FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K063481 |
09/14/2007 |
MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM |
ABBOTT VASCULAR INC. |
NADINE SMITH |
K071845 |
09/28/2007 |
RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A |
ACCLARENT, INC. |
KERI YEN |
K072504 |
09/21/2007 |
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM |
ACCURAY INCORPORATED |
ANNE SCHLAGENHAFT |
K071824 |
09/04/2007 |
ACME TALON PEDICLE SCREW |
ACME SPINE, LLC. |
J. D WEBB |
K072167 |
09/06/2007 |
COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE |
ADVANCED VASCULAR DYNAMICS |
HERBERT J SEMLER |
K071945 |
09/20/2007 |
S4 SPINAL SYSTEM |
AESCULAP IMPLANT SYSTEMS |
KATHY A RACOSKY |
K071499 |
09/14/2007 |
COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY |
AESCULAP IMPLANT SYSTEMS, INC. |
KATHY A RACOSKY |
K072357 |
09/18/2007 |
NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM |
AFP IMAGING CORP. |
MARY MCNAMARA-CULLINANE |
K072413 |
09/27/2007 |
MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM |
AGAMATRIX |
CONNIE HERTEL |
K071604 |
09/19/2007 |
ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM |
ALVEOLUS, INC |
DONALD V CANAL |
K063658 |
09/12/2007 |
INTRAVASCULAR INTRODUCER SYSTEM |
APPLIED MEDICAL RESOURCES CORP. |
CHERYL BLAKE |
K071998 |
09/26/2007 |
ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT |
ARROW INTL., INC. |
KIRSTEN STOWELL |
K071887 |
09/18/2007 |
SPORTMESH OR ARTELON TISSUE REINFORCEMENT |
ARTIMPLANT AB |
TERRY S POWELL |
K072431 |
09/26/2007 |
ASAHI PTCA GUIDE WIRE, X-TREME |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
K072316 |
09/17/2007 |
PRECIOUS PLUS GUIDE CATHETER |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
K062736 |
09/14/2007 |
SIASCOPE V |
ASTRON CLINICA LIMITED |
E.J. Smith |
K071221 |
09/06/2007 |
SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12 |
AUTOMEDX INC. |
JAMES D EVANS |
K071567 |
09/14/2007 |
AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE |
AUTOSAFE-REFELX INC. |
JOHN D STEPHENS |
K072283 |
09/19/2007 |
DORADO PTA BALLOON DILATATION CATHETER |
BARD PERIPHERAL VASCULAR, INC. |
GENEVIEVE BALUTOWSKI |
K070809 |
09/24/2007 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
K071321 |
09/12/2007 |
POCKETCPR |
BIO-DETEK, INC. |
MARK TOTMAN |
K070361 |
09/13/2007 |
MRSASELECT |
BIO-RAD |
FRAN WHITE |
K072389 |
09/18/2007 |
MODIFICATION TO HYPERQ SYSTEM |
BIOLOGICAL SIGNAL PROCESSING, LTD. |
GEORGE J HATTUB |
K071121 |
09/11/2007 |
TRIBONE 80 |
BIOMATLANTE |
ADELINE FILLIATRE |
K072038 |
09/12/2007 |
VITEK 2 GRAM NEGATIVE LEVOFLOXACIN |
BIOMERIEUX, INC. |
JOLYN TENLIADO |
K072161 |
09/20/2007 |
BIOMET FEMORAL LOCKING NAIL SYSTEM |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
K071577 |
09/06/2007 |
BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER |
BIOMET MICROFIXATION, INC. |
KIM REED |
K071816 |
09/20/2007 |
HARPOON SUTURE ANCHOR |
BIOMET SPORTS MEDICINE, INC. |
ELIZABETH WRAY |
K071704 |
09/17/2007 |
SLEEVE AND BUTTON SOFT TISSUE DEVICES |
BIOMET SPORTS MEDICINE, INC. |
ELIZABETH WRAY |
K071546 |
09/18/2007 |
EOS |
BIOSPACE MED |
JOHN J SMITH |
K072517 |
09/26/2007 |
ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3 |
BOSTON SCIENTIFIC CORP. |
CHRISTINE DUNBAR |
K070556 |
09/25/2007 |
BRAINSUITE NET |
BRAINLAB AG |
RAINER BIRKENBACH |
K071449 |
09/14/2007 |
BRM3 BRAIN MONITOR |
BRAINZ INSTRUMENTS LTD. |
CHRIS MANDER |
K070156 |
09/26/2007 |
BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100 |
CARDIODYNAMICS INTERNATIONAL CORP. |
PAUL L SHAFFER |
K072297 |
09/12/2007 |
BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM |
CARDIVA MEDICAL, INC. |
KIT CARIQUITAN |
K072514 |
09/21/2007 |
VISULAS TRION |
CARL ZEISS MEDITEC AG |
KENT W JONES |
K062028 |
09/07/2007 |
CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01 |
CELERA DIAGNOSTICS |
VICTORIA MACKINNON |
K071854 |
09/07/2007 |
AQUADEX FLEXFLOW SYSTEM |
CHF SOLUTIONS, INC. |
CHRIS SCAVOTTO |
K071272 |
09/12/2007 |
TROJAN THINTENSITY BRAND MALE LATEX CONDOM |
CHURCH & DWIGHT CO., INC. |
STEPHEN C KOLAKOWSKY |
K070339 |
09/26/2007 |
DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES |
CINCINNATI SUB-ZERO PRODUCTS, INC |
DAN WITTMER |
K071614 |
09/11/2007 |
FIDUCIAL MARKERS |
CIVCO |
JIM LEONG |
K061539 |
09/20/2007 |
GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE |
CLINICAL INNOVATIONS, LLC |
WM DEAN WALLACE |
K071196 |
09/06/2007 |
DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS |
COEUR, INC. |
DEBRA F MANNING |
K072368 |
09/20/2007 |
CONFORMIS METAL BACKED TIBIAL COMPONENT |
CONFORMIS, INC. |
MICHAEL SHARP |
K071962 |
09/26/2007 |
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER) |
CORDIS NEUROVASCULAR, INC. |
Amarilys Machado |
K071533 |
09/28/2007 |
FITMATE SERIES |
COSMED S.R.L. |
ROBERT SCHIFF |
K072539 |
09/13/2007 |
CURE CATHETER |
CURE MEDICAL LLC. |
James Smith |
K071980 |
09/11/2007 |
DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H |
DADE BEHRING, INC. |
ANNA MARIE ENNIS |
K072304 |
09/19/2007 |
FIBRINOGEN CALIBRATOR KIT |
DADE BEHRING, INC. |
RADAMES RIESGO |
K071805 |
09/25/2007 |
NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX |
DATASCOPE CORP. |
KATHLEEN KRAMER |
K071817 |
09/04/2007 |
OSTEOGRAF/N-300 |
DENTSPLY INTERNTIONAL |
HELEN LEWIS |
K071379 |
09/11/2007 |
DELTA XTEND REVERSE SHOULDER MODULAR STEM |
DEPUY ORTHOPAEDICS, INC. |
NATALIE S HECK |
K070554 |
09/11/2007 |
DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
KATHY HARRIS |
K071830 |
09/28/2007 |
DEPUY DELTA TS CERAMIC FEMORAL HEADS |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
K071016 |
09/04/2007 |
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT |
DEPUY ORTHOPAEDICS, INC. |
KATHY HARRIS |
K070387 |
09/18/2007 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER KLACZYK |
K063675 |
09/24/2007 |
DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT |
DIAGNOSTIC HYBRIDS, INC. |
GAIL GOODRUM |
K063798 |
09/21/2007 |
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000 |
DIAGNOSTIC HYBRIDS, INC. |
GAIL GOODRUM |
K071971 |
09/17/2007 |
DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL |
DIAZYME LABORATORIES |
CHARLES YU |
K071431 |
09/21/2007 |
GLOBUS GENESY 1100 STIMULATOR |
DOMINO S.R.L. |
GIOVANNI M CIRIANI |
K072023 |
09/12/2007 |
ELLIPSE JUVIA, MODEL 9EJU7465 |
ELLIPSE A/S |
OLE KOFOD |
K070282 |
09/06/2007 |
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM |
ENDIUS, INC. |
REGINA WAGNER |
K071651 |
09/14/2007 |
EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES |
ENDOGASTRIC SOLUTIONS, INC. |
MICHAEL A DANIEL |
K072355 |
09/26/2007 |
OSSIFUSE BONE SUBSTITUTE MATERIAL |
ETEX CORP. |
PAMELA W ADAMS |
K072203 |
09/25/2007 |
HARMONIC 10CM COMBINATION HOOK BLADE |
ETHICON ENDO-SURGERY, LLC |
ELIZABETH MILLER |
K071951 |
09/05/2007 |
COMFY SERIES: EV-804, EV-805 & EV-806 |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
JAY MANSOUR |
K070640 |
09/13/2007 |
ARCHITECT STAT TROPONIN-1; MYOGLOBIN |
FISHER DIAGNOSTICS |
HEATHER CAMERON |
K071744 |
09/25/2007 |
AVIAFIT PULSATING LEGBAND |
FLOWMEDIC LTD. |
AHAVA STEIN |
K071510 |
09/24/2007 |
HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950 |
FOCUS DIAGNOSTICS, INC. |
CONSTANCE BRIDGES |
K070822 |
09/28/2007 |
ARCHITECT SIROLIMUS ASSAY |
FUJIREBIO DIAGNOSTICS, INC. |
DIANA LYN DICKSON |
K072232 |
09/07/2007 |
GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL |
GAMBRO RENAL PRODUCTS, INC. |
KAE MILLER |
K071982 |
09/21/2007 |
MODIFICATION TO: UNITY NETWORK ID |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
LISA M BAUMHARDT |
K072439 |
09/14/2007 |
GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
JAMES P RASKOB |
K072224 |
09/21/2007 |
ZIP'R PC |
GLOBAL FABTECH WHEEL CHAIR (SHANGHAI) CO., LTD. |
JUNNATA CHANG |
K072320 |
09/14/2007 |
GREINER VACUETTE QUICKSHIELD COMPLETE |
GREINER BIO-ONE NORTH AMERICA, INC. |
Judi Smith |
K071910 |
09/06/2007 |
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK) |
HARTALEGA SDN BHD |
NURUL AISYAH KONG BT ABDULLAH |
K072279 |
09/21/2007 |
MAGNETIC RESONANCE DIAGNOSTIC DEVICE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
K072272 |
09/07/2007 |
HONEYWELL HOMMED CENTRAL STATION 4.0 |
HONEYWELL HOMMED, LLC |
MICHAEL LEIGH |
K071471 |
09/10/2007 |
CORIN ADAPTOR SLEEVE |
HOWMEDICA OSTEONICS CORP |
KAREN ARIEMMA |
K071082 |
09/13/2007 |
STRYKER MODULAR HIP SYSTEM |
HOWMEDICA OSTEONICS CORP |
VIVIAN KELLY |
K071255 |
09/07/2007 |
ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A |
HYPHEN BIOMED |
OLA ANDERSON |
K070979 |
09/19/2007 |
PULL TAB SQUEEZE FLUSH |
ICU MEDICAL, INC |
TRACY BEST |
K071346 |
09/24/2007 |
IMMULISA INTRINSIC FACTOR ANTIBODY ELISA |
IMMCO DIAGNOSTICS, INC. |
KEVIN LAWSON |
K071911 |
09/07/2007 |
CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR |
INNOVISION A/S |
RICHARD O WOOD |
K071966 |
09/05/2007 |
1.5T MRGFUS PELVIC COIL |
INSIGHTEC-TXSONICS, INC. |
Nadir Alikacem |
K071357 |
09/26/2007 |
P.004 NC ANATOMIC ABUTMENTS |
INSTITUT STRAUMANN AG |
PAIGE SWEENEY |
K072497 |
09/26/2007 |
P.004 NC GOLD ABUTMENT FOR CROWNS |
INSTITUT STRAUMANN AG |
ELAINE ALAN |
K070927 |
09/17/2007 |
HEMOSIL D-DIMER HS |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K072208 |
09/07/2007 |
MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS |
INTEGRA LIFESCIENCES CORPORATION |
HELDER A SOUSA |
K071428 |
09/17/2007 |
INQU |
ISTO TECHNOLOGIES, INC. |
PATSY J TRISLER |
K071118 |
09/07/2007 |
GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE |
IVES EEG SOLUTIONS, INC. |
JOHN R IVES |
K072338 |
09/21/2007 |
CERVITEC PLUS |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
K072152 |
09/07/2007 |
JUNIPER CLN1 DERMAL COOLING DEVICE |
JUNIPER MEDICAL INC. |
DONALD V JOHNSON |
K072387 |
09/13/2007 |
KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
SUSIE CHEN |
K071437 |
09/12/2007 |
MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
CRYSTAL DIZOL |
K072384 |
09/21/2007 |
MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE |
KENSEY NASH CORP. |
JENNIFER J BOSLEY |
K071429 |
09/10/2007 |
TI2200 TRANSILLUMINATION CABLE |
KERR CORPORATION |
COLLEEN BOSWELL |
K071067 |
09/14/2007 |
BACTRACK LCD ALCOHOL DETECTOR |
KHN SOLUTIONS, LLC |
DANIEL KAMM |
K071877 |
09/17/2007 |
LANX SPINAL FIXATION SYSTEM |
LANX, LLC |
JANICE M HOGAN |
K071472 |
09/21/2007 |
PLANET 55 |
LARSEN & TOUBRO LIMITED |
HARRY P GUGNANI |
K062003 |
09/19/2007 |
NEURO WAVE 6 |
LHASA OMS, INC. |
MARK W SHEEHAN |
K071578 |
09/27/2007 |
BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17 |
LIFESCIENCE PLUS, INC. |
AUDREY VITALE |
K071773 |
09/12/2007 |
CPAP NASAL MASK WITH PILLOWS |
LIFESOURCE |
PAUL DRYDEN |
K063297 |
09/20/2007 |
LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR |
LIGHTMED CORP. |
DENNIS DOWELL |
K072246 |
09/14/2007 |
VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601 |
MAINE STANDARDS CO. |
HOLLY CRESSMAN |
K071575 |
09/10/2007 |
SANDMAN INTRO |
MALLINCKRODT DEVELOPPEMENT FRANCE |
JAMES BONDS |
K071612 |
09/11/2007 |
MODUS TRILOCK 2.0/2.3/2.5 |
MEDARTIS AG |
LINDA SCHULZ |
K072542 |
09/25/2007 |
MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR |
MEDEGEN MEDICAL MANUFACTURING SYSTEM |
ALEX MAZZA |
K071832 |
09/18/2007 |
MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM |
MEDICAL SCIENTIFIC, INC. |
PAUL NARDELLA JR |
K071133 |
09/21/2007 |
APEXNRG-BLUE ELECTRONIC APEX LOCATOR |
MEDICNRG LTD. |
GEORGE J HATTUB |
K070276 |
09/21/2007 |
MODIFICATION TO PASSMED SPINAL SYSTEM |
MEDICREA TECHNOLOGIES |
J. D WEBB |
K070291 |
09/21/2007 |
MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX |
MEDIX I.C.S.A. |
JAMES H KNAUSS |
K072315 |
09/18/2007 |
MIDAS REX CURVED BUR |
MEDTRONIC POWERED SURGICAL SOLUTIONS |
JEFFREY HENDERSON |
K072429 |
09/28/2007 |
MODIFICATION TO TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
LEE GRANT |
K070742 |
09/14/2007 |
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
LEE GRANT |
K072317 |
09/18/2007 |
MODIFICATION TO:TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
LEE GRANT |
K071348 |
09/07/2007 |
EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM |
MENNEN MEDICAL LTD. |
MICHA OESTEREICH |
K062644 |
09/11/2007 |
FLEXWARMER, MODELS KZ-1 AND KZ-2 |
MERLYN ASSOCIATES, INC. |
KAREN CHEN |
K070897 |
09/17/2007 |
BONEMEDIK, AND BONEMEDIK-S |
META BIOMED CO., LTD. |
TAE-HOON KIM |
K070590 |
09/11/2007 |
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT19S1R |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
K070816 |
09/19/2007 |
PERIPHERAL GUIDING SHEATH |
MICRUS DESIGN TECHNOLOGY, INC. |
MARIANNE GRUNWALDT, MS, CQE |
K071741 |
09/24/2007 |
TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM |
MIGADA PLANT |
YOSSI SHACHAR |
K070694 |
09/10/2007 |
CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS) |
MIKE MINER |
MIKE MINER |
K071964 |
09/26/2007 |
MIM 4.1 (SEASTAR) |
MIMVISTA CORP. |
PETER SIMMELINK |
K070812 |
09/14/2007 |
DISPOSABLE LAPAROSCOPIC INSTRUMENT |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
ROBERT STILLMAN |
K071414 |
09/10/2007 |
BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
MOLNLYCKE HEALTH CARE US, LLC |
STEVEN DOWDLEY |
K071565 |
09/10/2007 |
BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT |
MOLNLYCKE HEALTH CARE US, LLC |
STEVEN DOWDLEY |
K071465 |
09/11/2007 |
BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT |
MOLNLYCKE HEALTHCARE, US LLC |
STEVEN DOWDLEY |
K071700 |
09/11/2007 |
BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT |
MOLNLYCKE HEALTHCARE, US LLC |
STEVEN DOWDLEY |
K071798 |
09/17/2007 |
MONDEAL DISTAL RADIUS SYSTEM |
MONDEAL MEDICAL SYSTEMS GMBH |
JAY EVANS |
K071797 |
09/17/2007 |
MONDEAL HAND CONTOUR SYSTEM |
MONDEAL MEDICAL SYSTEMS GMBH |
JAY EVANS |
K070804 |
09/17/2007 |
VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST |
NANOSPHERE, INC |
SUE KENT |
K071553 |
09/18/2007 |
ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR |
NDO SURGICAL, INC. |
JOHN J VOZELLA |
K072021 |
09/12/2007 |
NEOPIP INFANT RESUSCITATOR |
NEOFORCE GROUP, INC. |
MONICA FERRANTE |
K061519 |
09/28/2007 |
MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM |
NIKKISO CO. LTD. |
FUMIAKI KANAI |
K071145 |
09/07/2007 |
NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD |
K060676 |
09/07/2007 |
NES REPROCESSED ENDOSCOPIC TROCAR |
Northeast Scientific, Inc. |
CRAIG ALLMENDINGER |
K071056 |
09/28/2007 |
NEUTROPHASE WOUND CLEANSER |
NOVABAY PHARMACEUTICALS |
LUANA STAIGER |
K072222 |
09/07/2007 |
SPY FLUORESCENT IMAGING SYSTEM |
NOVADAQ TECHNOLOGIES, INC. |
ALLISON MANNERS |
K072150 |
09/13/2007 |
DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL |
NOVOCOL, INC. |
STEVE RUDOLPH |
K072445 |
09/14/2007 |
INTEGRATED BRACHYTHERAPY UNIT - DIGITAL |
NUCLETRON CORP. |
LISA DIMMICK |
K070937 |
09/21/2007 |
MULTIPLE BRAND MALE LATEX CONDOM |
NULATEX SDN. BHD. |
KIM L LEE |
K063259 |
09/14/2007 |
OLYMPUS CAPSULE ENDOSCOPE SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
K071762 |
09/27/2007 |
OMNIWAVE ENDOVASCULAR SYSTEM |
OMNISONICS MEDICAL TECHNOLOGIES |
ANNE M KULIS |
K071250 |
09/28/2007 |
CA, MODEL: CAM |
OPTOVUE, INC. |
JAY WEI |
K072515 |
09/20/2007 |
EMBRACE GEL |
ORISON CORPORATION |
AL SANDY |
K072443 |
09/24/2007 |
VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY |
Ortho-Clinical Diagnostics, Inc. |
MARLENE HANNA |
K072440 |
09/20/2007 |
VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) |
Ortho-Clinical Diagnostics, Inc. |
MARLENE HANNA |
K071929 |
09/19/2007 |
NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL |
ORTHOSOFT, INC. |
CHRISTOPHER MCLEAN |
K072184 |
09/18/2007 |
VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE |
ORTHOVITA, INC. |
GINA M NAGVAJARA |
K063861 |
09/21/2007 |
GS SYSTEM |
OSSTEM IMPLANT CO.,LTD |
CATHRYN N CAMBRIA |
K071650 |
09/12/2007 |
C350 POWERED WHEELCHAIR |
PERMOBIL AB |
JAN ASTROM |
K071391 |
09/07/2007 |
PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521 |
PHILIPS MEDICAL SYSTEMS, INC. |
PAUL SCHRADER |
K071800 |
09/27/2007 |
PHILIPS AVALON FETAL MONITORS FM20 AND FM30 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
MICHAEL ASMALSKY |
K072318 |
09/21/2007 |
POWRSYRINGE INJECTOR |
PINYONS MEDICAL TECHNOLOGY, INC. |
SHAWN P FOJTIK |
K072345 |
09/21/2007 |
POWRSYRINGE MONITOR |
PINYONS MEDICAL TECHNOLOGY, INC. |
SHAWN P FOJTIK |
K072244 |
09/21/2007 |
PLANMECA PROONE |
PLANMECA OY |
LARS MORING |
K071507 |
09/10/2007 |
PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
K072269 |
09/08/2007 |
ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552 |
POSSIS MEDICAL, INC. |
MIKE BURNSIDE |
K071708 |
09/27/2007 |
I45, I45S, I60, AND I60S |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
K063735 |
09/19/2007 |
PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112 |
PRESYM, INC. |
TAMIM HAMID |
K071827 |
09/20/2007 |
ALWAYS MENSTRUAL PADS |
PROCTER & GAMBLE, INC. |
LENORE FAULHABER |
K072364 |
09/19/2007 |
PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES |
PULSION MEDICAL SYSTEMS AG |
Jamie Sulley |
K072034 |
09/20/2007 |
DIODE MEDICAL LASER FAMILY, MODELS 4, 6, 30 |
QUANTA SYSTEM, S.P.A. |
ISABELLA CARRER |
K071457 |
09/25/2007 |
MODIFICATION TO RADIUS SNARE |
RADIUS MEDICAL TECHNOLOGIES, INC. |
MAUREEN FINLAYSON |
K072242 |
09/11/2007 |
COR ANALYZER II, MODEL V1.7 |
RCADIA MEDICAL IMAGING LTD. |
DAN LAOR |
K063637 |
09/27/2007 |
RELIANCE VBS SYSTEM |
Reliance Medical Systems, LLC |
Bret M Berry |
K071688 |
09/07/2007 |
RELIANCE S.E.P. |
RELIANCE ORTHODONTIC PRODUCTS, INC. |
PAUL GANGE |
K072418 |
09/12/2007 |
OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER |
RESPIRONICS NEW JERSEY, INC. |
Lauren Ziegler |
K071486 |
09/10/2007 |
RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053 |
RESTORATIVE THERAPIES INC. |
ANDREW BARRISKILL |
K072394 |
09/12/2007 |
PORTRAIT STAND-OFF |
RHYTEC INCORPORATED |
Robert Zoletti |
K071239 |
09/14/2007 |
TOTAL PROTEIN URINE/CSF GEN.3 |
Roche Diagnostics |
CORINA HARPER |
K071644 |
09/12/2007 |
ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 |
ROCHE DIAGNOSTICS CORP. |
DIMITRIS DEMIRTZOGLOU |
K071922 |
09/18/2007 |
INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC |
RSB SPINE LLC. |
KAREN E WARDEN |
K070670 |
09/18/2007 |
EYETRACKER/IDEAS |
S.A. INSTRUMENTATION DIFRA |
GUIDO PAGNACCO |
K070881 |
09/26/2007 |
LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 |
SAPI MED S.P.A |
E.J. Smith |
K071965 |
09/10/2007 |
I-SURGE |
SATELEC |
STEVE SALESKY |
K072181 |
09/19/2007 |
MINI LED AUTOFOCUS |
SATELEC |
STEVE SALESKY |
K071891 |
09/13/2007 |
STATIS DENTAL HANDPIECES |
SCICAN LTD. |
BRENDA MURPHY |
K072541 |
09/25/2007 |
SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM |
SENORX, INC. |
|
K071672 |
09/12/2007 |
SENTEC DIGITAL MONITORING SYSTEM |
SENTEC AG |
STEPHEN H GORSKI |
K072164 |
09/05/2007 |
DC-6 DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
LI DONGLING |
K063609 |
09/12/2007 |
RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER |
SHL TELEMEDICINE INTERNATIONAL LTD. |
GEORGE J HATTUB |
K072392 |
09/25/2007 |
OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIM RENDON |
K072090 |
09/14/2007 |
SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMS |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
KRISTEN DORROUGH |
K071541 |
09/10/2007 |
SBI TWISTOFIX |
SMALL BONE INNOVATIONS INC. |
ROBERT HOEHN |
K071170 |
09/14/2007 |
POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
K071071 |
09/19/2007 |
CROSSLINKED POLYETHYLENE ARTICULAR INSERTS |
SMITH & NEPHEW, INC. |
RISHI SINHA |
K072322 |
09/18/2007 |
ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS |
SMITH & NEPHEW, INC. |
JULIE ACKER |
K071418 |
09/04/2007 |
DANA 3CC SYRINGE INSULIN RESERVOIR |
SOOIL DEVELOPMENT CO., LTD. |
CYNTHIA NOLTE, PH.D |
K072308 |
09/12/2007 |
D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
K071970 |
09/25/2007 |
CLEAR IMAGE ALIGNER |
SPECIALTY APPLIANCE WORKS, INC. |
JAMES W KOLKA |
K070922 |
09/19/2007 |
MODIFICATION TO SPINAL USA VBR SYSTEM |
SPINAL USA |
JEFFREY JOHNSON |
K072278 |
09/13/2007 |
BRK TRANSSEPTAL NEEDLE |
ST. JUDE MEDICAL |
Laura Moen-Ftacek |
K071732 |
09/24/2007 |
MARROWMINER |
STEMCOR SYSTEMS, INC. |
SHARON ROCKWELL |
K070859 |
09/12/2007 |
REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS |
STERILMED, INC. |
CAROLINE BUTTERFIELD |
K070895 |
09/05/2007 |
VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK; 275F 3 CHALLENGE PACK; 275F 10 CHALLENGE PACK |
STERIS Corporation |
JOHN SCOVILLE |
K070478 |
09/20/2007 |
P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP) |
STRAUMANN MANUFACTURING, INC. |
ELAINE ALAN |
K072151 |
09/11/2007 |
P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS |
STRAUMANN USA |
PAIGE SWEENEY |
K071919 |
09/26/2007 |
P.004 ABUTMENTS |
STRAUMANN USA (ON BEHALF OF INSTITUT STRAUMANN AG) |
PAIGE SWEENEY |
K071859 |
09/20/2007 |
STRYKER CROSSFIRE SYSTEM |
Stryker Endoscopy |
K. JEFFREY SEMONE |
K071157 |
09/17/2007 |
STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS |
Stryker Endoscopy |
JEFF SEMONE |
K071689 |
09/07/2007 |
DEVILBISS INTELLIPAP MODEL DV 5 SERIES |
SUNRISE MEDICAL |
JOSEPH E OLSAVSKY |
K072153 |
09/10/2007 |
QUICKIE QX MANUAL FOLDING WHEELCHAIR |
SUNRISE MEDICAL, INC. |
JOSEPH E OLSAVSKY |
K071823 |
09/19/2007 |
PERMA FACIAL IMPLANTS |
SURGISIL |
CYNTHIA J NOLTE |
K072493 |
09/27/2007 |
ENSEAL TISSUE SEALING DEVICE |
SURGRX INC |
LINDA OLESON |
K072177 |
09/05/2007 |
ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM |
SURGRX, INC. |
LINDA OLESON |
K071615 |
09/21/2007 |
FIXAFLOSS |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
K072095 |
09/27/2007 |
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS |
SYNTHES (USA) |
JILL SHERMAN |
K072489 |
09/20/2007 |
REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
ERICA LI |
K071661 |
09/05/2007 |
ALPHAONE BIOFEEDBACK SYSTEM |
TELEDIAGNOSTIC SYSTEMS, INC. |
LARRY WOODWARD |
K072296 |
09/26/2007 |
POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 |
THERAGENICS CORP. |
BETSY CORTELLONI |
K063838 |
09/27/2007 |
LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH |
THERMO ELECTRON OY |
PAIVI SORMUNEN |
K070531 |
09/04/2007 |
ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER |
Thermo Fisher Scientific |
BOLA NICHOLSON |
K071453 |
09/19/2007 |
SPI EASY 4.0 ABUTMENT |
THOMMEN MEDICAL, AG |
LINDA K SCHULZ |
K072311 |
09/21/2007 |
TILITE AERO X |
TISPORT, LLC |
RICHARD S FORMAN |
K063048 |
09/14/2007 |
TRANS-CATHETER EXTRACTOR |
TRAN PA-C, INC. |
TOM TRAN |
K070685 |
09/14/2007 |
KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662 |
TYCO HEALTHCARE |
PAUL W EVANS |
K070653 |
09/12/2007 |
KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662 |
TYCO HEALTHCARE |
PAUL W EVANS |
K072062 |
09/20/2007 |
UCP MULTIPLE DRUG SCREEN TEST CUPS |
UCP BIOSCIENCES, INC. |
NANCY CHEN |
K071920 |
09/28/2007 |
AUTOSUTURE ABSORBABLE TACK AND APPLICATOR |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
Daniel Campion |
K072405 |
09/13/2007 |
USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE |
USGI MEDICAL |
MARY LOU MOONEY |
K071727 |
09/28/2007 |
QXT EXTRACTION CATHETER |
VASCULAR SOLUTIONS, INC. |
JULIE TAPPER |
K071976 |
09/06/2007 |
VECTEC DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES |
VECTEC |
DIANE M HORWITZ |
K072069 |
09/28/2007 |
SPACER |
VERICOM CO., LTD. |
ALBERT REGO |
K070432 |
09/24/2007 |
GENERAL SURGERY DRAPES |
WELMED INC. |
Glen Feye |
K072337 |
09/21/2007 |
WU'S 4-WHEELED NEO SCOOTER, MODEL WT-M4A |
WU'S TECH CO., LTD. |
Ke-Min Jen |
K072282 |
09/14/2007 |
CAPLESS LI PEDICLE SCREW SYSTEM |
X-SPINE SYSTEMS, INC. |
DAVID KIRSCHMAN |
K072085 |
09/04/2007 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
ZIBO HONGYE SHANGQIN PLASTIC RUBBERT CO LTD |
CHU XIAOAN |
K071439 |
09/20/2007 |
ZIMMER PATIENT-SPECIFIC ABUTMENT, INTERNAL HEX, TITANIUM |
ZIMMER DENTAL INC. |
ERIN MCVEY |
K072183 |
09/05/2007 |
ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600 |
ZIMMER SPINE, INC. |
TIM CRABTREE |
K072281 |
09/06/2007 |
NEXGEN PROLONG ALL-POLY PATELLA |
ZIMMER, INC. |
BRANDON HIPSHER |
K072160 |
09/05/2007 |
NEXGEN TRABECULAR METAL TIBIAL TRAY |
ZIMMER, INC. |
BRANDON HIPSHER |