| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K072824 |
10/02/2007 |
FOX SV PTA CATHETER |
ABBOTT LABORATORIES |
GEORGE J PRENDERGAST |
| K072798 |
10/02/2007 |
VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER |
ABBOTT VASCULAR-VASCULAR SOLUTIONS |
DANIELLE M TAYLOR |
| K073041 |
10/29/2007 |
RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER |
ACCLARENT, INC. |
KERI YEN |
| K072891 |
10/10/2007 |
SINUS SPACER |
ACCLARENT, INC. |
KERI YEN |
| K072836 |
10/05/2007 |
CHOLESTRAK HDL CHOLESTEROL HOME TEST |
ACCUTECH, LLC. |
GARY LEHNUS |
| K072850 |
10/04/2007 |
MRI SYSTEM, MODEL MAGFINDER II / AI 3200 |
ADVANCED IMAGING LABORATORY |
STEPHEN T MLCOCH |
| K072993 |
10/23/2007 |
REUSABLE HEADREST WITH NASAL SEAL |
AEIOMED, INC. |
GARY SYRING |
| K072816 |
10/02/2007 |
NIOX MINO |
AEROCRINE AB |
JOEL SLOMOFF |
| K072899 |
10/11/2007 |
ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0 |
AESCULAP IMPLANT SYSTEMS, INC. |
MATTHEW M HULL |
| K072887 |
10/12/2007 |
G-TRAINER MEDICAL |
ALTER-G, INC. |
GLEN MANGSETH |
| K072901 |
10/11/2007 |
AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101 |
AMDL, INC. |
GARY DREHER |
| K073030 |
10/29/2007 |
AG-605 BLOOD GLUCOSE MONITORING SYSTEM |
ANDON HEALTH CO.,LTD |
MS. MONA |
| K073034 |
10/26/2007 |
AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419) |
APPLIED MEDICAL TECHNOLOGY, INC. |
BRIAN BAKER |
| K073047 |
10/29/2007 |
APROXI 1100 AND 4000 SERIES DENTAL INLAYS |
APROXI APS |
KIRSTEN RONO |
| K072883 |
10/09/2007 |
ICE-SENSE |
ARBEL MEDICAL LTD. |
ZVI LADIN |
| K073019 |
10/29/2007 |
SILVERMED ANTIMICROBIAL SILVER HYDROGEL |
ARGENTIS BIOMEDICAL INCORPORATED |
TONI MILLER |
| K072865 |
10/05/2007 |
MODIFICATON TO: ARTHROCARE ARTHROWANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K073010 |
10/25/2007 |
ROYALE AE 9036 LSP INJECTOR |
ASICO LLC |
RAVI NALLAKRISHNAN |
| K072974 |
10/22/2007 |
SURGIMESH XB |
ASPIDE MEDICAL |
HOWARD M HOLSTEIN |
| K073014 |
10/29/2007 |
INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN |
AUTOGENOMICS, INCORPORATED |
EVELYN G LOPEZ |
| K072876 |
10/09/2007 |
PRONTOSAN WOUND IRRIGATION SOLUTION |
B. BRAUN MEDICAL, INC. |
REBECCA STOLARICK |
| K073007 |
10/24/2007 |
CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL |
BARCOVIEW, MEDICAL IMAGING SYSTEMS |
NEIL PHILLIPS |
| K072875 |
10/09/2007 |
NIO 5MP DISPLAY, MODEL E5620 |
BARCOVIEW, MEDICAL IMAGING SYSTEMS |
NEIL PHILLIPS |
| K073023 |
10/29/2007 |
STERILS SINGLE-USE I/A HANDPIECES |
BAUSCH & LOMB, INC. |
NED LUCE |
| K072825 |
10/02/2007 |
FINGERTIP PULSE OXIMETER, MODEL MD300I |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
DIANA HONG |
| K073080 |
10/31/2007 |
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 |
BIO-RAD LABORATORIES |
MARIA ZEBALLOS |
| K073063 |
10/30/2007 |
15W CERALAS D 1470NM DIODE LASER |
BIOLITEC, INC. |
JONATHAN S KAHAN |
| K072804 |
10/01/2007 |
COMPREHENSIVE RS SHOULDER SYSTEM |
BIOMET MANUFACTURING CORP. |
PATRICIA S BERES |
| K072879 |
10/10/2007 |
INNERVUE DIAGNOSTIC SCOPE SYSTEM |
BIOMET ORTHOPEDICS, INC. |
SUSAN ALEXANDER |
| K072848 |
10/05/2007 |
ACTIVASCREW |
BIORETEC LTD |
MARI RUOTSALAINEN |
| K072892 |
10/16/2007 |
TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 |
BIOSITE INCORPORATED |
FIL V BUENVIAJE |
| K072862 |
10/25/2007 |
BOSTON-BAND CRANIAL REMODLING ORTHOSIS |
BOSTON BRACE INTL., INC. |
JAMES H WYNNE |
| K073018 |
10/25/2007 |
STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT |
BRAINLAB AG |
RAINER BIRKENBACH |
| K072964 |
10/19/2007 |
NICOLET CORTICAL STIMULATOR |
CARDINAL HEALTH, INC. |
GARY SYRING |
| K072800 |
10/01/2007 |
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM |
CARDIOVASCULAR SYSTEMS, INC. |
JOHN CARLINE |
| K073038 |
10/30/2007 |
CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B |
CAREMATIX INC. |
SUKHWANT KHANUJA |
| K073054 |
10/30/2007 |
MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER |
CAYENNE MEDICAL, INC. |
DAVID J COLLETTE |
| K072960 |
10/19/2007 |
CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET |
CDP, LTD. |
DORON DAVID |
| K073016 |
10/25/2007 |
TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT |
CHURCH & DWIGHT CO., INC. |
STEPHEN C KOLAKOWSKY |
| K073022 |
10/26/2007 |
CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830 |
CLAREBLEND, INC. |
JILL CREASY |
| K073000 |
10/24/2007 |
LUMAPROBE |
CLAREBLEND, INC. |
JILL CREASY |
| K072947 |
10/24/2007 |
SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS |
CLEARSTREAM TECHNOLOGIES, LTD. |
IAN P GORDON |
| K072851 |
10/04/2007 |
POLYSTAR 79 DENTURE BASE RESIN |
CMP INDUSTRIES LLC. |
DEVON O HOWE |
| K073061 |
10/31/2007 |
THE PROXIVENT KIT |
COLL PARTNERS LTD. |
ELI M ORBACH |
| K072808 |
10/05/2007 |
SPEEDICATH COMPACT |
COLOPLAST CORP. |
REBEKA STOLTMAN |
| K073013 |
10/25/2007 |
CTU676 DEVICE |
COMPRESSION TECHNOLOGIES UNLIMITED, INC. |
DOUGLASS HALE |
| K072796 |
10/01/2007 |
MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044 |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
| K073009 |
10/25/2007 |
ONEPORT SURGICAL TROCAR SYSTEM |
CONMED CORPORATION |
BRIAN KILLORAN |
| K072962 |
10/19/2007 |
CABS'AIR |
COUSIN BIOTECH S.A.S. |
STEPHEN PLOQUIN |
| K072866 |
10/05/2007 |
ISSYS LP SPINAL FIXATION SYSTEM |
CUSTOM SPINE, INC. |
SAAD ATTIYAH |
| K072950 |
10/22/2007 |
CYGNUS 12 LEAD ECG MODULE |
CYGNUS, LLC |
NARCIS NAYDENOV |
| K072868 |
10/09/2007 |
ACCOLADE II LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K073072 |
10/31/2007 |
DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B |
DADE BEHRING, INC. |
PAMELA A JURGA |
| K073055 |
10/30/2007 |
DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 |
DADE BEHRING, INC. |
VICTOR M CARRIO |
| K072965 |
10/29/2007 |
DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
| K072752 |
10/29/2007 |
BP LIMBO XL, BPTANGO XL, BP SALSA XL |
DATADANCER MEDICAL SYSTEMS |
MICHAEL KOHUT |
| K072930 |
10/24/2007 |
DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT |
DEMETECH CORP. |
A.J. DIMERCURIO |
| K072807 |
10/01/2007 |
I LIGHT |
DENT'N CO |
ALAN DONALD |
| K073067 |
10/30/2007 |
ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K073073 |
10/31/2007 |
ANKYLOS TEMPORARY ABUTMENT BALANCE |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K073075 |
10/31/2007 |
FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K072989 |
10/23/2007 |
AXIS SYSTEM |
DENTSPLY INTL., INC. |
HELEN LEWIS |
| K072832 |
10/03/2007 |
ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K072963 |
10/19/2007 |
DEPUY PINNACLE ALTRX ACETABULAR LINERS |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
| K072956 |
10/19/2007 |
MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY |
DERMA SCIENCES, INC. |
MARY MCNAMARA-CULLINANE |
| K073488 |
10/22/2007 |
DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX |
DIAZYME LABORATORIES |
CHARLES YU |
| K073070 |
10/30/2007 |
DIO BIOTITE-H IMPLANT SYSTEM |
DIO DEPARTMENT DSI, INC. |
STEVE CHANG |
| K072885 |
10/09/2007 |
CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110 |
DRAEGER MEDICAL AG & CO. KG |
KATHY ANDERSON |
| K072884 |
10/09/2007 |
FABIUS MRI |
DRAEGER MEDICAL AG & CO. KG |
KATHY ANDERSON |
| K072985 |
10/23/2007 |
DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 |
DUCKWORTH & KENT, LTD. |
MARTIN LOCK |
| K073021 |
10/26/2007 |
MULTI-SPECT |
EAGLE HEART IMAGING, LLC |
JOHN KOSS |
| K072946 |
10/17/2007 |
HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM |
EMPI |
SANDRA WALROD |
| K072789 |
10/01/2007 |
DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES |
ENCISION, INC. |
JUDITH V KING |
| K072888 |
10/10/2007 |
REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED) |
ENCORE MEDICAL, L.P. |
TIFFANY HUTTO |
| K072840 |
10/04/2007 |
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM |
ENDIUS, INC. |
CHRISTINE KUNTZ-NASSIF |
| K072919 |
10/15/2007 |
VENDYS, MODEL 6000 B B/C |
ENDOTHELIX, INC. |
DOUG BLAKELY |
| K072890 |
10/10/2007 |
STASILON FR |
ENTEGRION, INC. |
E.S. ESKRIDGE, JR. |
| K073046 |
10/29/2007 |
ETHICON ENDO SURGERY ARTICULATING NEEDLE KNIFE, MODEL 2504 |
ETHICON ENDO-SURGERY, INC. |
GLENDA C MARSH |
| K072776 |
10/04/2007 |
THE CROSSER SYSTEM |
FLOWCARDIA, INC. |
DUSTIN MICHAELS |
| K072870 |
10/09/2007 |
MICROWAVE TISSUE COAGULATION SYSTEM (MTCS) |
FOUNDRY NEWCO X, INC. |
GREGORY MATHISON |
| K072939 |
10/17/2007 |
HE4 EIA, MODEL: 404-10 US |
FUJIREBIO DIAGNOSTICS, INC. |
DIANA L DICKSON |
| K072908 |
10/12/2007 |
PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY |
GAMBRO RENAL PRODUCTS |
FEI LAW |
| K072986 |
10/23/2007 |
INTEGRADWEB PACS SYSTEM |
GE HEALTHCARE |
JILLIAN M REED |
| K072976 |
10/22/2007 |
MODEL 250CX SERIES MATERNAL/FETAL MONITOR |
GE HEALTHCARE |
AGATA SMIEJA |
| K072664 |
10/02/2007 |
GE LUNAR FEMUR STRENGTH SOFTWARE |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
JAMES RASKOB |
| K072998 |
10/24/2007 |
IDEAL SOFTWARE OPTION FOR GE MR SCANNERS |
GE MEDICAL SYSTEMS, LLC |
MARK M STAUFFER |
| K072977 |
10/22/2007 |
DIAZYME APOLIPOPROTEIN A-1 ASSAY |
GENERAL ATOMICS |
ABHIJIT DATTA |
| K072952 |
10/18/2007 |
GE ECHOPAC |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K072797 |
10/01/2007 |
GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K073062 |
10/30/2007 |
OMNI-VUE SYSTEM |
GENESIS DIGITAL IMAGING, INC. |
CARL ALLETTO |
| K072970 |
10/22/2007 |
PATRIOT SPACERS |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K072991 |
10/23/2007 |
PATRIOT SPACERS: COLONIAL ACDF |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K073064 |
10/30/2007 |
GRAFTYS BCP |
GRAFTYS |
ANTHONY LE NAOUR |
| K073044 |
10/29/2007 |
HEARTWAY POWER MOBILITY SCOOTER, MODEL PT7 |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
KE-MIN JEN |
| K072900 |
10/12/2007 |
EXCELARREST FOAM |
HEMOSTASIS, LLC |
KEITH ROBERTS |
| K073059 |
10/30/2007 |
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM |
HITACHI, LTD., POWER SYSTEMS GROUP |
JONATHAN S KAHAN |
| K072847 |
10/04/2007 |
APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS |
HOLOGIC, INC. |
BRYAN COWELL |
| K072906 |
10/11/2007 |
SILK'N |
HOME SKINOVATIONS LTD. |
AMIR WALDMAN |
| K073076 |
10/31/2007 |
HOFFMANN LIGHT SYSTEM |
HOWMEDICA OSTEONICS CORP. |
FRANCISCO HARO |
| K072867 |
10/10/2007 |
IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K |
IMIX ADR FINLAND OY |
JAMES TAYLOR |
| K073033 |
10/26/2007 |
LEGACY DENTAL IMPLANTS |
IMPLANT DIRECT LLC |
THOMAS GOTTENBOS |
| K073049 |
10/29/2007 |
SCREWPLUS DENTAL IMPLANTS (HA) |
IMPLANT DIRECT LLC |
THOMAS GOTTENBOS |
| K072822 |
10/02/2007 |
FUNHALER, MODEL V-201E |
INFAMED LTD. |
JOHN GREENBAUM |
| K072932 |
10/16/2007 |
INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 |
INFRAREDX, INC. |
STEVEN J CHARTIER |
| K073060 |
10/30/2007 |
CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
INNOVA VISION INC. |
JENNIFER REICH |
| K072925 |
10/24/2007 |
CANDELA-INOLASE SERENITY PRO PSF SYSTEM |
INOLASE, LTD. |
GEORGE J HATTUB |
| K072944 |
10/17/2007 |
QUANTA LITE CCP3.1 IGG/IGA ELISA |
INOVA DIAGNOSTICS, INC. |
RUFUS BURLINGAME |
| K072967 |
10/30/2007 |
QUANTA LITE F-ACTIN IGA ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K073042 |
10/29/2007 |
HEMOSIL D-DIMER |
INSTRUMENTATION LABORATORY |
CAROL MARBLE |
| K072929 |
10/16/2007 |
LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030 |
INTEGRA LIFESCIENCES CORPORATION |
DARLENE M WELSH |
| K072863 |
10/05/2007 |
ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES |
INTERNACIONAL FARMACEUTICA, S.A. DE C.V. |
ALLAN P SCHWARTZ |
| K072859 |
10/05/2007 |
ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES |
INTERNACIONAL FARMACEUTICA, S.A. DE C.V. |
ALAN P SCHWARTZ |
| K072874 |
10/23/2007 |
LBS-127-16 BREAST ARRAY COIL |
INVIVO |
JEFF WILKINSON |
| K072873 |
10/22/2007 |
LBS-63-16 BREAST ARRAY COIL |
INVIVO |
JEFF WILKINSON |
| K072911 |
10/12/2007 |
ION MEDICAL BIPOLAR COAGULATION PEN |
ION MEDICAL, LLC |
KEITH HURON |
| K072833 |
10/04/2007 |
P-NAIN SYSTEM |
JEISYS MEDICAL, INC. |
KEVIN WALLS |
| K072914 |
10/16/2007 |
NATURAL BRIDGE LP TRANSVERSE CONNECTORS |
K2M, INC. |
RICHARD W WOODS |
| K072788 |
10/01/2007 |
STORZ MODULITH LITHOTRIPTER SLX-F2-F180 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
CRYSTAL DIZOL |
| K072811 |
10/01/2007 |
MARIONETTE SA, MODEL 001 001 & 001 002 |
KINETIC SURGICAL LLC |
JIM CAPUTO |
| K073008 |
10/24/2007 |
KFH ENERGY, MODEL: E1 |
KINGFISHER HEALTHCARE NV |
NEIL R ARMSTRONG |
| K072795 |
10/01/2007 |
MODELS EMS 5.0, EMS 5.1 |
KOALATY PRODUCTS, INC. |
JEFF LENOIR |
| K073032 |
10/29/2007 |
PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS |
LIFECORE BIOMEDICAL, INC. |
JUDITH MEDLOCK-HAYES |
| K072926 |
10/15/2007 |
HELONTIX VENT |
LINDE GAS THERAPEUTICS |
ANN-CATHRIN JAREMAN |
| K072995 |
10/23/2007 |
TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER |
LUMEN DEVELOPMENT AND MANUFACTURING, INC. |
CALVIN D OSTLER |
| K072806 |
10/02/2007 |
MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS) |
MAKO SURGICAL CORP. |
WILLIAM TAPIA |
| K073024 |
10/26/2007 |
MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K072857 |
10/05/2007 |
TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT |
MEDACTA INTERNATIONAL, SA |
PAMELA J WEAGRAFF |
| K072898 |
10/11/2007 |
HEXAPOD EVO RT COUCH TOP |
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
MICHAEL WOLFF |
| K073051 |
10/29/2007 |
MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY |
MEDRAD, INC. |
LESLIE S O'NAN |
| K072886 |
10/09/2007 |
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T |
MEDRAD, INC. |
LISA M CASAVANT |
| K072972 |
10/22/2007 |
MEDSTREAMING MEDICAL OFFICE SOFTWARE |
MEDSTREAMING, LLC |
KARLA PATTEN |
| K072990 |
10/24/2007 |
GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID |
MEDTRONIC INC. |
KAREN A BROZOWSKI |
| K073058 |
10/30/2007 |
RESCUE INTERNAL IMPLANT SYSTEM |
MEGAGEN CO., LTD. |
STEVE CHANG |
| K072823 |
10/03/2007 |
MERILAS 532A |
MERIDIAN AG |
KEVIN WALLS |
| K073035 |
10/29/2007 |
PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS |
MERIT MEDICAL SYSTEMS, INC. |
SHIRLEY HYINK |
| K072978 |
10/22/2007 |
TENDER ORTHO BOND-ENA BOND-ENA ETCH |
MICERIUM S.P.A. |
EUGENIO MICELI |
| K072979 |
10/22/2007 |
SPIROBANK G |
MIR MEDICAL INTL. RESEARCH SRL |
SIMON FOWLER |
| K072793 |
10/03/2007 |
LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688 |
MOELLER MEDICAL GMBH & CO. KG |
BILL KELLEY |
| K072931 |
10/16/2007 |
MC 3003G-32R HEAD COIL |
MR INSTRUMENTS, INC. |
MARK WATSON |
| K072881 |
10/09/2007 |
NEOMED FEEDING TUBE |
NEOMED, INC. |
PENNY NORTHCUTT |
| K072997 |
10/24/2007 |
NEOMED URINARY CATHETER |
NEOMED, INC. |
PENNY NORTHCUTT |
| K072905 |
10/11/2007 |
3TEST SUPREME GLUCOSE MONITORING SYSTEM |
NEUERO ENGINEERING INC. |
KE-MIN JEN |
| K072841 |
10/04/2007 |
NEUVIZ SPIRAL CT SCANNER SYSTEM |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
TIAN TANFANG |
| K072984 |
10/23/2007 |
SATURN 9000-550 |
NEW MEDICAL CO., LTD. |
YOUNG-HOON SHIN |
| K072983 |
10/23/2007 |
SATURN 9000-750 |
NEW MEDICAL CO., LTD. |
YOUNG-HOON SHIN |
| K072831 |
10/03/2007 |
FROG |
NEWBY-COOMBS, LLC |
KARLA COOMBS |
| K072843 |
10/04/2007 |
YG-125T AND YG-135T NASAL ADAPTER |
NIHON KOHDEN AMERICA, INC. |
JACK COGGAN |
| K072988 |
10/23/2007 |
NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD |
| K072980 |
10/23/2007 |
NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS |
NOBEL BIOCARE AB |
KAM LEUNG |
| K072917 |
10/16/2007 |
JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM |
ODONTIT SA |
MARIO GERSBERG |
| K072937 |
10/16/2007 |
OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET |
OLSEN MEDICAL |
JOHN P WATERS |
| K072957 |
10/24/2007 |
EVIS EXERA II 180 SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K073045 |
10/29/2007 |
SAPPHIRE CERAMIC BRACKET |
ORTHO TECHNOLOGY, INC |
PAUL WILLIAMS |
| K072882 |
10/09/2007 |
PAIN VISION, MODEL PS-2100 |
OSACHI CO., LTD. |
JAMES R GREENWOOD |
| K072770 |
10/10/2007 |
TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) |
OSCOR INC. |
MILA DOSKOCIL |
| K072896 |
10/11/2007 |
GS FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
KIM M JOO |
| K072959 |
10/19/2007 |
MS SYSTEM (DENTURE) |
OSSTEM IMPLANT CO.,LTD |
MIN JOO KIM |
| K072871 |
10/10/2007 |
MS SYSTEM (PROVISIONAL) |
OSSTEM IMPLANT CO.,LTD |
CATHRYN N CAMBRIA |
| K073065 |
10/30/2007 |
OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM |
OSTEOMED L.P. |
PIEDAD PENA |
| K072969 |
10/22/2007 |
DSS |
PARADIGM SPINE, LLC |
JUSTIN EGGLETON |
| K072982 |
10/23/2007 |
PARI HYDRATE V |
PARI INNOVATIVE MANUFACTURERS, INC. |
MIKE JUDGE |
| K073057 |
10/30/2007 |
PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040 |
PEAK SURGICAL, INC. |
GRACE CARLSON |
| K072830 |
10/03/2007 |
RM BOND, MODEL J032 |
PENTRON CLINICAL TECHNOLOGIES |
GREG MOREAU |
| K072813 |
10/01/2007 |
EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG) |
PHASEIN AB |
DAVID WEISSBURG |
| K072812 |
10/01/2007 |
PHILIPS HEARTSTART SMARTPADS III |
PHILIPS MEDICAL SYSTEMS |
LARRY WALKER |
| K072869 |
10/09/2007 |
POINTCARE NOW SYSTEM |
POINTCARE TECHNOLOGIES INC. |
MAURICE N DOIRE |
| K073001 |
10/24/2007 |
IDRIVES, IDRIVEC, IDRIVEF |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
| K073039 |
10/29/2007 |
SPERMCHECK VASECTOMY |
PRINCETON BIOMEDITECH CORP. |
KYUNG-AH KIM |
| K073029 |
10/29/2007 |
PROFLU+ ASSAY |
PRODESSE, INC. |
KAREN HARRINGTON |
| K072487 |
10/09/2007 |
FAST1 INTRAOSSEOUS INFUSION SYSTEM |
PYNG MEDICAL CORP. |
MAYA BUTTERFIELD |
| K072935 |
10/17/2007 |
SPEEDER 1.5T WRIST ARRAY COIL |
QUALITY ELECTRODYNAMICS |
CHRISTIE ZYDYK |
| K073066 |
10/30/2007 |
308 DERMATOLOGICAL EXCIMER SYSTEM |
QUANTEL MEDICAL, INC. |
GEORGE MYERS |
| K072846 |
10/11/2007 |
CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 |
R & D SYSTEMS, INC. |
NANCY C RING |
| K072953 |
10/18/2007 |
REDLINE ALCOHOL BREATH TESTER |
REDLINE PRODUCTS (PTY) LTD. |
HUGH A BUTLER |
| K072827 |
10/03/2007 |
RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE |
REMEL, INC. |
ANDRE HSIUNG |
| K072940 |
10/17/2007 |
MIRAGE MICRO |
RESMED LTD. |
DAVID D'CRUZ |
| K072996 |
10/24/2007 |
REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM |
RESPIRONICS, INC. |
ZITA A YURKO |
| K072753 |
10/02/2007 |
REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES |
RG MEDICAL USA |
WINFRIED REICH |
| K072920 |
10/15/2007 |
HANDHELD BASE UNIT |
ROCHE DIAGNOSTICS CORP. |
JASON FISHER |
| K073048 |
10/29/2007 |
PETERIO UNIVERSAL LASER SCANNING HANDPIECE |
SCILEX, LTD. |
ALEX RAPOPORT |
| K073043 |
10/29/2007 |
SET PP |
SDI LTD. |
RAY CAHILL |
| K072729 |
10/11/2007 |
SIERRA |
SEASPINE, INC. |
ETHEL BERNAL |
| K072909 |
10/12/2007 |
1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL |
SIEMENS AG, MEDICAL SOLUTIONS |
LUTZ MAHN |
| K072794 |
10/01/2007 |
IMMULITE 2500 OM-MA, MODEL L5KOP |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
MAYA MAHUE-GIANGRECO |
| K072786 |
10/01/2007 |
ACUSON S2000 ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
| K073003 |
10/24/2007 |
SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY |
SIEMENS MEDICAL SOLUTIONS, INC. |
CORRINE MCLEOD |
| K073040 |
10/29/2007 |
SMH FLEX "S" |
SMH BIOMATERIAL AG |
ASHLEY TRUITT |
| K072785 |
10/01/2007 |
TWINFIX FT PK |
SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
DEANA BOUSHELL |
| K072817 |
10/02/2007 |
ECHELON TITANIUM HIP SYSTEM |
SMITH & NEPHEW, INC. |
MARLON D RIDLEY |
| K072818 |
10/02/2007 |
PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K072852 |
10/10/2007 |
SL-PLUS STANDARD AND LATERAL HIP STEMS |
SMITH & NEPHEW, INC. |
NICHOLAS B TABRIZI |
| K072858 |
10/05/2007 |
TC-PLUS PRIMARY KNEE SYSTEM |
SMITH & NEPHEW, INC. |
RISHI SINHA |
| K072783 |
10/02/2007 |
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH |
SMITHS MEDICAL ASD, INC. |
BRIAN FARIAS |
| K072955 |
10/19/2007 |
CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CARE (21-6276) |
SMITHS MEDICAL MD, INC. |
DAVID H SHORT |
| K072904 |
10/11/2007 |
SONOCA 180/195 WOUND CARE SYSTEM |
SOERING GMBH |
CARL THOMAS |
| K073004 |
10/24/2007 |
SOMNOMED BFLEX |
SOMNOMED INC. |
ASHLEY TRUITT |
| K072912 |
10/12/2007 |
SOPRO 225 DUAL HALOGEN LIGHT SOURCE |
SOPRO |
STEVE SALESKY |
| K073050 |
10/29/2007 |
SAFESTEP MAX POWER-INJECTABLE INFUSION SET |
SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC. |
MARK NELSON |
| K072750 |
10/19/2007 |
SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066 |
SPECTRANETICS CORP. |
MICHAEL K HANDLEY |
| K072961 |
10/19/2007 |
LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) |
SRA DEVELOPMENTS, LTD. |
MICHAEL J.R. YOUNG |
| K072864 |
10/05/2007 |
ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM |
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
COLLEEN CANAN |
| K073017 |
10/25/2007 |
STRYKER STRI-SHIELD FLYTE TOGAS |
STRYKER INSTRUMENTS, INSTRUMENTS DIV. |
PAULETTE D JOHNSON |
| K072757 |
10/02/2007 |
DIVE AND SHALLOW AND GRAND DIVE |
SUMMIT TO SEA |
BRUCE MCKEEMAN |
| K072834 |
10/03/2007 |
SIBEL SA VASCULAR CLAMP |
SURGICAL INSTRUMENTS BELGIUM SA |
WILLIAM F GREENROSE |
| K072913 |
10/12/2007 |
SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM |
SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY |
PAULA A GRAY |
| K072921 |
10/15/2007 |
DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM |
SYMBIOS MEDICAL PRODUCTS, LLC |
JEFFREY ALHOLM |
| K072787 |
10/01/2007 |
GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111 |
SYNCRO MEDICAL INNOVATIONS, INC. |
WILLIAM MCLAIN |
| K072791 |
10/01/2007 |
ORACLE SPACER, OPAL SPACER |
SYNTHES SPINE |
STACEY BONNELL |
| K072981 |
10/31/2007 |
SYNTHES ZERO-P |
SYNTHES SPINE CO.LP |
SUSAN LEWANDOWSKI |
| K072784 |
10/02/2007 |
PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK TD-4227 BLOOD GLUCOSE MONITORING SYSTEM |
TAIDOC TECHNOLOGY CORPORATION |
ERICA LI |
| K073006 |
10/24/2007 |
OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM |
TAKIRON CO., LTD |
KUNIHIRO HATA |
| K072894 |
10/11/2007 |
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) |
TERUMO EUROPE N.V. |
M.J. AERTS |
| K072889 |
10/11/2007 |
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K072849 |
10/04/2007 |
MODIFICATION TO THERMAGE THERMACOOL SYSTEM |
THERMAGE, INC. |
PAMELA M BUCKMAN |
| K073027 |
10/26/2007 |
SPECTRA MRSA |
THERMO FISHER SCIENTIFIC |
MARY ANN SILVIUS |
| K073025 |
10/30/2007 |
VASCUTRAK II PTA DILATATION CATHETER |
THERMOPEUTIX INC. DBA YMED INC. |
THOMAS SCHROEDER |
| K072933 |
10/16/2007 |
SPI CONTACT PLATFORM O 4.0 MM |
THOMMEN MEDICAL, AG |
FLOYD G LARSON |
| K072856 |
10/05/2007 |
SPI VARIOMULTI ABUTMENT |
THOMMEN MEDICAL, AG |
LINDA K SCHULZ |
| K072746 |
10/02/2007 |
E-1 ESTHETIC COMPOSITE SYSTEM |
TOKUYAMA DENTAL CORPORATION |
KEITH A BARRITT |
| K072971 |
10/22/2007 |
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS |
TOPCON MEDICAL SYSTEMS, INC. |
JONATHAN S KAHAN |
| K072826 |
10/03/2007 |
APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K072918 |
10/15/2007 |
MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K072968 |
10/24/2007 |
STRESSGARD NIGHTGUARD |
TOTALGARD CORPORATION |
LOUIS P IZZI |
| K072922 |
10/15/2007 |
3S HEMI TOE |
TRILLIANT SURGICAL LTD |
JD WEBB |
| K072854 |
10/05/2007 |
DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM |
TYSON BIORESEARCH, INC. |
WEN-HAI TSAI |
| K072802 |
10/01/2007 |
SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE |
ULTRAWIN SDN BHD |
SIEW-HOE MAH |
| K073053 |
10/30/2007 |
COLPO-MASTER |
UNITED PRODUCTS & INSTRUMENTS, INC. |
GEORGE MYERS |
| K072845 |
10/04/2007 |
PRECISION FLOW |
VAPOTHERM, INC. |
JONATHAN S KAHN |
| K073020 |
10/26/2007 |
ECLIPSE TREATMENT PLANNING SYSTEM |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K072916 |
10/12/2007 |
TRILOGY SYSTEM WITH RAPIDARC |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K072810 |
10/10/2007 |
PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010 |
VASCULAR SOLUTIONS, INC. |
DORALIE POGANSKI |
| K073028 |
10/26/2007 |
VENOWAVE MODELS VW5-6, VW5-10, VW5-20 AND VW5-30 |
VENOWAVE, INC. |
JOHN SARINGER |
| K073069 |
10/30/2007 |
MODIFICATION TO AVEA VENTILATOR |
VIASYS RESPIRATORY CARE INC |
TOM GUTIERREZ |
| K073056 |
10/30/2007 |
DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9 |
VIEWORKS CO., LTD. |
KIM RAZA |
| K072799 |
10/01/2007 |
TARGET STERILE ELECTRODE |
VISION QUEST INDUSTRIES, INC. |
JAIME X PULLEY |
| K072821 |
10/02/2007 |
VITREA 4DCT |
VITAL IMAGES, INC. |
TIMOTHY J KAPPERS |
| K072943 |
10/17/2007 |
BUTREX BUTTRESS PLATING SYSTEM |
X-SPINE SYSTEMS, INC. |
DAVID KIRSCHMAN |
| K072860 |
10/05/2007 |
YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500 |
YA HORNG ELECTRONIC CO., LTD. |
KE-MIN JEN |
| K072878 |
10/09/2007 |
MODIFICATION TO: LOCATOR IMPLANT ANCHOR |
ZEST ANCHORS, INC. |
RICHARD OVERTON |
| K073005 |
10/24/2007 |
ELITE GLASS |
ZHERMACK S.P.A. |
GERALD W SHIPPS |
| K072923 |
10/17/2007 |
ZOLL E SERIES DEFIBRILLATOR |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
SEAN REYNOLDS |
