCISCO HARO |
| K073076 |
02/15/2008 |
HOFFMANN LIGHT SYSTEM |
HOWMEDICA OSTEONICS CORP. |
FRANCISCO HARO |
| K083437 |
12/18/2008 |
MODIFICATION TO T2 RECON NAIL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
AVITAL MERL-MARGULIES |
| K073332 |
02/14/2008 |
V-RASER DIODE LASER SYSTEM |
HOYA CONBIO, INC |
LIZA BURNS |
| K073369 |
02/27/2008 |
EI DOWNPAK BARRIER SLEEVES |
HU-FRIEDY MFG. CO., INC |
KEITH DUNN |
| K080077 |
02/13/2008 |
CLAVE STOPCOCK |
ICU MEDICAL, INC |
TRACY BEST |
| 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 |
| K072382 |
02/15/2008 |
MODEL I-2000 MONITOR |
INFINITE BIOMEDICAL TECHNOLOGIES |
MANAN HATHI |
| 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 |
| K073145 |
02/12/2008 |
QUANTA LITE H-TTG SCREEN |
INOVA DIAGNOSTICS, INC. |
JOSEPH PHILLIPS |
| K072632 |
02/11/2008 |
QUANTA PLEX CELIAC IGG PROFILE |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| 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 |
| K073384 |
02/28/2008 |
SMART COUPLER, MODEL M015401 |
INTELLIGENT HEARING SYSTEMS |
EDWARD MISKIEL |
| K072254 |
02/05/2008 |
VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM |
INTERACOUSTICS A/S |
DANIEL EGGAN |
| K082795 |
12/12/2008 |
SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT |
INTERVENTIONAL SPINE, INC. |
CAROL EMERSON |
| K072627 |
02/07/2008 |
INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCER |
INTUITIVE SURGICAL, INC. |
MICHAEL H YRAMATEGUI |
| K081207 |
12/19/2008 |
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE |
INTUITIVE SURGICAL, INC. |
JERRY TSUTSUMI |
| K070947 |
02/14/2008 |
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPER |
INTUITIVE SURGICAL, INC. |
MICHAEL H YRAMATEGUI |
| K072211 |
02/28/2008 |
INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS |
INTUITIVE SURGICAL, INC. |
MICHAEL H YRAMATEGUI |
| K071307 |
02/12/2008 |
INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003 |
INVIRO MEDICAL DEVICES, INC. |
JIM BARLEY |
| 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 |
| K072609 |
02/12/2008 |
SINGLE STEP MEDIUM |
IRVINE SCIENTIFIC SALES CO., INC. |
WENDELL LEE |
| K070541 |
12/11/2008 |
IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II |
IVIVI TECHNOLOGIES, INC. |
ANDRE DIMINO |
| K073704 |
02/21/2008 |
I-DIXEL |
J. MORITA USA, INC. |
KEITH A BARRITT |
| 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 |
| K071866 |
02/01/2008 |
NTRAINER SYSTEM |
KCBIOMEDIX, INC. |
JAMES E STANLEY |
| K073162 |
02/08/2008 |
SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING |
KENSEY NASH CORPORATION |
ROBIN FATZINGER |
| K080229 |
02/29/2008 |
5.5 MM SUTURE LOCK BONE SCREW ANCHOR |
KFX MEDICAL |
GAYLE HIROTA |
| K080253 |
02/26/2008 |
KIMBERLY-CLARK INTRODUCER KITS |
KIMBERLY-CLARK CORP. |
SHERRY SAURINI |
| K062763 |
02/22/2008 |
NONCON ROBO PACHY F&A |
KONAN MEDICAL, INC. |
GEORGE MYERS |
| K082509 |
12/15/2008 |
EOS SPINAL SYSTEM |
KOREA BONE BANK CO., LTD |
JUNG BAE BANG |
| K073516 |
02/21/2008 |
DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR |
KYPHON, INC. |
PAMELA SEGALE |
| K082922 |
12/09/2008 |
FREEWAY AND RAILRUNNER GUIDEWIRES |
LAKE REGION MFG., INC. |
DEEP PAL |
| K080144 |
02/26/2008 |
MANDREL GUIDEWIRES OR M-WIRES |
LAKE REGION MFG., INC. |
DEEP PAL |
| K080173 |
02/08/2008 |
STAR 55 |
LARSEN & TOUBRO LIMITED |
S.B. BHOSALE |
| K071490 |
02/22/2008 |
LEONE ORTHODONTIC MINI IMPLANT |
LEONE SPA |
ELIA LADANI |
| K080106 |
02/01/2008 |
SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE |
LEONHARD LANG GMBH |
ELAINE DUNCAN |
| K082590 |
12/17/2008 |
SYMPHONY METER REMOTE |
LIFESCAN, INC. |
MARTHA MURARI |
| K062991 |
02/15/2008 |
GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE |
LIGHT BIOSCIENCE, LLC |
JONATHAN S KAHAN |
| 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 |
| K073024 |
02/08/2008 |
MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K073337 |
02/13/2008 |
MECTACER BIOLOX FORTE-FEMORAL HEADS |
MEDACTA INTERNATIONAL, SA |
NATALIE J KENNEL |
| K082792 |
12/29/2008 |
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS |
MEDACTA INTERNATIONAL, SA |
NATALIE J KENNEL |
| K072857 |
02/04/2008 |
TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT |
MEDACTA INTERNATIONAL, SA |
PAMELA J WEAGRAFF |
| 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 |
| K072494 |
02/12/2008 |
AG-CLASSIC |
MEDEL S.P.A. |
TERRANCE M O'BRIEN |
| K080810 |
12/10/2008 |
EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT |
MEDICA CORP. |
Photios Makris |
| K072249 |
02/20/2008 |
EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT |
MEDICA CORP. |
FRAN WHITE |
| K082472 |
12/30/2008 |
VIROCULT, MODEL MW950 |
MEDICAL WIRE & EQUIPMENT COMPANY (BATH) LTD |
DAVID ELLIS |
| K080113 |
02/15/2008 |
APEX DAL ELECTRONIC APEX LOCATOR |
MEDICNRG LTD. |
GEORGE J HATTUB |
| 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 |
| K072447 |
02/15/2008 |
PENTABORN |
MEDISCITEC INC. |
Kevin Walls |
| K081355 |
12/18/2008 |
BIOFLEX LD-R100 TREATMENT HEAD |
MEDITECH INTERNATIONAL, INC. |
FRED KAHN |
| K072942 |
02/08/2008 |
MEDLINE DISPOSABLE VAGINAL SPECULUM |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K080334 |
02/21/2008 |
INSTARAD |
MEDSPHERE TECHNOLOGIES PVT LTD. |
CARL ALLETTO |
| 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 |
| K080288 |
02/15/2008 |
TRAVEL PAL FOUR WHEEL SCOOTER, MODEL MM114 |
MEGA MOTION, INC. |
TOM AMICO |
| 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 |
| K073110 |
02/06/2008 |
MERITS E600 SERIES STAIR LIFT |
MERITS HEALTH PRODUCTS CO., LTD. |
STEVE CHAO |
| K073079 |
02/14/2008 |
THUMPER, MODEL: 1008 |
MICHIGAN INSTRUMENTS, INC. |
HOWARD M HOSTEIN |
| 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 |
| K073442 |
02/26/2008 |
MICRUS MICROCOIL SYSTEMS |
MICRUS ENDOVASCULAR CORPORATION |
JULIA GROSS |
| K072563 |
02/12/2008 |
MILTEX RIGID CONTAINER SYSTEMS |
MILTEX, INC. |
PATRICIA KIHN |
| 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 |
| K072189 |
02/05/2008 |
PATHFAST NTPROBNP AND D-DIMER TESTS |
MITSUBISHI KAGAKU IATRON |
HELEN LANDICHO |
| K082946 |
12/29/2008 |
MORTARA ELI 350 ELECTROCARDIOGRAPH |
MORTARA INSTRUMENT, INC. |
CHARLES MORREALE |
| K073646 |
02/25/2008 |
MINITAPE URETHRAL SLING |
MPATHY MEDICAL DEVICES, LTD. |
LOUIS J MAZZARESE |
| K073329 |
02/28/2008 |
SYGNAL DBM |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY BENNEWITZ |
| K073521 |
02/04/2008 |
MUSMATE WALKING AID |
MUSMATE LTD |
ANDREW JAMES WYND |
| K082203 |
12/30/2008 |
NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025 |
NCONTACT SURGICAL, INC. |
JANE RICUPERO |
| K080320 |
02/21/2008 |
PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300 |
NDS SURGICAL IMAGING |
JIM LANG |
| K073596 |
02/22/2008 |
NEOMED SINGLE LUMEN UMBILICAL CATHETER |
NEOMED, INC. |
PENNY NORTHCUTT |
| K073651 |
02/01/2008 |
NEOTRACT ANCHOR SYSTEM |
NEOTRACT, INC. |
SUZAN MOSER |
| K080219 |
02/28/2008 |
MODIFICATION TO:NESS L300 |
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS |
EVAN ROSENFELD |
| 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 |
| K073375 |
02/21/2008 |
NEWDEAL TIBIAXYS SYSTEM |
NEWDEAL SAS |
JUDITH O'GRADY |
| 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 |
| K080342 |
02/26/2008 |
NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES |
NIHON KOHDEN AMERICA, INC. |
JACK COGGAN |
| K071596 |
02/15/2008 |
POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7 |
NIHON SEIMITSU SOKKI CO., LTD. |
KOJI KUBO |
| K072988 |
02/21/2008 |
NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD |
| 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 |
| K072129 |
02/22/2008 |
NOBELACTIVE ZIRCONIA ABUTMENT |
NOBEL BIOCARE AB |
HERBERT CRANE |
| 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 |
| K073489 |
02/11/2008 |
OLYMPUS IGA REAGENT |
OLYMPUS AMERICA INC. |
STEPHANIE G DONNELLY |
| K073490 |
02/11/2008 |
OLYMPUS IGG REAGENT |
OLYMPUS AMERICA INC. |
STEPHANIE G DONNELLY |
| K073487 |
02/11/2008 |
OLYMPUS IGM REAGENT |
OLYMPUS AMERICA INC. |
STEPHANIE G DONNELLY |
| K081173 |
12/23/2008 |
ENDOSCOPIC CO2 REGULATION UNIT UCR |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K073150 |
02/27/2008 |
APEX-LNK POLY ACETABULAR CUP LINERS |
OMNI LIFE SCIENCE, INC. |
EDWARD J CHEAL |
| K083335 |
12/15/2008 |
MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM |
OMNISONICS MEDICAL TECHNOLOGIES |
ANNE M KULIS |
| K073602 |
02/14/2008 |
MODIFICATION TO: APEX KNEE SYSTEM |
OMNLIFE SCIENCE |
WILLIAM MCCALLUM |
| K080289 |
02/26/2008 |
1500 PRO |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
| K080048 |
02/06/2008 |
MSK EXTREME MR SCANNER, MODEL AA5000 |
ONI MEDICAL SYSTEMS, INC. |
MARK PUOPOLO |
| K073407 |
02/28/2008 |
PACIFICA |
OR-NIM MEDICAL LTD. |
CAMPBELL HUTTON |
| 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 |
| K073344 |
02/19/2008 |
ORTHOPEDIATRICS PLATING SYSTEM |
ORTHOPEDIATRICS, LLC |
GARY BARNETT |
| K073228 |
02/29/2008 |
DC ULNAR SHORTENING SYSTEM |
ORTHOPRO LLC |
J.D. WEBB |
| K081786 |
12/02/2008 |
ZIOCERA & CONVERTIBLE SYSTEM |
OSSTEM IMPLANT CO LTD |
MINJOO KIM |
| K072959 |
02/04/2008 |
MS SYSTEM (DENTURE) |
OSSTEM IMPLANT CO.,LTD |
MIN JOO KIM |
| K073065 |
02/21/2008 |
OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM |
OSTEOMED L.P. |
PIEDAD PENA |
| K070985 |
02/01/2008 |
AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC |
OSYPKA MEDICAL, INC. |
MARKUS OSYPKA |
| K073568 |
02/06/2008 |
PSL BIOZIR BLOCK |
P.S.L. INTERNATIONAL INC. |
CATHERINE FENG |
| K080149 |
12/18/2008 |
HEATER BASE, MODEL PMH7000 |
PACIFIC MEDICO CO., LTD. |
YOSHIMO TOYAMA |
| K063350 |
02/01/2008 |
DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN QUASS |
| 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 |
| K072812 |
02/26/2008 |
PHILIPS HEARTSTART SMARTPADS III |
PHILIPS MEDICAL SYSTEMS |
LARRY WALKER |
| K083498 |
12/17/2008 |
PHILIPS MODEL MX 16 SLICE CT SYSTEM |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
MICHAEL CHILBERT |
| K072228 |
02/08/2008 |
SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) |
PINNACLE CO., LTD. |
DAVID DING |
| K072227 |
02/15/2008 |
VINYL EXAMINATION GLOVE POWDER FREE |
PINNACLE CO., LTD. |
DAVID DING |
| K072223 |
02/21/2008 |
VINYL EXAMINATION GLOVE, POWDERED |
PINNACLE CO., LTD. |
DAVID DING |
| 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 |
| K080145 |
02/28/2008 |
PRIMAEVA MEDICAL SYSTEM |
PRIMAEVA MEDICAL, INC. |
BRIAN GRIGSBY |
| K073224 |
02/06/2008 |
ORAL-B SUB-BRAND MANUAL TOOTHBRUSH |
PROCTER & GAMBLE |
MICHAEL A KAMINSKI |
| K080240 |
02/07/2008 |
CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE |
PROMIDENT LLC |
GARY KRIS |
| K073542 |
02/14/2008 |
CYCLETRAC CT-5000 |
PT PRODUCTS, LLC |
MICHELE CONWAY |
| K082302 |
12/09/2008 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM |
PT. MEDISAFE TECHNOLOGIES |
ANIL TANEJA |
| K072487 |
02/13/2008 |
FAST1 INTRAOSSEOUS INFUSION SYSTEM |
PYNG MEDICAL CORP. |
MAYA BUTTERFIELD |
| K081592 |
12/03/2008 |
POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES |
QUALITY GALLANT SDN. BHD. |
SEAH BEE HOON |
| K073549 |
02/28/2008 |
Q-PLUS T |
QUANTA SYSTEM, S.P.A. |
ISABELLA CARRER |
| 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 |
| K080206 |
02/26/2008 |
MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM |
RADI MEDICAL SYSTEMS AB |
HELENE EKSTRAND |
| 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 |
| K071839 |
02/27/2008 |
SOCT COPERNICUS, MODEL 15205 |
REICHERT, INC. |
SANDRA BROWN |
| K073349 |
02/13/2008 |
RELIANCE BUTTRESS WASHER SYSTEM |
Reliance Medical Systems, LLC |
Bret M Berry |
| K073243 |
02/08/2008 |
LED PRO SEAL |
RELIANCE ORTHODONTIC PRODUCTS, INC. |
PAUL GANGE |
| 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 |
| K072534 |
02/08/2008 |
BIO-MAT 2000 |
RICHWAY INTL., INC. |
LEROY KLIMA |
| K073419 |
02/14/2008 |
PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES |
RJ MEDICAL, INC. |
JIM INNES |
| K072437 |
02/05/2008 |
ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET |
Roche Diagnostics |
KAY TAYLOR |
| K080147 |
02/27/2008 |
ELECSYS PROBNP II CALCHECK |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| 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 |
| K073533 |
02/07/2008 |
SANARUS V2 TREATMENT SYSTEM |
SANARUS MEDICAL, INC. |
LISA HENRY |
| K070761 |
02/07/2008 |
SANATMETAL NAILS AND PINS |
SANATMETAL MFR. OF ORTHOPAEDIC/TRAUMATOLOGIC PROD. |
DONALD GUTHNER |
| K082116 |
12/17/2008 |
HEMOSTASYL PASTE |
SATELEC |
RICK ROSATI |
| K073319 |
02/04/2008 |
STATMATIC 31 HANDPIECE MAINTENANCE UNIT |
SCICAN LTD. |
BRENDA MURPHY |
| K073048 |
02/28/2008 |
PETERIO UNIVERSAL LASER SCANNING HANDPIECE |
SCILEX, LTD. |
ALEX RAPOPORT |
| 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 |
| K070126 |
02/08/2008 |
OCCLUSION BALLOON CATHETER |
SENTREHEART INC. |
LINDA GUTHRIE |
| 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 |
| K073366 |
02/08/2008 |
TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041 |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
CHARLES MACK |
| K072018 |
02/01/2008 |
BS-200 CHEMISTRY ANALYZER, MODE BS-200 |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| 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 |
| K080068 |
02/28/2008 |
BEAUTIFIL OPAQUER |
SHOFU DENTAL CORP. |
DAVID P MORAIS |
| K073418 |
02/29/2008 |
SYNGO IMAGING CCF VA10A |
SIEMENS AG, MEDICAL SOLUTIONS |
SABINE SCHROEDEL |
| 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 |
| K073290 |
02/11/2008 |
ARTIS ZEE AND ZEEGO |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
GARY JOHNSON |
| K081148 |
12/22/2008 |
SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
SHEILA PICKERING |
| K073003 |
02/07/2008 |
SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY |
SIEMENS MEDICAL SOLUTIONS, INC. |
CORRINE MCLEOD |
| 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 |
| K072107 |
02/14/2008 |
PERIOSCAN, MODEL: D 3496 |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
| K073466 |
02/22/2008 |
SMITH & NEPHEW INTRADISCAL CATHETER SYSTEM |
SMITH & NEPHEW, INC. |
MASON W ROBBINS |
| K073188 |
02/08/2008 |
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE |
SMITHS MEDICAL ASD, INC. |
BRIAN FARIAS |
| K082783 |
12/17/2008 |
CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE |
SMITHS MEDICAL MD, INC. |
PHIL NEURURER |
| K072955 |
02/13/2008 |
CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CARE (21-6276) |
SMITHS MEDICAL MD, INC. |
DAVID H SHORT |
| K071809 |
02/21/2008 |
ENSPLINTRX BONE FIXATION SYSTEM |
SONOMA ORTHOPEDIC PRODUCTS, INC. |
CHARLES L NELSON |
| K082344 |
12/17/2008 |
STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO) |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
| K073380 |
02/29/2008 |
SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL FILTER AND HARDSHELL VENOUS/CARIOTOMY RESERVOI |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
| 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 |
| K053527 |
02/01/2008 |
SPECTRA HAIR REMOVAL LASER |
SPECTRAGENICS, INC. |
JONATHAN S KAHAN |
| 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 |
| K073320 |
02/07/2008 |
CIMPLICITY SPINAL SYSTEM |
SPINE SMITH PARTNERS L.P. |
ROBERT JONES |
| 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 |
| K073232 |
02/20/2008 |
INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX |
SPINEFRONTIER, INC. |
THOMAS A CARLSON |
| 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 |
| K072158 |
02/21/2008 |
AQUA PURE DEIONIZER EXCHANGE SERVICE |
STAUBACH BARROR WATER SYSTEMS, INC. |
JARROD J STAUBACH |
| K081814 |
12/17/2008 |
REPROCESSED ENT SHAVERS |
STERILMED, INC. |
JOSHUA CLARIN |
| K073613 |
02/12/2008 |
REPROCESSED SCISSOR TIPS |
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 |
| K080016 |
02/05/2008 |
NRBC-CHEX FOR ADVIA |
Streck |
ERIN JOHNSON |
| 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 |
| K080143 |
02/14/2008 |
MODIFICATION TO STRYKER SPINE OASYS SYSTEM |
STRYKER SPINE |
CURTIS TRUESDALE |
| K073437 |
02/13/2008 |
THOR ANTERIOR PLATING SYSTEM |
STRYKER SPINE |
CURTIS TRUESDALE |
| K083109 |
12/04/2008 |
SUINSA DIAGNOSTIC X-RAY SYSTEM |
SUINSA |
DANIEL KAMM |
| K072757 |
02/08/2008 |
DIVE AND SHALLOW AND GRAND DIVE |
SUMMIT TO SEA |
BRUCE MCKEEMAN |
| 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 |
| K073460 |
02/21/2008 |
SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K083213 |
12/30/2008 |
SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K073402 |
02/29/2008 |
SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM |
SYNTHES (USA) |
KARL J NITTINGER |
| K082914 |
12/11/2008 |
CLAMPFIX |
SYNTHES SPINE |
JASON LIPMAN |
| K072981 |
02/11/2008 |
SYNTHES ZERO-P |
SYNTHES SPINE CO.LP |
SUSAN LEWANDOWSKI |
| 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 |
| K080234 |
02/14/2008 |
TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO |
TERATECH CORP. |
|
| 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 |
| K072889 |
02/01/2008 |
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER |
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 |
| K073027 |
02/28/2008 |
SPECTRA MRSA |
Thermo Fisher Scientific |
MARY ANN SILVIUS |
| K073191 |
02/28/2008 |
ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL |
THERMO FISHER SCIENTIFIC OY |
PAIVI SORMUNEN |
| K073355 |
02/28/2008 |
CALCIUM, SCAL, NORTROL, ABTROL |
THERMO FISHER SCIENTIFIC OY |
PAIVI SORMUNEN |
| K072856 |
02/15/2008 |
SPI VARIOMULTI ABUTMENT |
THOMMEN MEDICAL, AG |
LINDA K SCHULZ |
| 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 |
| K080160 |
02/08/2008 |
APLIO ARTIDA, MODEL SSH-880CV DIAGNOSTIC ULTRASOUND SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K083282 |
12/12/2008 |
MODEL TSX-301B AQUILION CT SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K071794 |
02/11/2008 |
15M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2123A (MS51I2) |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K073435 |
02/11/2008 |
KODAK 9000, KODAK 9000 3D |
TROPHY |
MARIE-PIERRE LABAT-CAMY |
| 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 |
| K080249 |
02/08/2008 |
FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505 |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
| K072802 |
02/29/2008 |
SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE |
ULTRAWIN SDN BHD |
SIEW-HOE MAH |
| 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 |
| K071896 |
02/22/2008 |
FOX 940, MODEL 940 |
VALAM INC. |
KIRSTEN PAULSON |
| K072704 |
02/19/2008 |
UNICOMPARTMENTAL KNEE |
VALPO ORTHOPEDIC TECHNOLOGY, INC. |
HANS STOVER |
| K073241 |
02/08/2008 |
VASCULAR PATHWAYS RIVS RAPID INTRAVASCULAR CATHETER START SYSTEM |
VASCULAR PATHWAYS |
MARY PASCUAL GALLUP |
| K073200 |
02/01/2008 |
GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582 |
VASCULAR SOLUTIONS, INC. |
JULIE TAPPER |
| 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 |
| K071560 |
02/08/2008 |
PROVENT NASAL DILATOR, MODEL BR2 |
VENTUS MEDICAL, INC. |
CINDY DOMECUS |
| K082456 |
12/01/2008 |
VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600 |
VERATHON INCORPORATED |
RICHARD A ZEINE |
| K080265 |
02/06/2008 |
DENFIL ETCHANT-37 |
VERICOM CO., LTD. |
MYUNG-HWAN OH |
| K080266 |
02/06/2008 |
WELL-PEX |
VERICOM CO., LTD. |
MYUNG-HWAN OH |
| K073338 |
02/26/2008 |
CELLSEARCH CIRCULATING TUMOR CELL KIT |
VERIDEX, LLC |
DEBRA J RASMUSSEN |
| K073245 |
02/15/2008 |
EXTENDED VERTIFLEX SPINAL SCREW SYSTEM |
VERTIFLEX, INC. |
STEVE REITZLER |
| 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 |
| K072821 |
02/20/2008 |
VITREA 4DCT |
VITAL IMAGES, INC. |
TIMOTHY J KAPPERS |
| K071199 |
02/01/2008 |
BONALIVE GRANULES |
VIVOXID LTD. |
CONSTANCE G BUNDY |
| K082607 |
12/05/2008 |
MRI-PLAQUE VIEW, VERSION 1.1.2003 |
VPDIAGNOSTICS, INC |
MICHAEL HARTMANN |
| K080295 |
02/27/2008 |
CHARLOTTE CLAW 3.5 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SARAH HOLTGREWE |
| K082673 |
12/12/2008 |
CONSERVE PRESSFIT FEMORAL COMPONENT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
THERESA LEISTER |
| K072656 |
02/06/2008 |
DYNASTY CERAMIC FEMORAL HEAD |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MATT PAUL |
| K080071 |
02/07/2008 |
SIDEKICK RAIL FIXATOR |
WRIGHT MEDICAL TECHNOLOGY, INC. |
PEGGY S RIVERS |
| K083202 |
12/15/2008 |
COMBOCARE 2000 |
XANACARE TECHNOLOGIES, LLC |
ROBERT N CLARK |
| K073457 |
02/01/2008 |
MSTAR MPD4500 |
XINAOMDT TECHNOLOGY CO., LTD. |
DIANA HONG |
| K072683 |
02/29/2008 |
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM |
XOFT, INC. |
ERIC HASHEMIAN |
| K072860 |
02/25/2008 |
YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500 |
YA HORNG ELECTRONIC CO., LTD. |
Ke-Min Jen |
| K080247 |
02/27/2008 |
QUIKCLOT NOSEBLEED |
Z-MEDICA CORPORATION |
RONALD E PETERSON |
| K082630 |
12/19/2008 |
VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES |
ZEFON INTL. |
SCOTT RYAN |
| K073620 |
02/27/2008 |
GUARDIAN HEMOSTASIS VALVE |
ZERUSA LIMITED |
GER BRETT |
| K072145 |
02/26/2008 |
MEDICAL GLOVE SERIES |
ZHANJIANG JIALI GLOVE PRODUCTS CO., LTD |
Diana Hong |
| 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 |
| K073347 |
02/08/2008 |
DYNESYS TOP-LOADING SPINAL SYSTEM |
ZIMMER SPINE, INC |
ELSA A LINKE |
| K080367 |
02/22/2008 |
ZIMMER MIS LIGHT |
ZIMMER SPINE, INC. |
ELSA A LINKE |
| 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 |
