| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K070984 |
11/01/2007 |
THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS |
ABBOTT DIABETES CARE INC. |
MARIA E TREJO |
| K072672 |
11/28/2007 |
SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES |
ABBOTT SPINE, INC. |
DAVID PADGETT |
| K072019 |
11/05/2007 |
AKITA2 APIXNEB |
ACTIVAERO AMERICA, INC. |
PAUL DRYDEN |
| K072309 |
11/19/2007 |
MICROLUX/BLU |
ADDENT, INC. |
JOSHUA FRIEDMAN, DDS |
| K072850 |
11/21/2007 |
MRI SYSTEM, MODEL MAGFINDER II / AI 3200 |
ADVANCED IMAGING LABORATORY |
STEPHEN T MLCOCH |
| K071385 |
11/29/2007 |
STERRAD 100NX STERILIZER |
ADVANCED STERILIZATION PRODUCTS |
REUBEN LAWSON |
| K072359 |
11/08/2007 |
AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C |
AEARO COMPANY |
ANN L PHILLIPS |
| K072313 |
11/02/2007 |
AMPLATZER TORQVUE DELIVERY SYSTEM |
AGA MEDICAL CORP. |
PATRICIA A LAFORTE |
| K062624 |
11/05/2007 |
NEXT GENERATION LASER |
ALCON LABORATORIES |
TERRY J DAGNON |
| K071165 |
11/07/2007 |
ISCALERT SENSOR SYSTEM |
ALERTIS MEDICAL AS |
CONSTANCE G BUNDY |
| K072659 |
11/15/2007 |
RAD VISION, MODELS E AND EU |
ALMANA MEDICAL IMAGING |
DANIEL KAMM |
| K071890 |
11/09/2007 |
ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM |
ALPHATEC SPINE, INC. |
MARY STANNERS |
| K072022 |
11/19/2007 |
VALEO PEDICLE SCREW SPINAL SYSTEM |
AMEDICA CORP. |
JUSTIN EGGLETON |
| K072378 |
11/09/2007 |
PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626 |
ARTHREX, INC. |
ANN WATERHOUSE |
| K070874 |
11/02/2007 |
ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006; ACCESSORIES FOR MR GENERATOR |
ARTHRO KINETICS INC. |
JAMES HOBBS |
| K071413 |
11/09/2007 |
HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM |
ARTHROSURFACE, INC. |
DAWN J WILSON |
| K073010 |
11/07/2007 |
ROYALE AE 9036 LSP INJECTOR |
ASICO LLC |
RAVI NALLAKRISHNAN |
| K072286 |
11/20/2007 |
BIS EEG VISTA MONITOR SYSTEM AND BISX |
ASPECT MEDICAL SYSTEMS, INC. |
VIKRAM VERMA |
| K072483 |
11/16/2007 |
ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTS |
ATLANTIS COMPONENTS, INC. |
BETSY A BROWN |
| K072247 |
11/08/2007 |
STERICAN HYPODERMIC NEEDLES |
B. BRAUN MEDICAL, INC. |
CHRISTINE FORD |
| K063245 |
11/28/2007 |
ELUTIA COATED CLOSED SURGICAL WOUND DRAIN |
BACTERIN INTERNATIONAL INC. |
JOSEPH M AZARY |
| K072576 |
11/06/2007 |
CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED |
BAXTER HEALTHCARE CORP. |
NANETTE HEDDEN |
| K070691 |
11/20/2007 |
BBL CHROMAGAR 0157 |
BECTON, DICKINSON & CO. |
DENNIS R MERTZ |
| K072666 |
11/05/2007 |
BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM |
BIO COMPRESSION SYSTEMS, INC. |
JAMES JOCHEN ROGERS |
| K072306 |
11/15/2007 |
BIOXTRA MOISTURIZING GEL |
BIO-X HEALTHCARE S.A. |
EMALEE MURPHY |
| K072082 |
11/05/2007 |
GUMEASE DENTAL MOUTHPIECE |
BIOMEDEVICE LTD. |
BRICE L YODER |
| K073146 |
11/21/2007 |
PADNET+ |
BIOMEDIX, INC. |
WILLIAM ROGERS |
| K072695 |
11/16/2007 |
VITEK 2 GRAM POSITIVE TIGECYCLINE |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K073102 |
11/27/2007 |
BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
| K070015 |
11/30/2007 |
COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT |
BIOMET MANUFACTURING CORP. |
GARY E BAKER, MS RAC |
| K072336 |
11/05/2007 |
REGENEREX POROUS TITANIUM SLEEVE AUGMENTS |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
| K072848 |
11/02/2007 |
ACTIVASCREW |
BIORETEC LTD |
MARI RUOTSALAINEN |
| K072202 |
11/19/2007 |
CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01) |
BIOSENSE WEBSTER, INC. |
NATALIE BENNINGTON |
| K072436 |
11/01/2007 |
MEGA SPINE SYSTEM |
BK MEDITECH CO., LTD. |
HENRY YANG |
| K072049 |
11/29/2007 |
CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS |
BMEYE B.V. |
Jacqueline Emery |
| K071957 |
11/08/2007 |
PINNACLE PELVIC FLOOR REPAIR KITS |
BOSTON SCIENTIFIC CORP. |
MICHELLE BERRY |
| K071365 |
11/06/2007 |
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE |
C.R. BARD, INC. |
MICHELLE R GUDITH |
| K072215 |
11/01/2007 |
TITANIUM POWERPORT ISP IMPLANTED PORT |
C.R. BARD, INC. |
SUSAN D SCOTT |
| K072549 |
11/14/2007 |
TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER |
C.R. BARD, INC. |
SUSAN D SCOTT |
| K072133 |
11/20/2007 |
AVAFLEX VERTEBRAL AUGMENTATION NEEDLE |
CARDINAL HEALTH, INC. |
SHARON NICHOLS |
| K072748 |
11/09/2007 |
MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM |
CARDIOVASCULAR SYSTEMS, INC. |
JOHN CARLINE |
| K072260 |
11/27/2007 |
NUFACE, MODEL NU-4003 |
Carol Cole Company |
HOWARD ASHER |
| K072245 |
11/08/2007 |
EMULATE ADVANCED |
CAVEX HOLLAND B.V. |
RICHARD WOORTMAN |
| K073054 |
11/27/2007 |
MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER |
CAYENNE MEDICAL, INC. |
DAVID J COLLETTE |
| K072960 |
11/08/2007 |
CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET |
CDP, LTD. |
DORON DAVID |
| K070968 |
11/15/2007 |
CHOY COMPRESSION FRAME |
CHOY MEDICAL TECHNOLOGIES, INC. |
JONATHAN S KAHAN |
| K073016 |
11/09/2007 |
TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT |
CHURCH & DWIGHT CO., INC. |
STEPHEN C KOLAKOWSKY |
| K073180 |
11/19/2007 |
SMARTSPONGE PLUS SYSTEM |
CLEARCOUNT MEDICAL SOLUTIONS, INC. |
JEFF WOLFGONG |
| K073124 |
11/16/2007 |
COLLIMARE COLLIMATOR FAMILY |
COLLIMARE, LLC |
HOWARD C THOMAS |
| K072808 |
11/09/2007 |
SPEEDICATH COMPACT |
COLOPLAST CORP. |
REBEKA STOLTMAN |
| K072604 |
11/16/2007 |
DUO TEMP |
COLTENE/WHALEDENT AG |
HENRY J VOGELSTEIN |
| K073013 |
11/21/2007 |
CTU676 DEVICE |
COMPRESSION TECHNOLOGIES UNLIMITED, INC. |
DOUGLASS HALE |
| K072698 |
11/16/2007 |
CONFIDANT 2.5 |
CONFIDANT INC. |
DANIEL R PLONSKI |
| K072586 |
11/08/2007 |
CONFORMIS UNI-CONDYLAR KNEE SYSTEM |
CONFORMIS, INC. |
S. MICHAEL SHARP |
| K072521 |
11/20/2007 |
COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH |
COOK UROLOGICAL, INC. |
CINDY FOOTE |
| K072724 |
11/09/2007 |
CXI SUPPORT CATHETER |
COOK, INC. |
KAREN BRADBURN |
| K072240 |
11/08/2007 |
GUNTHER TULIP VENA CAVA FILTER |
COOK, INC. |
MOLLY BUSENBARK |
| K070690 |
11/16/2007 |
THE LIFE VESSEL |
COTTONWOOD VESSEL CORPORATION |
MIKI KOLTON |
| K073122 |
11/21/2007 |
MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE |
COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR |
DEBORA STAPLETON |
| K072868 |
11/05/2007 |
ACCOLADE II LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K071224 |
11/13/2007 |
DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR |
DADE BEHRING, INC. |
LORRAINE H PIESTRAK |
| K072807 |
11/21/2007 |
I LIGHT |
DENT'N CO |
ALAN DONALD |
| K070228 |
11/20/2007 |
IMPLANTIUM PROSTHETICS |
DENTIUM CO., LTD. |
CATHRYN N CAMBRIA |
| K072522 |
11/16/2007 |
THERMOFORM SHEET MATERIALS AND ACCESSORIES |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K072423 |
11/07/2007 |
4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY. |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K071059 |
11/09/2007 |
DEPUY SPA POROUS COATED PROXIMAL SLEEVE |
DEPUY ORTHOPAEDICS, INC. |
KATHY HARRIS |
| K071927 |
11/21/2007 |
MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT |
DEPUY SPINE, A JOHNSON & JOHNSON COMPANY |
SHARON STAROWICZ |
| K072956 |
11/07/2007 |
MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY |
DERMA SCIENCES, INC. |
MARY MCNAMARA-CULLINANE |
| K071202 |
11/30/2007 |
DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS) |
DERMAPORT, INC |
Gary Syring |
| K070569 |
11/08/2007 |
SM INTERNAL./EXTERNAL IMPLANT SYSTEM |
DIO DEPARTMENT DSI, INC. |
KENNY LIM |
| K072532 |
11/02/2007 |
TRUEPIX LCD MEDICAL DISPLAY MONITOR, MODELS TX-5M, TX-3M, TX-2M |
DOOYANG SYSTEMS INC |
DANIEL KAMM |
| K073021 |
11/06/2007 |
MULTI-SPECT |
EAGLE HEART IMAGING, LLC |
JOHN KOSS |
| K070375 |
11/15/2007 |
EARLYSENSE ES-16 SYSTEM |
EARLYSENSE LTD. |
DORIT WINITZ |
| K072383 |
11/29/2007 |
HABIB ENDOBLATE |
EMCISION, LTD. |
NAGY HABIB |
| K072946 |
11/16/2007 |
HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM |
EMPI |
SANDRA WALROD |
| K072919 |
11/02/2007 |
VENDYS, MODEL 6000 B B/C |
ENDOTHELIX, INC. |
DOUG BLAKELY |
| K072248 |
11/09/2007 |
VIAPEEL PEELABLE INTRODUCER |
ENPATH MEDICAL, INC. |
PATRICE STROMBERG |
| K072470 |
11/16/2007 |
BIOELAST 5-0 SUTURE, MODEL 500100 |
ENTRIGUE SURGICAL, INC. |
GABRIELE NIEDERAUER |
| K063050 |
11/19/2007 |
CAP PLUS |
ETEX CORP. |
FRANCES A FLORENCE |
| K071624 |
11/27/2007 |
EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR |
EVERLIFE MEDICAL EQUIPMENT CO., LTD. |
JEN KE-MIN |
| K072641 |
11/01/2007 |
DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4. |
FAMIDOC TECHNOLOGY CO., LTD |
STEELJIN |
| K071826 |
11/09/2007 |
THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910 |
FOX HOLLOW TECHNOLOGIES |
SRIDEVI SHESHADRI |
| K072755 |
11/16/2007 |
GALEMED CPAP MASK |
GALEMED CORP. |
PAUL DRYDEN |
| K070643 |
11/02/2007 |
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35 |
GAMBRO, INC. |
THOMAS B DOWELL |
| K072986 |
11/20/2007 |
INTEGRADWEB PACS SYSTEM |
GE HEALTHCARE |
JILLIAN M REED |
| K073203 |
11/29/2007 |
CARESCAPE V100 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
KAREN RUSSELL |
| K072502 |
11/19/2007 |
MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
PATRICIA TAIGE |
| K072998 |
11/01/2007 |
IDEAL SOFTWARE OPTION FOR GE MR SCANNERS |
GE MEDICAL SYSTEMS, LLC |
MARK M STAUFFER |
| K072952 |
11/16/2007 |
GE ECHOPAC |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K071388 |
11/06/2007 |
GENTIAN CYSTATIN C IMMUNOASSAY |
GENTIAN AS |
RONALD G LEONARDI |
| K073182 |
11/28/2007 |
GYN DISPOSABLES TENACULUM 356T |
GYN-DISPOSABLES, INC. |
JAMES K PATTERSON |
| K070513 |
11/26/2007 |
HAMILTON-G5 |
HAMILTON MEDICAL AG |
JOERG SCHNEIDER |
| K071875 |
11/05/2007 |
V-CATH POLY PICC |
HDC CORP. |
EARL SMART |
| K072593 |
11/15/2007 |
A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE |
HEALTHSTATS INTERNATIONAL PTE. LTD. |
STEPHEN GORSKI |
| K072778 |
11/19/2007 |
BRIO ACUPUNCTURE NEEDLES |
HELIO MEDICAL SUPPLIES, INC. |
YUKUO HSU |
| K063852 |
11/09/2007 |
ACCESSA CHOLESTEROL PANEL |
HOME ACCESS HEALTH CORP. |
KAREN L HANSON |
| K072115 |
11/30/2007 |
ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H |
HORIBA ABX |
OLIVIER DUCAMP |
| K072446 |
11/29/2007 |
MOBIL-O-GRAPH NG 24 H ABP-CONTROL |
I.E.M. GMBH |
GUENTER GINSBERG |
| K072867 |
11/21/2007 |
IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K |
IMIX ADR FINLAND OY |
JAMES TAYLOR |
| K072101 |
11/19/2007 |
RIGI-FIX HIP STEM SYSTEM |
IMPLANTS INTL. LTD. |
MOHAN EMMANUEL |
| K072822 |
11/26/2007 |
FUNHALER, MODEL V-201E |
INFAMED LTD. |
JOHN GREENBAUM |
| K073060 |
11/29/2007 |
CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
INNOVA VISION INC. |
JENNIFER REICH |
| K071921 |
11/16/2007 |
INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS) |
INNOVASIS, INC. |
WARREN DANSIE |
| K072650 |
11/28/2007 |
IST ANTERIOR CERVICAL PLATE SYSTEM |
INNOVATIVE SPINAL TECHNOLOGIES INC |
GINA YEH |
| K073134 |
11/16/2007 |
A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I |
INVACARE CORPORATION |
CARROLL MARTIN |
| K071265 |
11/30/2007 |
SMARTCHECK INR SYSTEM |
INVERNESS MEDICAL INNOVATIONS, INC. |
LESLEY MOORE |
| K072874 |
11/16/2007 |
LBS-127-16 BREAST ARRAY COIL |
INVIVO |
JEFF WILKINSON |
| K072873 |
11/16/2007 |
LBS-63-16 BREAST ARRAY COIL |
INVIVO |
JEFF WILKINSON |
| K072325 |
11/30/2007 |
BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205 |
JAWON MEDICAL CO., LTD. |
Won-Hee Park |
| K072216 |
11/09/2007 |
KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 |
KAPP SURGICAL INSTRUMENT, INC. |
ALBERT N SANTILLI |
| K071955 |
11/01/2007 |
WIM-PC, MODEL 1010 |
KARMEL SONIX |
YORAM LEVY |
| K072250 |
11/09/2007 |
SUPERCABLE GRIP AND PLATE SYSTEM |
KINAMED, INC. |
VINEET K SARIN |
| K070270 |
11/05/2007 |
PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 |
KIRCHNER & WILHELM GMBH + CO.KG |
NATALYA VALERIO |
| K072795 |
11/27/2007 |
MODELS EMS 5.0, EMS 5.1 |
KOALATY PRODUCTS, INC. |
JEFF LENOIR |
| K070550 |
11/06/2007 |
AUSCO ES-3100 |
KORATEK COMPANY, LTD. |
PAUL SUMNER |
| K072135 |
11/07/2007 |
KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT |
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. |
HEATHER VIELE |
| K072580 |
11/05/2007 |
JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23 |
LANG DENTAL MFG. CO., INC. |
CHAH SHEN |
| K062931 |
11/28/2007 |
IMPLUS IMPLANT SYSTEM |
LEADER ITALIA S.R.L. |
HENRY J VOGELSTEIN |
| K073104 |
11/16/2007 |
SKINTACT AND VARIOUS OTHER TRADENAMES |
LEONHARD LANG GMBH |
ELAINE DUNCAN |
| K072241 |
11/09/2007 |
PRIMACONNEX CAD/CAM ABUTMENT SYSTEM |
LIFECORE BIOMEDICAL, INC. |
JUDITH MEDLOCK-HAYES |
| K073032 |
11/16/2007 |
PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS |
LIFECORE BIOMEDICAL, INC. |
JUDITH MEDLOCK-HAYES |
| K072681 |
11/02/2007 |
BLOODSTOP HEMOSTATIC GAUZE; IX HEMOSTATIC GAUZE |
LIFESCIENCE PLUS, INC. |
AUDRY VITALE |
| K072048 |
11/16/2007 |
LUMACARE MODEL LC-122M NON-COHERENT LIGHT SOURCE AND MODEL LUM-P FIBRE OPTIC PROBE |
LYNTON LASERS LIMITED |
ANDREW JOHN BERRY |
| K071802 |
11/09/2007 |
TESLA GUARD, MODEL EFT G04 |
MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN GMBH |
ROBERT N CLARK |
| K072509 |
11/26/2007 |
PRO-PICC, BASIC TRAY; LONG WIRE TRAY; BASIC NURSING TRAY; FULL NURSING TRAY |
MEDCOMP |
JEAN CALLOW |
| K071610 |
11/05/2007 |
MEDIAID PULSE OXIMETER M30 AND M34 |
MEDIAID INC. |
JAYESH PATEL |
| K072053 |
11/06/2007 |
SMARTBLOCK PAIN PUMP |
MEDICAL FLOW SYSTEMS LTD |
MARK DOLLINGER |
| K070669 |
11/01/2007 |
IOL INJECTOR SET |
MEDICEL AG |
GEORGE MYERS |
| K073323 |
11/29/2007 |
SA-3000P |
MEDICORE CO., LTD. |
YOO BYUNG-KUK |
| K072972 |
11/06/2007 |
MEDSTREAMING MEDICAL OFFICE SOFTWARE |
MEDSTREAMING, LLC |
KARLA PATTEN |
| K071655 |
11/21/2007 |
REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538 |
MEDTRONIC INC. |
MICHELLE NIVALA |
| K071641 |
11/21/2007 |
REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539) |
MEDTRONIC INC. |
MICHELLE NIVALA |
| K071813 |
11/09/2007 |
MASTERGRAFT PUTTY |
MEDTRONIC SOFAMOR DANEK |
CHRISTINE SCIFERT |
| K071416 |
11/01/2007 |
PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CHRISTINE SCIFERT |
| K062264 |
11/08/2007 |
COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM |
MEDTRONIC VASCULAR |
JENNIFER HACKNEY |
| K072372 |
11/21/2007 |
PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE |
MEGO AFEK |
AHAVA STEIN |
| K073140 |
11/21/2007 |
VITALOGIK MODEL 4000/4500 |
MENNEN MEDICAL LTD. |
IFAT OREN |
| K071657 |
11/15/2007 |
TRU FLU |
MERIDIAN BIOSCIENCE, INC. |
SUSAN ROLIH |
| K072556 |
11/20/2007 |
HEMOSTASIS VALVE |
MERIT MEDICAL SYSTEMS, INC. |
SHIRLEY HYINK |
| K073035 |
11/20/2007 |
PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS |
MERIT MEDICAL SYSTEMS, INC. |
SHIRLEY HYINK |
| K063733 |
11/14/2007 |
RESOLVE BILIARY DRAINAGE CATHETER |
MERIT MEDICAL SYSTEMS, INC. |
AMY MCKINNEY |
| K072740 |
11/19/2007 |
MONDEAL EXTREMITY BONE FIXATION SYSTEM |
MONDEAL MEDICAL SYSTEMS GMBH |
JAY EVANS |
| K071579 |
11/20/2007 |
PEF TUBE |
N.M. BEALE CO. INC. |
PAMELA PAPINEAU |
| K073236 |
11/30/2007 |
NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE |
NEOCOIL |
BRIAN BROWN |
| K073181 |
11/21/2007 |
NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL |
NEOCOIL, LLC |
BRIAN BROWN |
| K072984 |
11/14/2007 |
SATURN 9000-550 |
NEW MEDICAL CO., LTD. |
YOUNG-HOON SHIN |
| K072983 |
11/13/2007 |
SATURN 9000-750 |
NEW MEDICAL CO., LTD. |
YOUNG-HOON SHIN |
| K072710 |
11/08/2007 |
NEXFIX COMPRESSION PIN |
NEXA ORTHOPEDICS, INC. |
COREY WILSON-WIRTH |
| K072843 |
11/29/2007 |
YG-125T AND YG-135T NASAL ADAPTER |
NIHON KOHDEN AMERICA, INC. |
JACK COGGAN |
| K071815 |
11/28/2007 |
NOVEON, MODEL LS1100-01-0968 |
NOMIR MEDICAL TECHNOLOGIES, INC. |
RICHARD BURTT |
| K073099 |
11/20/2007 |
FMRI HARDWARE SYSTEM |
NORDICNEUROLAB |
CONSTANCE G BUNDY |
| K071588 |
11/26/2007 |
DISPENSER DP 20 |
NOUVAG AG |
ERICH FORSTER |
| K071619 |
11/09/2007 |
SPY FLUORESCENT IMAGING SYSTEM |
NOVADAQ TECHNOLOGIES, INC. |
ALLISON MANNERS |
| K072643 |
11/16/2007 |
CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US |
OLYMPUS CORPORATION |
FUMIAKI KANAI |
| K073100 |
11/30/2007 |
INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S |
Oscor Inc. |
MILA DOSKOCIL |
| K072896 |
11/06/2007 |
GS FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
KIM M JOO |
| K072033 |
11/13/2007 |
OTODYNAMICS OTOPORT |
OTODYNAMICS, LTD. |
CHRISTINA NORRIS |
| K071768 |
11/05/2007 |
ERBIUM FRACTIONAL HANDPIECE |
PALOMAR MEDICAL PRODUCTS, INC. |
Sharon Timberlake |
| K072982 |
11/29/2007 |
PARI HYDRATE V |
PARI INNOVATIVE MANUFACTURERS, INC. |
MIKE JUDGE |
| K072480 |
11/21/2007 |
GENERATION 8 SE ADHESIVE |
PENTRON CLINICAL TECHNOLOGIES |
GREG MARCEAU |
| K072391 |
11/19/2007 |
PFM PICC |
PFM MEDICAL, INC |
SALVADORE PALOMARES |
| K072661 |
11/20/2007 |
IMMUNOCAP THYRLOBULIN IMMUNOCAP |
PHADIA US INC. |
MARTIN R MANN |
| K072769 |
11/14/2007 |
ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS |
POSSIS MEDICAL, INC. |
MIKE BURNSIDE |
| K062658 |
11/26/2007 |
PRIMUS A1CARE ASSAY |
PRIMUS CORP. |
BRITT EINSPAHR |
| K062575 |
11/26/2007 |
MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP |
PRINCETON BIOMEDITECH CORP. |
KYUNG-AH KIM |
| K072846 |
11/26/2007 |
CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 |
R & D SYSTEMS, INC. |
NANCY C RING |
| K072268 |
11/20/2007 |
HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S |
R & D SYSTEMS, INC. |
NANCY C RING |
| K072780 |
11/26/2007 |
MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR |
RALCO S.R.L. |
DANIEL KAMM |
| K072479 |
11/09/2007 |
FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD |
RAPID INJECTION SYSTEMS CORP. |
SOL SOROCA |
| K071051 |
11/02/2007 |
FRAXEL III SR LASER SYSTEM AND ACCESSORIES |
RELIANT TECHNOLOGIES, INC. |
HEATHER MACFALLS |
| K072827 |
11/26/2007 |
RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE |
REMEL, INC. |
Andre Hsiung |
| K072194 |
11/29/2007 |
RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 |
RENU MEDICAL, INC. |
BRUCE PIERSON |
| K072398 |
11/21/2007 |
RT300-S AND RT300-SP FES CYCLE ERGOMETER |
RESTORATIVE THERAPIES INC. |
ANDREW BARRISKILL |
| K072554 |
11/14/2007 |
ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES |
SABLE INDUSTRIES, INC. |
KEVIN RANDALL |
| K072030 |
11/19/2007 |
IMPLANT CENTER |
SATELEC-ACTEON GROUP |
STEVE SALESKY |
| K072463 |
11/29/2007 |
SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM |
SATYRNE MEDICAL |
SCOTT LOVALD |
| K072134 |
11/02/2007 |
SCHICK COMPUTED ORAL RADIOLOGY SYSTEM |
SCHICK TECHNOLOGIES, INC. |
DANIEL MITCHELL |
| K072639 |
11/19/2007 |
YUYUAN LATEX EXAMINATION GLOVE, POWDERED |
SHANDONG YUYUAN LATEX GLOVES COMPANY LTD. |
JESSIE SUN |
| K072346 |
11/29/2007 |
PM-7000 PATIENT MONITOR |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K072794 |
11/05/2007 |
IMMULITE 2500 OM-MA, MODEL L5KOP |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
MAYA MAHUE-GIANGRECO |
| K070799 |
11/01/2007 |
MODULARIS VARIOSTAR |
SIEMENS MEDICAL SOLUTIONS USA INC. |
KIM RENDON |
| K072786 |
11/13/2007 |
ACUSON S2000 ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
| K071228 |
11/21/2007 |
FIDELITY 200 CARDIAC EVENT RECORDER |
SIGNALIFE, INC. |
WILLIAM MATTHEWS |
| K072818 |
11/19/2007 |
PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K062607 |
11/09/2007 |
POLYGRAFT BGS |
SMITH & NEPHEW, INC. |
DEANA BOUSHELL |
| K072858 |
11/20/2007 |
TC-PLUS PRIMARY KNEE SYSTEM |
SMITH & NEPHEW, INC. |
RISHI SINHA |
| K072419 |
11/09/2007 |
ADVANTIV SAFETY I.V. CATHETER |
SMITHS MEDICAL ASD, INC. |
BARBARA LAW |
| K072482 |
11/29/2007 |
HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY |
SMITHS MEDICAL ASD, INC. |
BRIAN FARIAS |
| K072783 |
11/30/2007 |
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 |
| K071958 |
11/21/2007 |
THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS |
SMITHS MEDICAL ASD, INC. |
CHRISTINE LLOYD |
| K072059 |
11/01/2007 |
GRIPPER MICRO NEEDLE |
SMITHS MEDICAL MD, INC. |
BRIAN L HAUGSTAD |
| K072912 |
11/16/2007 |
SOPRO 225 DUAL HALOGEN LIGHT SOURCE |
SOPRO |
STEVE SALESKY |
| K071161 |
11/16/2007 |
ENDOSSEOUS DENTAL IMPLANT SYSTEM |
SOUTHERN IMPLANTS, INC. |
GRETA M HOLS |
| K071724 |
11/09/2007 |
LUCENT |
SPINAL ELEMENTS, INC. |
KERRI DIMARTINO |
| K071151 |
11/07/2007 |
TENSION BAND ANTERIOR SPINAL SYSTEM |
SPINAL INSTRUMENTATION SIMPLIFICATION SYSTEMS LLC |
KAREN E WARDEN |
| K072289 |
11/01/2007 |
SPINEFRONTIER DORADO VBR |
SPINEFRONTIER, INC. |
TOM CARLSON |
| K072371 |
11/14/2007 |
ODYSSEY WORKSTATION |
STEREOTAXIS, INC. |
DENNIS POZZO |
| K071895 |
11/14/2007 |
VERIFY 275 DEGREE F. 3-10 INDICATOR; 10 INDICATOR; 3 INDICATOR |
STERIS Corporation |
JOHN SCOVILLE |
| K073017 |
11/30/2007 |
STRYKER STRI-SHIELD FLYTE TOGAS |
STRYKER INSTRUMENTS, INSTRUMENTS DIV. |
PAULETTE D JOHNSON |
| K070935 |
11/09/2007 |
T.B.R. ZIRCONNECT |
SUDIMPLANT SA |
DIDIER SAILHAN |
| K072921 |
11/26/2007 |
DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM |
SYMBIOS MEDICAL PRODUCTS, LLC |
JEFFREY ALHOLM |
| K072578 |
11/28/2007 |
SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM |
SYNTHES (USA) |
SHERI MUSGNUNG |
| K071667 |
11/30/2007 |
SYNTHES VECTRA-ONE SYSTEM |
SYNTHES SPINE |
STACEY BONNELL |
| K071967 |
11/20/2007 |
SYSMEX XE-5000 |
SYSMEX AMERICA, INC. |
NINA M GAMPERLING |
| K071711 |
11/07/2007 |
ASCA-CHEK |
TECHLAB INC., CORPORATE RESEARCH CENTER |
CHARLES PENNINGTON |
| K072520 |
11/29/2007 |
TEPHAFLEX SURGICAL FILM |
TEPHA, INC. |
MARY LEGRAW |
| K071521 |
11/21/2007 |
TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
MARK A BUR |
| K072894 |
11/06/2007 |
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) |
TERUMO EUROPE N.V. |
M.J. AERTS |
| K071576 |
11/02/2007 |
TEXTRONICS ECG ELECTRODE |
TEXTRONICS, INC |
JANICE HOGAN |
| K070900 |
11/30/2007 |
FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K071692 |
11/05/2007 |
THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS |
THERATEST LABORATORIES, INC. |
MARIUS TEODORESCU |
| K071918 |
11/09/2007 |
CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002 |
THERMOGEAR, INC. |
WAYNE FIELDS |
| K073025 |
11/09/2007 |
VASCUTRAK II PTA DILATATION CATHETER |
THERMOPEUTIX INC. DBA YMED INC. |
THOMAS SCHROEDER |
| K072933 |
11/15/2007 |
SPI CONTACT PLATFORM O 4.0 MM |
THOMMEN MEDICAL, AG |
FLOYD G LARSON |
| K072693 |
11/01/2007 |
CSNP-001A NEURO PACKAGE |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K073165 |
11/16/2007 |
DRAD-3000E, RADREX-I |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K073081 |
11/21/2007 |
JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K072922 |
11/28/2007 |
3S HEMI TOE |
TRILLIANT SURGICAL LTD |
JD WEBB |
| K071371 |
11/19/2007 |
COPA AMD ANTIMICROBIAL WOUND DRESSING |
TYCO HEALTHCARE GROUP, LP |
JAMES WALSH |
| K072747 |
11/15/2007 |
UNIDUS MAGNUM MALE LATEX CONDOM |
UNIDUS CORP. |
CLAUDE L WRIGHT |
| K072646 |
11/07/2007 |
UNICAPRONE |
UNITED MEDICAL INDUSTRIES CO. LTD. |
R RAGHUNATHAN |
| K072644 |
11/07/2007 |
UNICRYL QUICK |
UNITED MEDICAL INDUSTRIES CO. LTD. |
R. RAGHUNATHAN |
| K072645 |
11/07/2007 |
UNIGLACTIN |
UNITED MEDICAL INDUSTRIES CO. LTD. |
R RAGHUNATHAN |
| K073053 |
11/15/2007 |
COLPO-MASTER |
UNITED PRODUCTS & INSTRUMENTS, INC. |
GEORGE MYERS |
| K071406 |
11/21/2007 |
AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
JENNIFER BRENNAN |
| K072156 |
11/09/2007 |
OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER |
USCI IRELAND |
MAUREEN O'CONNELL |
| K073133 |
11/16/2007 |
INTERSTITIAL NEEDLES |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K071760 |
11/09/2007 |
MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K072916 |
11/09/2007 |
TRILOGY SYSTEM WITH RAPIDARC |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K072618 |
11/21/2007 |
TWIN-PASS OTW CATHETER, MODEL 5201 |
VASCULAR SOLUTIONS, INC. |
ALYSSA MALINSKI |
| K071729 |
11/20/2007 |
CELLSEARCH CIRCULATING TUMOR CELL KIT |
VERIDEX, LLC |
DEBRA J RASMUSSEN |
| K073056 |
11/13/2007 |
DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9 |
VIEWORKS CO., LTD. |
KIM RAZA |
| K071127 |
11/16/2007 |
FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM |
VISION-SCIENCES, INC. |
PAMELA PAPINEAU |
| K072014 |
11/08/2007 |
VITASCORE |
VITASCORE B.V. |
WIM MARTENS |
| K070705 |
11/30/2007 |
MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 |
VYGON CORP. |
COURTNEY SMITH |
| K072449 |
11/29/2007 |
CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS |
WELCH ALLYN, INC. |
JOHN SAWYER |
| K073108 |
11/21/2007 |
ZENO ZR DISC |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K072092 |
11/15/2007 |
XPOD/XMAP NERVE STIMULATOR |
XAVANT TECHNOLOGY (PTY), LTD. |
ROCHE VAN RENSBURG |
| K071535 |
11/19/2007 |
BIOLOX DELTA CERAMIC FEMORAL HEAD |
ZIMMER, INC. |
PATRICIA JENKS |
| K072619 |
11/21/2007 |
NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS |
ZIMMER, INC. |
DANIEL J WILLIMAN |
| K072430 |
11/06/2007 |
ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE |
ZOLL MEDICAL CORPORATION |
SEAN REYNOLDS |
