| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K081325 |
07/24/2008 |
ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML |
AB BIODISK |
ANETTE ENGELHARDT |
| K080739 |
07/10/2008 |
ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT |
ABBOTT MOLECULAR, INC. |
PAULA E MARTIN |
| K080200 |
07/10/2008 |
WATER WORKS DOUCHING DEVICE |
ABBOTT RESEARCH GROUP, INC. |
ROSINA ROBINSON |
| K080647 |
07/08/2008 |
ACCIN BIPOLAR HEAD SYSTEM |
ACCELERATED INNOVATION, LLC |
MICHAEL KVITMITSKY |
| K080545 |
07/24/2008 |
ACTITRAINER |
ACTIGRAPH, LLC |
JOHN SCHEIDER |
| K081208 |
07/18/2008 |
CINCH ANCHOR, MODEL 1194 |
ADVANCED NEUROMODULATION SYSTEMS |
PENNY HOUSTON |
| K080995 |
07/30/2008 |
MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM |
Affymetrix, Inc. |
MAUREEN J MENDE |
| K080252 |
07/21/2008 |
MODIFICATION TO MAMMAPRINT |
AGENDIA BV |
Guido Brink |
| K081963 |
07/25/2008 |
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS |
AGFA HEALTHCARE CORPORATION |
JEFFERY A JEDLICKA |
| K081976 |
07/28/2008 |
IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION |
AGFA HEALTHCARE CORPORATION |
|
| K072143 |
07/14/2008 |
S40 CLINICAL ANALYZER, S TEST ALB |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
DAVID SLAVIN |
| K072678 |
07/02/2008 |
LAGUNA SIZE 8 PEDICLE SCREW |
ALLEZ SPINE, LLC |
HARTMUT LOCH |
| K080463 |
07/23/2008 |
ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES |
ALMA LASERS LTD. |
ANNE WORDEN |
| K081843 |
07/15/2008 |
ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 |
ALOKA CO., LTD. |
RICHARD CEHOVSKY |
| K081158 |
07/03/2008 |
ZODIC POLYAXIAL SPINAL FIXATION SYSTEM |
ALPHATEC SPINE, INC. |
MARY STANNERS |
| K072901 |
07/01/2008 |
AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101 |
AMDL, INC. |
GARY DREHER |
| K081841 |
07/16/2008 |
AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER |
AMPLIVOX, LTD. |
DANIEL KAMM |
| K080468 |
07/25/2008 |
LIASYS WITH MODELS LIASYS |
AMS S.R.L. ANALYZER MEDICAL SYSTEM |
STEFANO CORRADI |
| K073030 |
07/21/2008 |
AG-605 BLOOD GLUCOSE MONITORING SYSTEM |
ANDON HEALTH CO.,LTD |
MS. MONA |
| K080326 |
07/31/2008 |
KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO.,LTD |
|
| K080319 |
07/02/2008 |
KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO.,LTD |
MS. MONA |
| K080287 |
07/03/2008 |
ONCOBIONIC BIPOLAR ELECTRODE |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K080451 |
07/03/2008 |
UNIBLATE ELECTROSURGICAL DEVICE |
ANGIODYNAMICS, INC. |
BRIAN KUNST |
| K082031 |
07/31/2008 |
APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES |
APPASAMY ASSOCIATES |
R.N. KASTHURI |
| K073621 |
07/03/2008 |
INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT |
ART OPTICAL CONTACT LENS, INC. |
MARTIN DALSING |
| K081497 |
07/28/2008 |
OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503) |
ARTHROCARE CORP. |
LAURA N KASPEROWICZ |
| K081329 |
07/09/2008 |
REPROCESSED ELECTROPHYSIOLOGY CATHETERS |
ASCENT HEALTHCARE SOLUTIONS |
KATIE BRAY |
| K081238 |
07/29/2008 |
REPROCESSED MASIMO PULSE OXIMETER SENSORS |
ASCENT HEALTHCARE SOLUTIONS |
KATIE BRAY |
| K081718 |
07/25/2008 |
EXPRESS CHEST DRAIN |
ATRIUM MEDICAL CORP. |
KAREN HALL |
| K081323 |
07/22/2008 |
BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 |
B-K MEDICAL APS |
JENS RASMUSSEN |
| K080672 |
07/08/2008 |
BIRTHTRACK |
BARNEV, LTD. |
AHAVA STEIN |
| K081446 |
07/17/2008 |
BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237 |
BECTON DICKINSON & CO. |
PASQUALE AMATO |
| K081125 |
07/02/2008 |
WRIST PULSE OXIMETER MD300W |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
LEI WANG |
| K073341 |
07/09/2008 |
GENEX PUTTY |
BIOCOMPOSITES LTD. |
SIMON FITZER |
| K081015 |
07/08/2008 |
CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 |
BIOLITEC, INC. |
JONATHAN S KAHAN |
| K080864 |
07/21/2008 |
CAM STRUCTSURE PRECISION MILLED BARS |
BIOMET 3I, INC. |
TAMARA WEST |
| K081172 |
07/17/2008 |
COMPOSITE HITCH SUTURE ANCHOR |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
| K080426 |
07/29/2008 |
MAESTRO WRIST FRACTURE IMPLANT |
BIOMET MANUFACTURING CORP. |
PATRICIA SANDBORN BERES |
| K081501 |
07/02/2008 |
SOLITAIRE ANTERIOR SPINAL SYSTEM |
BIOMET SPINE |
VIVIAN KELLY |
| K081244 |
07/30/2008 |
LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS |
BIOMET TRAUMA |
PATRICIA S BERES |
| K080642 |
07/09/2008 |
COMPREHENSIVE REVERSE SHOULDER |
BIOMET, INC. |
PATRICIA S BERES |
| K081403 |
07/25/2008 |
GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK |
BIONOSTICS, INC. |
RANDY BYRD |
| K081177 |
07/23/2008 |
BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM |
BLACKSTONE MEDICAL, INC. |
WHITNEY G TORNING |
| K080982 |
07/14/2008 |
STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS |
BOSTON SCIENTIFIC CORP. |
MARK MURPHY |
| K081431 |
07/24/2008 |
MEG LAPAROSCOPIC ELECTRODES |
BOVIE MEDICAL |
RICHARD KOZLOFF |
| K081444 |
07/31/2008 |
BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM |
BRAEMAR, INC. |
DARREN DERSHEM |
| K081272 |
07/31/2008 |
PORCINE SURGICAL MESH; DERMAL MATRIX |
BRENNEN MEDICAL, LLC |
KENNETH B HERLAND |
| K080804 |
07/09/2008 |
BUSSE PLASTIC LOR SYRINGE |
BUSSE HOSIPITAL DISPOSABLES |
MUHAMAD ANSARI |
| K081288 |
07/18/2008 |
ASPIRA PERITONEAL DRAINAGE SYSTEM |
C.R. BARD, INC. |
HENRY BOLAND |
| K080668 |
07/30/2008 |
G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS |
C.R. BARD, INC. |
GENEVIEVE BALUTOWSKI |
| K081157 |
07/22/2008 |
ACCUFRAME |
CAGENIX INC. |
LINDA K SCHULZ |
| K081836 |
07/30/2008 |
CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM |
CARESTREAM HEALTH,INC. |
CHRISTINE EHMANN |
| K070888 |
07/03/2008 |
COMBI 8 MAX |
CEC ELECTRONICA S.R.L. |
BENNY ARAZY |
| K081531 |
07/18/2008 |
AOC SOLUBLE IMPLANT MATERIAL |
CEREMED, INC. |
TADEUSZ WELLISZ |
| K081176 |
07/28/2008 |
FLOCHANNEL |
CHAD THERAPEUTICS, INC. |
KEVIN MCCULLOH |
| K081619 |
07/18/2008 |
CHROMOLITE EP |
CHROMOGENEX TECHNOLOGIES LIMITED |
PETER R BEVAN |
| K081677 |
07/22/2008 |
SAVI APPLICATOR KIT |
CIANNA MEDICAL, INC. |
GARY MOCNIK |
| K080445 |
07/16/2008 |
LION SE ONE STEP ORTHODONTIC ADHESIVE |
CLASSONE ORTHODONTICS, INC. |
JUDY RIBORDY |
| K080583 |
07/18/2008 |
MODIFIED HD GUIDE CATHETER |
CONCENTRIC MEDICAL, INC. |
LARAINE PANGELINA |
| K072291 |
07/14/2008 |
CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR |
CONMED LINVATEC |
JON WARD |
| K081113 |
07/30/2008 |
COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS |
COOK, INC. |
SUSANNE GALIN |
| K081690 |
07/14/2008 |
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER |
COOK, INC. |
NATHAN SIMON |
| K081249 |
07/21/2008 |
DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM |
DADE BEHRING, INC. |
ANNA MARIE KATHLEEN ENNIS |
| K081161 |
07/28/2008 |
DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST |
DADE BEHRING, INC. |
HELEN M LEE |
| K081829 |
07/11/2008 |
CAPIMAGE |
DANISH DIAGNOSTIC DEVELOPMENT A/S |
NIELS SORENSEN |
| K081669 |
07/10/2008 |
IMPROVED COMFORT-FIT NIGHTGUARD |
DENTEK ORAL CARE, INC. |
HOWARD M HOLSTEIN |
| K080991 |
07/02/2008 |
DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
DAWN SINCLAIR |
| K072884 |
07/30/2008 |
FABIUS MRI |
DRAEGER MEDICAL AG & CO. KG |
KATHY ANDERSON |
| K071446 |
07/02/2008 |
ELECTRODE ARRAY CAP |
ELECTRODE ARRAYS |
ELVIRA GARCIA |
| K073616 |
07/23/2008 |
FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE |
ELECTROMEDICS CO. LTD. |
JOHN SCHOLZ |
| K081430 |
07/28/2008 |
ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING |
ELEKTA NEUROMAG OY |
DANIEL KAMM |
| K081565 |
07/02/2008 |
INTEGRE PRO, MODEL L2RY |
Ellex Medical Pty. Ltd. |
KEVIN HOWARD |
| K080780 |
07/30/2008 |
ANCHORAGE SCOPE, MODEL 000003 |
EPITEK, INC. |
WERNER HAMPL |
| K081794 |
07/10/2008 |
MODEL 7340 ULTRASOUND SYSTEM |
ESAOTE, S.P.A. |
CARRI GRAHAM |
| K080972 |
07/03/2008 |
ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP |
ETHICON ENDO-SUGERY, LLC |
RUTH A WOOD |
| K080849 |
07/25/2008 |
MICROSHEATH LP AND LP-AT |
FLOWCARDIA, INC. |
Dustin Michaels |
| K073382 |
07/28/2008 |
PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G |
FOCUS DIAGNOSTICS, INC. |
CONSTANCE BRIDGES |
| K080974 |
07/01/2008 |
TLS FIXATION SYSTEM |
FOURNITURES HOSPITALIERES INDUSTRIE |
PATRICIA DONNARD |
| K081870 |
07/31/2008 |
MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO |
GE HEALTHCARE FINLAND OY |
JOHN PENDERGAST |
| K081437 |
07/15/2008 |
MAC 1600 ECG ANALYSIS SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MARGARET MUCHA |
| K081916 |
07/22/2008 |
GE SIGNA MR ONCOLOGY PACKAGE |
GE MEDICAL SYSTEMS, LLC |
Daniel Biank |
| K080745 |
07/30/2008 |
GENADYNE A4 POWERED SUCTION PUMP |
GENADYNE BIOTECHNOLOGIES, INC. |
JOHN PAPPAN |
| K072977 |
07/16/2008 |
DIAZYME APOLIPOPROTEIN A-1 ASSAY |
GENERAL ATOMICS |
Abhijit Datta |
| K082033 |
07/31/2008 |
NANNOLIGHT INTENSE PULSED LIGHT SYSTEM |
GLOBAL USA DISTRIBUTION, LLC. |
MATT MAKOUSKY |
| K080664 |
07/25/2008 |
RELIEVE LAMINOPLASTY FIXATION SYSTEM |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K081391 |
07/03/2008 |
VIP ANTERIOR CERVICAL PLATE SYSTEM |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K081234 |
07/14/2008 |
GN OTOMETRICS INSERT EARPHONES |
GN OTOMETRICS |
DANIEL SANSONETTI |
| K073246 |
07/23/2008 |
ZENIEVA |
GORBEC PHARMACEUTICAL SERVICES, INC. |
SANDRA R KIRCUS |
| K081954 |
07/31/2008 |
GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE |
GYRUS ACMI, INC. |
TERRENCE E SULLIVAN |
| K081263 |
07/01/2008 |
STARCERAM |
H.C. STARCK CERAMICS GMBH & CO.KG |
ROBERT N CLARK |
| K081061 |
07/18/2008 |
HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES |
HARVARD MEDICAL DEVICES LTD. |
PAUL AYLETT |
| K081171 |
07/22/2008 |
TRITANIUM ACETABULAR SHELL SYSTEM |
HOWMEDICA OSTEONICS CORP |
KIMBERLY LANE |
| K081284 |
07/18/2008 |
VARIAX DISTAL FIBULA PLATE |
HOWMEDICA OSTEONICS CORP. |
ANDREA M DWYER |
| K081506 |
07/25/2008 |
HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS |
HYPERBARIC AMERICA, LLC |
TOM WORKMAN |
| K080538 |
07/03/2008 |
IDEAL LIFE POD (MODEL ILP 0001) |
IDEAL LIFE INC. |
Diane Horwitz |
| K081630 |
07/29/2008 |
MAMMO WORKSTATION |
IMAGE DIAGNOST INTERNATIONAL GMBH |
PETER HEINLEIN |
| K081698 |
07/30/2008 |
MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) |
IMAGE STREAM MEDICAL, INC. |
CHAS BURR |
| K080633 |
07/15/2008 |
SCREWINDIRECT DENTAL IMPLANTS |
IMPLANT DIRECT LLC |
THOMAS GOTTENBOS |
| K072741 |
07/16/2008 |
PRE-VA VAGINAL LUBRICANT |
INGFERTILITY, LLC |
DENNIS CLIFTON |
| K071810 |
07/11/2008 |
INION SPINAL GRAFT CONTAINMENT SYSTEM |
INION LTD. |
KATI MARTTINEN |
| K073042 |
07/31/2008 |
HEMOSIL D-DIMER |
INSTRUMENTATION LABORATORY |
CAROL MARBLE |
| K081070 |
07/23/2008 |
INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM |
INTERLACE MEDICAL, INC. |
RON ADAMS |
| K080067 |
07/18/2008 |
ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER |
ISCIENCE INTERVENTIONAL |
GRACE BARTOO |
| K081112 |
07/29/2008 |
FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM |
ISODOSE CONTROL B.V. |
HUB VAN DE BERGH |
| K081218 |
07/21/2008 |
BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST |
IT-V MEDIZINTECHNIK, GMBH |
CORNELIA DAMSKY |
| K080220 |
07/28/2008 |
PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE |
ITALIA MEDICA S.R.L. |
BERTHOIN CLAUDE |
| K081655 |
07/21/2008 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (LIGHT YELLOW) |
JIANGSU CUREGUARD GLOVE CO., LTD. |
CHU XIAOAN |
| K073074 |
07/10/2008 |
KEY LASER III 1243 US WITH DETECT |
KAVO AMERICA |
DANIEL KAMM |
| K080975 |
07/15/2008 |
FENCER 308 EXCIMER LASER SYSTEM |
KERA HARVEST/LASER MAX MEDICAL TECHNOLOGIES CORP |
PAUL Y FANG |
| K081598 |
07/03/2008 |
SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE |
KFX MEDICAL |
GAYLE HIROTA |
| K081260 |
07/09/2008 |
KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES |
KIMBERLY-CLARK CORP. |
RICHARD V WOLFE |
| K081089 |
07/14/2008 |
KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM |
KIMBERLY-CLARK CORP. |
RICHARD V WOLFE |
| K081678 |
07/29/2008 |
CONMED BEAMER SYSTEM C600 |
KLS MARTIN GMBH + CO. KG |
BERNHARD HUG |
| K080862 |
07/21/2008 |
SONICWELD RX (RESORB-X) |
KLS-MARTIN L.P. |
TOM FAUCETT |
| K081637 |
07/01/2008 |
LASER IMAGER DRYPRO MODEL 873 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
RUSSELL MUNVES |
| K080178 |
07/28/2008 |
VALVULOTOME BY KOVEN |
KOVEN TECHNOLOGY, INC. |
J. HARVEY KNAUSS |
| K081583 |
07/28/2008 |
CLEARFIL SA CEMENT |
KURARAY MEDICAL INC. |
KOJI NISHIDA |
| K081781 |
07/09/2008 |
NUWAV |
LABORIE MEDICAL TECHNOLOGIES, CORP |
BARBARA MORNET |
| K081552 |
07/31/2008 |
SKYLINE 55 |
LARSEN & TOUBRO LIMITED |
A B DESHPANDE |
| K063841 |
07/23/2008 |
NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS |
LIPOSCIENCE |
MARK A DEL VECCHIO |
| K071759 |
07/30/2008 |
LTC VAD SYSTEM, MODELS #VAD.400 (ELECTROSURGICAL GENERATOR); PCS-900 AND PCC-900 (HAND PIECE INSTRUMENTS) |
LIVE TISSUE CONNECT, INC. |
HOWARD M HOLSTEIN |
| K080496 |
07/07/2008 |
MOSAIC ECO2 LASER SYSTEM |
LUTRONIC CORPORATION |
MAUREEN O'CONNELL |
| K081402 |
07/18/2008 |
SIMPLANT ORTHO ; VISTADENT 3D |
MATERIALISE DENTAL NV |
CARL VAN LIERDE |
| K080357 |
07/24/2008 |
MEDELA INVIA WOUND THERAPY |
MEDELA AG |
BRUNO GRETLER |
| K080212 |
07/23/2008 |
MEDELA THOPAZ, MODEL 200 0288 |
MEDELA AG |
BRUNO GRETLER |
| K080969 |
07/25/2008 |
HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 |
MEDI NUCLEAR CORP., INC. |
JERRY SCHOEN |
| K081593 |
07/23/2008 |
POWER ASPIRATOR, MODEL LS2 OR LS2DP |
MEDICAL DEVICE RESOURCE CORP. |
MEL KIMSEY |
| K080878 |
07/17/2008 |
MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT) |
MEDICAL TECHNOLOGIES OF GEORGIA, INC. |
CINDI SARTAIN |
| K073555 |
07/11/2008 |
INSULIN PROTECTOR |
MEDICOOL, INC. |
EUGENE CHANG |
| K081676 |
07/02/2008 |
SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
KYUNG-AM SHIM |
| K080097 |
07/09/2008 |
MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET |
MEDTRADE PRODUCTS LTD. |
JONATHAN D RANFIELD |
| K081512 |
07/18/2008 |
STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE |
MEDTRONIC NAVIGATION, INC. |
KEVIN MORNINGSTAR |
| K081950 |
07/18/2008 |
PROGENIX PLUS |
MEDTRONIC SOFAMOR DANEK, INC. |
RYAN MASSEY |
| K081513 |
07/18/2008 |
MERETE 3.0 AND 3.5 MM LOCKING SCREWS |
MERETE MEDICAL GMBH |
JORG MIETZNER |
| K080512 |
07/23/2008 |
REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT |
METRO OPTICS OF AUSTIN, INC. |
MARTIN DALSING |
| K080666 |
07/11/2008 |
HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS |
MICROVENTION, INC. |
KEVIN E DALY |
| K081039 |
07/10/2008 |
LIPO CANNULA |
MILLENNIUM MEDICAL TECHNOLOGIES, INC. |
GREGORY M MILES |
| K070779 |
07/09/2008 |
SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM |
MISONIX, INC. |
RONALD MANNA |
| K081356 |
07/09/2008 |
OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM |
MYLAD ORTHOPEDIC SOLUTIONS, LLC |
SCOTT EDWARDS |
| K073678 |
07/10/2008 |
VARIOSURG |
NAKANISHI, INC. |
KEITH BARRITT |
| K081366 |
07/15/2008 |
KUMAR T-ANCHORS HERNIA SET |
NASHVILLE SURGICAL INSTRUMENTS |
SARBJEET KUMAR |
| K081515 |
07/21/2008 |
NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 |
NEOMED, INC. |
PENNY NORTHCUTT |
| K080695 |
07/01/2008 |
MOBILE I.V. SYSTEMS 10,20,60 |
NORTHWIND TECHNOLOGIES, CORP. |
DAWN I MOORE |
| K081680 |
07/10/2008 |
NUCLEUS-X, MODEL 230X |
NUMED, INC. |
NICHELLE LAFLESH |
| K080807 |
07/18/2008 |
BLOOD TUBING SETS (STERILE FLUID PATH) |
NXSTAGE MEDICAL, INC. |
MICHAEL DOYLE |
| K081043 |
07/07/2008 |
LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT |
NXSTAGE MEDICAL, INC. |
MARY LOU STROUMBOS |
| K081140 |
07/17/2008 |
VISENSIA |
OBS MEDICAL |
WAYNE NETHERCUTT |
| K081561 |
07/28/2008 |
OSFERION D |
OLYMPUS TERUMO BIOMATERIALS CORPORATION |
STACY A KLUESNER |
| K081776 |
07/22/2008 |
CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM |
OMEGA CRITICAL CARE LIMITED |
ALAN SHORT |
| K081407 |
07/22/2008 |
ORTHOPEDIATRICS PEDIPLATES SYSTEM |
ORTHOPEDIATRICS, CORP. |
GARY BARNETT |
| K073720 |
07/17/2008 |
ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT |
OSMETECH MOLECULAR DIAGNOSTICS |
ROBERT DICHECK |
| K080744 |
07/17/2008 |
HG II FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
MINJOO KIM |
| K081078 |
07/15/2008 |
NT/IT SYSTEM |
OSSTEM IMPLANT CO.,LTD |
MINJOO KIM |
| K081227 |
07/22/2008 |
PLEXUR M |
OSTEOTECH, INC. |
CHRIS TALBOT |
| K080731 |
07/17/2008 |
PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE |
OSYRIS |
JAOUAD ZEMMOURI |
| K073386 |
07/30/2008 |
JOINT STIM, MODEL 1000 |
PAIN MANAGEMENT TECHNOLOGIES |
JOSHUA LEFKOVITZ |
| K071668 |
07/02/2008 |
ORTHOBIOM SPINAL SYSTEM |
PARADIGM SPINE |
MARCI HALEVI |
| K081328 |
07/17/2008 |
PATHWAY PV ATHERECTOMY SYSTEM |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
BRIAN CLEARY |
| K080896 |
07/30/2008 |
PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST |
PATHWORK DIAGNOSTICS, INC. |
Erika B Ammirati |
| K073057 |
07/22/2008 |
PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040 |
PEAK SURGICAL, INC. |
GRACE CARLSON |
| K081964 |
07/29/2008 |
K450 POWERED WHEELCHAIR |
PERMOBIL AB |
JAN ASTROM |
| K081802 |
07/11/2008 |
CX50 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
ROB BUTLER |
| K073089 |
07/29/2008 |
LIFEPAK 20E |
PHYSIO-CONTROL, INC. |
MICHELLE ACKERMANN |
| K081826 |
07/25/2008 |
INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
| K080689 |
07/09/2008 |
SPECTRA THERAPY SYSTEM A1000 LASER DEVICE |
PREMIER DYNAMICS, INC. |
JOHN J STEPHAN |
| K073693 |
07/03/2008 |
COSTORSOL |
PRESERVATION SOLUTIONS, INC. |
NEIL BURRIS |
| K080848 |
07/25/2008 |
ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR |
Q3 INNOVATIONS, LLC |
DANIEL KAMM |
| K080905 |
07/16/2008 |
QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI |
QUANTUM MEDICAL IMAGING, LLC. |
PAMELA PAPINEAU |
| K080813 |
07/01/2008 |
PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER |
RADI MEDICAL SYSTEMS AB |
BJORN PALMGREN |
| K072109 |
07/31/2008 |
STATMAP, MODEL 7200 |
RAMSEY MEDICAL, INC. |
DARRYL PARMET |
| K081383 |
07/02/2008 |
RELIANCE VBS SYSTEM |
Reliance Medical Systems, LLC |
Bret M Berry |
| K080915 |
07/01/2008 |
FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES |
RELIANT TECHNOLOGIES, INC. |
HEATHER MACFALLS |
| K080797 |
07/09/2008 |
HUMIDAIRE 2I |
RESMED LTD. |
DAVID D'CRUZ |
| K081206 |
07/28/2008 |
HOMELOX |
RESPIRONICS, INC. |
ZITA A YURKO |
| K063662 |
07/21/2008 |
RAMP NT-PROBNP ASSAY |
RESPONSE BIOMEDICAL CORP. |
KEN PILGRIM |
| K081389 |
07/15/2008 |
ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM |
Roche Diagnostics |
Scott Thiel |
| K080092 |
07/28/2008 |
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB |
ROCHE DIAGNOSTICS CORP. |
STEPHANIE GREEMAN |
| K080914 |
07/15/2008 |
ULTRASHARP CONCENTRIC NEEDLES |
ROCHESTER ELECTRO MEDICAL, INC. |
CHARLES C BERKINS |
| K080922 |
07/25/2008 |
SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR |
SALTER LABS, DIVISION OF REGULATORY AFFAIRS |
DUANE KAZAL |
| K073500 |
07/03/2008 |
ACTIVE ANTERIOR CERVICAL PLATE SYSTEM |
SANACOR |
MIKE ENSIGN |
| K081273 |
07/10/2008 |
ULTRACAPS S |
SDI LTD. |
RAY CAHILL |
| K080916 |
07/01/2008 |
CAPILLARYS URINE |
SEBIA |
KAREN ANDERSON |
| K080370 |
07/31/2008 |
ABL 80 CO-OX SYSTEM |
SENDX MEDICAL, INC. |
MARK A DZENDZEL |
| K081370 |
07/11/2008 |
SERIM DISINTEK OPA TEST STRIP |
SERIM RESEARCH CORP. |
PATRICIA RUPCHOCK |
| K081873 |
07/16/2008 |
EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE |
SHENZHEN EMPEROR ELECTRONIC TECHNOLOGY CO. LTD. |
CHENG GUIYUAN |
| K080047 |
07/11/2008 |
CARDIOSEN'C |
SHL TELEMEDICINE INTERNATIONAL LTD. |
YORAM LEVY |
| K071074 |
07/02/2008 |
MYKRES SPINAL SYSTEM |
SHOWA IKA KOHGYO CO.,LTD. |
FLOYD G LARSON |
| K072334 |
07/18/2008 |
SIALO DRAIN |
SIALO TECHNOLOGY, LTD. |
AHAVA STEIN |
| K081734 |
07/03/2008 |
SYNGO IMAGING (VERSION V31) |
SIEMENS AG, MEDICAL SOLUTIONS |
|
| K081643 |
07/03/2008 |
DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 |
SIEMENS HEALTHCARE DIAGNOSTICS |
YUK-TING LEWIS |
| K081300 |
07/02/2008 |
DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE |
SIEMENS HEALTHCARE DIAGNOSTICS |
PAMELA A JURGA |
| K081683 |
07/07/2008 |
LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 |
SIEMENS HEALTHCARE DIAGNOSTICS |
YUK-TING LEWIS |
| K081716 |
07/17/2008 |
ADVIA CENTAUR HAVM ASSAY |
Siemens Healthcare Diagnostics Inc. |
MARY SEEGER |
| K081294 |
07/29/2008 |
ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS |
Siemens Healthcare Diagnostics Inc. |
PHILIP LIU |
| K080199 |
07/03/2008 |
SYMMETRIC TOTAL KNEE SYSTEM |
SIGNAL MEDICAL CORPORATION |
BRIAN KATERBERG |
| K081108 |
07/14/2008 |
MONOPOLY PEDICLE SCREW SYSTEM |
SIGNUS MEDICAL LLC. |
RICHARD JANSEN |
| K081631 |
07/18/2008 |
SINTEA BIOTECH PLS MULTI-AXIAL SCREWS |
SINTEA BIOTECH, INC. |
DANIELLE WERNIKOWSKI |
| K081466 |
07/30/2008 |
STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
| K081098 |
07/16/2008 |
ENDOBUTTON CONTINUOUS LOOP (CL) |
SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
CHRISTINA FLORES |
| K081111 |
07/23/2008 |
LEGION HINGE KNEE SYSTEM |
SMITH & NEPHEW, INC. |
NICHOLAS B TABRIZI |
| K081124 |
07/31/2008 |
MDF REVISION HIP SYSTEM |
SMITH & NEPHEW, INC. |
RISHI SINHA |
| K081351 |
07/24/2008 |
MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT |
SMITH & NEPHEW, INC. |
NICHOLAS B TABRIZI |
| K080875 |
07/18/2008 |
PIGALILEO 4TH GENERATION SYSTEM |
SMITH & NEPHEW, INC. |
RISHI SINHA |
| K081229 |
07/21/2008 |
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING |
SMITHS MEDICAL ASD, INC. |
BRIAN FARIAS |
| K081156 |
07/18/2008 |
CADD MEDICATION CASSETTE RESERVOIR |
SMITHS MEDICAL MD, INC. |
DAVID H SHORT |
| K080224 |
07/03/2008 |
KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK |
SOADCO, S.L. |
MARIA MITJANETA |
| K073249 |
07/25/2008 |
SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES |
SOLARIS MEDICAL TECHNOLOGY, INC. |
ALAN SCHWARTZ |
| K080778 |
07/10/2008 |
ENSPLINT TM BONE SCREW |
SONOMA ORTHOPEDIC PRODUCTS, INC. |
AMY CONUEL |
| K080122 |
07/11/2008 |
SOPRO 670 ARTHROSCOPIC PUMP |
SOPRO |
STEVE SALESKY |
| K080832 |
07/30/2008 |
STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
| K081524 |
07/29/2008 |
SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L |
SPECTRA MEDICAL DEVICES, INC. |
SCOTT HENDERSON |
| K081233 |
07/28/2008 |
T-STAT 303 ISCHEMIA MONITORING SYSTEM |
SPECTROS CORPORATION |
BILL CURNAN |
| K081418 |
07/14/2008 |
SPINAL ELEMENTS BUTTRESS PLATE SYSTEM |
SPINAL ELEMENTS, INC. |
KERRI DIMARTINO |
| K080971 |
07/02/2008 |
SPINESMITH CIMPLICITY SPINAL SYSTEM |
SPINE SMITH PARTNERS L.P. |
ROBERT JONES |
| K081132 |
07/14/2008 |
SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM |
SPINE SMITH PARTNERS L.P. |
ROBERT JONES |
| K081331 |
07/23/2008 |
FIXXSURE CROSS LINK |
SPINEWORKS, LLC |
J.D. WEBB |
| K081879 |
07/30/2008 |
SPSMEDICAL SPORVIEW PA CULTURE SET |
SPS MEDICAL SUPPLY CORP. |
GARY J SOCOLA |
| K080292 |
07/25/2008 |
EPICOR ABLATION SYSTEM |
ST. JUDE MEDICAL |
KAREN J MCKELVEY |
| K081719 |
07/18/2008 |
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM |
STANBIO LABORATORY |
KIRK JOHNSON |
| K080552 |
07/31/2008 |
CYTO-CHEX BCT |
Streck |
CARL THOMPSON |
| K080450 |
07/17/2008 |
STRYKER POWER TOOL NAVIGATOR ATTACHMENT |
STRYKER CORP. |
BECKY DITTY |
| K082014 |
07/28/2008 |
STRYKER SPINE AVS PL PEEK SPACERS |
STRYKER CORP. |
VIKKI M O'CONNOR |
| K072370 |
07/24/2008 |
SURGICRAFT SURGICAL MESH SYSTEM |
SURGICRAFT LTD. |
DONALD GUTHNER |
| K081129 |
07/28/2008 |
ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL |
SURGRX, INC. |
LINDA OLESON |
| K073303 |
07/02/2008 |
NORIAN DRILLABLE |
SYNTHES (USA) |
JEFFREY L DOW |
| K073115 |
07/15/2008 |
ORTHOMESH |
SYNTHES (USA) |
JEFFREY L DOW |
| K081205 |
07/01/2008 |
SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS |
SYNTHES (USA) |
KARL J NITTINGER |
| K081452 |
07/18/2008 |
SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM |
SYNTHES (USA) |
JILL R SHERMAN |
| K081700 |
07/17/2008 |
SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION |
SYNTHES (USA) |
AMNON TALMOR |
| K081353 |
07/23/2008 |
SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES |
SYNTHES (USA) |
KARL J NITTINGER |
| K081609 |
07/02/2008 |
CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237 |
TaiDoc Technology Corporation |
Yuhua Chen |
| K081714 |
07/25/2008 |
FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM |
TaiDoc Technology Corporation |
Yuhua Chen |
| K080897 |
07/15/2008 |
VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
TALLEY MEDICAL |
JACK VAN DYKE |
| K081099 |
07/15/2008 |
TEPHAFLEX ABSORBABLE SUTURE |
TEPHA, INC. |
MARY P LEGRAW |
| K073581 |
07/11/2008 |
ICI P AND S SERIES IR CAMERAS |
TEXAS INFRARED |
IAN P GORDON |
| K081429 |
07/30/2008 |
THD SLIDE |
THD SPA |
MAUREEN O'CONNELL |
| K081760 |
07/29/2008 |
RSVP PHANTOM PELVIS, MODEL TLP260 |
THE PHANTOM LABORATORY, INC. |
JOSHUA LEVY |
| K080822 |
07/02/2008 |
VU APOD INTERVERTABRAL BODY FUSION DEVICE |
THEKEN SPINE LLC |
DALE DAVISON |
| K071677 |
07/11/2008 |
SRT II MUSCLE STIMULATOR |
THERAPEUTIC INNOVATIONS, INC. |
HOWARD MANN |
| K081345 |
07/10/2008 |
AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY) |
THERMOGENESIS CORP. |
JOHN CHAPMAN, PHD |
| K081059 |
07/17/2008 |
AEQUALIS REVERSED SHOULDER PROSTHESIS |
TORNIER |
DAMIEN GUILLAUD |
| K081707 |
07/17/2008 |
AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS |
TORNIER, INC. |
JEFF ONDRLA |
| K072968 |
07/01/2008 |
STRESSGARD NIGHTGUARD |
TOTALGARD CORPORATION |
LOUIS P IZZI |
| K073159 |
07/23/2008 |
TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5 |
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. |
Diana Hong |
| K081790 |
07/24/2008 |
MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM |
TRINITY ORTHOPEDICS, LLC |
KEVIN A THOMAS |
| K080841 |
07/23/2008 |
COSMIC SYSTEM |
ULRICH GMBH & CO. KG |
MERLE SYMES |
| K072845 |
07/17/2008 |
PRECISION FLOW |
VAPOTHERM, INC. |
JONATHAN S KAHN |
| K081188 |
07/14/2008 |
TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K053310 |
07/03/2008 |
VASCON ROAMER MICROCATHETER |
VASCON LLC |
STEPHEN F VADAS |
| K081597 |
07/02/2008 |
MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM |
VERTEBRON, INC. |
LUIS NESPRIDO |
| K081567 |
07/03/2008 |
VERTEBRON SSP CERVICAL PLATING SYSTEM |
VERTEBRON, INC. |
LUIS NESPRIDO |
| K080814 |
07/24/2008 |
VOCO PROFLUORID VARNISH |
VOCO GMBH |
M.TH PLAUMANN |
| K080341 |
07/21/2008 |
ENDODRAPE(TM) |
VORTEK SURGICAL, LLC |
THOMAS SZYMCZAK |
| K080939 |
07/29/2008 |
SURGICAL HANDPIECES, MIKRO SAW HANDPIECES |
W & H DENTALWERK BUERMOOS GMBH |
GABRIELE WIENBECK |
| K081184 |
07/22/2008 |
GORE VIABIL BILILARY ENDOPROSTHESIS |
W.L. GORE & ASSOCIATES INC, MEDICAL PRODUCTS DIV. |
Michael Ivey |
| K080123 |
07/17/2008 |
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 |
WAKO CHEMICALS USA, INC. |
PETER PANFILI |
| K080125 |
07/18/2008 |
APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 |
WAKO CHEMICALS USA, INC. |
PETER PANFILI |
| K073383 |
07/10/2008 |
WELL LEAD REINFORCED ENDOTRACHEAL TUBE |
WELL LEAD MEDICAL INSTRUMENTS |
ARTHUR J WARD |
| K081905 |
07/15/2008 |
ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP |
Westmed, Inc. |
CHARLES M HART |
| K072136 |
07/15/2008 |
ULTRASONIC NEBULISER MODEL 2010 |
WILFRED KROMKER GMBH |
STEPHEN GORSKI |
| K081373 |
07/03/2008 |
EVOLVE EPS SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
THERESA LEISTER |
| K080465 |
07/18/2008 |
WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES |
WS FAR IR MEDICAL TECHNOLOGY CO., LTD. |
JENNIFER REICH |
| K081882 |
07/11/2008 |
MODIFICATION TO XYLOS SURGICAL MESH |
XYLOS CORPORATION |
GERRY ANN OSTER |
