FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K073284 |
12/14/2007 |
AIR-FLOW MASTER STANDARD |
(EMS SA) ELECTRO MEDICAL SYSTEMS |
SUSAN M BONAPACE |
K063023 |
02/23/2007 |
3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870 |
3M COMPANY |
DIANNE GIBBS |
K072697 |
12/20/2007 |
3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES |
3T MEDICAL SYSTEMS, LLC |
ROBERT P EATON |
K072637 |
12/11/2007 |
DIVO |
A2D IMAGING LLC |
DON WAUCHOPE |
K062554 |
02/06/2007 |
STARCLOSE HEX-HUB DILATOR |
ABBOTT VASCULAR INC. |
Daun Putnam |
K070225 |
12/13/2007 |
SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE |
ABIOMED, INC. |
ROBERT T KUNG |
K072354 |
12/07/2007 |
GUIDEWIRE, MODEL G-V220-3527S AND OTHERS |
ACCELLENT INC. |
KARL STEINECK |
K072836 |
12/27/2007 |
CHOLESTRAK HDL CHOLESTEROL HOME TEST |
ACCUTECH, LLC. |
Gary Lehnus |
K063418 |
02/02/2007 |
ACON DIGITAL THERMOMETER PROBE COVERS |
ACON LABORATORIES, INC. |
JINN-NAN LIN, PH.D |
K070028 |
02/08/2007 |
CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER |
ACTHERM, INC. |
RICHARD HSIEH |
K070197 |
02/23/2007 |
ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY |
ACUMEN MEDICAL, INC. |
Marybeth Gamber |
K062961 |
02/08/2007 |
MICROLUX TRANSILLUMINATOR |
ADDENT, INC. |
JOSHUA FRIEDMAN |
K071537 |
12/18/2007 |
STERRAD 100NX TEST PACK |
ADVANCED STERILIZATION PRODUCTS |
REUBEN LAWSON |
K073170 |
12/03/2007 |
R-PORT II LAPAROSCOPIC ACCESS DEVICE |
ADVANCED SURGICAL CONCEPTS |
MARY MCNAMARA-CULLINANE |
K062012 |
02/09/2007 |
S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM |
AESCULAP, INC. |
LISA M BOYLE |
K070238 |
02/28/2007 |
AMPLATZER RELIANT CATHETER DELIVERY SYSTEM |
AGA MEDICAL CORP. |
DAVID D COX |
DEN070009 |
02/06/2007 |
MAMMAPRINT |
AGENDIA BV |
GUILDO BRINK |
K073271 |
12/05/2007 |
ORTHOGON |
AGFA HEALTHCARE CORPORATION |
TOM HOLBROOK |
K070722 |
12/14/2007 |
PLASMAIR, MODEL T2006 |
AIRINSPACE B.V. |
WADE TETSUKA |
K063617 |
02/08/2007 |
EUSOL-C |
AL.CHI.MI.A |
GEORGE MYERS |
K061467 |
02/15/2007 |
EXSEPT WC WOUND CLEANSER |
ALCAVIS INTERNATIONAL, INC. |
GARY J MISHKIN |
K071236 |
12/12/2007 |
ALCON MULTI-PURPOSE SOLUTION |
ALCON, INC. |
KIM B KRACKE |
K071697 |
12/03/2007 |
NEURONAV SYSTEM AND NEURONAV DRIVE |
ALPHA OMEGA LTD. |
BAHEEJ DANIAL |
K070161 |
02/15/2007 |
QUATTRO CATHETER MODEL IC4593 |
ALSIUS CORP. |
KENNETH A COLLINS |
K063511 |
02/02/2007 |
CERAMILL ZI |
AMANN GIRRBACH AMERICA, INC. |
DANIEL KAMM |
K071164 |
12/07/2007 |
LIFE+CEL BATTERY |
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. |
ALEX HENDERSON |
K073125 |
12/05/2007 |
VALEO VBR |
AMEDICA CORP. |
ADAM HERDER |
K063713 |
02/22/2007 |
AMS SMART SLING SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
BRAD ONSTAD |
K063716 |
12/28/2007 |
AEROSOL SYSTEM |
AMICI, INC. |
MICHAEL BONO |
K070873 |
12/19/2007 |
AMSURE BLADDER IRRIGATION SET |
AMSINO INTL., INC. |
YI CHEN |
K072375 |
12/13/2007 |
SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET |
ANGIODYNAMICS, INC. |
BRIAN KUNST |
K071746 |
12/13/2007 |
DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES |
ANSELL HEALTHCARE PRODUCTS, LLC |
CYNTHIA A INGRAM |
K071671 |
12/28/2007 |
SCANSCOPE XT SYSTEM |
APERIO TECHNOLOGIES |
PERRY JOHNSTON |
K070088 |
02/16/2007 |
ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM |
APEX BIOTECHNOLOGY CORP. |
THOMAS Y.S. SHEN |
K062799 |
02/06/2007 |
GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM |
APEX BIOTECHNOLOGY CORP. |
BRUCE A MACFARLANE |
K072883 |
12/10/2007 |
ICE-SENSE |
ARBEL MEDICAL LTD. |
ZVI LADIN |
K071616 |
12/19/2007 |
ARC SURGICAL BIOTRAK PIN SYSTEM |
ARC SURGICAL LLC. |
ED BOEHMER |
K070069 |
02/05/2007 |
ZIPPREP ELECTRODE |
ASPECT MEDICAL SYSTEMS, INC. |
VIKRAM VERMA |
K061445 |
02/01/2007 |
SURGIMESH WN |
ASPIDE MEDICAL |
HOWARD M HOLSTEIN |
K062197 |
02/28/2007 |
ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT |
ATLANTIS COMPONENTS, INC. |
BETSY A BROWN |
K062069 |
02/14/2007 |
ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANT |
ATLANTIS COMPONENTS, INC. |
BETSY A BROWN |
K063205 |
02/26/2007 |
ATLAS SPINE VERTEBRAL BODY REPLACEMENT |
ATLAS SPINE LLC |
FLOYD G LARSON |
K060564 |
02/07/2007 |
INFINITI SYSTEM |
AUTOGENOMICS, INC |
EVELYN LOPEZ |
K072137 |
12/07/2007 |
AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB |
AVITA CORPORATION |
JENNIFER REICH |
K073205 |
12/19/2007 |
NIO 5MP, MODEL MDNG-5121 |
BARCOVIEW, MEDICAL IMAGING SYSTEMS |
NEIL PHILLIPS |
K063696 |
02/27/2007 |
COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163 |
BAXTERHEALTHCARE, INC. |
JEME WALLACE |
K063845 |
12/07/2007 |
ADVIA CHEMISTRY TOTAL BILIRUBIN_2 |
BAYER HEALTHCARE, LLC |
PHILIP LIU |
K072478 |
12/19/2007 |
BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD |
BAYLIS MEDICAL CO., INC. |
MEGHAL KHAKHAR |
K071026 |
12/20/2007 |
BD GENEOHM STAPHSR ASSAY |
BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC) |
RAYMOND BOULE |
K070144 |
02/01/2007 |
INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS |
BECKMAN COULTER, INC. |
TYLER J FOUTCH |
K063824 |
02/14/2007 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM (GN) 0.5-64UG/ML |
BECTON, DICKINSON & CO. |
JANINE MATLAK |
K063811 |
02/09/2007 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/ML |
BECTON, DICKINSON & CO. |
JANINE MATLAK |
K063704 |
02/20/2007 |
BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101 |
BEKS INCORPORATED |
JILL CREASY |
K073360 |
12/19/2007 |
PROPLATE |
BIO PROTECH, INC. |
E.J. Smith |
K072553 |
12/14/2007 |
SYSTEM-ARMS, MODEL 390,E60 |
BIO-MEDICAL RESEARCH, LTD. |
ANNE-MARIE KEENAN |
K072835 |
12/11/2007 |
LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK |
BIO-RAD, DIAGNOSTICS GRP. |
SUZANNE PARSONS |
K072721 |
12/11/2007 |
LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC |
BIO-RAD, DIAGNOSTICS GRP. |
ELIZABETH PLATT |
K072068 |
12/21/2007 |
BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS |
BIOARTIFICIAL GEL TECHNOLOGIES (BAGTECH) INC |
JONATHAN KAHAN |
K062756 |
02/20/2007 |
PATHIAM IMAGING SOFTWARE FOR HER2/NEU |
BIOIMAGENE, INC. |
ANNA LONGWELL |
K072078 |
12/19/2007 |
QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 |
BIOKIT S.A. |
JOAN GUIXER |
K071210 |
12/19/2007 |
MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 |
BIOMEDICAL DIAGNOSTICS (BMD) SA |
COURIVAUD CHRISTELLE |
K070458 |
12/21/2007 |
MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 |
BIOMEDICAL DIAGNOSTICS (BMD) SA |
COURIVAUD CHRISTELLE |
K072138 |
12/21/2007 |
VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 |
BIOMERIEUX, INC. |
NIKITA S MAPP |
K063243 |
12/14/2007 |
VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448 |
BIOMERIEUX, INC. |
NIKITA S MAPP |
K073083 |
12/10/2007 |
VITEK 2 GRAM NEGATIVE PIPERACILLIN |
BIOMERIEUX, INC. |
Nancy Weaver |
K072642 |
12/20/2007 |
BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS |
BIOMET 3I, INC. |
DIANA TAYLOR |
K063614 |
02/20/2007 |
ALTRA FX HIP SYSTEM |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
K063570 |
02/27/2007 |
BIOMET TIBIAL LOCKING NAIL SYSTEM |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
K072804 |
12/12/2007 |
COMPREHENSIVE RS SHOULDER SYSTEM |
BIOMET MANUFACTURING CORP. |
PATRICIA S BERES |
K063515 |
02/02/2007 |
TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE |
BIOMET MANUFACTURING, INC. |
SUSAN ALEXANDER |
K072330 |
12/06/2007 |
CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM |
BIOMET, INC. |
PAULA DEMING |
K062567 |
02/16/2007 |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM |
BIONIME CORPORATION |
SUSAN D GOLDSTEIN-FALK |
K072344 |
12/03/2007 |
APL MEDICAL SYSTEM |
BIOS S.R.L. |
ALDO CASALINO |
K072892 |
12/07/2007 |
TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 |
BIOSITE INCORPORATED |
FIL V BUENVIAJE |
K062603 |
02/15/2007 |
BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230 |
BIOSPACE CORPORATION LIMITED |
DANIEL KAMM |
K073230 |
12/20/2007 |
MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS |
BIOTRONIK, INC. |
Jon Brumbaugh |
K072765 |
12/12/2007 |
PASSEO 18 |
BIOTRONIK, INC. |
Jon Brumbaugh |
K072577 |
12/05/2007 |
BISICO IMPRESSION SILICONES & ALGINATES |
BISICO GMBH & CO KG |
DAGMAR MAESER |
K071930 |
12/18/2007 |
ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C |
BLUE CROSS BIO-MEDICAL CO., LTD. |
HILDA HONG YANG |
K061919 |
02/05/2007 |
VERSATILE 1 EZCARE WOUND VACUUM SYSTEM |
BLUE SKY MEDICAL GROUP INCORPORATED |
JASPER BENKE |
K072476 |
12/14/2007 |
THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT |
Boston Scientific Corporation |
VIRGINIA CARR |
K063236 |
02/16/2007 |
BETA-POWDER |
BRAINBASE CORPORATION |
SATOSHI NOAKE |
K063777 |
02/23/2007 |
ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE |
BRIGHT ELEMENT SDN BHD |
SEOW LAW AUDIE |
K073199 |
12/21/2007 |
3M ESPE LAVA CHAIRSIDE ORAL SCANNER |
BRONTES TECHNOLOGIES |
JOHN GREENBAUM |
K072453 |
12/03/2007 |
CRY-AC TRACKER, MODEL(S) B-700T, AND B-800T |
BRYMILL CORP. |
STEPHEN WILLIAMS |
K063839 |
02/08/2007 |
POSITIONER |
C-RAD POSITIONING AB |
BENGT ERIC ROSTH |
K063118 |
02/13/2007 |
BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE |
C.R. BARD, INC. |
SUSAN SCOTT |
K070582 |
12/07/2007 |
BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS |
C.R. BARD, INC. |
SKIP RIMER |
K070558 |
12/07/2007 |
BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS |
C.R. BARD, INC. |
SKIP RIMER |
K073423 |
12/19/2007 |
MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER |
C.R. BARD, INC. |
SUSAN D SCOTT |
K070025 |
02/01/2007 |
C.T.M. MOBILITY SCOOTER, MODEL HS-310 |
C.T.M. HOMECARE PRODUCT, INC. |
LINDA J BOVARD |
K073226 |
12/07/2007 |
CINCH KNOTLESS FIXATION IMPLANT SYSTEM |
C2M MEDICAL, INC. |
GABRIELE G NIEDERAUER |
K063800 |
02/05/2007 |
CANDELA FLUORESCENT PULSED LIGHT SYSTEM |
CANDELA CORP. |
JEFFREY ROBERTS |
K071995 |
12/18/2007 |
CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
K073123 |
12/06/2007 |
CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150 |
CARDICA, INC. |
ISKRA MRAKOVIC |
K073304 |
12/20/2007 |
CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES |
CARDICA, INC. |
ISKRA MRAKOVIC |
K072105 |
12/28/2007 |
ALARIS SYSTEM WITH MMS, MODEL 8XXX |
CARDINAL HEALTH 303, INC. |
STACY L LEWIS |
K070268 |
02/23/2007 |
SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X |
CARDINAL HEALTH 303, INC. |
STACY L LEWIS |
K071400 |
12/14/2007 |
SMARTSITE STOPCOCK |
CARDINAL HEALTH, ALARIS PRODUCTS |
STACY L LEWIS |
K072558 |
12/05/2007 |
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005 |
CARDIONET, INC |
JACK GAIKWAD |
K072473 |
12/10/2007 |
CHASE MR SYSTEM |
CHASE MEDICAL, LP |
DAVID M HERNON |
K062952 |
02/21/2007 |
C300 SERIES AIR NEBULIZER COMPRESSOR |
CHOICE SMART HEALTH CARE CO. LTD. |
JANICE MA |
K072621 |
12/13/2007 |
ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR |
CINCINNATI SUB-ZERO PRODUCTS, INC |
FATMA ALI |
K071706 |
12/20/2007 |
ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) |
CLINICAL DATA, INC. |
WYNN STOCKING |
K063114 |
02/09/2007 |
DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES |
COEUR, INC. |
DEBRA F MANNING |
K062200 |
02/13/2007 |
COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS |
COLLAGEN MATRIX, INC. |
PEGGY HANSON |
K061516 |
02/06/2007 |
STAODYN MAX PRESET, MODEL 4470 |
COMPEX TECHNOLOGIES, INC. |
CARL BEAURLINE |
K072796 |
12/18/2007 |
MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044 |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
K073009 |
12/07/2007 |
ONEPORT SURGICAL TROCAR SYSTEM |
CONMED CORPORATION |
BRIAN KILLORAN |
K073378 |
12/28/2007 |
ADVANCE 18LP PTA DILATATION CATHETER |
COOK, INC. |
NATHAN SIMON |
K072625 |
12/13/2007 |
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) |
COOK, INC. |
KAREN BRADBURN |
K063349 |
02/16/2007 |
CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR |
CORMATRIX CARDIOVASCULAR, INC. |
KIT CARIQUITAN |
K063626 |
02/08/2007 |
DURAFLEX |
COSMETIC DENTAL MATERIALS INC |
ROBERT BOWERS |
K072537 |
12/18/2007 |
CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM |
CREASPINE SAS |
CYNTHIA J.M NOLTE |
K062977 |
02/28/2007 |
CRITIVIEW, MODEL CRV3 |
CRITISENSE LTD. |
PAUL DRYDEN |
K072518 |
12/20/2007 |
CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS) |
CRS MEDICAL DIAGNOSTICS INC. |
DANIEL KAMM |
K070357 |
12/28/2007 |
FLEXCATH STEERABLE SHEATH & DILATOR |
CRYOCATH TECHNOLOGIES, INC. |
FRED MILDER |
K072651 |
12/07/2007 |
CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM |
CSA MEDICAL, INC. |
JENNIFER CARTLEDGE |
K072866 |
12/13/2007 |
ISSYS LP SPINAL FIXATION SYSTEM |
CUSTOM SPINE, INC. |
SAAD ATTIYAH |
K072484 |
12/27/2007 |
CYNOSURE YAG FAMILY LASER |
CYNOSURE, INC. |
GEORGE CHO |
K073394 |
12/12/2007 |
SMARTLIPO LASER |
CYNOSURE, INC. |
GEORGE CHO |
K072587 |
12/10/2007 |
CYTORI AFT SYSTEM |
CYTORI THERAPEUTICS, INC. |
KENNETH KLEINHENZ |
K063754 |
02/23/2007 |
DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632 |
DADE BEHRING, INC. |
PAMELA A JURGA |
K063608 |
02/23/2007 |
DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
K072965 |
12/21/2007 |
DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
K063425 |
02/15/2007 |
DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
K072717 |
12/12/2007 |
DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210 |
DADE BEHRING, INC. |
HELEN M LEE |
K063655 |
02/15/2007 |
DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
K063564 |
02/08/2007 |
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CHLORAMPHENICOL (4-16 UG/ML) |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
K062894 |
02/08/2007 |
INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0 |
DAILYCARE BIOMEDICAL INC |
DANIEL J CHANG |
K062569 |
02/14/2007 |
SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING |
DATASCOPE CORP. |
SUSAN MANDY |
K062098 |
02/05/2007 |
SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX |
DATASCOPE CORP. |
KATHLEEN KRAMER |
K070297 |
02/05/2007 |
CLEARVIEW DENTAL HANDPIECE LUBRICATOR AND LUBRICANT |
DENTAL AIR SOLUTIONS OF NC, INC. |
THOMAS FEE |
K073117 |
12/19/2007 |
DENTIN DESENSITIZER AGENT |
DENTSPLY INTL., INC. |
HELEN LEWIS |
K072832 |
12/14/2007 |
ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
K062250 |
02/02/2007 |
DELTA XTEND REVERSE SHOULDER SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
NATALIE S HECK |
K063686 |
12/20/2007 |
DEPUY LPS DISTAL FEMORAL COMPONENT |
DEPUY ORTHOPAEDICS, INC. |
REBECCA LENNARD |
K063652 |
02/01/2007 |
GLOBAL AP POROUS COATED HUMERAL STEM |
DEPUY ORTHOPAEDICS, INC. |
REBECCA LENNARD |
K073126 |
12/06/2007 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER KLACZYK |
K062339 |
02/05/2007 |
DERMOTHERAP GUN |
DERMOEQUIPOS S.R.L. |
BENNY ARAZY |
K072599 |
12/20/2007 |
PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 |
DIADEXUS, INC. |
ROBERT WOLFERT PH.D |
K061820 |
02/26/2007 |
DIASORIN LIAISON VZV IGG |
DIASORIN, INC. |
Mari Meyer |
K071375 |
12/21/2007 |
MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE) |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
JONATHAN S KAHAN |
K071679 |
12/17/2007 |
METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
YAEL RUBIN |
K073518 |
12/20/2007 |
FLASHLITE REBEL* |
DISCUS DENTAL, INC. |
VIVIAN LAI |
K070189 |
02/21/2007 |
ACCU-CHEK ULTRAFLEX INFUSION SET |
DISETRONIC MEDICAL SYSTEMS AG |
MIKE FLIS |
K062388 |
02/22/2007 |
ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM |
DOCUSYS |
GORDON J PETERS |
K061379 |
02/16/2007 |
INFINITY TELESMART TELEMETRY SYSTEM |
Draeger Medical Systems, Inc. |
THOMAS M MCINTOSH |
K071562 |
12/11/2007 |
D3 HEMATOLOGY ANALYZER, MODEL D3 |
DREW SCIENTIFIC, INC. |
ROGER BOURREE |
K072146 |
12/18/2007 |
EMS PIEZON MASTER SURGERY |
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
SUSAN BONAPACE |
K073221 |
12/28/2007 |
CADENCE II |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
K073340 |
12/19/2007 |
COLOR LCD MONITOR, FLEXSCAN MX300W |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
K070122 |
02/08/2007 |
MONOCHROME LCD MONITOR, MODEL RADIFORCE GX320 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
K070131 |
02/15/2007 |
RADIFORCE GX220 AND GS220 MONOCHROME LCD MONITORS |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
K072159 |
12/27/2007 |
SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER |
EL.EN. ELECTRONIC ENGINEERING SPA |
ANDREA TOZZI |
K072154 |
12/14/2007 |
FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
K072840 |
12/07/2007 |
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM |
ENDIUS, INC. |
CHRISTINE KUNTZ-NASSIF |
K070246 |
02/16/2007 |
DOWN PAK |
ENDO TWINN B.V. |
F.M. VERHOEVEN |
K060846 |
12/03/2007 |
THERAPEUTIC MASSAGE COMPANION |
ENDURANCE THERAPEUTICS |
BRAD BREZDEN |
K072890 |
12/10/2007 |
STASILON FR |
ENTEGRION, INC. |
E.S. ESKRIDGE, JR. |
K073399 |
12/21/2007 |
TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE |
ENVISIONEERING, LLC. |
DAVID KENNEDY |
K070053 |
12/03/2007 |
EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2 |
EPS BIO TECHNOLOGY CORP. |
Y.C. LEI |
K072231 |
12/26/2007 |
THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE) |
ESM TECHNOLOGIES, LLC. |
CLIFF TRIBUS |
K072555 |
12/13/2007 |
EDTA PLUS |
ESSENTIAL DENTAL SYSTEMS, INC. |
BRIAN RASIMICK |
K063856 |
02/06/2007 |
EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM |
ESSENTIAL DENTAL SYSTEMS, INC. |
SUSAN D GOLDSTEIN-FALK |
K072475 |
12/21/2007 |
BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION) |
ETAC SVERIGE AB |
IAN GORDON |
K062869 |
02/26/2007 |
CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G |
ETHICON ENDO-SURGERY, LLC |
DENNIS HAHN |
K063562 |
02/26/2007 |
GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS |
ETHICON, INC. |
PATRICE NAGODA |
K070789 |
12/31/2007 |
EUROIMMUN ANTI-CCP ELISA |
EUROIMMUN US LLC |
KATHRYN KOHL |
K063569 |
02/23/2007 |
EQUINOXE REVERSE SHOULDER SYSTEM |
EXACTECH, INC. |
AMNON TALMOR |
K061497 |
02/23/2007 |
SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML |
EXCELSIOR MEDICAL CORP. |
JOHN TALARICO |
K073251 |
12/14/2007 |
HYALOMATRIX PA |
FIDIA ADVANCED BIOPOLYMERS SRL |
SHARON A SEGAL |
K063111 |
02/01/2007 |
FINOMETER MODEL-2 WITH ACCESSORIES |
FINAPRES MEDICAL SYSTEMS BV |
GERAD J LANGEWOUTERS |
K072776 |
12/07/2007 |
THE CROSSER SYSTEM |
FLOWCARDIA, INC. |
Dustin Michaels |
K062543 |
02/01/2007 |
HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G |
FOCUS DIAGNOSTICS, INC. |
MICHEAL J WAGNER,ESQ. |
K063642 |
12/13/2007 |
FD EMS, MODEL # D-FJ30E |
FUJI DYNAMICS LIMITED |
IRENE CHEUNG |
K063183 |
02/15/2007 |
PRISMA M10 PRE SET |
GAMBRO RENAL PRODUCTS, INC. |
JEFFREY R SHIDEMAN |
K070319 |
02/26/2007 |
GC FUJI IX GP EXTRA |
GC AMERICA, INC. |
TERRY L JORITZ-LYONS |
K062580 |
12/21/2007 |
GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784) |
GE HEALTHCARE |
JOEL KENT |
K072976 |
12/20/2007 |
MODEL 250CX SERIES MATERNAL/FETAL MONITOR |
GE HEALTHCARE |
AGATA SMIEJA |
K073408 |
12/19/2007 |
GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
NICOLE LANDREVILLE |
K073297 |
12/18/2007 |
GE LOGIQ P6 |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
K071781 |
12/19/2007 |
PF4 IGG |
GENETIC TESTING INSTITUTE |
SUZETTE C CHANCE |
K070280 |
02/23/2007 |
CARDIODAY, VERSION 2.0 |
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
ROMIL RAMBHIA |
K073172 |
12/13/2007 |
BEACON STABILIZATION SYSTEM |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
K071187 |
12/20/2007 |
MICROFUSE BONE VOID FILLER |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
K072513 |
12/07/2007 |
DM-EMG |
GVP ELETTRONICA SRL |
JOHN ROMANO |
K072594 |
12/13/2007 |
GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM |
GYRUS ACMI, INC. |
GRAHAM A BAILLIE |
K073237 |
12/27/2007 |
REHASTIM & REHAMOVE |
HASOMED GMBH |
MATTHIAS WEBER |
K063517 |
02/16/2007 |
HEALADEX-P |
HEALAGENICS, INC. |
PAUL STRATI |
K073044 |
12/07/2007 |
HEARTWAY POWER MOBILITY SCOOTER, MODEL PT7 |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
Ke-Min Jen |
K071150 |
12/12/2007 |
TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE |
HEINZ KURZ GMBH MEDIZINTECHNIK |
DAGMAR MAESER |
K061991 |
02/23/2007 |
PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA |
HELENA LABORATORIES |
PATRICIA FRANKS |
K072690 |
12/07/2007 |
HEMAWAY SEAT |
HEMAWAY LLC |
ARCHIE ROSENBLUM |
K062256 |
02/26/2007 |
HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM |
HILL LABORATORIES CO. |
BRANDY ALTER |
K073059 |
12/10/2007 |
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM |
HITACHI, LTD., POWER SYSTEMS GROUP |
JONATHAN S KAHAN |
K063522 |
02/08/2007 |
POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR) |
HL RUBBER INDUSTRIES SDN BHD |
KENNY HOE |
K043617 |
12/21/2007 |
IMAGECHECKER CT CAD SOFTWARE SYSTEM |
HOLOGIC, INC. |
ARTHUR FRIEDMAN |
K070187 |
02/13/2007 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVE |
HONG DI PLASTIC PRODUCTS CO, LTD. |
KATHY LIU |
K063857 |
02/26/2007 |
SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT |
HOWMEDICA OSTEONICS CORP. |
TIFFANI ROGERS |
K063268 |
02/23/2007 |
CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235 |
HSINER CO., LTD. |
TOM SHANKS |
K063672 |
02/02/2007 |
FIBULA PLATE PROLOCK WITH ANGULAR STABILITY |
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
AL LIPPINCOTT |
K072631 |
12/20/2007 |
JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 |
IDAHO TECHNOLOGY, INC. |
BETH LINGENFELTER |
K072547 |
12/19/2007 |
JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124 |
IDAHO TECHNOLOGY, INC. |
BETH LINGENFELTER |
K063320 |
02/27/2007 |
ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13) |
IMC-HEARTWAY, LLC |
MICHAEL CHEN |
K063307 |
02/27/2007 |
ELECTRIC POWERED WHEELCHAIR, MODEL - RUMBA SR (4R) |
IMC-HEARTWAY, LLC |
MICHAEL CHEN |
K063203 |
02/13/2007 |
ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4) |
IMC-HEARTWAY, LLC |
MICHAEL CHEN |
K073033 |
12/10/2007 |
LEGACY DENTAL IMPLANTS |
IMPLANT DIRECT LLC |
THOMAS GOTTENBOS |
K073049 |
12/13/2007 |
SCREWPLUS DENTAL IMPLANTS (HA) |
IMPLANT DIRECT LLC |
THOMAS GOTTENBOS |
K061629 |
02/23/2007 |
CERTAIN PREVAIL DENTAL IMPLANT |
IMPLANT INNOVATIONS, INC. |
JIM BANIC |
K062432 |
02/22/2007 |
NANOTITE DENTAL IMPLANTS |
IMPLANT INNOVATIONS, INC. |
JACQUELYN A HUGHES |
K072660 |
12/12/2007 |
ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 |
IMTEC CORP. |
J. BRAD VANCE |
K070301 |
02/23/2007 |
HEMOSIL ANTITHROMBIN |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K073367 |
12/27/2007 |
HEMOSIL FIBRINOGEN-C |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K072929 |
12/07/2007 |
LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030 |
INTEGRA LIFESCIENCES CORPORATION |
DARLENE M WELSH |
K063682 |
02/09/2007 |
INTRALASE FUSION LASER |
INTRALASE CORP. |
Judy Gordon |
K071928 |
12/12/2007 |
THE INVACARE FLYER, MODEL IPC 100 |
INVACARE CORP. |
CARROLL MARTIN |
K063465 |
02/28/2007 |
CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE |
IOMED, INC. |
CURTIS JENSON |
K072911 |
12/13/2007 |
ION MEDICAL BIPOLAR COAGULATION PEN |
ION MEDICAL, LLC |
KEITH HURON |
K072640 |
12/21/2007 |
IRISPEC,CA/CB/CC |
IRIS DIAGNOSTICS |
GERALD HADDOCK |
K070021 |
12/07/2007 |
ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0 |
JG MEDICAL PRODUCTS LLC |
WILLAIM STERN |
K070076 |
02/22/2007 |
POWDER FREE VINYL PATINET EXAMINATION GLOVES, CLEAR (NON-COLORED) |
JIANGSU CUREGUARD GLOVE CO., LTD. |
CHU XIAOAN |
K070075 |
02/09/2007 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
JIANGSU CUREGUARD GLOVE CO., LTD. |
CHU XIAOAN |
K063715 |
02/05/2007 |
JUNIPER COOLING DEVICE XTRA |
JUNIPER MEDICAL INC. |
DON JOHNSON |
K063399 |
02/23/2007 |
ALEUTIAN SPACER SYSTEM |
K2M, INC. |
RICH WOODS |
K063544 |
02/14/2007 |
MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM |
K2M, INC. |
RICH WOODS |
K062464 |
02/16/2007 |
MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
K072788 |
12/26/2007 |
STORZ MODULITH LITHOTRIPTER SLX-F2-F180 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
CRYSTAL DIZOL |
K063624 |
02/08/2007 |
KAVO EVEREST C-TEMP |
KAVO AMERICA |
DANIEL KAMM |
K071695 |
12/31/2007 |
KENSEY NASH MACROPORE SHIELD |
KENSEY NASH CORP. |
CINDY VARUGHESE |
K072622 |
12/04/2007 |
STANDOUT 2 |
KERR CORP. |
Wendy Garman |
K072764 |
12/20/2007 |
KLS MARTIN XTERNAL FIXATOR |
KLS MARTIN L.P. |
TOM FAUCETT |
K072707 |
12/19/2007 |
PATIENT CONTOURED MESH-PEEK (PCM-P) |
KLS-MARTIN L.P. |
JENNIFER DAMATO |
K062764 |
02/27/2007 |
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED |
KOSSAN LATEX INDUSTRIES(M)SDN BHD |
LIM KWAN HWA |
K063593 |
02/02/2007 |
CLEARFIL MAJESTY FLOW |
KURARAY AMERICA, INC. |
KOJI NISHIDA |
K063595 |
02/09/2007 |
CLEARFIL MAJESTY POSTERIOR |
KURARAY AMERICA, INC. |
KOJI NISHIDA |
K070012 |
12/27/2007 |
POLYBONE |
KYUNGWON MEDICAL CO., LTD. |
JOO YEON LEE |
K071905 |
12/28/2007 |
POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) |
LANX, LLC |
JANICE M HOGAN |
K063855 |
02/01/2007 |
LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047 |
LIBERTY HEALTHCARE GROUP, INC. |
JOHN C GORMLEY |
K070400 |
02/28/2007 |
LC THERAPY, MODEL LCT-1000 |
LITECURE, LLC |
BRIAN PRYOR, PH.D. |
K072995 |
12/18/2007 |
TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER |
LUMEN DEVELOPMENT AND MANUFACTURING, INC. |
CALVIN D OSTLER |
K073436 |
12/28/2007 |
SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEM |
LUTRONIC CORPORATION |
MAUREEN O'CONNELL |
K073248 |
12/12/2007 |
MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM |
MAKO SURGICAL CORP. |
WILLIAM F TAPIA |
K062793 |
02/07/2007 |
SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION |
MAQUET CRITICAL CARE AB |
JAMIE YIEH |
K063404 |
02/15/2007 |
SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800 |
MAQUET CRITICAL CARE AB |
JAMIE YIEH |
K063488 |
02/22/2007 |
MAXO2 CU |
MAXTEC, INC. |
PAUL DRYDEN |
K072360 |
12/12/2007 |
K-Y BRAND INTRIGUE INTENSE WARMING SENSATION |
MCNEIL-PPC, INC. |
NADER FOTOUHU, PH.D. |
K062901 |
02/08/2007 |
HEMOCATH II |
MED-CONDUIT, INC. |
GERALD G BOUSQUET |
K071878 |
12/07/2007 |
DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB |
MED-LECTRIC CORPORATION |
M. LEE GUNTER |
K063336 |
02/26/2007 |
MEDELA DOMINANT 50 LIPO, MODEL 600-5706 |
MEDELA AG |
WERNER FREI |
K072550 |
12/07/2007 |
SIGHTSURE OPERATIONAL INDICATOR, MODEL SS301 |
MEDEVICE, INC. |
MICHELE H VOVOLKA |
K070085 |
02/26/2007 |
BALANCE REHABILITATION UNIT (BRU) |
MEDICAA (URUGUAY) S.A. |
IAN GORDON |
K063700 |
02/08/2007 |
SPYGLASS IRRIGATION SYSTEM |
MEDICAL SCIENTIFIC, INC. |
PAUL NARDELLA, JR. |
K072226 |
12/10/2007 |
IMPIX SPACER |
MEDICREA TECHNOLOGIES |
J.D. WEBB |
K061309 |
02/08/2007 |
EMBRYOASSIST |
MEDICULT A/S |
RONALD G LEONARDI |
K072511 |
12/13/2007 |
SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM |
MEDIMOP MEDICAL PROJECTS, LTD. |
ARI Y SOBEL |
K072759 |
12/13/2007 |
VIAL2BAG |
MEDIMOP MEDICAL PROJECTS, LTD. |
ARI Y SOBEL |
K062953 |
02/12/2007 |
MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE |
MEDISYSTEMS CORP. |
FREDRIC SWINDLER |
K072886 |
12/21/2007 |
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T |
MEDRAD, INC. |
LISA M CASAVANT |
K072328 |
12/21/2007 |
MEDTRADE PRODUCTS CELOX SOLBAG, ANTI - COAGULANT |
MEDTRADE PRODUCTS LTD. |
JONATHAN D RANFIELD |
K062478 |
02/08/2007 |
CLAVIS |
MEDTRONIC A/S |
ANN-CHRISTINE PROVOOST |
K071942 |
12/11/2007 |
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
MICHELLE WILLIS |
K063100 |
02/23/2007 |
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE |
MEDTRONIC SOFAMOR DANEK, INC. |
CHRISTINE SCIFERT |
K070356 |
12/18/2007 |
MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM |
MEDWAVES INCORPORATED |
TED ORMSBY |
K073456 |
12/20/2007 |
T-QUEST SYSTEM |
MEDX, INC. |
MICHAEL HANUSHEWSKY |
K071941 |
12/04/2007 |
MEMOMETAL BONE ANCHORS |
MEMOMETAL TECHNOLOGIES |
GILLES AUDIC |
K072823 |
12/14/2007 |
MERILAS 532A |
MERIDIAN AG |
Kevin Walls |
K062546 |
02/14/2007 |
IMMUNOCARD STAT! EHEC, MODEL 751630 |
MERIDIAN BIOSCIENCE, INC. |
SUSAN ROLIH |
K072552 |
12/14/2007 |
MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE |
MERIT MEDICAL SYSTEMS, INC. |
WILLIAM D JORDAN |
K073397 |
12/20/2007 |
MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50) |
MICROLIFE CORP. |
SUSAN D GOLDSTEIN-FALK |
K073398 |
12/20/2007 |
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100) |
MICROLIFE CORP. |
SUSAN D GOLDSTEIN-FALK |
K073300 |
12/04/2007 |
MILESMAN PREMIUM |
MILESMAN S.L. |
NATALYA VALERIO |
K072979 |
12/26/2007 |
SPIROBANK G |
MIR MEDICAL INTL. RESEARCH SRL |
SIMON FOWLER |
K070001 |
02/02/2007 |
MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE |
MTI PRECISION PRODUCTS |
TOD BRENNER |
K062527 |
02/20/2007 |
BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE |
MULTISAFE SDN BHD |
ABD HADI BIN HUSIN |
K062205 |
02/05/2007 |
DBX STRIP |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY BENNEWITZ |
K063135 |
02/05/2007 |
SONIC-STIM |
NAIMCO, INC. |
JULIE CREASMAN |
K062459 |
02/26/2007 |
ORIGEN DBM WITH BIOACTIVE GLASS |
NANOTHERAPEUTICS |
PAULA WILKERSON |
K073448 |
12/20/2007 |
MEDICAL DISPLAY, MD205MG |
NEC DISPLAY SOLUTIONS, LTD. |
SHUICHI KINO |
K070899 |
12/13/2007 |
PURITAN BENNETT LEGENDAIR XL2 |
NELLCOR PURITAN BENNETT |
JAMES BONDS |
K071691 |
12/19/2007 |
DUAL SHOT ALPHA |
NEMOTO KYORINDO CO., LTD. |
MICHAEL HIEDA |
K072997 |
12/19/2007 |
NEOMED URINARY CATHETER |
NEOMED, INC. |
PENNY NORTHCUTT |
K070150 |
02/15/2007 |
VASCUPUNCTURE PICC GUIDEWIRE |
NEOMETRICS, INC. |
GENE CHAMPEAU |
K063820 |
02/08/2007 |
LISFRANC PLATE |
NEWDEAL S.A. |
JUDITH E O'GRADY |
K070241 |
02/08/2007 |
MODIFICATION TO LAPIDUS PLATE |
NEWDEAL S.A. |
JUDITH E O'GRADY |
K070160 |
02/08/2007 |
MODIFICATION TO TTC PLATES |
NEWDEAL S.A. |
JUDITH E O'GRADY |
K063831 |
02/07/2007 |
BASAL DORSAL PLATES |
NEWDEAL SAS |
JUDITH E O'GRADY |
K071613 |
12/14/2007 |
AMIGO INSULIN PUMP |
NIPRO DIABETES SYSTEMS, INC. |
HARRY RUSSELL |
K063368 |
02/05/2007 |
NIPRO BIOHOLE NEEDLE |
NIPRO MEDICAL CORP. |
JESSICA OSWALD |
K063521 |
02/05/2007 |
NISSIN PEDIATRIC SERIES WHEELCHAIR |
NISSIN MEDICAL INC. |
TAKAHIRO HARUYAMA |
K063592 |
02/27/2007 |
ADAPTER PS RP-NP, 34551, ADAPTER PS WP-RP,34552, ABUTMENT SCREW PS RP-NP, 34553, ABUTMENT SCREW PS WP-RP, 34554 |
NOBEL BIOCARE AB |
HERBERT CRANE |
K072570 |
12/28/2007 |
NOBELACTIVE MULTI UNIT ABUTMENT |
NOBEL BIOCARE AB |
HERBERT CRANE |
K070857 |
12/28/2007 |
NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
K072980 |
12/20/2007 |
NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS |
NOBEL BIOCARE AB |
KAM LEUNG |
K063549 |
02/12/2007 |
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT |
NovaBone Products, LLC |
DAVID M GAISSER |
K063596 |
02/22/2007 |
PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL |
NovaBone Products, LLC |
DAVID M GAISSER |
K063477 |
02/09/2007 |
NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET |
NOVAMED, LLC |
PAUL DRYDEN |
K073273 |
12/11/2007 |
EQUAL DOSE 1.0 |
NUCLETRON CORPORATION |
LISA DIMMICK |
K073107 |
12/07/2007 |
VALENCIA SKIN APPLICATOR SET, MODEL: 189.701 |
NUCLETRON CORPORATION |
LISA] DIMMICK |
K063304 |
12/21/2007 |
LIFE4C |
NUMEDIS, INC. |
MARY E FREDDO |
K071795 |
12/04/2007 |
NUVASIVE COROENT SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
K062444 |
02/22/2007 |
HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT |
OASIS MEDIKAL URUNLER KIMYA SANAYI VE TIC A.S. |
CHARLES H KYPER |
K063026 |
02/09/2007 |
OK METER BLOOD GLUCOSE MONITORING SYSTEM |
OK BIOTECH CO., LTD. |
Ke-Min Jen |
K072937 |
12/28/2007 |
OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET |
OLSEN MEDICAL |
JOHN P WATERS |
K063683 |
02/08/2007 |
OLYMPUS XEU-M60A ENDOSCOPIC ULTRASOUND CENTER; XGF-UM180 ULTRASONIC GASTROVIDEOSCOPE |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
K070157 |
02/01/2007 |
OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER |
OMNIGUIDE, INC. |
DOUGLAS W WOODRUFF |
K073409 |
12/14/2007 |
OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM |
OMNIGUIDE, INC. |
DOUGLAS W WOODRUFF |
K062263 |
02/23/2007 |
OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22 |
OMRON HEALTHCARE, INC. |
RANNDY KELLOGG |
K062852 |
02/23/2007 |
BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870 |
ONSET MEDICAL CORPORATION |
ALBERT REGO |
K073045 |
12/18/2007 |
SAPPHIRE CERAMIC BRACKET |
ORTHO TECHNOLOGY, INC |
PAUL WILLIAMS |
K073157 |
12/07/2007 |
VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 |
Ortho-Clinical Diagnostics, Inc. |
MARLENE HANNA |
K061131 |
02/08/2007 |
DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY |
ORTHOCON, INC. |
Howard Schrayer |
K061897 |
02/14/2007 |
EXCEL CONTRA ANGLE HANDPIECE |
ORTHOSOURCE, INC. |
LLOYD TAYLOR |
K072601 |
12/10/2007 |
OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT |
OSTEOSYMBIONICS, LLC |
CYNTHIA M BROGAN |
K061982 |
02/07/2007 |
PLEXUR P |
OSTEOTECH, INC. |
CHRISTOPHER W TALBOT |
K062532 |
02/09/2007 |
ELECTROPULSE - LOW BACK PAIN |
PAIN RELIEF TECHNOLOGIES |
KENDALL GORHAM |
K063697 |
02/14/2007 |
SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN QUASS |
K061652 |
02/27/2007 |
PALOMAR LUX1540 HANDPIECE |
PALOMAR MEDICAL PRODUCTS, INC. |
Sharon Timberlake |
K063571 |
02/09/2007 |
PALOMAR LUX2940 HANDPIECE |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Sharon Timberlake |
K072670 |
12/13/2007 |
MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER |
PARI INNOVATIVE MANUFACTURERS, INC. |
JAMES MCINTIRE |
K070107 |
02/23/2007 |
PARI HYDRATE G |
PARI INNOVATIVE MANUFACTURERS, INC. |
MICHAEL JUDGE |
K071063 |
12/20/2007 |
LINASYS |
PATHFINDER THERAPEUTICS, INC. |
JAMES D STEFANSIC |
K072830 |
12/04/2007 |
RM BOND, MODEL J032 |
PENTRON CLINICAL TECHNOLOGIES |
GREG MOREAU |
K072718 |
12/28/2007 |
PENUMBRA SYSTEM |
PENUMBRA, INC. |
THERESA BRANDNER-ALLEN |
K073210 |
12/12/2007 |
MODIFICATION TO: T-PORT HP INFUSION PORT |
PFM MEDICAL, INC |
SALVADORE PALOMARES |
K072393 |
12/07/2007 |
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 |
PHADIA US INC. |
MARTIN R MANN |
K070009 |
12/07/2007 |
AT HOME DRUG TEST MODELS, 9308T AND 9308X |
PHAMATECH INC. |
CARL MONGIOVI |
K070098 |
12/07/2007 |
QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC |
PHAMATECH INC. |
CARL MONGIOVI |
K072813 |
12/28/2007 |
EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG) |
PHASEIN AB |
DAVID WEISSBURG |
K063167 |
02/06/2007 |
EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG) |
PHASEIN AB |
DAVID WEISSBURG |
K071885 |
12/20/2007 |
ANTIMICROBIAL AND SINGLE-PATIENT CUFFS |
PHILIPS MEDICAL SYSTEMS |
PETER SCHIPELLITI |
K070260 |
02/23/2007 |
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0 |
PHILIPS MEDICAL SYSTEMS |
DENISE HALEY |
K063725 |
02/08/2007 |
MP5 INTELLIVUE PATIENT MONITOR |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
MARKUS STACHA |
K070287 |
02/12/2007 |
PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 |
PHOTONIC OPTISCHE GERATE GMBH & COKG |
DIETER FEGER |
K072376 |
12/12/2007 |
PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS |
PLAYTEX PRODUCTS, INC. |
KEITH EDGETT |
K070757 |
12/04/2007 |
MICROPROTEIN REAGENT SET |
POINTE SCIENTIFIC, INC. |
RON JAMISON |
K072766 |
12/11/2007 |
PVMED DDR 2520 DIGITAL IMAGING SYSTEM |
PORTAVISION MEDICAL |
IAN GORDEN |
K073001 |
12/18/2007 |
IDRIVES, IDRIVEC, IDRIVEF |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
K073148 |
12/07/2007 |
IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
K063408 |
02/28/2007 |
CTLOGICS NAVIGATIONS SYSTEMS |
PRAXIM MEDIVISION, SA |
MADY BATAILH |
K072267 |
12/10/2007 |
TOTAL HIP SURGETICS NAVIGATION SYSTEM |
PRAXIM SA |
JIHANE ZEMMOURI |
K063096 |
02/27/2007 |
PRECISION OXYGEN MONITOR |
PRECISION MEDICAL, INC. |
JAMES PARKER |
K073220 |
12/19/2007 |
THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT |
PRESTIGE BRANDS, INC. |
KAREN A COSTA-STRACHAN |
K072261 |
12/26/2007 |
FINESSE SYSTEM |
PRIMAEVA MEDICAL, INC. |
SEVRINA CIUCCI |
K061252 |
02/12/2007 |
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM |
PRIMUS CONSULTING |
CAROLYN M PRIMUS |
K062565 |
02/20/2007 |
STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE |
PRINCETON BIOMEDITECH CORP. |
KYUNG-AH KIM |
K073353 |
12/07/2007 |
DO-ALL DENTAL HANDPIECE LUBRICANT |
PRODRIVE SYSTEMS, INC. |
TIMOTHY F NASON |
K072756 |
12/19/2007 |
NON-IV ADAPTER FOR INFANT NG TUBE |
PROMEDIC, INC. |
PAUL DRYDEN |
K072528 |
12/28/2007 |
ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES |
PROSURG, INC. |
ASHVIN DESAI |
K063650 |
02/15/2007 |
VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840 |
PURITAN BENNETT CORP. |
PATRICK GARVEY |
K072264 |
12/06/2007 |
FASTPACK HCG IMMUNOASSAY |
Qualigen, Inc. |
MICHAEL S POIRIER |
K073066 |
12/26/2007 |
308 DERMATOLOGICAL EXCIMER SYSTEM |
QUANTEL MEDICAL, INC. |
GEORGE MYERS |
K073178 |
12/27/2007 |
HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 |
R & D SYSTEMS, INC. |
NANCY C RING |
K063011 |
02/02/2007 |
MIRAGE LIBERTY FULL FACE MASK |
RESMED LTD. |
DAVID D'CRUZ |
K072940 |
12/13/2007 |
MIRAGE MICRO |
RESMED LTD. |
DAVID D'CRUZ |
K063122 |
02/02/2007 |
MIRAGE QUATTRO FULL FACE MASK |
RESMED LTD. |
DAVID D'CRUZ |
K072450 |
12/12/2007 |
ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000 |
RESPIRONICS CALIFORNIA, INC. |
MARA CALER |
K072588 |
12/18/2007 |
PERFORMAX SE TOTAL FACE MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA YURKO |
K072592 |
12/19/2007 |
PERFORMAX TOTAL FACE MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA YURKO |
K062689 |
02/16/2007 |
SIDESTREAM PLUS |
RESPIRONICS LTD. |
Lauren Ziegler |
K063540 |
02/22/2007 |
BIPAP AUTOSV |
RESPIRONICS, INC. |
ZITA A YURKO |
K063533 |
02/20/2007 |
BIPAP SYNCHRONY |
RESPIRONICS, INC. |
ZITA A YURKO |
K072996 |
12/27/2007 |
REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM |
RESPIRONICS, INC. |
ZITA A YURKO |
K072654 |
12/14/2007 |
PATIENT SAFE SYRINGE |
RETRACTABLE TECHNOLOGIES, INC. |
RHONDA WELLS |
K062445 |
02/16/2007 |
MONITORING EAR THERMOMETER, MODEL BTM-D1A |
RIO FLEXON TECHNOLOGY CO., LTD. |
JEFF LIAO |
K070101 |
02/14/2007 |
UNIBLATE ELECTROSURGICAL DEVICE |
RITA MEDICAL SYSTEMS, INC. |
KAM H LEUNG |
K062414 |
02/01/2007 |
VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET |
RITA MEDICAL SYSTEMS, INC. |
DAVID SMITH |
K063520 |
02/16/2007 |
ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS |
Roche Diagnostics |
KERWIN KAUFMAN |
K071093 |
12/06/2007 |
SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202 |
SAN SHIH ELECTRICAL ENTERPRISE CO., LTD. |
Ke-Min Jen |
K062739 |
02/13/2007 |
CINCH BONE ANCHOR SYSTEM |
SAPPHIRE MEDICAL, INC |
JANICE M HOGAN |
K072374 |
12/07/2007 |
COMPASS |
SCANDITRONIX WELLHOFER GMBH |
MARTIN AROLD |
K072466 |
12/19/2007 |
STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 |
SCICAN LTD. |
TERESA BOYCE |
K062912 |
02/05/2007 |
SCIENT'X SPINAL SYSTEM |
SCIENT'X |
J.D. WEBB |
K073043 |
12/14/2007 |
SET PP |
SDI LTD. |
RAY CAHILL |
K072605 |
12/20/2007 |
MALIBU SPINAL SYSTEM |
SEASPINE, INC. |
ETHEL BERNAL |
K070486 |
12/21/2007 |
CAPILLARYS URINE (PN 2012) |
Sebia, Inc. |
KAREN ANDERSON |
K070244 |
02/09/2007 |
AEGIS |
SENTINELLE MEDICAL, INC. |
STEPHEN LEUNG |
K073127 |
12/20/2007 |
BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G |
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. |
Diana Hong |
K071353 |
12/14/2007 |
FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C |
SHANGHAI FOSHION MEDICAL INSTRUMENTS CO., LTD. |
WILLIAM MCLAIN |
K071886 |
12/27/2007 |
SELF SEAL STERILIZATION POUCH |
SHANGHAI JIANZHONG MEDICAL PACKAGING CO., LTD. |
LONGFU SONG |
K062893 |
02/05/2007 |
KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A |
SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LTD. |
ZHAO J YU |
K062646 |
02/05/2007 |
RUIKE, MODEL 3411 |
SHANGHAI RUIKE SPORTS GOODS CO., LTD. |
JUNNATA CHANG |
K063471 |
02/28/2007 |
SHIJIAZHUANG JUNFEI PLASTICS PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG JUNFEI PLASTIC PRODUCTS CO., LTD. |
KC CHEUNG |
K070037 |
02/20/2007 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVE |
SHIJIAZHUANG LIANHE SHUNDA PLASTIC PRODUCTS CO., L |
KATHY LIU |
K070046 |
02/07/2007 |
POWDERED VINYL PATIENT GLOVE |
SHIJIAZHUANG LIANHE SHUNDA PLASTIC PRODUCTS CO., L |
KATHY LIU |
K073193 |
12/20/2007 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD |
CHU XIAOAN |
K073373 |
12/18/2007 |
SYNGO VOLUME PERFUSION-CT BODY |
SIEMENS AG, MEDICAL SOLUTIONS |
RALF HOFMANN |
K072676 |
12/18/2007 |
ACUSON X300 ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
MARTINA VOGT |
K072485 |
12/27/2007 |
ARTISTE MV SA |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ERIK RODRIGUEZ |
K070322 |
02/27/2007 |
SYNGO DYNAMICS, VERSION 6.0 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SIEGLINDE NINA WEST |
K071730 |
12/20/2007 |
STUDIODOP VICORDER |
SKIDMORE MEDICAL, LIMITED |
DAVID W WAGNER |
K070236 |
02/21/2007 |
SBI LATERAL RADIO CAPITELLUM |
SMALL BONE INNOVATIONS, INC. |
ROBERT HOEHN |
K073040 |
12/13/2007 |
SMH FLEX S |
SMH BIOMATERIAL AG |
ASHLEY TRUITT |
K072785 |
12/10/2007 |
TWINFIX FT PK |
SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
DEANA BOUSHELL |
K070266 |
02/22/2007 |
560 HIGH DEFINITION CAMERA SYSTEM |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
K063535 |
02/26/2007 |
CAPTION APPLICATOR |
SMITH & NEPHEW, INC. |
KIM P KELLY |
K073175 |
12/20/2007 |
JOURNEY UNICONDYLAR FEMORAL IMPLANT |
SMITH & NEPHEW, INC. |
MARLON RIDLEY |
K073325 |
12/20/2007 |
LEGION POROUS PRIMARY |
SMITH & NEPHEW, INC. |
RISHI SINHA |
K072531 |
12/06/2007 |
LEGION STEM WITH HOLES |
SMITH & NEPHEW, INC. |
MEGAN BEVILL |
K063755 |
02/27/2007 |
PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE |
SMITHS MEDICAL ASD, INC. |
BRIAN FARIAS |
K072657 |
12/14/2007 |
POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS |
SMITHS MEDICAL MD, INC. |
BRIAN HAUGSTAD |
K072951 |
12/19/2007 |
PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES |
SOFRADIM PRODUCTION |
SHARON ALEXANDER |
K073196 |
12/19/2007 |
MASTER-VU |
SONOMED, INC. |
GEORGE MYERS |
K063126 |
02/02/2007 |
DANA DIABECARE IIS |
SOOIL DEVELOPMENT CO., LTD. |
JEREMY KIM |
K070102 |
02/20/2007 |
SOPRO 162 CAMERA |
SOPRO |
STEVE SALESKY |
K070783 |
12/13/2007 |
SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR |
SOPRO |
STEVE SALESKY |
K073350 |
12/19/2007 |
SCANORA 3D |
SOREDEX PALODEX GROUP OY |
JOUNI ONNELA |
K072750 |
12/04/2007 |
SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066 |
SPECTRANETICS CORP. |
MICHAEL K HANDLEY |
K073348 |
12/26/2007 |
LUCENT MAGNUM |
SPINAL ELEMENTS, INC. |
KERRI DIMARTINO |
K063441 |
02/12/2007 |
15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55 |
SPIRE BIOMEDICAL INC |
SHEKHAR NIMKAR |
K072961 |
12/19/2007 |
LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) |
SRA DEVELOPMENTS, LTD. |
MICHAEL J.R. YOUNG |
K063531 |
02/22/2007 |
SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM |
SRA DEVELOPMENTS, LTD. |
MICHAEL J.R. YOUNG |
K071818 |
12/20/2007 |
ENSITE FUSION DYNAMIC REGISTRATION TOOL |
ST. JUDE MEDICAL |
KAREN J MCKELVEY |
K072510 |
12/11/2007 |
VERIFY V-PRO CHEMICAL INDICATOR, VERSIONS 1 AND 2 |
STERIS Corporation |
JOHN ROBERT SCOVILLE |
K070199 |
02/23/2007 |
RETIC-CHEX LINEARITY FOR BC |
Streck |
KERRIE OETTER |
K061108 |
02/02/2007 |
STRYKER AUTO IRRIGATION SYSTEM |
Stryker |
VALERIE FRANCK |
K073151 |
12/06/2007 |
MANTIS SPINAL SYSTEM |
STRYKER CORP. |
CURTIS TRUESDALE |
K072271 |
12/18/2007 |
STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE |
STRYKER CORP. |
BECKY DITTY |
K072118 |
12/07/2007 |
STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT |
STRYKER CORP. |
JEAN SHEPPARD |
K070078 |
02/02/2007 |
STRYKER T4 HYTREL TOGA |
STRYKER INSTRUMENTS, INSTRUMENTS DIV. |
PAULETTE D JOHNSON |
K063816 |
02/02/2007 |
PCA ALUMINA FEMORAL HEADS |
STRYKER ORTHOPAEDICS |
PATRICIA SETTI-LAPERCH |
K070219 |
02/07/2007 |
SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM |
SUNI MEDICAL IMAGING, INC. |
DAVID STARK |
K070030 |
02/16/2007 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVE |
SUPER SAFE PLASTIC PRODUCTS CO., LTD. |
KATHY LIU |
K070043 |
02/08/2007 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE |
SUPER SAFE PLASTIC PRODUCTS CO., LTD. |
KATHY LIU |
K070042 |
02/23/2007 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, YELLOW |
SUPER SAFE PLASTIC PRODUCTS CO., LTD. |
KATHY LIU |
K062753 |
02/08/2007 |
FORSURE DISPOSABLE SYRINGE WITH NEEDLE, MODEL 1CC, 3C, 5CC, 10CC, 20CC, 50CC |
SURGIMED, INC. |
FERNANDO LAVOI |
K062350 |
02/26/2007 |
SURGINETICS ADVANTAGEBLADE |
SURGINETICS |
MANETA D LOLLAR |
K063603 |
02/07/2007 |
SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 |
SUTURTEK INCORPORATED |
ART RANKIS |
K071482 |
12/20/2007 |
STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 |
SYNERGETICS, INC |
DAN REGAN |
K072758 |
12/18/2007 |
SYNTHES (USA) 2.0MM TITANIUM T-PLATE |
SYNTHES (USA) |
ANDREA M TASKER |
K062789 |
02/27/2007 |
SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM |
SYNTHES (USA) |
JEFFREY DOW |
K073186 |
12/17/2007 |
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM |
SYNTHES (USA) |
KARL J NITTINGER |
K072791 |
12/26/2007 |
ORACLE SPACER, OPAL SPACER |
SYNTHES SPINE |
STACEY BONNELL |
K073372 |
12/07/2007 |
ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI) |
SYSTEMSONE |
THOMAS ARTHUR |
K072784 |
12/21/2007 |
PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK TD-4227 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
ERICA LI |
K072273 |
12/20/2007 |
BELMONT QUOLIS 5000 SERIES DENTAL UNIT |
TAKARA BELMONT USA, INC. |
ROBERT SCHIFF |
K071712 |
12/04/2007 |
LEUKO EZ VUE |
TECHLAB INC., CORPORATE RESEARCH CENTER |
CHARLES PENNINGTON |
K062437 |
02/16/2007 |
DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED |
TECHNOMED EUROPE |
RENE RONCKEN |
K063778 |
02/09/2007 |
FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE |
TELEFLEX MEDICAL |
LORI HAYS |
DEN060003 |
02/08/2007 |
TEPHAFLEX ABSORBABLE SUTURE |
TEPHA, INC. |
MARY P LEGRAW |
K071349 |
12/12/2007 |
NEUROSIGN LARYNGEAL ELECTRODES |
THE MAGSTIM COMPANY LTD. |
ANWEN EVANS |
K063622 |
02/08/2007 |
FINECUBE DENTAL CT |
THE YOSHIDA DENTAL MFG. CO., LTD. |
DANIEL KAMM |
K072407 |
12/21/2007 |
BODYFORM THORACIC FIXATION SYSTEM |
THEKEN SPINE LLC |
DALE DAVISON |
K070824 |
12/03/2007 |
CREATININE (ENZYMATIC) |
THERMO FISHER SCIENTIFIC OY |
PAIVI SORMUNEN |
K063748 |
02/01/2007 |
THERMOMED 1.8 |
THERMOSURGERY TECHNOLOGIES, INC. |
GENE ZISCHKE |
K073141 |
12/05/2007 |
SPI ART ABUTMENT |
THOMMEN MEDICAL, AG |
FLOYD G LARSON |
K072649 |
12/06/2007 |
SPI SYSTEM DENTAL IMPLANTS |
THOMMEN MEDICAL, AG |
LINDA K SCHULZ |
K073272 |
12/11/2007 |
WORKSTATIONONE BREAST IMAGING WORKSTATION |
THREE PALM SOFTWARE, LLC |
HEIDI D ZHANG |
K063639 |
02/22/2007 |
AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1 |
TISSUELINK MEDICAL, INC. |
VICKI ANASTASI |
K072746 |
12/04/2007 |
E-1 ESTHETIC COMPOSITE SYSTEM |
TOKUYAMA DENTAL CORPORATION |
KEITH A BARRITT |
K062946 |
02/15/2007 |
TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL |
TOP CORP. |
CATHRYN N CAMBRIA |
K073259 |
12/20/2007 |
XIDF-100A/B1 IMAGE PROCESSOR |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
K073147 |
12/03/2007 |
SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 |
TRANSOMA MEDICAL |
LISA STONE |
K071876 |
12/17/2007 |
CROSS.BONE |
TRIMED, INC. |
KELLI ANDERSON |
K063711 |
02/02/2007 |
TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA |
TUTTNAUER CO. LTD. |
MARK YACURA |
K052836 |
02/13/2007 |
BODIHEALTH SYSTEM |
USA LASER THERAPEUTICS, INC. |
M. JOYCE HEINRICH |
K073020 |
12/19/2007 |
ECLIPSE TREATMENT PLANNING SYSTEM |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
K070094 |
02/09/2007 |
TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
K073264 |
12/07/2007 |
D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005 |
VASCULAR SOLUTIONS, INC. |
JAMES CHAPMAN |
K063871 |
02/28/2007 |
D-STAT HANDLE, MODEL 8500-053 |
VASCULAR SOLUTIONS, INC. |
ALYSSA MALINSKI |
K072810 |
12/19/2007 |
PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010 |
VASCULAR SOLUTIONS, INC. |
DORALIE POGANSKI |
K063860 |
02/13/2007 |
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT |
VASCULAR SOLUTIONS, INC. |
JAMES CHAPMAN |
K070323 |
02/15/2007 |
TEMPORARY LIMB SALVAGE SHUNT |
VASCUTEK LTD. |
KAREN KELSO |
K073400 |
12/20/2007 |
VARICATH PERIPHERAL INFUSION CATHETER |
VEINRX INC. |
GREGORY MATHISON |
K072180 |
12/18/2007 |
VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM |
VISION-SCIENCES, INC. |
PAMELA PAPINEAU |
K061775 |
02/23/2007 |
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR |
WAKO CHEMICALS, USA, INC. |
LORI CREASY |
K063386 |
02/09/2007 |
LORENZ ORTHODONTIC ANCHORAGE SYSTEM |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
K072009 |
12/14/2007 |
WEINMANNCOMPACT, MODEL WM 27380; WEINMANNCLICK2, MODEL WM 27340 |
WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG |
ECKHARDT ALBERS |
K070060 |
12/18/2007 |
WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE) |
WELCH ALLYN, INC. |
JOHN SAWYER |
K072168 |
12/19/2007 |
OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412 |
WELL-LIFE HEALTHCARE LIMITED |
JENNY HSIEH |
K063660 |
02/07/2007 |
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407 |
WELL-LIFE HEALTHCARE LIMITED |
JENNY HSIEH |
K070128 |
02/15/2007 |
CO2 EASY |
Westmed, Inc. |
DALE BICKLEY |
K063840 |
02/06/2007 |
XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION |
WITT BIOMEDICAL CORP |
JAMES LUKER |
K070149 |
02/23/2007 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
WUXI SHENZHOU PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
K070145 |
02/28/2007 |
POWDERED VINYL PATIENT EXAMINATION GLOVES |
WUXI SHENZHOU PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
K072377 |
12/14/2007 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVE, WHITE COLOR |
XUZHOU FULL SUN MEDICAL PRODUCTS LTD. |
HSUN-HUI HUANG |
K072314 |
12/12/2007 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR |
XUZHOU FULL SUN MEDICAL PRODUCTS LTD. |
HSUN- HUI HUANG |
K071122 |
12/12/2007 |
DISPOSABLE POWDERED VINYL EXAM GLOVE, YELLOW COLOR |
XUZHOU FULL SUN MEDICAL PRODUCTS LTD. |
HSUN-HUI HUANG |
K072878 |
12/03/2007 |
MODIFICATION TO: LOCATOR IMPLANT ANCHOR |
ZEST ANCHORS, INC. |
RICHARD OVERTON |
K071219 |
12/06/2007 |
ATHENA MULTI-LYTE GBM TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
EWA NADOLCZAK |
K073005 |
12/12/2007 |
ELITE GLASS |
ZHERMACK S.P.A. |
GERALD W SHIPPS |
K070008 |
02/08/2007 |
POWDERED VINYL PATIENT EXAMINATION GLOVES |
ZIBO HENGDE PLASTIC & RUBBER PRODUCTS CO., LTD. |
CHU XIAOAN |
K063523 |
02/16/2007 |
ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11, 13, 16; ZOP37A10, 11, 13, 16; ZOP47S10, 11, 13, 16; ZOP4 |
ZIMMER DENTAL INC. |
ERIN MCVEY |
K062537 |
02/28/2007 |
ZOLL M SERIES WITH REAL CPR HELP |
ZOLL MEDICAL CORPORATION |
SEAN REYNOLDS |