| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K062027 |
01/19/2007 |
A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR |
A & D ENGINEERING, INC. |
JERRY WANG |
| 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 |
| K063782 |
01/19/2007 |
ACCIN UNI-KNEE SYSTEM |
ACCIN CORPORATION |
MICHAEL KVITNITSKY |
| 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 |
| K062009 |
01/17/2007 |
AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T |
AESCULAP, INC. |
MATTHEW M HULL |
| K072313 |
11/02/2007 |
AMPLATZER TORQVUE DELIVERY SYSTEM |
AGA MEDICAL CORP. |
PATRICIA A LAFORTE |
| K063409 |
01/12/2007 |
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 |
AGAMATRIX |
CONNIE HERTEL |
| K063285 |
01/12/2007 |
RELIANCE CI PROCESS INDICATOR |
ALBERT BROWNE LTD. |
CYNTHIA J.M. NOLTE |
| 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 |
| K063829 |
01/22/2007 |
THERMOGARD THERMAL REGULATION SYSTEM |
ALSIUS CORP. |
KENNETH A COLLINS |
| K062511 |
01/31/2007 |
AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX |
ALVEOLUS, INC. |
DONALD CANAL |
| K072022 |
11/19/2007 |
VALEO PEDICLE SCREW SPINAL SYSTEM |
AMEDICA CORP. |
JUSTIN EGGLETON |
| K062907 |
01/09/2007 |
ALEXIS WOUND RETRACTOR |
APPLIED MEDICAL RESOURCES |
CHERYL BLAKE |
| K062544 |
01/03/2007 |
AR1000 ULTRASONIC WOUND THERAPY SYSTEM |
AROBELLA MEDICAL, LLC |
Allison Scott |
| K063058 |
01/03/2007 |
ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS |
ARTHREX, INC. |
NANCY HOFT |
| 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 |
| K063370 |
01/12/2007 |
CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY |
ARTHROSURFACE, INC. |
DAWN J WILSON |
| K071413 |
11/09/2007 |
HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM |
ARTHROSURFACE, INC. |
DAWN J WILSON |
| K063819 |
01/26/2007 |
ASAHI PTCA GUIDE WIRE, FIELDER FC |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K062497 |
01/31/2007 |
REPROCESSED TROCARS |
ASCENT HEALTHCARE SOLUTIONS |
ELIZABETH RENKIN |
| 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 |
| K063630 |
01/26/2007 |
ATRICURE ABLATION SYSTEM |
ATRICURE, INC. |
ELSA C ABRUZZO |
| K062996 |
01/12/2007 |
DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES |
AXON SYSTEMS, INC. |
HOWARD BAILIN |
| K063470 |
01/05/2007 |
AYCAN WORKSTATION OSIRIX |
AYCAN DIGITALSYSTEME GMBH |
CARL ALLETTO |
| K072247 |
11/08/2007 |
STERICAN HYPODERMIC NEEDLES |
B. BRAUN MEDICAL, INC. |
CHRISTINE FORD |
| K063217 |
01/12/2007 |
VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL) |
B. BRAUN MEDICAL, INC. |
PAUL O'CONNELL |
| K062363 |
01/17/2007 |
BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM |
B&W TEK, INC. |
SEAN WANG |
| K063245 |
11/28/2007 |
ELUTIA COATED CLOSED SURGICAL WOUND DRAIN |
BACTERIN INTERNATIONAL INC. |
JOSEPH M AZARY |
| DEN060006 |
01/30/2007 |
COMPUTERIZED LABOR MONITORING SYSTEM |
BARNEV, LTD. |
ARAVA HACOHEN |
| K072576 |
11/06/2007 |
CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED |
BAXTER HEALTHCARE CORP. |
NANETTE HEDDEN |
| K052973 |
01/25/2007 |
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K |
BAXTER HEALTHCARE CORP. |
JOHN MANARIK |
| K062937 |
01/08/2007 |
TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU |
BAYLIS MEDICAL CO., INC. |
MEGHAL KHAKHAR |
| K063573 |
01/11/2007 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTAZIDIME (GN) 0.5-64 UG/ML |
BECTON DICKINSON & CO. |
VICKI KENNEDY WHITLEY |
| K070691 |
11/20/2007 |
BBL CHROMAGAR 0157 |
BECTON, DICKINSON & CO. |
DENNIS R MERTZ |
| K063300 |
01/29/2007 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFPODOXIME (GN) 0.125-8UG/ML |
BECTON, DICKINSON & CO. |
VICKI K WHITLEY |
| K063196 |
01/23/2007 |
LANDLEX, MODEL S403X |
BESTEAM TECHNOLOGY INC. |
JUNNATA CHANG |
| 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 |
| K063666 |
01/25/2007 |
SHARPS CONTAINER, MODEL 039-413 |
BIODEX MEDICAL SYSTEMS, INC. |
CLYDE SCHLEIN |
| K060818 |
01/23/2007 |
ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01 |
BIOKIT S.A. |
JOAN GUIXER |
| K061898 |
01/26/2007 |
EZLASE |
BIOLASE TECHNOLOGY, INC. |
IOANA M RIZOIU |
| K072082 |
11/05/2007 |
GUMEASE DENTAL MOUTHPIECE |
BIOMEDEVICE LTD. |
BRICE L YODER |
| K073146 |
11/21/2007 |
PADNET+ |
BIOMEDIX, INC. |
WILLIAM ROGERS |
| K063597 |
01/19/2007 |
VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K063623 |
01/11/2007 |
VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| 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 |
| K062998 |
01/19/2007 |
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG) |
BIOMET MANUFACTURING CORP. |
JING XIE |
| K063732 |
01/18/2007 |
MICROPLASTY TIBIAL TRAYS |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
| 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 |
| K062530 |
01/29/2007 |
TRIAGE PROTEIN C TEST |
BIOSITE INCORPORATED |
FIL V BUENVIAJE |
| K062318 |
01/03/2007 |
BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML |
BIOTOP TECHNOLOGY CO., LTD. |
LYDIA LEE |
| K061602 |
01/23/2007 |
DUET SYSTEM |
BIOVIEW LTD. |
DORIT WINITZ |
| K063780 |
01/19/2007 |
ACE BOND SE |
BISCO, INC. |
BENJAMIN LICHTENWALNER |
| 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 |
| K062289 |
01/03/2007 |
BONART ART-L3 LED CURING LIGHT |
BONART CO. LTD. |
ERIC L ONG |
| K071957 |
11/08/2007 |
PINNACLE PELVIC FLOOR REPAIR KITS |
BOSTON SCIENTIFIC CORP. |
MICHELLE BERRY |
| K062358 |
01/17/2007 |
MODIFICATION TO VECTORVISION TRAUMA |
BRAINLAB, AG |
RAINER BIRKENBACH |
| K063476 |
01/22/2007 |
BREAS ISLEEP 20I |
BREAS MEDICAL AB |
KARL-JOHAN HOLM |
| K063018 |
01/22/2007 |
GLASS LOSS OF RESISTANCE SYRINGE |
BUSSE HOSPITAL DISPOSABLES, INC. |
MUHAMAD ANSARI |
| K071365 |
11/06/2007 |
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE |
C.R. BARD, INC. |
MICHELLE R GUDITH |
| K063377 |
01/25/2007 |
POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER |
C.R. BARD, INC. |
MICHAELA RIVKOWICH |
| 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 |
| K063632 |
01/05/2007 |
X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER |
C.R. BARD, INC. |
TERRI MORRIS |
| K063717 |
01/23/2007 |
CF-1 |
CANON, INC. |
SHEILA DRISCOLL |
| K063644 |
01/11/2007 |
CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM |
CARDICA, INC. |
TIFFINI LALUDE |
| 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 |
| K063378 |
01/26/2007 |
CIRRUS HD-OCT, MODEL 4000 |
CARL ZEISS MEDITEC INC |
JUDITH A BRIMACOMBE |
| K072260 |
11/27/2007 |
NUFACE, MODEL NU-4003 |
Carol Cole Company |
HOWARD ASHER |
| K062503 |
01/19/2007 |
CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT |
CATACHEM, INC. |
LUIS P LEON |
| 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 |
| K070093 |
01/24/2007 |
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE |
CEREMED INC. |
TADEUSZ WELLISZ M.D. |
| 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 |
| K063774 |
01/24/2007 |
MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6 |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
| K062046 |
01/19/2007 |
MODIFIED MERCI RETRIEVER, MODEL 90050 |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
| 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 |
| K062082 |
01/25/2007 |
CONMED ABC DISSECTING BLADE ELECTRODE, MODEL 139330; BLUNT NEEDLE ELECTRODE, MODEL 139331 |
CONMED CORPORATION |
SHAWN RIEDEL |
| K063326 |
01/31/2007 |
CONMED LINVATEC 24K IRRIGATION SYSTEM |
CONMED LINVATEC |
SUE F DAUTERMAN |
| 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 |
| K061430 |
01/12/2007 |
SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR |
CUSTOM ULTRASONICS |
LAWRENCE F MUSCARELLA |
| K072868 |
11/05/2007 |
ACCOLADE II LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K070063 |
01/30/2007 |
YAG MIR II LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K063235 |
01/24/2007 |
CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT |
CYTORI THERAPEUTICS, INC. |
KENNETH K KLEINHENZ |
| K063621 |
01/17/2007 |
3 SERIES PHOTOTHERAPY CABINET |
DAAVLIN CO. |
TARA MANSUR |
| K063610 |
01/11/2007 |
DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
| K063272 |
01/26/2007 |
DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
| K063351 |
01/22/2007 |
DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH |
DADE BEHRING, INC. |
KATHLEEN A DRAY-LYONS |
| K063508 |
01/23/2007 |
DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN |
DADE BEHRING, INC. |
HELEN M LEE |
| K063322 |
01/24/2007 |
DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
| K071224 |
11/13/2007 |
DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR |
DADE BEHRING, INC. |
LORRAINE H PIESTRAK |
| K063525 |
01/05/2007 |
DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM |
DATASCOPE CORP. |
NANCY COHEN |
| K062099 |
01/25/2007 |
PHASE 3, MODEL DT-1 |
DATREND SYSTEMS, INC. |
RON EVANS |
| K062397 |
01/25/2007 |
SENTINEL |
DEL MAR REYNOLDS MEDICAL, LTD. |
GEORGE MYERS |
| K072807 |
11/21/2007 |
I LIGHT |
DENT'N CO |
ALAN DONALD |
| K063483 |
01/23/2007 |
DEN TEK NIGHTGUARD |
DENTEK ORAL CARE, INC. |
Jeffrey Shapiro |
| 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 |
| K070019 |
01/26/2007 |
CARRARA VOLUMIA |
DENTSPLY INTL. |
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 |
| K063509 |
01/04/2007 |
DEPUY PEAK FX HIP PLATE |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
| 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 |
| K063741 |
01/17/2007 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER KLACZYK |
| 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 |
| K063208 |
01/19/2007 |
MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 |
DIAGNOSTIC CHEMICALS LTD. |
DEBBIE M MURRAY |
| K070569 |
11/08/2007 |
SM INTERNAL./EXTERNAL IMPLANT SYSTEM |
DIO DEPARTMENT DSI, INC. |
KENNY LIM |
| K063828 |
01/25/2007 |
DIOMED DELTA 25 |
DIOMED, LTD. |
TIM PHIPPS |
| K062176 |
01/10/2007 |
RELIEF ACP ORAL CARE GEL |
DISCUS DENTAL INC. |
STEVEN L ZIEMBA |
| 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 |
| K063846 |
01/26/2007 |
EIGEN DSA 2000 |
EIGEN |
NATALIE J KENNEL |
| K063797 |
01/25/2007 |
GEODESIC EEG SYSTEM 300 |
ELECTRICAL GEODESICS, INCORPORATED |
LINDA J BOVARD |
| K063151 |
01/09/2007 |
HUMAPEN LUXURA HD |
ELI LILLY AND CO. |
LEEANN CHAMBERS |
| K072383 |
11/29/2007 |
HABIB ENDOBLATE |
EMCISION, LTD. |
NAGY HABIB |
| K072946 |
11/16/2007 |
HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM |
EMPI |
SANDRA WALROD |
| K061650 |
01/22/2007 |
SELECT TENS, MODEL 4600S |
EMPI |
CARL BEAURLINE |
| K063406 |
01/08/2007 |
ENCORE KNEE SYSTEM IFU |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K062354 |
01/26/2007 |
VECTRA GENISYS VMS FR |
ENCORE MEDICAL, L.P. |
MICHAEL TREAS |
| 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 |
| K062712 |
01/26/2007 |
ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094 |
ERBE USA, INC. |
JOHN TARTAL |
| K063050 |
11/19/2007 |
CAP PLUS |
ETEX CORP. |
FRANCES A FLORENCE |
| K063192 |
01/30/2007 |
HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP |
ETHICON ENDO-SURGERY, LLC |
ELIZABETH MILLER, MST |
| K062892 |
01/22/2007 |
EUKARE |
EUMED BIOTECHNOLOGY CO., LTD. |
Ke-Min Jen |
| K063785 |
01/19/2007 |
SPIDERFX EMBOLIC PROTECTION DEVICE |
EV3 INC |
David Worrell |
| 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 |
| K060272 |
01/12/2007 |
LOCOBASE WOUND AND SKIN EMULSION |
FERNDALE LABORATORIES, INC. |
RICHARD A HAMER |
| K062868 |
01/19/2007 |
THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02 |
FLOWCARDIA INC |
Dustin Michaels |
| 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 |
| K063290 |
01/30/2007 |
GAMBRO QUICKSET BLOODLINES |
GAMBRO RENAL PRODUCTS |
THOMAS B DOWELL |
| K061782 |
01/04/2007 |
GAMBRO POSICLEAR |
GAMBRO SERVICES, INC. |
JEFFERY R SHIDEMAN |
| 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 |
| K062675 |
01/04/2007 |
GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES |
GEMORE TECHNOLOGY CO., LTD. |
TONY C.S. CHANG |
| K063451 |
01/22/2007 |
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 |
GEN-PROBE, INC. |
E. JOSEPH MCMULLEN |
| K063664 |
01/25/2007 |
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 |
GEN-PROBE, INC. |
E. JOSEPH MCMULLEN |
| K072952 |
11/16/2007 |
GE ECHOPAC |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K063429 |
01/17/2007 |
GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200 |
GENERIC MEDICAL DEVICE, INC. |
MONICA MONTANEZ |
| K063121 |
01/11/2007 |
PORTABLE X-RAY SYSTEM, MODEL PORT-X II |
GENORAY CO., LTD. |
CHARLIE MACK |
| K071388 |
11/06/2007 |
GENTIAN CYSTATIN C IMMUNOASSAY |
GENTIAN AS |
RONALD G LEONARDI |
| K063739 |
01/17/2007 |
SEPRAMESH, MODEL 5959-1214 |
GENZYME CORPORATION |
MATTHEW HIBBERT |
| K063589 |
01/31/2007 |
GSO BONE FIXATION FASTENERS |
GOLD STANDARD ORTHOPAEDICS LLC |
DAVID BAUGHMAN |
| K073182 |
11/28/2007 |
GYN DISPOSABLES TENACULUM 356T |
GYN-DISPOSABLES, INC. |
JAMES K PATTERSON |
| K062604 |
01/31/2007 |
RAPIDTEG TEG-ACT TEST |
HAEMOSCOPE CORP. |
ELI COHEN |
| K070513 |
11/26/2007 |
HAMILTON-G5 |
HAMILTON MEDICAL AG |
JOERG SCHNEIDER |
| K070061 |
01/31/2007 |
36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT |
HAYES MEDICAL, INC. |
LUKE ROSE |
| 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 |
| K063524 |
01/23/2007 |
POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR) |
HL RUBBER INDUSTRIES SDN BHD |
KENNY HOE |
| 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 |
| K063423 |
01/22/2007 |
TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT |
HOWMEDICA OSTEONICS |
SHERYL R BAGALIO |
| K063834 |
01/25/2007 |
REVLITE C6 Q-SWITCHED ND:YAG LASER SYSTEM |
HOYA CONBIO, INC |
DONNA TEMPLEMAN |
| K070196 |
01/26/2007 |
FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT |
HR DENTAL PRODUCTS INC |
JIM RONALDS |
| K063530 |
01/26/2007 |
ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP |
I-FLOW CORP. |
JAMES J DAL PORTO |
| K072446 |
11/29/2007 |
MOBIL-O-GRAPH NG 24 H ABP-CONTROL |
I.E.M. GMBH |
GUENTER GINSBERG |
| K062755 |
01/04/2007 |
IKONISCOPE ONCOFISH BLADDER TEST SYSTEM |
IKONISYS INC |
OSCAR SANCHEZ |
| K070079 |
01/31/2007 |
X3C DIGITAL RADIOGRAPHIC DETECTOR |
IMAGING DYNAMICS COMPANY LTD. |
SHIRANTHAN SAMARAPPULI |
| K063475 |
01/23/2007 |
IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS) |
IMC-HEARTWAY, LLC |
MICHAEL CHEN |
| 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 |
| K063410 |
01/23/2007 |
INION CPS/OTPS FREEDOMPLATE |
INION LTD. |
KATI MARTTINEN |
| 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 |
| K062759 |
01/12/2007 |
PARAMOUNT VBR SYSTEM |
INNOVATIVE SPINAL TECHNOLOGIES INC |
GINA YEH |
| K063747 |
01/12/2007 |
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A |
INOVEL LLC |
WILLIAM WARZYNIAK |
| K063238 |
01/30/2007 |
ULTRACLIP II WING AND ULTRACLIP II COIL |
INRAD |
MELISSA LALOMIA |
| K063773 |
01/31/2007 |
VOLUMETRIC TOMOGRAPHY |
INSTRUMENTARIUM DENTAL INC. |
FRANK KASHINSKI |
| K063679 |
01/12/2007 |
ACL TOP |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K063124 |
01/19/2007 |
INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS |
INTEGRA LIFESCIENCES CORP. |
DIANA M BORDON |
| K070080 |
01/24/2007 |
INTELEPACS |
INTELERAD MEDICAL SYSTEMS INC. |
ANIBAL JODORCOVSKY |
| 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 |
| K063529 |
01/05/2007 |
PENCURE, MODEL VL-7 |
J. MORITA USA, INC. |
ROBERT A SILVERMAN |
| K072325 |
11/30/2007 |
BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205 |
JAWON MEDICAL CO., LTD. |
Won-Hee Park |
| K062439 |
01/08/2007 |
POWERTONE, MODEL PT-11 |
JOHARI DIGITAL HEALTHCARE, LTD. |
NISHA JOHARI |
| K063577 |
01/25/2007 |
FEMORAL INTRAFIX SCREW AND SHEATH |
JOHNSON & JOHNSON COMPANY |
Ruth Forstadt |
| K072216 |
11/09/2007 |
KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 |
KAPP SURGICAL INSTRUMENT, INC. |
ALBERT N SANTILLI |
| K062918 |
01/17/2007 |
KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
SUSIE CHEN |
| K063585 |
01/31/2007 |
KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
SUSIE CHEN |
| K071955 |
11/01/2007 |
WIM-PC, MODEL 1010 |
KARMEL SONIX |
YORAM LEVY |
| K063590 |
01/25/2007 |
V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423 |
KCI USA, INC. |
CHRISTY HUBBARD OVIATT |
| 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 |
| K063654 |
01/31/2007 |
ENDOGUIDE |
KMS MEDICAL LLC |
MARIO ARBESU |
| 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 |
| K062559 |
01/29/2007 |
URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER |
LABORATOIRES URGO |
SOPHIE FORTIN |
| 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 |
| K063396 |
01/17/2007 |
VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES |
LASERING S.R.L. |
ALLEN R HOWES |
| K063794 |
01/24/2007 |
MODIFICATION TO EASYSPINE SYSTEM |
LDR SPINE USA |
FLOYD G LARSON |
| 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 |
| K060305 |
01/18/2007 |
HAIRMAX LASERCOMB |
LEXINGTON INTERNATIONAL, LLC |
EDWARD BASILE |
| K063546 |
01/10/2007 |
INSUFLOW DEVICE, MODEL 6198 |
LEXION MEDICAL, LLC. |
DUANE LLOYD |
| K063601 |
01/25/2007 |
PILOT SPINAL SYSTEM |
LIFE SPINE |
REBECCA M BROOKS |
| K061208 |
01/03/2007 |
LIFECELL DURAL SUBSTITUTE MATRIX |
LIFECELL CORP. |
REY LIBROJO |
| 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 |
| K062535 |
01/26/2007 |
K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING |
MCNEIL-PPC, INC. |
NADER FOTOUHI PH.D. |
| K063472 |
01/31/2007 |
ULTRASONIC BIOMETER/ PACHYMETER FOR OPHTHALMOLOGY, MODEL ODM 2100, 2200 |
MEDA LTD. |
EDWARD A KROLL |
| K063433 |
01/29/2007 |
ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200 |
MEDA LTD. |
EDWARD A KROLL |
| K072509 |
11/26/2007 |
PRO-PICC, BASIC TRAY; LONG WIRE TRAY; BASIC NURSING TRAY; FULL NURSING TRAY |
MEDCOMP |
JEAN CALLOW |
| K063103 |
01/08/2007 |
AG-EDGE, MODEL 91200 |
MEDEL S.P.A. |
TERRENCE O'BRIEN |
| K070129 |
01/31/2007 |
SONOTIP II ULTRASOUND NEEDLE SYSTEM |
MEDI-GLOBE CORPORATION |
SCOTT KARLER |
| K071610 |
11/05/2007 |
MEDIAID PULSE OXIMETER M30 AND M34 |
MEDIAID INC. |
JAYESH PATEL |
| K063249 |
01/17/2007 |
BEAMAX |
MEDIC SHARPLIGHT LTD. |
DAN LAOR |
| K062780 |
01/05/2007 |
CLICKZIP, MODEL U-100 INSULIN SAFETY SYRINGE |
MEDICAL DEVICE MANUFACTURER (THAILAND) LTD. |
OYTIP KUNWUNLOP |
| K072053 |
11/06/2007 |
SMARTBLOCK PAIN PUMP |
MEDICAL FLOW SYSTEMS LTD |
MARK DOLLINGER |
| K063574 |
01/29/2007 |
LUMINEX LL LASER SYSTEM |
MEDICAL LASER SYSTEMS INC |
MIKI KOLTON |
| K070669 |
11/01/2007 |
IOL INJECTOR SET |
MEDICEL AG |
GEORGE MYERS |
| K063843 |
01/03/2007 |
APEXNRG XFR |
MEDICNRG LTD. |
GEORGE J HATTUB |
| K073323 |
11/29/2007 |
SA-3000P |
MEDICORE CO., LTD. |
YOO BYUNG-KUK |
| K062181 |
01/16/2007 |
C-JAWS CERVICAL COMPRESSIVE MINI FRAME |
MEDICREA TECHNOLOGIES |
J.D. WEBB |
| K061886 |
01/25/2007 |
ACTIM PROM AND CONTROLS |
MEDIX BIOCHEMICA |
CYNTHIA SINCLAIR |
| K072972 |
11/06/2007 |
MEDSTREAMING MEDICAL OFFICE SOFTWARE |
MEDSTREAMING, LLC |
KARLA PATTEN |
| K062968 |
01/03/2007 |
LAPMAN LAPAROSCOPE MANIPULATOR AND ACCESSORIES, MODEL 900-200 SERIES |
MEDSYS, S.A. |
JEFF MORGAN |
| K063510 |
01/26/2007 |
LIFEPAK 12 DEFIBRILLATOR/MONITOR |
MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. |
MICHELLE ACKERMANN |
| 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 |
| K063417 |
01/18/2007 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
LEE GRANT |
| K060415 |
01/05/2007 |
MODIFICATION TO: SATELLITE SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| 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 |
| K063487 |
01/22/2007 |
MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE |
MERETE MEDICAL GMBH |
DONNA COLEMAN |
| 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 |
| K063148 |
01/17/2007 |
SOCK IT! ORAL PAIN GEL |
MERLIN GROUP DBA MCMERLIN DENTAL COMPANY |
EILEEN VENNUM |
| K063170 |
01/12/2007 |
TENDER FIBER |
MICERIUM S.P.A. |
EUGENIO MICELI |
| K062899 |
01/25/2007 |
MICROTEK MEDICAL SURGICAL GOWN/TOGA |
MICROTEK MEDICAL, INC. |
THOMAS BONNER |
| K063653 |
01/17/2007 |
MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
| K063338 |
01/04/2007 |
HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER |
MIMOSA ACOUSTICS, INC. |
PATRICIA S JENG |
| K061554 |
01/25/2007 |
MEPILEX AG ABSORBENT SILICONE-COATED DRESSING |
MOLNLYCKE HEALTH CARE |
STEVEN DOWDLEY |
| K072740 |
11/19/2007 |
MONDEAL EXTREMITY BONE FIXATION SYSTEM |
MONDEAL MEDICAL SYSTEMS GMBH |
JAY EVANS |
| K063586 |
01/25/2007 |
MOORFLPI FULL-FIELD LASER PERFUSION IMAGER |
MOOR INSTRUMENTS LTD. |
XIABING HUANG |
| K063561 |
01/19/2007 |
MOORLDLS LASER DOPPLER LINE SCANNER |
MOOR INSTRUMENTS LTD. |
XIABING HUANG |
| K063439 |
01/22/2007 |
MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS |
MTD, INC. |
CHRISTINE NICHOLS |
| K071579 |
11/20/2007 |
PEF TUBE |
N.M. BEALE CO. INC. |
PAMELA PAPINEAU |
| K063462 |
01/12/2007 |
NEATSTITCH NEATCLOSE SUTURING DEVICE |
NEAT STITCH LTD. |
YOSSI MUNCHER, PH.D. |
| 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 |
| K063721 |
01/12/2007 |
NIPRO SAFETOUCH II GAMMA |
NIPRO MEDICAL CORP. |
JESSICA OSWALD |
| K063718 |
01/05/2007 |
SFB AND CFB IMPLANTS - 5.0 PLATFORM |
NOBEL BIOCARE AB |
HERBERT CRANE |
| K071815 |
11/28/2007 |
NOVEON, MODEL LS1100-01-0968 |
NOMIR MEDICAL TECHNOLOGIES, INC. |
RICHARD BURTT |
| K063539 |
01/17/2007 |
NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1 |
NORDICICEMEDICAL AS |
JAMES W KNOX |
| K073099 |
11/20/2007 |
FMRI HARDWARE SYSTEM |
NORDICNEUROLAB |
CONSTANCE G BUNDY |
| K063691 |
01/31/2007 |
NEUTRON THERAPY SYSTEM |
NORTHERN ILLINOIS UNIV. OUTREACH |
JONATHAN S KAHAN |
| K071588 |
11/26/2007 |
DISPENSER DP 20 |
NOUVAG AG |
ERICH FORSTER |
| K063821 |
01/24/2007 |
NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD, PHD |
| K071619 |
11/09/2007 |
SPY FLUORESCENT IMAGING SYSTEM |
NOVADAQ TECHNOLOGIES, INC. |
ALLISON MANNERS |
| K063345 |
01/12/2007 |
SPY IMAGING SYSTEM |
NOVADAQ TECHNOLOGIES, INC. |
ALLISON MANNERS |
| K062765 |
01/24/2007 |
MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K062590 |
01/18/2007 |
NUVASIVE ACP4 SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K061499 |
01/26/2007 |
OSFERION |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
| K072643 |
11/16/2007 |
CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US |
OLYMPUS CORPORATION |
FUMIAKI KANAI |
| K070071 |
01/25/2007 |
OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER |
OMNIGUIDE, INC. |
DOUGLAS W WOODRUFF |
| K062775 |
01/16/2007 |
EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM |
ORTHO DEVELOPMENT CORP. |
WILLIAM J GRIFFIN |
| K062666 |
01/25/2007 |
VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS |
ORTHO DEVELOPMENT CORP. |
WILLIAM J GRIFFIN |
| K062165 |
01/05/2007 |
VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS |
ORTHO-CLINICAL DIAGNOSTICS |
MARLENE HANNA |
| K063709 |
01/04/2007 |
TS-BONE HIP TOOL |
ORTHOPEDIC SCIENCES, INC |
JAMES K BRANNON |
| K073100 |
11/30/2007 |
INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S |
Oscor Inc. |
MILA DOSKOCIL |
| K070155 |
01/25/2007 |
INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC |
OSSEO SCIENTIFIC, LLC |
MICHAEL FELDMAN |
| K072896 |
11/06/2007 |
GS FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
KIM M JOO |
| K072033 |
11/13/2007 |
OTODYNAMICS OTOPORT |
OTODYNAMICS, LTD. |
CHRISTINA NORRIS |
| K061414 |
01/22/2007 |
EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS), MODELS 120B AND 30;MOBILE OXYGEN STORAGE TANK (MOST), MOD |
PACIFIC CONSOLIDATED INDUSTRIES, LLC |
GARY CLARK |
| K062900 |
01/12/2007 |
PAJUNKS STIMULONG TSUI-METHOD SET |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN QUASS |
| K063528 |
01/17/2007 |
TROCASYS |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN QUASS |
| 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 |
| K063736 |
01/17/2007 |
FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50 |
PDG PRODUCT DESIGN GROUP, INC. |
EDWARD A KROLL |
| K061720 |
01/31/2007 |
COSMELIGHT |
PENNTACK ENTERPRISES INC. |
PABLO PENA |
| K072480 |
11/21/2007 |
GENERATION 8 SE ADHESIVE |
PENTRON CLINICAL TECHNOLOGIES |
GREG MARCEAU |
| K060465 |
01/17/2007 |
PREMIO |
PETERS SURGICAL |
ANNIE LASSERRE |
| K072391 |
11/19/2007 |
PFM PICC |
PFM MEDICAL, INC |
SALVADORE PALOMARES |
| K072661 |
11/20/2007 |
IMMUNOCAP THYRLOBULIN IMMUNOCAP |
PHADIA US INC. |
MARTIN R MANN |
| K063559 |
01/04/2007 |
ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5 |
PHILIPS MEDICAL SYSTEMS |
JOSEPH S ARNAUDO |
| K063375 |
01/11/2007 |
HEARTSTART MRX, MODELS M3535A OR M3536A |
PHILIPS MEDICAL SYSTEMS |
DENISE HALEY |
| K063781 |
01/05/2007 |
PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
LYNN HARMER |
| K070017 |
01/31/2007 |
PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K063278 |
01/12/2007 |
PORTLAND COBALT CHROME FEMORAL HEAD |
PORTLAND ORTHOPAEDICS LIMITED |
ELAINE DUNCAN |
| K072769 |
11/14/2007 |
ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS |
POSSIS MEDICAL, INC. |
MIKE BURNSIDE |
| K063746 |
01/12/2007 |
POWER EXTENDERS MODEL# PEC200, PES200,PES200S |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA WHITMAN |
| K061242 |
01/25/2007 |
DERMATHERAPY, MODEL 22216 |
PRECISION FABRICS GROUP, INC. |
PAMELA J WEAGRAFF |
| 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 |
| K061678 |
01/12/2007 |
PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI-MAP-25 |
PRORHYTHM |
JOHN J TALARICO |
| 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 |
| K063405 |
01/08/2007 |
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM |
RADIANT MEDICAL |
SCOTT A WILSON |
| K063294 |
01/24/2007 |
TOPACS |
RADIOLOGICAL SPECIALISTS, INC. |
FRANK MCMURRAY |
| K063434 |
01/22/2007 |
TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM |
RADIOMETER BASEL AG |
JEAN-PIERRE PALMA |
| 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 |
| K063548 |
01/22/2007 |
COR ANALYZER 1, VERSION 1.4 |
RCADIA MEDICAL IMAGING LTD. |
DAN LAOR |
| K062303 |
01/31/2007 |
FRAXEL II SR LASER SYSTEM |
RELIANT TECHNOLOGIES, INC. |
HEATHER TANNER |
| 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 |
| K063744 |
01/17/2007 |
COBAS INTEGRA C 111 |
ROCHDIAG |
CORINA HARPER |
| K062114 |
01/31/2007 |
CERULOPLASMIN, MODEL 2055953 |
ROCHE DIAGNOSTICS CORP. |
CORINA HARPER |
| K063823 |
01/29/2007 |
COAGUCHEK XS PT CONTROLS |
ROCHE DIAGNOSTICS CORP. |
THERESA AMBROSE BUSH |
| K062925 |
01/29/2007 |
COAGUCHEK XS SYSTEM |
ROCHE DIAGNOSTICS CORP. |
THERESA BUSH |
| K062379 |
01/31/2007 |
COBAS INTEGRA CERULOPLASMIN |
ROCHE DIAGNOSTICS CORP. |
CORINA HARPER |
| K072554 |
11/14/2007 |
ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES |
SABLE INDUSTRIES, INC. |
KEVIN RANDALL |
| K062896 |
01/03/2007 |
V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600 |
SANARUS MEDICAL, INC. |
ALAN MARQUARDT |
| 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 |
| K061571 |
01/31/2007 |
ASTRA 300 |
SDI DIAGNOSTICS, INC. |
COSIMO CARIOLO |
| K062913 |
01/26/2007 |
ASTRAGUARD PULMONARY FUNCTION FILTER |
SDI DIAGNOSTICS, INC. |
COSIMO CARIOLO |
| K062966 |
01/12/2007 |
QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS |
SERADYN INC. |
JACK ROGERS |
| 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 |
| K070044 |
01/29/2007 |
POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION |
SHIJIAZHUANG LIANHE SHUNDA PLASTIC PRODUCTS CO., L |
KATHY LIU |
| K063762 |
01/05/2007 |
SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY |
SIEMENS AG, MEDICAL SOLUTIONS |
KRISTIN FROWEIN |
| 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 |
| K063761 |
01/04/2007 |
ACUSON P10 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
MICHAELA MAHL |
| K072786 |
11/13/2007 |
ACUSON S2000 ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
| K063826 |
01/12/2007 |
SYNGO MI APPLICATIONS 2007A |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
FRANK POKROP |
| K063803 |
01/05/2007 |
ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
MICHAELA MAHL |
| 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 |
| K062849 |
01/19/2007 |
SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM |
SMITH & NEPHEW, INC. |
KATHLEEN BURNS |
| 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 |
| K063450 |
01/25/2007 |
PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110 |
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 |
| K061931 |
01/31/2007 |
SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101 |
SOLARIS MEDICAL TECHNOLOGY, INC. |
THOMAS KROENKE |
| K060708 |
01/24/2007 |
SOMNOSCREEN |
SOMNOMEDICS GMBH & CO. KG |
CHERITA JAMES |
| K072912 |
11/16/2007 |
SOPRO 225 DUAL HALOGEN LIGHT SOURCE |
SOPRO |
STEVE SALESKY |
| K063255 |
01/11/2007 |
D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED |
SORIN GROUP ITALIA S.R.L |
BARRY SALL |
| 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 |
| K063431 |
01/29/2007 |
15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 |
SPIRE BIOMEDICAL INC |
SHEKHAR D NIMKAR |
| K063799 |
01/05/2007 |
STEAMPLUS STEAM INTEGRATOR |
SPS MEDICAL SUPPLY CORP. |
GARY J SOCOLA |
| K063211 |
01/18/2007 |
PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT |
STELKAST COMPANY |
DAVID J STUMPO |
| 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 |
| K063812 |
01/12/2007 |
STRAUMANN PREFGEL |
STRAUMANN USA |
LISA M QUAGLIA |
| K073017 |
11/30/2007 |
STRYKER STRI-SHIELD FLYTE TOGAS |
STRYKER INSTRUMENTS, INSTRUMENTS DIV. |
PAULETTE D JOHNSON |
| K063822 |
01/25/2007 |
MODIFICATION TO HIPSTAR FEMORAL STEM |
STRYKER ORTHOPAEDICS |
TIFFANI ROGERS |
| K062553 |
01/08/2007 |
SIMPLEX P BONE CEMENT |
STRYKER ORTHOPAEDICS |
TIFFANI D ROGERS |
| K070935 |
11/09/2007 |
T.B.R. ZIRCONNECT |
SUDIMPLANT SA |
DIDIER SAILHAN |
| K070035 |
01/23/2007 |
POWDERED VINYL PATIENT EXAMINATION GLOVE |
SUPER SAFE PLASTIC PRODUCTS CO., LTD. |
KATHY LIU |
| K070040 |
01/26/2007 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE |
SUPER SAFE PLASTIC PRODUCTS CO., LTD. |
KATHY LIU |
| K070165 |
01/29/2007 |
ENSEAL PTC TRIO |
SURGRX, INC. |
LINDA OLESON |
| K062528 |
01/26/2007 |
TISSUE SITE MARKING SYSTEM |
SUROS SURGICAL SYSTEMS, INC. |
HEIDI STRUNK |
| K061042 |
01/19/2007 |
LINGLOCK |
SYBRON DENTAL SPECIALTIES |
COLLEEN BOSWELL |
| K072921 |
11/26/2007 |
DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM |
SYMBIOS MEDICAL PRODUCTS, LLC |
JEFFREY ALHOLM |
| K063181 |
01/05/2007 |
SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM |
SYNTHES (USA) |
DEBORAH L JACKSON |
| 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 |
| K062933 |
01/31/2007 |
SYNTHES ORACLE SPACER |
SYNTHES SPINE CO.LP |
BONNIE J SMITH |
| K071967 |
11/20/2007 |
SYSMEX XE-5000 |
SYSMEX AMERICA, INC. |
NINA M GAMPERLING |
| K062800 |
01/12/2007 |
CLEVER CHEK TD-3213/ CLEVER CHEK TD-3215/ DR. T TD-3216/ CLEVER CHEK TD-3217/ CLEVER CHEK TD-3250 BLOOD GLUCOSE PLUS BLO |
TaiDoc Technology Corporation |
PI-SHIOU LI |
| K071711 |
11/07/2007 |
ASCA-CHEK |
TECHLAB INC., CORPORATE RESEARCH CENTER |
CHARLES PENNINGTON |
| K061419 |
01/26/2007 |
TECO MICROALBUMIN 2-1 COMBO STRIPS |
TECO DIAGNOSTICS |
JIAN VAECHES |
| K063438 |
01/17/2007 |
VSPSPN |
TECRES SPA |
CHRISTINE BRAUER |
| 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 |
| K063372 |
01/19/2007 |
RADIFOCUS GLIDEWIRE ADVANTAGE |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| K071576 |
11/02/2007 |
TEXTRONICS ECG ELECTRODE |
TEXTRONICS, INC |
JANICE HOGAN |
| K061297 |
01/26/2007 |
ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM |
THE ANSPACH EFFORT, INC. |
JAMES CARBONE |
| K063688 |
01/16/2007 |
SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE |
THE ANSPACH EFFORT, INC. |
JIM BANIC |
| 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 |
| K070007 |
01/10/2007 |
SPI ELEMENT PLATFORM O 4.0 MM |
THOMMEN MEDICAL, AG |
FLOYD G LARSON |
| K063456 |
01/09/2007 |
SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM |
TOPEX, INC |
ANTHONY PELLEGRINA |
| 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 |
| K063714 |
01/31/2007 |
AXCEL FLOW |
TRI DENTAL INNOVATORS |
LINDA NGUYEN |
| K072922 |
11/28/2007 |
3S HEMI TOE |
TRILLIANT SURGICAL LTD |
JD WEBB |
| K061613 |
01/10/2007 |
VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) |
TRIPATH IMAGING |
BRYAN J TUCKER |
| K063309 |
01/12/2007 |
TRU-CABLE |
TRUPHATEK INTERNATIONAL, LTD. |
PAUL DRYDEN |
| K063536 |
01/29/2007 |
POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING |
TYCO HEALTHCARE GROUP |
ROBERT ZOTT |
| 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 |
| K062978 |
01/16/2007 |
U2 HIP STEM, TI PLASMA SPRAY |
UNITED ORTHOPEDIC CORP. |
GENE HUANG |
| 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 |
| K061431 |
01/12/2007 |
EASYGLUCO, MODEL IGM-0002 G2 |
US DIAGNOSTICS, INC. |
EDWARD LETKO |
| 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 |
| K063851 |
01/26/2007 |
AUTO-FILL SYRINGE KIT, MODEL 7600 |
VASCULAR SOLUTIONS, INC. |
PATRICE STROMBERG |
| K062627 |
01/05/2007 |
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905 |
VASCULAR SOLUTIONS, INC. |
PATRICE STROMBERG |
| K062877 |
01/18/2007 |
TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230 |
VASCULAR SOLUTIONS, INC. |
JULIE TAPPER |
| 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 |
| K062670 |
01/12/2007 |
VERTIFLEX SPINAL SCREW SYSTEM |
VERTIFLEX (TM), INCORPORATED |
STEVE REITZLER |
| K063567 |
01/26/2007 |
EZ-MIO STERNAL |
VIDACARE CORPORATION |
GRACE HOLLAND |
| K073056 |
11/13/2007 |
DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9 |
VIEWORKS CO., LTD. |
KIM RAZA |
| K062615 |
01/29/2007 |
VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16 |
VISION BIOSYSTEMS INC. |
RONALD F LAGERQUIST |
| K071127 |
11/16/2007 |
FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM |
VISION-SCIENCES, INC. |
PAMELA PAPINEAU |
| K072014 |
11/08/2007 |
VITASCORE |
VITASCORE B.V. |
WIM MARTENS |
| K063554 |
01/12/2007 |
MERON PLUS |
VOCO GMBH |
MICHAEL SUS |
| K063604 |
01/22/2007 |
TWINKY STAR NF |
VOCO GMBH |
MANFRED THOMAS PLAUMANN |
| K063730 |
01/31/2007 |
DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0 |
VOLUME INTERACTIONS PTE LTD |
VALERIE FAN |
| K070705 |
11/30/2007 |
MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 |
VYGON CORP. |
COURTNEY SMITH |
| K062368 |
01/31/2007 |
WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401 |
WAKO CHEMICALS, USA, INC. |
LORI CREASY |
| K063052 |
01/12/2007 |
LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
| 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 |
| K061670 |
01/19/2007 |
LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE |
WILLIAM COOK EUROPE APS |
TINA H ANDERSON |
| K063677 |
01/05/2007 |
FUSION QUATTRO EXTRACTION BALLOON XL |
WILSON-COOK MEDICAL, INC. |
SCOTTIE FARIOLE |
| K063560 |
01/05/2007 |
HILGER DUAL-STIM NERVE STIMULATOR |
WR MEDICAL ELECTRONICS CO. |
Gary Syring |
| K072092 |
11/15/2007 |
XPOD/XMAP NERVE STIMULATOR |
XAVANT TECHNOLOGY (PTY), LTD. |
ROCHE VAN RENSBURG |
| K063587 |
01/09/2007 |
XODUS MEDICAL ANTI-FOG SOLUTION |
XODUS MEDICAL, INC. |
BRENDA NIEL |
| K070010 |
01/25/2007 |
QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER |
Z-MEDICA CORPORATION |
GIACOMO BASADONNA |
| K070006 |
01/19/2007 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZIBO HENGDE PLASTIC & RUBBER PRODUCTS CO., LTD. |
CHU XIAOAN |
| 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 |
| K063251 |
01/24/2007 |
ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY |
ZIMMER, INC. |
DALENE T BINKLEY |
| K072430 |
11/06/2007 |
ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE |
ZOLL MEDICAL CORPORATION |
SEAN REYNOLDS |
