FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K071260 |
07/17/2007 |
HERMES BOND 3 |
3M ESPE AG DENTAL PRODUCTS |
DESI W SOEGIARTO |
K071131 |
07/25/2007 |
UNO |
3M ESPE AG DENTAL PRODUCTS |
DESI W SOEGIARTO |
K070663 |
07/05/2007 |
A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT |
A-DEC, INC. |
THOMAS H LOUISELL |
K070428 |
07/17/2007 |
MEDICOM SELF-SEALING STERILIZATION POUCH |
A.R. MEDICOM, INC. |
JASON LUDVIG |
K071174 |
07/25/2007 |
PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS |
ABBOTT SPINE, INC. |
ZARA OAKES |
K070929 |
07/30/2007 |
ACON U120 URINE ANALYZER, MODEL U111-101 |
ACON LABORATORIES, INC. |
MARTIN O'CONNOR |
K070333 |
07/10/2007 |
ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL |
ACRYMED, INC. |
BRUCE GIBBONS |
K071715 |
07/18/2007 |
ACUMED CONGRUENT BONE PLATE SYSTEM |
ACUMED LLC |
ED BOEHMER |
K062331 |
07/10/2007 |
HIGHPAK-12 |
AD ELEKTRONIK GMBH |
GREGORY J MATHISON |
K070581 |
07/13/2007 |
SILVER ALGINATE II WOUND DRESSING |
ADVANCED MEDICAL SOLUTIONS LIMITED |
GRAHAME SOMERVILLE |
K071393 |
07/20/2007 |
JAZZ BLOOD GLUCOSE MONITORING SYSTEM |
AGAMATRIX |
CONNIE HERTEL |
K071972 |
07/30/2007 |
ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS |
AGFA HEALTHCARE CORP. |
TOM HOLBROOK |
K062703 |
07/23/2007 |
ONE STEP HCG PREGNANCY TEST |
AI DE DIAGNOSTIC CO., LTD. |
LIN WANG |
K070636 |
07/13/2007 |
AUTOVENT 4000 WITH CPAP |
ALLIED HEALTHCARE PRODUCTS, INC. |
WAYNE KARCHER |
K062824 |
07/03/2007 |
AOS UNIVERSAL CONECTING GUIDE TUBE |
ALPHA-OMEGA SERVICES, INC. |
BOB A ROBNETT |
K071186 |
07/30/2007 |
MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE |
AMBU A/S |
SANJAY PARIKH |
K071111 |
07/17/2007 |
NON-ABSORBABLE SILK SUTURE |
ARROW INTL., INC. |
KARL J NITTINGER |
K071622 |
07/03/2007 |
ARTHREX FIBERWIRE |
ARTHREX, INC. |
ANN WATERHOUSE |
K071721 |
07/13/2007 |
ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371 |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
K071602 |
07/23/2007 |
IMAGIC V2.0 |
ASHVA TECHNOLOGIES, PVT. LTD |
CARL ALLETTO |
K043579 |
07/05/2007 |
ATRICURE BIPOLAR SYSTEM |
ATRICURE, INC. |
ELSA C ABRUZZO, RAC |
K070253 |
07/11/2007 |
AXYA SUTURE WELDING SYSTEM AND KIT |
AXYA MEDICAL, INC. |
Howard Schrayer |
K071664 |
07/13/2007 |
TRELLIS-6 PERIPHERAL INFUSION SYSTEM |
BACCHUS VASCULAR, INC. |
ANTHONY SOWUNMI |
K071745 |
07/19/2007 |
BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE |
BAYLIS MEDICAL CO., INC. |
MEGHAL KHAKHAR |
K070293 |
07/10/2007 |
BENVENUE VCF OSTEO COIL SYSTEM |
BENVENUE MEDICAL, INC. |
LAURENT SCHALLER |
K071675 |
07/03/2007 |
LIQUICHEK TUMOR MARKER CONTROL |
Bio-Rad Laboratories |
MARIA ZEBALLOS |
K063495 |
07/26/2007 |
C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS |
BIOMATERIALS KOREA INC. |
KEVIN WALLS, RAC |
K063527 |
07/30/2007 |
MBCP+ |
BIOMATLANTE |
ADELINE FILLIATRE |
K071395 |
07/09/2007 |
BIOMET VISION FOOTRING SYSTEM |
BIOMET MANUFACTURING CORP. |
ROBERT FRIDDLE |
K071498 |
07/31/2007 |
SUBTALAR IMPLANT |
BIOMET SPORTS MEDICINE, INC. |
ELIZABETH WRAY |
K071325 |
07/26/2007 |
BIOMET VARIABLE LOCKING PLATE SYSTEM |
BIOMET TRAUMA |
SUSAN ALEXANDER |
K071569 |
07/02/2007 |
ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER |
BIOMET, INC. |
ELIZABETH WRAY |
K071665 |
07/18/2007 |
SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552 |
BIOTRONIK, INC. |
Jon Brumbaugh |
K062981 |
07/13/2007 |
I-CHROMA CRP TEST |
BODITECH DIAGNOSTICS, INC. |
Gary Lehnus |
K071309 |
07/13/2007 |
BLUE MAX BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
KARI CHRISTIANSON |
K071634 |
07/12/2007 |
MODIFICATION TO:CONTOUR SE MICROSPHERES |
BOSTON SCIENTIFIC CORP. |
SHILPA PREM |
K071733 |
07/24/2007 |
DL900 SERIES HOLTER RECORDER |
BRAEMAR, INC. |
DARREN DERSHEM |
K070465 |
07/19/2007 |
BUSSE EPIDURAL CATHETER |
BUSSE HOSPITAL DISPOSABLES, INC. |
MUHAMAD ANSARI |
K071776 |
07/26/2007 |
ANEUROPLASTIC, MODEL 43-1290 |
Codman & Shurtleff, Inc. |
RACHEL CREME |
K071791 |
07/30/2007 |
MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 |
Codman & Shurtleff, Inc. |
RACHEL CREANE |
K071444 |
07/27/2007 |
MECHANICAL WHEELCHAIR - L-FRAME SERIES |
COLOURS 'N MOTION |
VICTOR R BOX |
K071534 |
07/09/2007 |
CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS |
CONFIRMA, INC. |
PATRICIA A MILBANK |
K071640 |
07/12/2007 |
VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM |
COOK, INC. |
Theodore Heise |
K070515 |
07/30/2007 |
A-VIEW BASIC AND PLUS |
CORDATEC N.V. |
BARBARA DEBIASE |
K071550 |
07/18/2007 |
PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS |
CP MEDICAL |
BETSY CORTELLONI |
K063133 |
07/02/2007 |
CRANIAL SOLUTION ORTHOSIS |
CRANIAL SOLUTIONS |
KIRK A LUCYK |
K070346 |
07/18/2007 |
DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
K071284 |
07/26/2007 |
MODEL SEGAEGO 3D SCOOTER |
DALTON MEDICAL CORP. |
WILL RIDGWAY |
K071282 |
07/27/2007 |
MODEL SEGAEGO 4D SCOOTER |
DALTON MEDICAL CORP. |
WILL RIDGWAY |
K061495 |
07/18/2007 |
VR LUNG ELECTROSONOGRAPH |
DEEP BREEZE LTD. |
PHILIP J PHILLIPS |
K071334 |
07/02/2007 |
DEPUY CAS HEMI ASR HIP INSTRUMENTS |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
K071784 |
07/25/2007 |
DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
K063772 |
07/10/2007 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER KLACZYK |
K053095 |
07/12/2007 |
HONEY ALGINATE DRESSING |
DERMA SCIENCES CANADA, INC. |
SHARMINI ATHERAY |
K070811 |
07/05/2007 |
CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000 |
DEXCO |
ROBERT MAZZAFERRO |
K070062 |
07/30/2007 |
COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE |
DIESSE DIAGNOSTICA SENESE S.P.A |
RAUL ALVAREZ |
K071701 |
07/23/2007 |
TRACKLEAF-10 |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
K070704 |
07/13/2007 |
TRILOGY ANALYZER |
DREW SCIENTIFIC, INC. |
CYNTHIA SINCLAIR |
K070358 |
07/30/2007 |
MAXINSIGHT |
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH |
DANIEL KAMM |
K071166 |
07/23/2007 |
UNIWEB, VERSION 5.0 |
ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM) |
ANDY YEW |
K071574 |
07/05/2007 |
STIFFER COAXIAL MICRO-INTRODUCER KIT |
ENPATH MEDICAL, INC. |
PATRICE STROMBERG |
K070903 |
07/02/2007 |
MYLAB40 |
ESAOTE EUROPE B.V. |
CARRI GRAHAM |
K070401 |
07/11/2007 |
ENDO-CHX |
ESSENTIAL DENTAL SYSTEMS, INC. |
SUSAN GOLDSTEIN-FALK |
K071581 |
07/11/2007 |
BACKPACK MEDICAL OXYGEN SYSTEM |
ESSEX CRYOGENICS OF MISSOURI, INC. |
ELIZABETH HUNNICUTT |
K063154 |
07/10/2007 |
FACIAL RECONSTRUCTIVE MESH (FRM) |
EVERA MEDICAL, INC. |
RANDY KESTEN |
K071676 |
07/19/2007 |
EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS |
EXACTECH, INC. |
GRAHAM CUTHBERT |
K070299 |
07/16/2007 |
EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101) |
EZFIT TECHNOLOGY INC. |
OU YANG |
K071364 |
07/25/2007 |
MICROTARGETING GUIDELINE 4000 |
FHC, INC. |
LEE D MARGOLIN |
K070451 |
07/31/2007 |
ABLE CENTRAL VENOUS CATHETER |
FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD |
Diana Hong |
K071175 |
07/17/2007 |
OHMEDA MEDICAL GIRAFFE OMNIBED |
GE HEALTHCARE |
AGATA SMIEJA |
K071214 |
07/31/2007 |
ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING |
Genesee BioMedical, Inc. |
JOHN T WRIGHT |
K070689 |
07/03/2007 |
LG SPERM FREEZING |
GENX INTL., INC. |
MICHAEL D CECCHI |
K071022 |
07/05/2007 |
POWDER-FREE VINYL EXAMINATION GLOVES |
GLORMED COLOMBIA S.A. |
SAM KAO |
K070966 |
07/20/2007 |
GSO GS1 SPINAL SYSTEM |
GOLD STANDARD ORTHOPAEDICS, LLC |
DAVID BAUGHMAN |
K063357 |
07/10/2007 |
MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES |
GREINER BIO-ONE NORTH AMERICA, INC. |
Judi Smith |
K071119 |
07/24/2007 |
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE) |
GX CORPORATION SDN BHD |
FOO KHON PU |
K071209 |
07/25/2007 |
MASTER GUARD LATEX POWDER FREE EXAMINATION GLOVES |
HIGH MOMENTUM SDN BHD |
HUE K FAH |
K071208 |
07/30/2007 |
MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES |
HIGH MOMENTUM SDN BHD |
HUE K FAH |
K071583 |
07/25/2007 |
CERMET III ACETABULAR CUP SYSTEM |
IMPLANTS INTERNATIONAL, LTD |
MOHAN EMMANUEL |
K070784 |
07/24/2007 |
INION BIORESTORE |
INION OY |
KATI MARTINEN |
K071390 |
07/20/2007 |
WHEELCHAIR MODEL STS |
INNOVATIVE PRODUCTS, INC. |
JIM STEINKE |
K063837 |
07/02/2007 |
SIGMA M |
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY |
JOUNI ONNELA |
K070608 |
07/18/2007 |
SMARTEP, MODEL M010000 |
INTELLIGENT HEARING SYSTEMS |
EDWARD MISKIEL |
K062616 |
07/06/2007 |
WELLNESSPRO 2010 |
INTELSOURCE GROUP, INC. |
E.J. Smith |
K062992 |
07/27/2007 |
SPINAL SPHERES |
INTERBODY INNOVATIONS LLP |
J D WEBB |
K071587 |
07/30/2007 |
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY |
INVERNESS MEDICAL INNOVATIONS, INC. |
JAMES DELANEY |
K071251 |
07/26/2007 |
DEMI |
KERR CORPORATION |
COLLEEN BOSWELL |
K071599 |
07/11/2007 |
EASYGUIDE |
KEYSTONE DENTAL, INC. |
MARTIN J LEIGHTON |
K070183 |
07/13/2007 |
KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT |
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. |
HEATHER VIELE |
K070767 |
07/24/2007 |
EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION |
LAPIS LAZULI INTERNATIONAL NV |
MARTIN DALSING |
K071542 |
07/05/2007 |
DIGITAL STEREOLOC II |
LORAD, A HOLOGIC CO. |
GAIL YAEKER-DAUNIS |
K070392 |
07/13/2007 |
MOSAIC LASER SYSTEM |
LUTRONIC CORPORATION |
MAUREEN O'CONNELL |
K063427 |
07/25/2007 |
LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM |
LYNTON LASERS LIMITED |
ANDREW JOHN BERRY |
K071088 |
07/05/2007 |
LIFE LATCH SHARPS & BIOHAZARD CONTAINER |
M&M INDUSTRIES, INC. |
NORMAN F ESTRIN |
K062377 |
07/03/2007 |
MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100 |
MEDAPPS, INC. |
KENT E DICKS |
K070112 |
07/13/2007 |
RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM |
MEDCOOL INC |
MAUREEN O'CONNELL |
K070794 |
07/10/2007 |
ATLANTIK |
MEDICAL BIOMAT |
AURELIEN BIGNON |
K071870 |
07/08/2007 |
HEXAPOD RT COUCH TOP |
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
MICHAEL WOLFF |
K063063 |
07/03/2007 |
SILVACIDE SKIN & WOUND MOISTURIZING SOLUTION |
MEDICAL MOLECULAR THERAPUETICS LLC |
ARTHUR B FLICK |
K063069 |
07/13/2007 |
SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION |
MEDICAL MOLECULAR THERAPUETICS LLC |
ARTHUR B FLICK |
K070730 |
07/03/2007 |
FLEX-NECK ARC CATHETER |
MEDIGROUP, INC. |
JOHN A NAVIS |
K071423 |
07/18/2007 |
MEDLINE LATEX FOLEY CATHETER |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
K070577 |
07/13/2007 |
ON THE GO SHARPS |
MEDPORT, INC. |
FRAN WHITE |
K070175 |
07/25/2007 |
AQUANOVA SUPER-ABSORBENT GELLING DRESSING, OTC |
MEDTRADE PRODUCTS LTD. |
JONATHAN D RANFIELD |
K071253 |
07/03/2007 |
AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 |
MEDTRONIC VASCULAR |
JESSICA SIXBERRY |
K070598 |
07/26/2007 |
MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE |
MEMOMETAL TECHNOLOGIES |
GILLES AUDIC |
K070877 |
07/27/2007 |
ENDOCERVICAL ELECTRODE # 2 |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
BOB STILLMAN |
K062436 |
07/30/2007 |
SIS SINUS IMPLANT STABILIZER |
MONDEAL MEDICAL SYSTEMS GMBH |
ANGELIKA SCHERP |
K071354 |
07/13/2007 |
MEPILEX AG DRESSING |
MONLYCKE HEALTH CARE |
STEVEN DOWDLEY |
K071819 |
07/26/2007 |
NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515 |
NCONTACT SURGICAL, INC. |
JANE RICUPERO |
K063710 |
07/16/2007 |
SATURN 9000 |
NEW MEDICAL CO., LTD. |
YOUNG-HOON SHIN |
K071639 |
07/09/2007 |
QWIX POSITIONING SCREW |
NEWDEAL SAS |
JUDITH E O'GRADY |
K071147 |
07/20/2007 |
NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM |
NEXA ORTHOPEDICS, INC. |
MARY MCNAMARA-CULLINANE |
K070500 |
07/16/2007 |
BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM |
NI MEDICAL |
JAMES COLLIE |
K071182 |
07/11/2007 |
PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
K070611 |
07/11/2007 |
BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6 |
NOMOS CORP. |
MARITA BRUST |
K071285 |
07/12/2007 |
DIGITAL PULSE OXIMETER, MODEL 7500 |
NONIN MEDICAL, INC. |
LORI M ROTH |
K070960 |
07/11/2007 |
NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
K071191 |
07/23/2007 |
NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT |
NOVARTIS NUTRITION CORP. |
|
K063355 |
07/27/2007 |
D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW |
NOVOSCI CORP. |
DAVID MAKANANI |
K063805 |
07/13/2007 |
SILCRYST SILVER ANTIMICROBIAL WOUND CREAM, MODEL A-00901 |
NUCRYST PHARMACEUTICALS, INC. |
STEVEN J CHARTIER |
K070148 |
07/31/2007 |
GRAFT CONTAINMENT DEVICE |
NUVASIVE, INC. |
LAETITIA COUSIN |
K070377 |
07/11/2007 |
GIRAFFE AND PANDA WARMER |
OHMEDA MEDICAL |
AGATA SMIEJA |
K070983 |
07/05/2007 |
OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
K071645 |
07/02/2007 |
MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
K071673 |
07/18/2007 |
ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032 |
ONC SOLUTIONS, INC. |
JOHN SCHWAMB |
K071801 |
07/20/2007 |
VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659 |
Ortho-Clinical Diagnostics, Inc. |
MARLENE HANNA |
K070132 |
07/13/2007 |
TRIPORE, MODELS HA, BP90, BP15 |
ORTHOGEM LIMITED |
ROD RUSTON |
K070555 |
07/13/2007 |
ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES |
ORTHOPRO LLC |
CHRISTOPHER COOK |
K071714 |
07/20/2007 |
NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003 |
ORTHOSOFT, INC. |
CHRISTOPHER MCLEAN |
K061934 |
07/17/2007 |
XTAC |
OSTEOGENICS, INC. |
MICHAEL DEUTSCH |
K071105 |
07/30/2007 |
OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEM |
OSTEOMED L.P. |
DAWN D TINDALL |
K070298 |
07/03/2007 |
MODIFICATION TO PALOMAR LUXIR HANDPIECE |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Sharon Timberlake |
K070973 |
07/03/2007 |
QUANTUM SPINAL SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN M GILBERT |
K070731 |
07/31/2007 |
PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM |
PLUS ORTHOPEDICS AG |
PAMELA J WEAGRAFF |
K062118 |
07/13/2007 |
POINTE 360 |
POINTE SCIENTIFIC, INC. |
RON JAMISON |
K071342 |
07/31/2007 |
ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039 |
POSSIS MEDICAL, INC. |
MARK STENOIEN |
K071514 |
07/31/2007 |
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 |
POSSIS MEDICAL, INC. |
FRANK B FREEDMAN |
K070516 |
07/02/2007 |
POWERLASER |
POWERMEDIC APS |
ARNE GRINSTED |
K070846 |
07/02/2007 |
MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM |
PROSURG, INC. |
ASHVIN DESAI |
K070737 |
07/25/2007 |
XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES |
PROSURG, INC. |
ASHVIN DESAI |
K070766 |
07/26/2007 |
PSI BANDS |
PSI HEALTH SOLUTIONS, INC. |
ROMY TAORMINA |
K071322 |
07/13/2007 |
POWDER FREE LATEX EXAMINATION GLOVES |
QUALITY GALLANT SDN. BHD. |
SEAH B HOON |
K070805 |
07/11/2007 |
ULTRAWAVE II EX 1320 |
QUANTA SYSTEM, S.P.A. |
JONATHAN S KAHAN |
K071590 |
07/31/2007 |
THERMA-CURE |
RELIANCE ORTHODONTIC PRODUCTS, INC. |
PAUL GANGE |
K070746 |
07/13/2007 |
RESTRAXX DATA CENTRE, MODEL R10 |
RESMED LTD. |
DAVID D'CRUZ |
K071171 |
07/10/2007 |
VPAP AUTO WITH H3I |
RESMED LTD. |
DAVID D'CRUZ |
K071212 |
07/30/2007 |
ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000 |
RESPIRONICS CALIFORNIA, INC. |
MARA CALER |
K071113 |
07/05/2007 |
RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053 |
RESTORATIVE THERAPIES INC. |
ANDREW BARRISKILL |
K071786 |
07/26/2007 |
PORTRAIT PSR |
RHYTEC INCORPORATED |
Robert Zoletti |
K071292 |
07/19/2007 |
VIEW MD OFFICE SYSTEM, MODEL 41066.5540 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
K071211 |
07/30/2007 |
COBAS C 111 ANALYZER |
Roche Diagnostics |
CORINA HARPER |
K070709 |
07/13/2007 |
ROCHE ELECSYS PTH TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
KAY TAYLOR |
K070915 |
07/06/2007 |
SAPIMED DISPOSABLE SIGMOIDOSCOPE |
SAPIMED S.P.A. |
E J SMITH |
K071155 |
07/03/2007 |
MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER |
SCIENCE FOR BIOMATERIALS |
DENIS CLEMENT |
K071060 |
07/26/2007 |
NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE) |
SGMP CO., LTD. |
JANNA P TUCKER |
K071847 |
07/23/2007 |
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL |
SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD |
SONGTAO ZHANG |
K071882 |
07/18/2007 |
MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH, |
SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD |
SONGTAO ZHANG |
K063757 |
07/27/2007 |
MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES |
SHANGHAI MOTEX HEALTHCARE CO., LTD. |
Ke-Min Jen |
K063641 |
07/13/2007 |
PC-60, NON-INVASIVEPULSE OXIMETER |
SHENZHEN CREATIVE INDUSTRY CO., LTD |
MACK CHARLES |
K070852 |
07/13/2007 |
VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR |
SHIJIAZHANG HONGXIANG PLASTIC PRODUCTS CO., LTD. |
KATHY LIU |
K071717 |
07/05/2007 |
GE OEC ALTITUDE |
SHIMADZU CORP. |
AKIRA SHIGEYASU |
K071452 |
07/09/2007 |
FL BOND II |
SHOFU DENTAL CORP. |
DAVID MORAIS |
K071950 |
07/27/2007 |
SYNGO TRUED |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JAMES KUHN |
K071698 |
07/06/2007 |
AURORA LED SERIES SURGICAL LIGHTS |
SKYTRON, DIV. THE KMW GROUP, INC. |
LARRY PEREZ |
K071300 |
07/20/2007 |
MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE |
SMITH & NEPHEW, INC. |
KATHY REDDIG |
K070732 |
07/09/2007 |
BCI AUTOCON 3304 DIGITAL PULSE OXIMETER |
SMITHS MEDICAL PM, INC. |
DONALD ALEXANDER |
K071629 |
07/10/2007 |
PARIETEX POLYESTER MESH WITH INTRODUCER |
SOFRADIM PRODUCTION |
RENEE BORGESANO |
K071556 |
07/18/2007 |
SOMNOSCREEN EEG10-20 |
SOMNOMEDICS GMBH |
CHERITA JAMES |
K062584 |
07/05/2007 |
PRESSIO ICP MONITORING SYSTEM |
SOPHYSA SA |
ESTHER SALTZ |
K071318 |
07/06/2007 |
MODIFICATION TO: STOCKERT S5 SYSTEM |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
K071156 |
07/03/2007 |
SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER |
SOUNMED, INC. |
JHOANA LORES |
K070634 |
07/11/2007 |
SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110 |
SOYEE PRODUCT, INC. |
STEPHEN T MLCOCH |
K071227 |
07/11/2007 |
CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15 |
SPECTRANETICS CORP. |
MICHAEL K HANDLEY |
K071725 |
07/11/2007 |
M2 MONITOR |
SPECTRUM MEDICAL LTD |
STEVE TURNER |
K061914 |
07/26/2007 |
SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS |
SPORT-ELEC S.A. |
ARMELLE LAPRELLE |
K070743 |
07/02/2007 |
Z6 STIMULATOR |
ST CARDIO TECHNOLOGIES, LLC |
BILL ABBOUD |
K070461 |
07/17/2007 |
VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4 |
STERIS Corporation |
JOHN SCOVILLE |
K071585 |
07/11/2007 |
P.004 HEALING ABUTMENTS AND CLOSURE SCREWS |
STRAUMANN USA |
ELAINE ALAN |
K070882 |
07/20/2007 |
STRYKER PEEK TWINLOOP TAC |
Stryker Endoscopy |
JEFF SEMONE |
K070631 |
07/13/2007 |
DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
K071473 |
07/12/2007 |
MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2 |
SUPERDIMENSION, LTD. |
CLAY ANSELMO |
K071571 |
07/30/2007 |
SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM |
SURGIQUEST, INC. |
KOUROSH AZARBARZIN |
K071728 |
07/13/2007 |
MODIFICATION TO: ENSEAL PTC TISSUE SEALING DEVICE |
SURGRX, INC. |
LINDA OLESON |
K071288 |
07/19/2007 |
MODIFICATION TO KAVO QUATTROCARE |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
K071735 |
07/19/2007 |
MODIFICATION TO DISPOSABLE INFUSION PUMP KIT |
SYMBIOS MEDICAL PRODUCTS, LLC |
MICHAEL JAMES |
K070092 |
07/27/2007 |
MODIFICATION TO VELASMOOTH, SHAPER |
SYNERON MEDICAL LTD. |
YONI IGER |
K071503 |
07/26/2007 |
SYSTEM, TOMOGRAPHY, COMPUTED EMISSION |
SYNTERMED, INC. |
KENNETH F VAN TRAIN |
K071264 |
07/09/2007 |
SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE |
SYNTHES (USA) |
DEBORAH L JACKSON |
K063275 |
07/27/2007 |
DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810-116_126-03 (05,07) RIGHT 1811-116_126-03 (05,07) |
TERRAY CORP. |
STEVEN WILLIS |
K071572 |
07/23/2007 |
CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER |
TERUMO CORP. |
GARRY A COURTNEY |
K071494 |
07/16/2007 |
CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER |
TERUMO CORP. |
GARY COURTNEY |
K071630 |
07/11/2007 |
TERUMO 31G THINPRO INSULIN SYRINGE |
TERUMO MEDICAL CORP. |
EILEEN DORSEY |
K071743 |
07/06/2007 |
PILLAR PEDICLE SCREW SYSTEM |
THE 4TH COLUMN, LLC |
DAVID J COLLETTE |
K071031 |
07/30/2007 |
VU E*POD VERTEBRAL BODY REPLACEMENT |
THEKEN SPINE LLC |
DALE DAVISON |
K053613 |
07/25/2007 |
L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE |
THEO MANUFACTURING BV |
BARBARA DEBIASE |
K070599 |
07/13/2007 |
CUSTOMIZED SOUND THERAPY (CST) |
TINNITUS OTOSOUND PRODUCTS, LLC |
GERALDINE CREAN |
K071821 |
07/27/2007 |
COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65 |
TONICA ELEKTRONIK A/S |
LISE TERKELSEN |
K072000 |
07/30/2007 |
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.0 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
K071027 |
07/20/2007 |
TRIBOGLIDE LUBRICATED SILICONE-FREE SYRINGE |
TRIBOFILM RESEARCH, INC. |
VINAY SAKHRANI |
K071381 |
07/18/2007 |
GAMMAMEDPLUS IX SERIES HDR AFTERLOADER |
VARIAN MEDICAL SYSTEMS |
VY TRAN |
K071467 |
07/16/2007 |
VARISOURCE IX HDR AFTERLOADER |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
K070406 |
07/30/2007 |
ENDODRAPE |
VORTEK SURGICAL, LLC |
THOMAS SZYMCZAK |
K071183 |
07/20/2007 |
ALLEGRO OCULYZER |
WAVELIGHT AG |
ALEXANDER POPP |
K071163 |
07/18/2007 |
WEINMANNCOMFORT 2, MODEL WM 27600 AND WEINMANNAQUA, MODEL WM 27603 |
WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG |
ECKHARDT ALBERS |
K070936 |
07/16/2007 |
WELMED HYPODERMIC SYRINGE |
WELMED INC. |
DARREN REEVES |
K070435 |
07/17/2007 |
DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400 |
WHITTLESTONE, INC. |
GLEN THIBAULT |
K070785 |
07/11/2007 |
DYNASTY ACETABULAR SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MATT PAUL |
K071201 |
07/30/2007 |
ZEO CE LIGHT & ZEO QUICK PORCELAIN |
XPDENT CORP. |
CARMEN PEREZ |
K071123 |
07/30/2007 |
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR |
XUZHOU FULL SUN MEDICAL PRODUCTS LTD. |
HSUN-HUI HUANG |
K070578 |
07/11/2007 |
CLINICAL THERMOMETER/MODEL ZSDT-XXXX DIGITAL THERMOMETER AND ZSET-XXX INFRARED THERMOMETER |
ZEN STRONG MEDICAL TECHNOLOGY CO., LTD |
CHENG ROEI-SHENG |
K070317 |
07/05/2007 |
ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
EWA NADOLCZAK |
K071107 |
07/06/2007 |
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON |
ZIMMER, INC. |
BRANDON HIPSHER |
K071718 |
07/13/2007 |
TRILOGY LONGEVITY CONSTRAINED LINER |
ZIMMER, INC. |
STEPHEN MCKELVEY |
K071856 |
07/30/2007 |
ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES |
ZIMMER, INC. |
DALENE BINKLEY |
K070978 |
07/03/2007 |
ZIMMER SEGMENTAL SYSTEM |
ZIMMER, INC. |
BRANDON HIPSHER |