| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K061440 |
06/27/2006 |
P.D |
.DECIMAL, INC. |
DANIEL BENNETT |
| K053409 |
06/19/2006 |
3M LIQUID BANDAGE |
3M COMPANY |
BRYAN BECKER |
| K061456 |
06/21/2006 |
A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR |
A & D ENGINEERING, INC. |
JERRY WANG |
| K060691 |
06/12/2006 |
EASY X-TRAC SYSTEM |
A. TITAN INSTRUMENTS, INC. |
MICHAEL TUBER |
| K060875 |
06/14/2006 |
ABBOTT AXSYM TROPONIN-I ADV |
ABBOTT LABORATORIES |
MARGARET PROCHNIAK |
| K061249 |
06/02/2006 |
AXSYM DIGOXIN III |
ABBOTT LABORATORIES |
KENTON SMITH |
| K061193 |
06/23/2006 |
CREATININE |
ABBOTT LABORATORIES INC |
LINDA MORRIS |
| K060670 |
06/02/2006 |
ACCIN UNI-KNEE SYSTEM |
ACCIN CORPORATION |
MICHAEL KVITNITSKY |
| K060888 |
06/23/2006 |
ACELL POWDER WOUND DRESSING |
ACELL, INC |
PATSY J TRISLER |
| K053033 |
06/06/2006 |
ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000 |
ACRO BIOTECH LLC. |
GREGORY LEE |
| K053037 |
06/15/2006 |
ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100 |
ACRO BIOTECH LLC. |
GREGORY LEE |
| K053034 |
06/06/2006 |
ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000 |
ACRO BIOTECH LLC. |
GREGORY LEE |
| K053400 |
06/19/2006 |
ACUMEN SINGLE-LUMEN DELIVERY SHEATH |
ACUMEN MEDICAL, INC. |
Marybeth Gamber |
| K061206 |
06/19/2006 |
ACUTE BONE SCREW |
ACUTE INNOVATIONS LLC |
ALYSSA THOMAS |
| K061395 |
06/23/2006 |
CALSET COMPOSITE HEATER |
ADDENT, INC. |
JOSHUA FRIEDMAN |
| K060299 |
06/06/2006 |
ART BRACHYTHERAPY APPLICATOR |
ADVANCED RADIATION THERAPY, LLC |
RAYMOND BRICAULT |
| K061538 |
06/30/2006 |
ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200 |
ALARA, INC. |
DIANE KING |
| K053422 |
06/15/2006 |
RAPIDONE-COCAINE-150 TEST |
AMERICAN BIO MEDICA CORP. |
HENRY WELLS |
| K061039 |
06/29/2006 |
AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE |
AMSINO INTERNATIONAL, INC. |
CHING CHING SEAH |
| K061178 |
06/12/2006 |
ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K060939 |
06/26/2006 |
RANGER IRRIGATION FLUID WARMING SYSTEM |
ARIZANT HEALTHCARE INC. |
DAVID WESTLIN |
| K060693 |
06/06/2006 |
MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR |
ARTHROTEK, INC. |
LESTER F PADILLA |
| K060745 |
06/23/2006 |
ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K053476 |
06/26/2006 |
ALLWOUND |
AT SQUARED, LLC |
JULIA C TIERNEY |
| K053373 |
06/30/2006 |
ATLANTIS ABUTMENT FOR ZIMMER INTERFACE |
ATLANTIS COMPONENTS, INC. |
BETSY BROWN |
| K052764 |
06/09/2006 |
DIACAP ULTRA DIALYSIS FLUID FILTER |
B. BRAUN MEDIZINTECHNOLOGIE GMBH |
SCOTT J PEASE |
| K060347 |
06/05/2006 |
B&L L-BETA, MODEL WL-B1 |
B&L BIOTECH CO., LTD. |
DANIEL KAMM |
| K061038 |
06/23/2006 |
BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-125490 |
BARRIERMED GLOVE CO. |
VICTOR J RAGUCCI |
| K061157 |
06/22/2006 |
SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS |
BAUSCH & LOMB |
DEBRA KETCHUM |
| K060375 |
06/06/2006 |
BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 |
BD Biosciences |
CARTER NAVARRO |
| K061282 |
06/02/2006 |
ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585 |
BECKMAN COULTER, INC. |
JENNIFER RUETHER |
| K061355 |
06/07/2006 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN (GN) 0.5-32 UG/ML |
BECTON, DICKINSON & CO. |
JANINE MATLAK |
| K060641 |
06/02/2006 |
PLATELIA ASPERGILLUS EIA, MODEL 62793 |
BIO-RAD |
CHRISTOPHER BENTSEN |
| K060030 |
06/27/2006 |
THE DOUBLE GLOVE |
BIOBARRIER, INC. |
DAVID W MULLIS |
| K060732 |
06/02/2006 |
MBCP GEL |
BIOMATLANTE |
MYRIAM VINCENT |
| K061347 |
06/20/2006 |
VITEK 2 GRAM POSITIVE VRSA SCREEN |
BIOMERIEUX, INC. |
Nancy Weaver |
| K060716 |
06/12/2006 |
VERSA-DIAL HUMERAL HEAD PROSTHESIS |
BIOMET MANUFACTURING CORP. |
SUSAN ALEXANDER |
| K061312 |
06/06/2006 |
36MM BIOLOX DELTA CERAMIC HEADS |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K061089 |
06/20/2006 |
MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 |
BIOPRO, INC. |
DAVID MRAK |
| K060047 |
06/19/2006 |
CARTO RMT EP NAVIGATION SYSTEM V8 |
BIOSENSE WEBSTER, INC. |
DIANA THORSON |
| K060791 |
06/22/2006 |
TRIAGE TOX DRUG SCREEN, MODEL 94400 |
BIOSITE INCORPORATED |
Robin Weiner |
| K061171 |
06/02/2006 |
SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX |
BIOSPHERE MEDICAL, INC. |
ROSINA ROBINSON |
| K051342 |
06/02/2006 |
MEDICAL INTERPOROUS |
BONYF AG |
DONNA MARIE HARTNETT |
| K052254 |
06/01/2006 |
MYTIS ARROW XXXX |
BRAINBASE CORPORATION |
CRAIG R BRUNS |
| K053159 |
06/06/2006 |
VECTORVISION SPINE |
BRAINLAB AG |
RAINER BIRKENBACH |
| K061351 |
06/05/2006 |
ORAL-B SONIC COMPLETE |
BRAUN GMBH |
AMANDA HEFFERNAN |
| K061057 |
06/23/2006 |
BREAS ISLEEP 20+ |
BREAS MEDICAL AB |
KARL-JOHAN HOLM |
| K060402 |
06/09/2006 |
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR) |
BRIGHTWAY HOLDINGS SDN. BHD. |
G. BASKARAN |
| K060551 |
06/07/2006 |
BRIVANT GUIDEWIRE |
BRIVANT LIMITED |
TOMAS FUREY |
| K061341 |
06/12/2006 |
PALMLIGHT 10, MODEL 001-00030 |
CAO GROUP, INC. |
ROBERT K LARSEN |
| K061308 |
06/05/2006 |
TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N |
CARDINAL HEALTH 200, INC. |
LAVENIA FORD |
| K061114 |
06/06/2006 |
WDS, SIZE 2 AND SIZE 2 |
CEFLA S.C.R.L. |
Claude Berthoin |
| K061161 |
06/26/2006 |
BLOOD PRESSURE METER, MODEL CH-311B |
CITIZEN WATCH CO., LTD. |
JOSEPH D EDMONDSON JR. |
| K060249 |
06/12/2006 |
ULTRATINE FOREHEAD |
COAPT SYSTEMS, INC. |
LINDA RUEDY |
| K060248 |
06/12/2006 |
ULTRATINE TRANSBLEPH |
COAPT SYSTEMS, INC. |
LINDA RUEDY |
| K061110 |
06/07/2006 |
GLUCOMMANDER PLUS |
COLLABORATIVEMED, LLC |
ROBERT BOOTH |
| K061487 |
06/26/2006 |
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE |
COLLAGEN MATRIX, INC. |
PEGGY HANSEN |
| K061173 |
06/09/2006 |
CPIVISION DIGITAL IMAGING SYSTEM |
COMMUNICATIONS & POWER INDUSTRIES CANADA, INC. |
NORM MORIKAWA |
| K061183 |
06/01/2006 |
CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093 |
CONFLUENT SURGICAL,INC |
ERIC P ANKERUD |
| K053464 |
06/06/2006 |
SERVICE MANAGER SM40SE |
CONMED INTEGRATED SYSTEMS, CANADA, ULC |
MICHAEL T TAGGART |
| K060526 |
06/09/2006 |
TIPI |
CONTIPI LTD. |
PAUL DRYDEN |
| K060908 |
06/29/2006 |
SONOHYSTEROGRAPHY BIOPSY DEVICE |
COOK UROLOGICAL, INC. |
CINDY RUMPLE |
| K061301 |
06/23/2006 |
COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM |
COPAN DIAGNOSTICS, INC. |
CYNTHIA SINCLAIR |
| K042955 |
06/19/2006 |
CUTICOVER SKIN BARRIER DEVICE |
D & D HOLDINGS, LLC |
MARK CITRON |
| K061503 |
06/22/2006 |
DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) |
DADE BEHRING, INC. |
ANDREA M TASKER |
| K061218 |
06/30/2006 |
DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140 |
DADE BEHRING, INC. |
VICTOR M CARRIO |
| K052759 |
06/14/2006 |
DAN MONOPOLAR LAP ACCESSORIES |
DANNORITZER MEDIZINTECHNIK GMBH & CO. KG |
ANGELIKA SCHERP |
| K061609 |
06/27/2006 |
GE DATEX-OHMEDA AISYS |
DATEX-OHMEDA, INC. |
DAN KOSEDNAR |
| K060862 |
06/05/2006 |
GE DATEX-OHMEDA ENGSTROM CARESTATION |
DATEX-OHMEDA, INC. |
DAN KOSEDNAR |
| K061314 |
06/02/2006 |
BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH |
DAVOL INC., SUB. C.R. BARD, INC. |
ROBIN N DRAGO |
| K052513 |
06/28/2006 |
BABY SNOOPY WATER FILLED TEETHER, MODEL 95367 |
DELTA ENTERPRISE CORPORATION |
MARIA E CELIS |
| K060501 |
06/16/2006 |
IMPLANTIUM II |
DENTIUM CO., LTD. |
CATHRYN N CAMBRIA |
| K060500 |
06/16/2006 |
SPEEDY ORTHODONTIC SCREW |
DENTIUM CO., LTD. |
CATHRYN N CAMBRIA |
| K061427 |
06/26/2006 |
PRE-IMPRESSION CONDITIONING SOLUTION |
DENTSPLY INTL. |
HELEN LEWIS |
| K060664 |
06/06/2006 |
FASTIN RC ANCHOR |
Depuy Mitek |
Ruth Forstadt |
| K060830 |
06/15/2006 |
MILAGRO INTERFERENCE SCREW |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
Ruth Forstadt |
| K061144 |
06/08/2006 |
DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT |
DEPUY ORTHOPAEDICS, INC. |
NATALIE S HECK |
| K060874 |
06/28/2006 |
DEPUY GLOBAL AP SHOULDER SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
NATALIE S HECK |
| K061520 |
06/23/2006 |
VIPER SPINE SYSTEM |
DEPUY SPINE, INC. |
MARY GRAY |
| K060488 |
06/08/2006 |
DERMATECH IV HOLDER |
DERMATECH MEDICAL INC |
GLENN THIBAULT |
| K060668 |
06/12/2006 |
SAFE TIP SYRINGE |
DEVON SAFETY PRODUCTS, INC. |
ELAINE DUNCAN |
| K061296 |
06/13/2006 |
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR |
DIAZYME LABORATORIES |
ROLAND STRICKLAND |
| K060300 |
06/21/2006 |
CONFIDENCE HIGH VISCOSITY BONE CEMENT |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
HILA WACHSLER-AVRAHAMI |
| K060876 |
06/15/2006 |
ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA |
DISETRONIC MEDICAL SYSTEMS AG |
Scott Thiel |
| K060524 |
06/15/2006 |
DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES |
DOLPHIN MEDICAL INC. |
BILL CURNAN |
| K051573 |
06/26/2006 |
TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) |
DR. HOWARD MARTIN, P.A. |
KYLE H SIBINOVIC |
| K060705 |
06/14/2006 |
CARINA HOME |
DRAEGER MEDICAL B.V. |
MONICA FERRANTE |
| K060510 |
06/19/2006 |
DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT |
DREW SCIENTIFIC LTD. |
DIANE HILL |
| K060642 |
06/07/2006 |
DUTECK BODY COMPOSITION ANALYZER |
DUTECK INDUSTRIAL CO., LTD. |
JOSEPH CHEN |
| K060814 |
06/14/2006 |
DYNATRON ION IONTOPHORESIS ELECTRODE |
DYNATRONICS CORP. |
KELVYN CULLIMORE, JR |
| K061328 |
06/13/2006 |
THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM) |
E-SAN LIMITED |
KRISTIN M ZIELINSKI |
| K061563 |
06/23/2006 |
EBI ARRAY SPINAL SYSTEM |
EBI, L.P. |
JENNIFER P HARAKAL |
| K061016 |
06/08/2006 |
EBI ESL PEEK-OPTIMA SPINE SYSTEM |
EBI, L.P. |
JENNIFER HARAKAL |
| K061244 |
06/06/2006 |
MUCOGRAFT |
ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE |
PETER S REICHERTZ |
| K052661 |
06/07/2006 |
QUIX DIGITAL RADIOGRAPHIC UPGRADE |
EDGE MEDICAL DEVICES LTD. |
VERED SCHARF |
| K061235 |
06/05/2006 |
LIFESTENT TURBO BILIARY STENT SYSTEM |
EDWARDS LIFESCIENCES, LLC. |
KEVIN DRISKO |
| K060759 |
06/29/2006 |
Y-CLICK CONNECTOR |
ELCAM MEDICAL ACAL |
TALI HAZAN |
| K061174 |
06/28/2006 |
SURGI-MAX |
ELLMAN INT'L INC. |
JON GARITO |
| K052711 |
06/23/2006 |
EMJOI TENS DEVICE |
EMJOI, INC. |
MIKE JUDGE |
| K061345 |
06/06/2006 |
MODIFICATION TO ENDIUS ATAVI SYSTEM |
ENDIUS, INC. |
CHRISTINE KUNTZ-NASSIF |
| K060537 |
06/08/2006 |
EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120 |
ENGINIVITY LLC |
PENELOPE GRECO |
| K053195 |
06/23/2006 |
SPIDERX EMBOLIC PROTECTION DEVICE |
EV3 INC. |
BRENDA JOHNSON |
| K060997 |
06/15/2006 |
SNAP II EEG MONITOR |
EVEREST BIOMEDICAL INSTRUMENTS CO. |
RANDALL J KROHN |
| K061454 |
06/12/2006 |
EXACTECH EQUINOXE SHOULDER STEMS |
EXACTECH, INC. |
MARITZA ELIAS |
| K060316 |
06/23/2006 |
COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS |
FRESENIUS KABI DEUTSCHLAND GMBH |
BARBARA BREUER-THAL |
| K061672 |
06/29/2006 |
SYNAPSE MIP/MPR IMAGE VISUALIZATION SOFTWARE OBLIQUUS |
FUJIFILM MEDICAL SYSTEMS USA, INC. |
DEBBIE PEACOCK |
| K061625 |
06/26/2006 |
AUTOBONE2 |
GE HEALTHCARE |
LARRY A KROGER |
| K061587 |
06/23/2006 |
FULLCARD ANALYSIS |
GE HEALTHCARE |
LARRY A KROGER |
| K061163 |
06/07/2006 |
INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT |
GE MEDICAL SYSTEMS, LLC |
LARRY A KROGER |
| K061028 |
06/07/2006 |
PRECISION THUNIS 800+ |
GE MEDICAL SYSTEMS, LLC |
LARRY KROGER |
| K061129 |
06/01/2006 |
GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000 |
GENERAL ELECTRIC CO. |
PATRICIA TAIGE |
| K061459 |
06/30/2006 |
TRANQUIL TRI-BTE |
GENERAL HEARING INSTRUMENTS, INC. |
ROGER P JUNEAU |
| K061508 |
06/12/2006 |
OSOM INFLUENZA A&B TEST |
GENZYME CORP. |
FRED D LASKY |
| K061380 |
06/08/2006 |
RETAIN RADIOLUCENT SPACER |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K061007 |
06/14/2006 |
GOOD MEDY, DISPOSABLE THERMOMETER SHEATHS |
GOOD MEDY ENTERPRISE LTD. |
JEN KE-MIN |
| K060518 |
06/28/2006 |
PARTIAL OSSICULAR REPLACEMENT PROSTHESES |
Grace Medical, Inc. |
JEFF COBB |
| K061453 |
06/22/2006 |
HI-TORQUE WHISPER VIEW GUIDE WIRE |
GUIDANT CORP. |
KATHLEEN VITTUM |
| K060817 |
06/15/2006 |
OMNILINK. 018 BILIARY STENT SYSTEM |
GUIDANT ENDOVASCULAR SOLUTIONS, INC. |
MARA CALER |
| K061115 |
06/30/2006 |
SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 11216 |
GVS SPA |
DAWN I MOORE |
| K052583 |
06/14/2006 |
BLUE POWDER FREE NITRILE EXAMINATION GLOVES |
HARTALEGA SDN BHD |
KUAN KAM HON |
| K052469 |
06/05/2006 |
GLUCOPACK |
HEALTHPIA AMERICA CORP. |
STEVEN KIM |
| K061047 |
06/08/2006 |
HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 |
HEMOCUE AB |
ALLAN WHITE |
| K060858 |
06/08/2006 |
LATEX POWDERED EXAMINATION GLOVE |
HIGH MOMENTUM SDN BHD |
HUE K FAH |
| K061087 |
06/09/2006 |
GENESIS OTC MONITOR |
HONEYWELL HOMMED, LLC |
TOMMIE J MORGAN |
| K061088 |
06/09/2006 |
SENTRY OTC MONITOR |
HONEYWELL HOMMED, LLC |
TOMMIE J MORGAN |
| K061159 |
06/26/2006 |
OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN |
HOSPIRA, INC. |
THOMAS KOZMA |
| K061006 |
06/05/2006 |
IKOENGELO |
IKOETECH, LLC. |
HUIMIN CHAO |
| K060463 |
06/06/2006 |
HEMA SCREEN SPECIFIC IFOBT |
IMMUNOSTICS, INC. |
JEFFREY FLEISHMAN |
| K061032 |
06/21/2006 |
DEPOTONE |
IMPRINT PHARMACEUTICALS LIMITED |
MERVYN LITTLE |
| K052908 |
06/23/2006 |
INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 |
Infraredx, Inc. |
Nandini Murthy |
| K061147 |
06/30/2006 |
OPTERYX ANTERIOR CERVICAL PLATE SYSTEM |
INNOVASIS, INC. |
DAVID N MCKEAN |
| K061281 |
06/19/2006 |
INSIGHT HEAD COIL |
INSIGHT NEUROIMAGING SYSTEMS LLC |
PATRICIA A MILBANK |
| K061443 |
06/23/2006 |
SMART USBLITE, MODEL M011120 |
INTELLIGENT HEARING SYSTEMS |
EDWARD MISKIEL |
| K060883 |
06/23/2006 |
PILOT TEST OR DETECTIVE AUDIOMETERS |
INTERACOUSTICS A/S |
DANIEL EGGAN |
| K053571 |
06/30/2006 |
MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM |
INTERLAB S.R.L. |
Gary Lehnus |
| K060280 |
06/13/2006 |
ICHEM 100 URINE CHEMISTRY ANALYZER |
IRIS INTERNATIONAL, INC. |
GERALD J HADDOCK |
| K052798 |
06/06/2006 |
CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C |
ISOVAC PRODUCTS LLC |
LISA S JONES |
| K061322 |
06/02/2006 |
PORCELAIN PRIMER |
J. MORITA USA, INC. |
HOWARD ROWE |
| K060844 |
06/06/2006 |
SILKLINE SOFT RELINING KIT, MODEL 28-100100 |
J. MORITA USA, INC. |
HOWARD ROWE |
| K060910 |
06/07/2006 |
POWDERED FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
JIANGSU EVERYGUARD PLASTIC PRODUCTS CO., LTD |
CHU XIA OAN |
| K060914 |
06/09/2006 |
TRIDENT ANCHOR |
JOHNSON & JOHNSON COMPANY |
Ruth Forstadt |
| K060580 |
06/06/2006 |
K-SHIELD PORT ACCESS INFUSION SET |
KAWASUMI LABORATORIES, INC. |
JACK PAVLO |
| K061197 |
06/30/2006 |
KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER |
KAWASUMI LABORATORIES, INC. |
SUZAN ONEL |
| K061271 |
06/30/2006 |
ERCH ARCH BAR, MODEL 38-690-00 |
KLS-MARTIN L.P. |
JENNIFER DAMATO |
| K061437 |
06/14/2006 |
SIGMA 5000 SERIES, IMAGIC |
KONTRON MEDICAL SYSTEMS SAS |
LARRY WALKER |
| K053444 |
06/09/2006 |
KOWA KT-800 |
KOWA CO. LTD. |
SHINICHI YAMANAKA |
| K061210 |
06/27/2006 |
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B |
KYPHON, INC. |
CINDY DOMECUS |
| K061255 |
06/13/2006 |
BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0 |
KYRON CLINICAL IMAGING, INC. |
JAMES L REUSS |
| K061360 |
06/27/2006 |
NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1) |
LAB VISION CORP. |
GRACE HSIAO-FEN CHANG |
| K061646 |
06/27/2006 |
LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES |
LASERSCOPE |
PAUL HARDIMAN |
| K052767 |
06/23/2006 |
AFIBALERT ATRIAL FIBRILLATION DETECTOR |
LECHNOLOGIES RESEARCH INC. |
TIM LOHMAN |
| K061080 |
06/14/2006 |
IR PRO 250 |
LHASA OMS, INC. |
MARK W SHEEHAN |
| K060517 |
06/19/2006 |
POINTER EXCEL |
LHASA OMS, INC. |
MARK W SHEEHAN |
| K060508 |
06/19/2006 |
POINTER PLUS |
LHASA OMS, INC. |
MARK W SHEEHAN |
| K060848 |
06/27/2006 |
BOD POD |
LIFE MEASUREMENT, INC. |
MICHAEL SULLIVAN |
| K061240 |
06/02/2006 |
SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES |
LUCENT MEDICAL SYSTEMS |
CYNTHIA PESTKA |
| K053372 |
06/30/2006 |
LBI CATHETER SYSTEM |
LUMEN BIOMEDICAL, INC. |
AMY PETERSON |
| K060885 |
06/05/2006 |
MODEL MI 44 TYMPANOMETER |
MAICO-DIAGNOSTICS |
DANIEL EGGAN |
| K061546 |
06/20/2006 |
QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140 |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
| K060143 |
06/16/2006 |
LNCS AND SPO2.COM SENSORS |
MASIMO CORPORATION |
JAMES J CRONIN |
| K060431 |
06/19/2006 |
ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 |
MBL INTERNATIONAL CORPORATION |
DANIEL KAMM |
| K053137 |
06/14/2006 |
ENDOTOOL DRUG DOSE CALCULATOR |
MD SCIENTIFIC LLC |
SHADE M MECUM |
| K060404 |
06/22/2006 |
AG-PLUS, MODEL 91210 |
MEDEL S.P.A. |
TERRENCE O'BRIEN |
| K061205 |
06/21/2006 |
MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR |
MEDELA AG |
WERNER FREI |
| K061435 |
06/08/2006 |
MEDELA VARIO SUCTION PUMPS |
MEDELA AG |
WERNER FREI |
| K061684 |
06/27/2006 |
MEDI-GLOBE ROTA-CUT SPHINCTEROTOME |
MEDI-GLOBE CORPORATION |
SCOTT KARLER |
| K060439 |
06/22/2006 |
LUNG FLUTE |
MEDICAL ACOUSTICS LLC |
NICOLAAS J SMIT |
| K061606 |
06/21/2006 |
DEFIBRILLATOR CABLE TESTER, MODEL DT2200 |
MEDICAL DEVICES/PADPRO, INC. |
DANIEL KAMM |
| K060819 |
06/16/2006 |
COOL.CLICK 2 |
MEDICAL HOUSE PRODUCTS LIMITED |
ROSE Y GUANG |
| K060456 |
06/19/2006 |
MEDLINE COLLAGEN WOUND DRESSING |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
| K061079 |
06/02/2006 |
MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX 762 HEMOSTATIC GRANULES |
MEDTRADE PRODUCTS LTD. |
JONATHAN D RANFIELD |
| K061254 |
06/23/2006 |
EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 |
MEDTRONIC PERFUSION SYSTEMS |
RONALD W BENNETT |
| K051965 |
06/16/2006 |
OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEM |
MERETE MEDICAL GMBH |
CARL KNOBLOCH |
| K060686 |
06/09/2006 |
MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP3AC1-1PC |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
ARIEL WANG |
| K061403 |
06/14/2006 |
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1-4U |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K061558 |
06/29/2006 |
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BU1-4U |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K061302 |
06/23/2006 |
DIGITAL PRINTER P6000D SERIES, MODEL P6000DU |
MITSUBISHI ELECTRIC CORPORATION KYOTO WORKS |
SHINICHI YAMANAKA |
| K060825 |
06/19/2006 |
MULTI-USE ELECTRONIC PREGNANCY TEST |
MIZUHO USA, INC. |
BENEDICT ZIN |
| K061117 |
06/20/2006 |
NANOLITE SKIN CARE SYSTEM |
NANOLITE TECHNOLOGY, INC. |
EDWIN BURGOS |
| K061280 |
06/27/2006 |
V-2200 INFANT INCUBATOR |
NEOFORCE GROUP, INC. |
MARY STANIEWICZ |
| K061003 |
06/30/2006 |
SFB & CFB IMPLANTS |
NOBEL BIOCARE AB |
HERBERT CRANE |
| K061169 |
06/20/2006 |
ENDOSSEOUS DENTAL IMPLANT |
NORTHERN IMPLANTS, LLC |
GRETA M HOLS |
| K060744 |
06/02/2006 |
O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE) |
O'BRIEN DENTAL LAB, INC. |
SUZIE DOWNING |
| K060201 |
06/06/2006 |
OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. |
OLYMPUS AMERICA, INC. |
BEV HARDING |
| K060243 |
06/23/2006 |
OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K060192 |
06/15/2006 |
APEX KNEE SYSTEM |
OMNI LIFE SCIENCE, INC. |
EDWARD J CHEAL |
| K060766 |
06/09/2006 |
PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801 |
OMRON HEALTHCARE, INC. |
DONNA DJINOVICH |
| K061464 |
06/15/2006 |
VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668 |
Ortho-Clinical Diagnostics, Inc. |
Darlene J Phillips |
| K060632 |
06/06/2006 |
VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158 |
Ortho-Clinical Diagnostics, Inc. |
LEAH DE WATER |
| K061400 |
06/29/2006 |
CALCANEAL TRAUMA SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
LEE A STRNAD |
| K060536 |
06/02/2006 |
OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM |
OSTEOMED L.P. |
DAWN T HOLDEMAN |
| K053172 |
06/09/2006 |
UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE) |
OWANDY SAS |
OLIVIER MAURIER |
| K060563 |
06/02/2006 |
EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV |
PAJUNK GMBH |
CHRISTAIN QUASS |
| K060311 |
06/13/2006 |
EPILONG KIT FOR ANESTHESIOLOGY |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN QUASS |
| K061381 |
06/02/2006 |
LC STAR WITH NASAL ADAPTER |
PARI INNOVATIVE MANUFACTURERS, INC. |
MICHAEL JUDGE |
| K060946 |
06/15/2006 |
CZ-S2000 |
PARKELL, INC. |
NELSON J GENDUSA |
| K061475 |
06/14/2006 |
ASTROTILT MANUAL WHEELCHAIR |
PDG PRODUCT DESIGN GROUP, INC. |
NANCY BALCOM |
| K061024 |
06/21/2006 |
PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60 |
PEREGRINE SURGICAL LTD. |
TODD RICHMOND |
| K060389 |
06/06/2006 |
CONFIDOSE IM AUTO-INJECTOR |
PHARMA-PEN, INC. |
JONATHAN S KAHN |
| K060616 |
06/29/2006 |
NPOSES (NOCTURNAL PULSE OXIMETRY STUDY EXPERT SYSTEM), MODEL NPOSES-100 |
PHD MEDICAL |
NANCY RUTH |
| K060937 |
06/05/2006 |
BRILLIANCE VOLUME |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ROBERT L TUROCY |
| K061426 |
06/05/2006 |
OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47 |
POROUS MEDIA CORP. |
DAVID RASCH |
| K061409 |
06/16/2006 |
SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET |
PRECISE MEDICAL PRODUCTS, LTD. |
OFER SHAY |
| K060842 |
06/21/2006 |
REVJET TURBO |
PROMEDIC, INC. |
PAUL DRYDEN |
| K053305 |
06/02/2006 |
SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE |
PT MAHAKARYA INTI BUANA |
P. SASITHARAN NAIR |
| K061320 |
06/02/2006 |
R&D LH-NRBC HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
RALPH E HOGANCAMP |
| K051336 |
06/29/2006 |
GERATHERM SOS-RESCUE BAG |
R.G. ENTERPRISES, INC. |
RONALD G LETOUTNEAU |
| K061034 |
06/23/2006 |
BIPAP PLUS M-SERIES BI-LEVEL SYSTEM |
RESPIRONICS, INC. |
ZITA A YURKO |
| K061261 |
06/28/2006 |
L4 OXYGEN CONCENTRATOR |
RESPIRONICS, INC. |
ZITA A YURKO |
| K051278 |
06/29/2006 |
GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE) |
RG ENT., INC. |
RONALD G LETOURNEAU |
| K060002 |
06/02/2006 |
RITRACT SAFETY SYRINGE |
RITRACT LTD. |
RUPERT NORTHCOTT |
| K060853 |
06/09/2006 |
ONLINE TDM TOBRAMYCIN |
ROCHE DIAGNOSTICS CORP. |
DIMIRIS DEMIRTZOGLOU |
| K061324 |
06/20/2006 |
EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7 |
RTC INC.-MEMCATH TECHNOLOGIES LLC |
MARC JAKER |
| K052934 |
06/12/2006 |
DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM |
S.O.R. INTERNACIONAL, S.A. |
IAN GORDON |
| K052291 |
06/27/2006 |
CAPILLARY'S HEMOGLOBIN(E) (PN 2007) |
SEBIA |
KAREN ANDERSON |
| K060721 |
06/02/2006 |
LARIAT LOOP APPLICATOR |
SENTREHEART |
ROBERT CHIN |
| K060709 |
06/15/2006 |
MULTIGENT GENTAMICIN |
SERADYN INC. |
EARL E KNIGHT |
| K061488 |
06/30/2006 |
CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM |
SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI |
BOB LEIKER |
| K061083 |
06/06/2006 |
CTS-7700 |
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
BOB LEIKER |
| K061189 |
06/01/2006 |
DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K060281 |
06/23/2006 |
VS-800 VITAL SIGNS MONITOR |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLSTEIN-FALK |
| K060141 |
06/12/2006 |
DAI-R |
SHL MEDICAL, USA |
LUCIO GIAMBATTISTA |
| K061472 |
06/09/2006 |
GALILEOS IMPLANT, V 1.0 |
SICAT GMBH & CO. KG |
MARKUS PARKER |
| K061051 |
06/13/2006 |
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER |
SICEL TECHNOLOGIES, INC. |
TAMMY B CARREA |
| K061671 |
06/29/2006 |
SYNGO TRUED, MODEL VC10A |
SIEMENS MEDICAL SOLUTIONS |
JAMES E KUHN |
| K061590 |
06/21/2006 |
SMDIE DEVICE INTERFACING SYSTEM |
SIEMENS MEDICAL SOLUTIONS HEALTH SERVICES CORPORAT |
IAN GORDON |
| K061097 |
06/07/2006 |
COHERENCE DOSIMETRIST, MODEL 2.2 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KEN NEHMER |
| K061545 |
06/30/2006 |
SCENIUM 1.1 |
SIEMENS MOLECULAR IMAGING LTD |
FRANK POKROP |
| K060237 |
06/15/2006 |
CMB ANTIMICROBIAL DRESSING |
SILVERLEAF MEDICAL PRODUCTS, INC. |
DEBBIE KOENEMAN |
| K061154 |
06/08/2006 |
KINSA SUTURE ANCHOR |
SMITH & NEPHEW, INC. |
DEANA BOUSHELL |
| K061352 |
06/08/2006 |
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTREMITY |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K060630 |
06/14/2006 |
REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING |
SMITH & NEPHEW, INC. |
KATIE LOGEROT |
| K061019 |
06/06/2006 |
TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K060945 |
06/19/2006 |
PORTEX PERCUTANEOUS TRACHEOSTOMY KIT |
SMITHS MEDICAL INTERNATIONAL |
STEWART LEE |
| K060702 |
06/22/2006 |
4CIS VANE SPINE SYSTEM |
SOLCO BIOMEDICAL CO., LTD. |
SAEYOUNG AHN |
| K052601 |
06/06/2006 |
STOCKERT HEATER-COOLER SYSTEM 3T |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
| K060053 |
06/02/2006 |
STOCKERT S5 SYSTEM |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
| K061527 |
06/27/2006 |
CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
| K061031 |
06/02/2006 |
D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
| K060900 |
06/23/2006 |
SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842 |
SPACELABS MEDICAL INC. |
AL VAN HOUDT |
| K060118 |
06/08/2006 |
SSP PEDICLE SCREW SYSTEM |
SPECIALTY SPINE PRODUCTS, LLC |
FLOYD G LARSON |
| K060916 |
06/08/2006 |
ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017. |
SPINAL EDGE, LLC |
CHRISTINA VACCA |
| K060098 |
06/08/2006 |
DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS |
SSL AMERICAS, INC. |
CHRIS ROBINSON |
| K052493 |
06/09/2006 |
SOCKET GRAFT |
STEINER LABORATORIES |
GREGORY GENE STEINER |
| K060901 |
06/29/2006 |
VASHE WOUND CLEANSING SYSTEM |
STERILOX TECHNOLOGIES, INC. |
HOWARD K MANN |
| K060820 |
06/07/2006 |
CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060 |
SUNTECH MEDICAL, INC. |
DAVID GALLICK |
| K061526 |
06/15/2006 |
ENSEAL PTC TISSUE SEALING DEVICE |
SURGRX INC |
LINDA OLESON |
| K061120 |
06/22/2006 |
SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES |
Synergeyes, Inc. |
RICHARD E LIPPMAN, O.D. |
| K060138 |
06/02/2006 |
SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K060924 |
06/28/2006 |
JSZ MULTIACTION GP CONTACT LENS SOLUTION |
SZABOCSIK AND ASSOCIATES |
JOHN M SZABOCSIK |
| K061073 |
06/02/2006 |
CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEM, MODEL TD-3250 |
TaiDoc Technology Corporation |
SHU-MEI WU |
| K060364 |
06/15/2006 |
VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE |
TECO DIAGNOSTICS |
JIAN VAECHES |
| K061407 |
06/29/2006 |
PRIMATRIX DERMAL REPAIR SCAFFOLD |
TEI BIOSCIENCES INC. |
KENNETH JAMES |
| K061035 |
06/05/2006 |
TIGERVIEW PROFESSIONAL |
TELEVERE SYSTEMS |
MELISSA MAHALL |
| K060666 |
06/29/2006 |
CAROTID ACCESS KIT |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| K053562 |
06/23/2006 |
ZIMMER COLLAGEN REPAIR PATCH |
TISSUE SCIENCE LABORATORIES, PLC |
ANGELA BUNN |
| K060627 |
06/07/2006 |
TAG-IT CYSTIC FIBROSIS KIT |
TM BIOSCIENCE CORPORATION |
NANCY KRUNIC |
| K061061 |
06/07/2006 |
20.1-INCH (51CM) COLOR LCD MONITOR CDL2009A (CCL204) |
TOKOTU ELECTRIC CO., LTD. |
MIKIO HASEGAWA |
| K061605 |
06/22/2006 |
NEMIO XG, SAA-580A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K061317 |
06/22/2006 |
ILED |
TRUMPF KREUZER MEDIZIN SYSTEME GMBH + CO.KG |
WILLIBALD HIEMER |
| K060963 |
06/06/2006 |
TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONITOR) |
TWIN STAR MEDICAL |
CHET SIEVERT |
| K060509 |
06/23/2006 |
PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING |
TYCO HEALTHCARE GROUP |
KEITH MARTIN |
| K052818 |
06/16/2006 |
EZ SMART-168 GLUCOSE MONITORING SYSTEM |
TYSON BIORESEARCH, INC. |
DAVID ROSEN |
| K061041 |
06/19/2006 |
US SPINE FACET FIXATION SYSTEM |
US SPINE |
RICHARD JANSEN |
| K060896 |
06/09/2006 |
MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT |
VARIAN INC |
LORNA GAMBOA |
| K061627 |
06/29/2006 |
MODIFICATION TO I VENT 201 |
VERSAMED MEDICAL SYSTEMS, INC. |
JERRY KORTEN |
| K061624 |
06/27/2006 |
VITREA, VERSION 3.9 |
VITAL IMAGES, INC. |
TIMOTHY J KAPPERS |
| K060483 |
06/23/2006 |
VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM |
VOLCANO CORPORATION |
Michelle J Badal |
| K061160 |
06/09/2006 |
M-VU CAD STATION |
VUCOMP, INC. |
SUSAN D GOLDSTEIN-FALK |
| K052197 |
06/09/2006 |
FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST |
W.H.P.M., INC. |
FRAN WHITE |
| K061384 |
06/06/2006 |
LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
| K060405 |
06/21/2006 |
SOYALA, SOYALA BLUE |
WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG |
ECKHARDT ALBERS |
| K053381 |
06/15/2006 |
WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE |
WELCH ALLYN, INC. |
CHRIS KLACZYK |
| K060871 |
06/09/2006 |
AS101, BLOOD PRESSURE CUFF |
WENZHOU LONGWAN MEDICAL INSTRUMENT COMPANY |
CHARLIE MACK |
| K061337 |
06/07/2006 |
WIEDENT ESTETIC |
XPDENT CORP. |
CARMEN PEREZ |
| K061203 |
06/19/2006 |
ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM |
ZIEHM IMAGING, INC. |
RICHARD WESTRICH |
| K061043 |
06/27/2006 |
ZIMMER CONTOUR RESTORATIVE SYSTEM |
ZIMMER DENTAL INC. |
ERIN L MCVEY |
| K061211 |
06/14/2006 |
NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES |
ZIMMER GMBH |
ANTHONY FRANCALANCIA |
