| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K080601 |
03/03/2008 |
ERGO++ VERSION 1.7 |
3D LINE MEDICAL SYSTEMS S.R.L. |
THOMAS VALENTINE |
| K080620 |
03/04/2008 |
MODIFICATION TO 3M TEGADERM CHG DRESSING |
3M COMPANY-3M HEALTH CARE |
MARIA RUIZ |
| K080703 |
03/12/2008 |
BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON EXCHANGE TANK |
4M VENTURES, INC. |
DENICE GALLAGHER |
| K080696 |
03/12/2008 |
ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01 |
ABBOTT LABORATORIES |
CAROL JOCHUM |
| K080739 |
03/17/2008 |
ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT |
ABBOTT MOLECULAR, INC. |
PAULA E MARTIN |
| K080647 |
03/07/2008 |
ACCIN BIPOLAR HEAD SYSTEM |
ACCELERATED INNOVATION, LLC |
MICHAEL KVITMITSKY |
| K080590 |
03/03/2008 |
AOS PROXIMAL HUMERAL PLATE |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
PAUL DONER |
| K080719 |
03/13/2008 |
YEAST TRAFFIC LIGHT PNA FISH |
ADVANDX, INC. |
HENRIK STENDER |
| K080868 |
03/28/2008 |
AONGEN COLLAGEN MATRIX |
AEON ASTRON EUROPE B.V. |
HORNG J LAI |
| K080584 |
03/03/2008 |
METHA SHORT STEM HIP SYSTEM |
AESCULAP IMPLANT SYSTEM, INC. |
KATHY A RACOSKY |
| K080753 |
03/17/2008 |
AESCULAP ENDOSCOPIC CLIP SYTEM |
AESCULAP, INC. |
LISA M BOYLE |
| K080757 |
03/18/2008 |
AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM |
AGA MEDICAL CORP. |
RASHMI BHUSHAN |
| K080692 |
03/11/2008 |
MACS CPAP SYSTEM |
AIRON CORPORATION |
ERIC GJERDE |
| K080606 |
03/04/2008 |
ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE |
ALATECH HEALTHCARE, LLC. |
NEIL ANDERSON |
| K080614 |
03/05/2008 |
DR VISION NEO, DR VISION DOU |
ALMANA MEDICAL IMAGING |
DANIEL KAMM |
| K080847 |
03/26/2008 |
RFVISION, MODEL 9.9D |
ALMANA MEDICAL IMAGING |
DANIEL KAMM, P.E |
| K080699 |
03/12/2008 |
NOVEL SPINAL SPACER SYSTEM |
ALPHATEC SPINE, INC. |
MARY STANNERS |
| K080838 |
03/25/2008 |
ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM |
ALVEOLUS, INC. |
TONY D ALEXANDER |
| K080872 |
03/31/2008 |
AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ |
AMEDICA BIOTECH, INC. |
Jeff Chen |
| K080803 |
03/21/2008 |
VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551 |
AMERICAN OPTISURGICAL, INC. |
DAVID SALZBERG |
| K080749 |
03/17/2008 |
RADIANCE |
AMERICAN ORTHODONTICS |
JEROME H SCHOMBERG |
| K080644 |
03/06/2008 |
AIRPURGE |
ANESTHESIA SAFETY PRODUCTS, LLC |
IHSAN A HADDAD |
| K080587 |
03/03/2008 |
EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE |
ANIMAS CORP. |
JENNIFER BOSLEY |
| K080639 |
03/06/2008 |
SYMPHONY GLUCOSE MANAGEMENT SYSTEM |
ANIMAS CORP. |
AMY SMITH |
| K080851 |
03/26/2008 |
A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY |
ANTICANCER INC |
YUYING TAN |
| K080736 |
03/17/2008 |
ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE |
APATECH LTD. |
CANDACE F CEDERMAN |
| K080604 |
03/04/2008 |
PRESSURE INJFECTABLE PICC |
ARROW INTERNATIONAL, INC. |
JULIE LAWSON |
| K080610 |
03/04/2008 |
ARTHROCARE ORTHOWAND SURGICAL DEVICE |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K080670 |
03/10/2008 |
MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM |
ATCOR MEDICAL |
JOHN ABRAM |
| K080691 |
03/11/2008 |
C-QUR EDGE MESH V-PATCH |
ATRIUM MEDICAL CORP. |
JOSEPH P DE PAOLO |
| K080688 |
03/11/2008 |
C-QUR LITE MESH V-PATCH |
ATRIUM MEDICAL CORP. |
JOSEPH P DE PAOLO |
| K080580 |
03/03/2008 |
COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D |
AXELGAARD MFG. CO., LTD. |
DAN P JEFFERY |
| K080672 |
03/10/2008 |
BIRTHTRACK |
BARNEV, LTD. |
AHAVA STEIN |
| K080755 |
03/17/2008 |
SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS |
BAUSCH & LOMB, INC. |
DEBRA KETCHUM |
| K080634 |
03/06/2008 |
ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495 |
BECKMAN COULTER, INC. |
LYNN WEIST |
| K080869 |
03/31/2008 |
ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC |
BECKMAN COULTER, INC. |
DAVID M IKEDA |
| K080812 |
03/24/2008 |
HEMOCCULT ICT |
BECKMAN COULTER, INC. |
SYLVIA ZORICH |
| K080857 |
03/27/2008 |
CHROMOPHARE E-SERIES |
BERCHTOLD HOLDING GMBH |
SILKE GORAL |
| K080766 |
03/18/2008 |
VIDAS RUB IGG |
BIOMERIEUX, INC. |
NIKITA S MAPP |
| K080864 |
03/28/2008 |
CAM STRUCTSURE PRECISION MILLED BARS |
BIOMET 3I, INC. |
TAMARA WEST |
| K080685 |
03/11/2008 |
HIPLOC COMPRESSION HIP SCREW |
BIOMET MANUFACTURING, INC. |
BECKY EARL |
| K080646 |
03/06/2008 |
C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM |
BIOMET SPINE |
JACQUELYN A HUGHES |
| K080642 |
03/06/2008 |
COMPREHENSIVE REVERSE SHOULDER |
BIOMET, INC. |
PATRICIA S BERES |
| K080879 |
03/31/2008 |
ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM |
BIORETEC LTD |
MARI RUOTSALAINEN |
| K080876 |
03/31/2008 |
DVX SPINE SYSTEM |
BK MEDITECH CO., LTD. |
ELAINE DUNCAN |
| K080761 |
03/18/2008 |
BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES |
BONART CO. LTD. |
ERIC L ONG |
| K080886 |
03/31/2008 |
IPLAN RT IMAGE |
BRAINLAB AG |
RAINER BIRKENBACH |
| K080888 |
03/31/2008 |
MODEIFICATION TO IPLAN RT DOSE |
BRAINLAB AG |
CARSTEN RAUPACH |
| K080678 |
03/10/2008 |
UNI-KNEE 2.0 |
BRAINLAB AG |
PER PERSSON |
| K080608 |
03/04/2008 |
DIGITAL LIGHTBOX |
BRAINLAB, AG |
RAINER BIRKENBACH |
| K080804 |
03/21/2008 |
BUSSE PLASTIC LOR SYRINGE |
BUSSE HOSIPITAL DISPOSABLES |
MUHAMAD ANSARI |
| K080668 |
03/10/2008 |
G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS |
C.R. BARD, INC. |
GENEVIEVE BALUTOWSKI |
| K080726 |
03/14/2008 |
CALYPSO 4D LOCALIZATION SYSTEM |
CALYPSO MEDICAL TECHNOLOGIES INC |
ERIC MEIER |
| K080883 |
03/31/2008 |
CR-1 |
CANON, INC. |
SHEILA DRISCOLL |
| K080845 |
03/26/2008 |
ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM |
Cardinal Health |
LAVENIA FORD |
| K080770 |
03/18/2008 |
IMAGENMD WITH IMAGENQ |
CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC |
MELANIE HASEK |
| K080624 |
03/05/2008 |
NAVSTATIONIRAD EMT, VERSION 1.1 |
CAS INNOVATIONS AG |
MARKUS NAGEL |
| K080595 |
03/03/2008 |
CELLAVISION DM96 WITH THE BODY FLUID APPLICATION |
CELLAVISION AB |
CONSTANCE G BUNDY |
| K080837 |
03/25/2008 |
XPERT MRSA/SA SSTI ASSAY |
CEPHEID |
RUSSEL K ENNIS |
| K080632 |
03/05/2008 |
CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS |
CLEARLAB SG PTE LTD. |
MARTIN DALSING |
| K080638 |
03/06/2008 |
CLARO |
CLRS TECHNOLOGY CORPORATION |
MAUREEN O'CONNELL |
| K080890 |
03/31/2008 |
SMARTSPOT PRIMAX |
CMT MEDICAL TECHNOLOGIES, LTD. |
DAN LAOR |
| K080799 |
03/21/2008 |
ATLAS-BASED AUTOSEGMENTATION |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
KATHRYN STINSON |
| K080752 |
03/17/2008 |
CONCEIVEX LATEX-FREE SEMEN COLLECTOR |
CONCEIVEX INC. |
BLIX WINSTON |
| K080583 |
03/03/2008 |
MODIFIED HD GUIDE CATHETER |
CONCENTRIC MEDICAL, INC. |
LARAINE PANGELINA |
| K080737 |
03/17/2008 |
MIRAFLEX HIGH FLOW MICROCATHETER |
COOK, INC. |
NATHAN SIMON |
| K080733 |
03/14/2008 |
COTTONS 100% NATURAL COTTON TAMPONS |
COTTONS PTY, LTD |
ROBERT SEIPLE |
| K080860 |
03/27/2008 |
CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM |
CREASPINE |
CYNTHIA J NOLTE |
| K080787 |
03/20/2008 |
BIOMOVE 5000 SYSTEM |
CURATRONIC, LTD. |
AHAVA STEIN |
| K080605 |
03/04/2008 |
SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL |
CURBELL ELECTRONICS INC. |
MICHAEL J WINTER |
| K080881 |
03/31/2008 |
CURE CATHETER CLOSED SYSTEM |
CURE MEDICAL LLC. |
James Smith |
| K080738 |
03/17/2008 |
DENTRON SENSOR |
DENTRON SYSTEMS LLC |
CLAUDE D BERTHOIN |
| K080828 |
03/25/2008 |
MOUNTAINEER OCT SPINAL SYSTEM |
DEPUY SPINE, INC. |
LISA GILMAN |
| K080585 |
03/03/2008 |
DESKTOP PRO |
ELEKTA LTD. |
PATRICK T.M. HULL |
| K080704 |
03/12/2008 |
LOW FLUID ALARM |
EM-TEC GMBH |
BERNHARD BRAND |
| K080717 |
03/13/2008 |
HABIB HEXABLATE 10 |
EMCISION, LTD. |
NAGY HABIB |
| K080836 |
03/25/2008 |
MODIFICATION TO ENDOFAST RELIANT SYSTEM |
ENDOGUN MEDICAL SYSTEMS |
DORIT WINITZ |
| K080780 |
03/19/2008 |
ANCHORAGE SCOPE, MODEL 000003 |
EPITEK, INC. |
WERNER HAMPL |
| K080715 |
03/13/2008 |
ERBE VIO ESU, MODEL VIO 200 S |
ERBE USA, INC. |
JOHN TARTAL |
| K080839 |
03/25/2008 |
ECHELON GRAY CARTRIDGE, MODEL ERC45M |
ETHICON ENDO-SURGERY, LLC |
RUTH ANN WOOD |
| K080621 |
03/05/2008 |
FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01 |
EUROPEAN CUSTOM MANUFACTURING BV |
WILLIAM GREENROSE |
| K080793 |
03/20/2008 |
FIRMGRIP |
FLEXICATH LTD. |
TALI HAZAN |
| K080765 |
03/18/2008 |
CROSSER LP SYSTEM |
FLOWCARDIA, INC. |
Dustin Michaels |
| K080849 |
03/26/2008 |
MICROSHEATH LP AND LP-AT |
FLOWCARDIA, INC. |
Dustin Michaels |
| K080684 |
03/10/2008 |
WG-SURGICAL SUTURES WITH NEEDLE |
FOOSIN MEDICAL SUPPLIES INC. |
Diana Hong |
| K080751 |
03/18/2008 |
ARCHITECT CYCLOSPORINE |
FUJIREBIO DIAGNOSTICS, INC. |
STACEY MOLL |
| K080649 |
03/07/2008 |
POGO SCREW |
FXDEVICES |
RICH LIPSCHUTZ |
| K080724 |
03/14/2008 |
GC OPB-100 |
GC AMERICA, INC. |
MARK HEISS |
| K080745 |
03/17/2008 |
GENADYNE A4 POWERED SUCTION PUMP |
GENADYNE BIOTECHNOLOGIES, INC. |
JOHN PAPPAN |
| K080853 |
03/26/2008 |
DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM |
GENEXEL-SEIN, INC. |
JAY MANSOUR |
| K080662 |
03/10/2008 |
GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR |
GENZYME CORPORATION |
ERIC LAWSON |
| K080708 |
03/12/2008 |
VISION HOLLOW FIBER OXYGENATOR WITH HA COATING |
GISH BIOMEDICAL, INC. |
HARVEY KNAUSS |
| K080697 |
03/12/2008 |
SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER |
GLOBAL USA DISTRIBUTION, LLC. |
RONALD BERGLUND |
| K080664 |
03/10/2008 |
RELIEVE LAMINOPLASTY FIXATION SYSTEM |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K080844 |
03/26/2008 |
G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE |
GYRUS ACMI, INC. |
LORRAINE CALZETTA |
| K080827 |
03/25/2008 |
HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810 |
HANDAN HENGYONG PROTECTIVE & CLEAN PRODUCTS CO., L |
MAGGIE ZHONG |
| K080682 |
03/10/2008 |
HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE |
HANDPIECE HEADQUARTERS INC. - HPR INC. |
TINA STEFFANIE-OAK |
| K080818 |
03/24/2008 |
HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING |
HEMCON MEDICAL TECHNOLOGIES, INC. |
KEVIN HAWKINS |
| K080711 |
03/13/2008 |
1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION |
HOLOGIC, INC. |
BRYAN COWELL |
| K080710 |
03/13/2008 |
TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81 |
HOME DIAGNOSTICS, INC. |
KAREN DEVINCENT |
| K080641 |
03/06/2008 |
TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81 |
HOME DIAGNOSTICS, INC. |
KAREN DEVINCENT |
| K080579 |
03/03/2008 |
EFFECTIV (TM) CAP |
HOSPIRA, INC. |
REBECCA ANDERSEN |
| K080667 |
03/10/2008 |
VARIAX DISTAL RADIUS TORX SCREWS |
HOWMEDICA OSTEONICS CORP. |
DANIELLE HILLMAN |
| K080636 |
03/06/2008 |
DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100 |
HUBDIC CO., LTD |
MARIA F GRIFFIN |
| K080706 |
03/12/2008 |
CONNEXX LOCKING TIBIA NAIL |
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
AL LIPPINCOTT |
| K080762 |
03/18/2008 |
IB NEURO, VERSION 1.0 |
IMAGING BIOMETRICS, LLC |
MICHAEL SCHMAINDA |
| K080825 |
03/24/2008 |
IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 |
IMPEDIMED PTY LTD. |
PHILIP S AUCKLAND |
| K080713 |
03/13/2008 |
REACTIVE DENTAL IMPLANT SYSTEM |
IMPLANT DIRECT LLC |
THOMAS GOTTENBOS |
| K080633 |
03/05/2008 |
SCREWINDIRECT DENTAL IMPLANTS |
IMPLANT DIRECT LLC |
THOMAS GOTTENBOS |
| K080809 |
03/21/2008 |
IEC MEDSIGHT AND MEDBRIGHT |
INNOVATIVE ENDOSCOPY COMPONENTS, LLC. |
GERALD GOIFITZER |
| K080602 |
03/03/2008 |
AUDICOR SENSOR, MODELS: 2.0, 3.0 |
INOVISE MEDICAL, INC. |
KENDRA RATHKEY |
| K080798 |
03/20/2008 |
INTEL HEALTH GUIDE, MODEL: PHS6000 |
INTEL CORP. |
TAE-WOONG KOO |
| K080598 |
03/03/2008 |
MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS |
INTRA-LOCK INTERNATIONAL |
JEFFREY SAKOFF |
| K080740 |
03/17/2008 |
CLEARVIEW ENDOSCOPE COVER |
INVOTEC INTERNATIONAL, INC. |
JEFFREY L AULL |
| K080779 |
03/19/2008 |
IRRISEPT WOUND CLEANSING SYSTEM |
IRRIMAX CORPORATION |
JULIE STEPHENS |
| K080623 |
03/05/2008 |
CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA |
JAS Diagnostics, Inc. |
SAMUEL BURGOS |
| K080618 |
03/05/2008 |
DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID |
JAS Diagnostics, Inc. |
SAMUEL BURGOS |
| K080759 |
03/18/2008 |
THERMOFLASH LX-26 |
JXB CO. LTD GUANGZHOU (CHINA) |
TRAY CUI |
| K080792 |
03/20/2008 |
K2M COCR ROD |
K2M, INC. |
RICHARD W WOODS |
| K080611 |
03/04/2008 |
MESA SPINAL SYSTEM |
K2M, INC. |
RICHARD W WOODS |
| K080677 |
03/10/2008 |
COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE |
KALTENBACH & VOIGT GMBH & CO. |
CLAUDIA ORTIZ |
| K080852 |
03/26/2008 |
KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
CRYSTAL DIZOL |
| K080821 |
03/24/2008 |
MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE |
KIMBERLY-CLARK CORP. |
SHERRI SAURINI |
| K080795 |
03/20/2008 |
ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN |
KIMBERLY-CLARK CORP. |
DAVID M LEE |
| K080862 |
03/27/2008 |
SONICWELD RX (RESORB-X) |
KLS-MARTIN L.P. |
TOM FAUCETT |
| K080661 |
03/10/2008 |
MODELS TENS 7000, EMS 7500 AND TWIN STIM |
KOALATY PRODUCTS, INC. |
JAY MANSOUR |
| K080681 |
03/10/2008 |
KOWA GENESIS-D |
KOWA CO. LTD. |
SATOHIKO TAKANASHI |
| K080728 |
03/14/2008 |
LDR SPINE ROI-C IMPLANT |
LDR SPINE USA |
NOAH BARTSCH |
| K080612 |
03/04/2008 |
LEICA FL800 |
LEICA MICROSYSTEMS (SCHWEIZ) AG |
COLLEEN BOSWELL |
| K080767 |
03/18/2008 |
CONQUEST SPINAL SYSTEM |
LIFE SPINE |
REBECCA M BROOKS |
| K080788 |
03/20/2008 |
VIVASCOPE SYSTEM, MODEL 1500, 3000 |
LUCID, INC. |
JAMES JOY |
| K080901 |
03/31/2008 |
LBI EMBOLECTOMY SYSTEM |
LUMEN BIOMEDICAL, INC. |
MARIA E BRITTLE |
| K080609 |
03/03/2008 |
SWC/DWC WARMING CABINETS |
MAC MEDICAL |
DANIEL KAMM |
| K080592 |
03/03/2008 |
HLM TUBING SET WITH BIOLINE COATING |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENGLENKS |
| K080764 |
03/18/2008 |
SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100 |
MAX ENDOSCOPY INC. |
RICHARD M WOLF |
| K080885 |
03/31/2008 |
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION |
MEDACTA INTERNATIONAL, SA |
NATALIE J KENNEL |
| K080742 |
03/17/2008 |
VERISUITE 1.6, VERISUITE-PARTICLE 1.6 |
MEDCOM GMBH |
STEFAN WALTER |
| K080657 |
03/07/2008 |
NEB-90 LARGE VOLUME MEDICATION NEBULIZER |
MEDI NUCLEAR CORP., INC. |
MICHAEL MCPECK |
| K080874 |
03/31/2008 |
EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT |
MEDICA CORP. |
Photios Makris |
| K080823 |
03/24/2008 |
EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT |
MEDICA CORP. |
Photios Makris |
| K080810 |
03/21/2008 |
EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT |
MEDICA CORP. |
Photios Makris |
| K080878 |
03/31/2008 |
MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT) |
MEDICAL TECHNOLOGIES OF GEORGIA, INC. |
CINDI SARTAIN |
| K080582 |
03/03/2008 |
MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA |
MEDICATECH USA |
DANIEL KAMM |
| K080800 |
03/21/2008 |
ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
SHIM KYUNG-AM |
| K080899 |
03/31/2008 |
ARCTIC BLAST INTRAVENOUS FLUID CHILLER |
MEDIVANCE, INC. |
LYNNE ARONSON |
| K080884 |
03/31/2008 |
QHRV 1 - HEALTH ASSESSMENT SYSTEM |
MEDTECHS, LLC |
MEGHAN ATH |
| K080635 |
03/06/2008 |
MEDTOXSCAN |
MEDTOX DIAGNOSTICS, INC. |
PHILLIP HARTZOG |
| K080824 |
03/24/2008 |
BIO-CONSOLE 560 |
MEDTRONIC PERFUSION SYSTEMS |
PREETI JAIN |
| K080805 |
03/21/2008 |
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
CHRISTINE SCIFERT |
| K080741 |
03/17/2008 |
MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE |
MEGADYNE MEDICAL PRODUCTS, INC. |
RONDA K MAGNESON |
| K080772 |
03/19/2008 |
BONEMEDIK-DM |
META BIOMED CO., LTD. |
TAE-HOON KIM |
| K080655 |
03/07/2008 |
CHRYSALIS |
META IMAGING SOLUTIONS, LLC |
ROBERT J STAAB |
| K080786 |
03/20/2008 |
ML830TP |
MICROLIGHT CORPORATION OF AMERICA |
FRED A SIMPSON |
| K080666 |
03/10/2008 |
HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS |
MICROVENTION, INC. |
KEVIN E DALY |
| K080863 |
03/28/2008 |
TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE |
MICROVENTION, INC. |
KEVIN E DALY |
| K080861 |
03/27/2008 |
MICRUS ASCENT OCCLUSION BALLOON CATHETER |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
| K080613 |
03/04/2008 |
CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045 |
MINIMALLY INVASIVE DEVICES LLC |
MICHAEL H SOUTHWORTH |
| K080820 |
03/24/2008 |
TEM 3002G- HN DUAL TUNE HEAD COIL |
MR INSTRUMENTS, INC. |
MARK WATSON |
| K080722 |
03/13/2008 |
PRIMADO SURGICAL DRILL |
NAKANISHI, INC. |
KEITH A BARRITT |
| K080589 |
03/03/2008 |
SATURN 9000-810 |
NEW MEDICAL CO., LTD. |
YOUNG-HOON SHIN |
| K080880 |
03/31/2008 |
RTM AND OVAL |
NEXT MOBILITY, LLC |
JOSEPH AZARY |
| K080695 |
03/11/2008 |
MOBILE I.V. SYSTEMS 10,20,60 |
NORTHWIND TECHNOLOGIES, CORP. |
DAWN I MOORE |
| K080871 |
03/31/2008 |
TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS |
NUCLETRON CORPORATION |
LISA DIMMICK |
| K080807 |
03/21/2008 |
BLOOD TUBING SETS (STERILE FLUID PATH) |
NXSTAGE MEDICAL, INC. |
MICHAEL DOYLE |
| K080586 |
03/03/2008 |
OLYMPUS XCHF TYPE B180Y1 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K080581 |
03/03/2008 |
VB IMAGE VIEWER |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K080842 |
03/25/2008 |
APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES] |
OMNI LIFE SCIENCE, INC. |
WILLIAM MCCALLUM |
| K080622 |
03/05/2008 |
ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 |
OPTIM, INC. |
ROBERT KRUPA |
| K080631 |
03/05/2008 |
CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER |
ORAL HEALTH TECHNOLOGIES, LLC |
ROBERT E TRICCA |
| K080648 |
03/07/2008 |
TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE |
ORE-MEDIX, LLC |
DONALD F GRABARZ |
| K080744 |
03/17/2008 |
HG II FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
MINJOO KIM |
| K080594 |
03/03/2008 |
MS SYSTEM (NARROW RIDGE) |
OSSTEM IMPLANT CO.,LTD |
MINJOO KIM |
| K080694 |
03/11/2008 |
OSTEOMED MODULAR LOCKING FIXATION SYSTEM |
OSTEOMED L.P. |
PIEDAD PENA |
| K080731 |
03/14/2008 |
PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE |
OSYRIS |
JAOUAD ZEMMOURI |
| K080675 |
03/10/2008 |
PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN QUASS |
| K080654 |
03/07/2008 |
PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN QUASS |
| K080674 |
03/10/2008 |
PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN QUASS |
| K080896 |
03/31/2008 |
PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST |
PATHWORK DIAGNOSTICS, INC. |
Erika B Ammirati |
| K080591 |
03/03/2008 |
TANDA SKINCARE SYSTEM, MODEL: PTSCS |
PHAROS LIFE CORPORATION |
PHIL CUSCUNA |
| K080794 |
03/20/2008 |
POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
POLYVUE DISTRIBUTION, INC. |
GAROLD L EDWARDS |
| K080806 |
03/21/2008 |
ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608 |
POSSIS MEDICAL, INC. |
MIKE BURNSIDE |
| K080689 |
03/11/2008 |
SPECTRA THERAPY SYSTEM A1000 LASER DEVICE |
PREMIER DYNAMICS, INC. |
JOHN J STEPHAN |
| K080629 |
03/05/2008 |
PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS |
PROMEDICAL PRODUCTS CO., LTD. |
LEO WEI |
| K080627 |
03/05/2008 |
PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A |
PROMEDICAL PRODUCTS CO., LTD. |
LEO WEI |
| K080865 |
03/28/2008 |
FAST1 INTRAOSSEOUS INFUSION SYSTEM |
PYNG MEDICAL CORP. |
MAYA BUTTERFIELD |
| K080848 |
03/26/2008 |
ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR |
Q3 INNOVATIONS, LLC |
DANIEL KAMM |
| K080813 |
03/21/2008 |
PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER |
RADI MEDICAL SYSTEMS AB |
BJORN PALMGREN |
| K080797 |
03/20/2008 |
HUMIDAIRE 2I |
RESMED LTD. |
DAVID D'CRUZ |
| K080652 |
03/07/2008 |
MERCURY VCO2 MODULE WITH CAPNOSTAT 5 |
RESPIRONICS NOVAMETRIX LLC |
KEVIN MADER |
| K080617 |
03/04/2008 |
POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
NIELS SCHMIDT |
| K080643 |
03/06/2008 |
ELECSYS ANTI-TSHR CALCHECK |
Roche Diagnostics |
STEPHANIE GREEMAN |
| K080607 |
03/04/2008 |
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160 |
ROCHE DIAGNOSTICS CORP. |
KATHIE J CUNNINGHAM |
| K080811 |
03/24/2008 |
TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET |
ROCHE DIAGNOSTICS CORP. |
KERWIN L KAUFMAN |
| K080687 |
03/11/2008 |
SMARTBURS |
S.S. WHITE BURS, INC. |
DEREK GLADDEN |
| K080588 |
03/03/2008 |
SCIENT'X TRIBECA VBR |
SCIENT'X USA, INC. |
JOHN SANDERS |
| K080789 |
03/20/2008 |
BLOOD PRESSURE MONITOR, MODELS BP-102, BP-103, BP-201 AND BP-202 |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
JIANYAO WU |
| K080791 |
03/20/2008 |
CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45 |
SENORX, INC. |
EBEN GORDON |
| K080698 |
03/12/2008 |
GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP |
SENORX, INC. |
EBEN GORDON |
| K080712 |
03/13/2008 |
SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 |
SERIM RESEARCH CORP. |
PATRICIA RUPCHOCK |
| K080640 |
03/06/2008 |
M5 DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K080701 |
03/11/2008 |
SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION |
SHIMADZU CORP. |
DON KARLE |
| K080834 |
03/25/2008 |
VINTAGE ART |
SHOFU DENTAL CORP. |
DAVID P MORAIS |
| K080578 |
03/03/2008 |
DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA |
Siemens Healthcare Diagnostics Inc. |
VICTOR M CARRIO |
| K080760 |
03/18/2008 |
ACUSON X300 ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
MARTINA VOGT |
| K080815 |
03/24/2008 |
TOSCA II ANTERIOR CERVICAL PLATE SYSTEM |
SIGNUS MEDIZINTECHNIK GMBH |
KAREN E WARDEN |
| K080882 |
03/31/2008 |
CEREC OPTI SPRAY |
SIRONA DENTAL SYSTEMS GMBH |
|
| K080875 |
03/31/2008 |
PIGALILEO 4TH GENERATION SYSTEM |
SMITH & NEPHEW, INC. |
RISHI SINHA |
| K080625 |
03/05/2008 |
SMITH & NEPHEW MIS HIP STEM WITH STIKTITE |
SMITH & NEPHEW, INC. |
RISHI SINHA |
| K080743 |
03/17/2008 |
LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP |
SMITHS MEDICAL MD, INC. |
DAVID H SHORT |
| K080769 |
03/18/2008 |
INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C |
SOMANETICS CORP. |
RONALD A WIDMAN |
| K080778 |
03/19/2008 |
ENSPLINT TM BONE SCREW |
SONOMA ORTHOPEDIC PRODUCTS, INC. |
AMY CONUEL |
| K080832 |
03/25/2008 |
STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
| K080796 |
03/20/2008 |
SRI LP DRAPE |
SRI/SURGICAL EXPRESS |
JEFFREY O STULL |
| K080707 |
03/12/2008 |
SRI PLR GOWN |
SRI/SURGICAL EXPRESS |
JEFFREY O STULL |
| K080723 |
03/12/2008 |
SRI LP GOWN |
SRI/SURGICAL EXPRESS, INC. |
JEFFERY O STULL |
| K080645 |
03/06/2008 |
STD MED PRIMO PORT POLY |
STD MED, INC. |
PAMELA PAPINEAU |
| K080637 |
03/06/2008 |
POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS |
STEREOTAXIS, INC. |
DENNIS POZZO |
| K080750 |
03/17/2008 |
BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR |
STERIS Corporation |
JOHN SCOVILLE |
| K080758 |
03/18/2008 |
AVS PL PEEK SPACERS, MODELS 48351 AND 48353 |
STRYKER CORP. |
VIKKI M O'CONNOR |
| K080773 |
03/19/2008 |
THOR ANTERIOR PLATING SYSTEM |
STRYKER SPINE |
CURTIS TRUESDALE |
| K080854 |
03/27/2008 |
DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100 |
SUNTECH MEDICAL, INC. |
DAVID GALLIK |
| K080680 |
03/10/2008 |
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE |
SURGICAL SPECIALTIES CORP. |
TRUDY D ESTRIDGE |
| K080887 |
03/31/2008 |
SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE |
SYSMEX AMERICA, INC. |
NINA GAMPERLING |
| K080782 |
03/19/2008 |
NITI-S ESOPHAGEAL STENT |
TAEWOONG MEDICAL CO., LTD |
CATHRYN N CAMBRIA |
| K080593 |
03/03/2008 |
FORA COMFORT 4 IN 1 EAR THERMOMETER, MODEL TD-1116 |
TaiDoc Technology Corporation |
Yuhua Chen |
| K080763 |
03/18/2008 |
TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT |
TALLEY MEDICAL |
JACK VAN DYKE |
| K080897 |
03/31/2008 |
VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
TALLEY MEDICAL |
JACK VAN DYKE |
| K080603 |
03/03/2008 |
HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED |
TE ME NA SAS |
ARTHUR WARD |
| K080873 |
03/31/2008 |
OPACITY + BONE CEMENT |
TEKNIMED SA |
J.D. WEBB |
| K080774 |
03/19/2008 |
CAPIOX SP PUMP (WITH OR WITHOUT X-COATING) |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
| K080802 |
03/21/2008 |
EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL |
THE ANSPACH EFFORT, INC. |
JIM BANIC |
| K080690 |
03/11/2008 |
MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM |
THEKEN SPINE LLC |
DALE DAVISON |
| K080790 |
03/20/2008 |
MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM |
THEKEN SPINE LLC |
DALE DAVISON |
| K080822 |
03/24/2008 |
VU APOD INTERVERTABRAL BODY FUSION DEVICE |
THEKEN SPINE LLC |
DALE DAVISON |
| K080700 |
03/11/2008 |
DUOFLO CATHETER |
THERMOPEUTIX INC. |
|
| K080833 |
03/25/2008 |
LOVE GUARD MALE LATEX CONDOM |
TIANJIN HUMAN-CARE LATEX CORPORATION |
SIMON LI |
| K080615 |
03/04/2008 |
ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD) |
TITAN SPINE, LLC |
KEVIN GEMAS |
| K080771 |
03/19/2008 |
TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC |
TOP CORP. |
CATHRYN N CAMBRIA |
| K080775 |
03/19/2008 |
MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS |
TOSAMA D.D. |
ANTONIJA VIDENSEK |
| K080650 |
03/07/2008 |
OMNI-DL SYSTEM |
TRANSVIVO INC. |
J. MICHAEL DELMAGE |
| K080889 |
03/31/2008 |
KODAK 9000C EXTRAORAL IMAGING SYSTEM |
TROPHY |
MARIE-PIERRE LABAT-CAMY |
| K080898 |
03/31/2008 |
AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT |
TYCO HEALTHCARE GROUP, LP |
SHARON ALEXANDER |
| K080660 |
03/10/2008 |
IV ADMINISTRATION SET |
U.S. SAFETY SYRINGES CO., INC. |
CHRISTINE SMITH |
| K080665 |
03/10/2008 |
NOVOLET |
U.S. SAFETY SYRINGES CO., INC. |
CHRISTINA SMITH |
| K080841 |
03/26/2008 |
COSMIC SYSTEM |
ULRICH GMBH & CO. KG |
MERLE SYMES |
| K080600 |
03/03/2008 |
ULTIMED ULTICARE SAFETY SYRINGE |
ULTIMED, INC. |
CAROLE STAMP |
| K080768 |
03/18/2008 |
ULTRATEMP FIRM, FAST AND REGULAR SET |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
| K080784 |
03/20/2008 |
WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE |
ULTRASPECT LTD. |
DAN LAOR |
| K080877 |
03/31/2008 |
1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2 |
UNILIFE MEDICAL SOLUTIONS LIMITED |
MICHELLE GOW |
| K080776 |
03/19/2008 |
GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72 |
USOPHTHALMIC, LLC |
AL WEISENBORN |
| K080673 |
03/10/2008 |
INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE |
VERTEBRAL TECHNOLOGIES, INC. |
PHILIP B JARVI |
| K080734 |
03/14/2008 |
FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT |
VIASYS HEALTHCARE GMBH |
THOMAS RUST |
| K080679 |
03/10/2008 |
MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 |
VIASYS MEDSYSTEMS |
STEPHANIE WASIELEWSKI |
| K080859 |
03/27/2008 |
DRF 4343 |
VILLA SISTEMI MEDICALI S.P.A. |
PAOLO C SANTIN |
| K080816 |
03/24/2008 |
VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT |
VISUAL FOOTCARE TECHNOLOGIES, LLC |
ANDREW SINGER |
| K080814 |
03/24/2008 |
VOCO PROFLUORID VARNISH |
VOCO GMBH |
M.TH PLAUMANN |
| K080891 |
03/31/2008 |
REVOLUTION 45MHZ IVUS IMAGING CATHETER |
VOLCANO CORPORATION |
JENNIFER MOTTO |
| K080686 |
03/11/2008 |
WESTCON HORIZON 49% (HIOXIFILCON B) |
WESTCON CONTACT LENS CO. |
KEVIN RANDALL |
| K080850 |
03/26/2008 |
DARCO HEADLESS COMPRESSION SCREW |
WRIGHT MEDICAL TECHNOLOGY, INC. |
THERESA LEISTER |
| K080663 |
03/10/2008 |
PROFEMUR LX REVISION 5/8 COATED HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
RYAN ROSS |
| K080735 |
03/17/2008 |
CRYOMINI |
ZIMMER ELEKTROMEDIZIN GMBH |
ARMIN PETRASCHKA |
