| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K081549 |
06/03/2008 |
RX ACCUNET LP EMBOLIC PROTECTION SYSTEM |
ABBOTT LABORATORIES |
VIRGINIA SINGER |
| K081622 |
06/10/2008 |
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM |
ABBOTT SPINE, INC. |
MARITZA ELIAS |
| K081523 |
06/02/2008 |
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM |
ABBOTT VASCULAR-VASCULAR SOLUTIONS |
DANIELLE TAYLOR |
| K081697 |
06/17/2008 |
THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 |
ACCESS SCIENTIFIC, INC. |
ALBERT MISAJON |
| K081588 |
06/05/2008 |
RE-ZORB PLATING SYSTEM |
ACUTE INNOVATIONS LLC |
ALYSSA THOMAS |
| K081751 |
06/19/2008 |
ADIN DENTAL IMPLANTS SYSTEM |
ADIN DENTAL IMPLANTS SYSTEM LTD |
BENNY ARAZY |
| K081545 |
06/02/2008 |
ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 |
ADVANCED MEDICAL OPTICS, INC. |
KIM REGIS |
| K081681 |
06/17/2008 |
VITRECTOMY CUTTER AND ACCESSORIES |
ADVANCED MEDICAL OPTICS, INC. |
Evelyn De La Vega |
| K081650 |
06/12/2008 |
AERONEB GO NEBULIZER |
AEROGEN (IRELAND) LTD |
FRANK ENRIGHT |
| K081612 |
06/09/2008 |
AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS |
AESCULIGHT, LLC |
PAUL DIAZ |
| K081843 |
06/30/2008 |
ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 |
ALOKA CO., LTD. |
RICHARD CEHOVSKY |
| K081730 |
06/18/2008 |
NOVEL CERVICAL SPINAL SPACER SYSTEM |
ALPHATEC SPINE, INC. |
MARY SCANNERS |
| K081710 |
06/17/2008 |
APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE |
AMERICAN MEDICAL SYSTEMS |
DENISE THOMPSON |
| K081613 |
06/09/2008 |
SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS |
AMERICAN MEDICAL SYSTEMS, INC. |
SARAH PETERSON |
| K081767 |
06/20/2008 |
AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 |
AMNISURE INTERNATIONAL, LLC |
MICHAEL FRIEDMAN |
| K081841 |
06/30/2008 |
AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER |
AMPLIVOX, LTD. |
DANIEL KAMM |
| K081853 |
06/30/2008 |
OVERSTITCH ENDOSCOPIC SUTURE SYSTEM |
APOLLO ENDOSURGERY, INC. |
DENNIS MCWILLIAMS |
| K081724 |
06/18/2008 |
HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSULFATED GLYCOSAMINOGLYCAN) WOUND GEL |
APPLIED NUTRITIONALS |
ANITA PETITO |
| K081664 |
06/13/2008 |
NOMAD PRO X-RAY SYSTEM |
ARIBEX, INC. |
D. CLARK TURNER |
| K081541 |
06/02/2008 |
DERMABLATE EFFECT |
ASCLEPION LASER TECHNOLOGIES GMBH |
ANTJE KATZER |
| K081752 |
06/20/2008 |
EDGE PACS |
ASHVA TECHNOLOGIES, PVT. LTD |
CARL ALLETTO |
| K081666 |
06/13/2008 |
ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTS |
ASTRA TECH, INC. |
BETSY A BROWN |
| K081551 |
06/03/2008 |
TWIN NEUROTRAC-III |
ASTRO-MED, INC. |
ALFREDO BUSTAMANTE |
| K081718 |
06/18/2008 |
EXPRESS CHEST DRAIN |
ATRIUM MEDICAL CORP. |
KAREN HALL |
| K081820 |
06/27/2008 |
AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR |
AVALON LABORATORIES, LLC |
DAVID C FURR |
| K081742 |
06/19/2008 |
BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 |
BAXANO, INC. |
TRENA DEPEL |
| K081717 |
06/18/2008 |
TRICOS A RESORBABLE BONE SUBSTITUTE |
BAXTER HEALTHCARE CORP. |
VALERIE FOLLOWELL |
| K081721 |
06/18/2008 |
TRICOS A RESORBABLE SUBSTITUTE |
BAXTER HEALTHCARE CORP. |
BARBARA K BARBEAU |
| K081822 |
06/27/2008 |
COULTER 6C CELL CONTROL, MODELS 628027 & A59925 |
BECKMAN COULTER, INC. |
LOURDES COBA |
| K081641 |
06/11/2008 |
COULTER LIN-X LINEARITY CONTROL |
BECKMAN COULTER, INC. |
NANCY NADLER |
| K081526 |
06/02/2008 |
FLOWCARE TLG REAGENT |
BECKMAN COULTER, INC. |
NANCY NADLER |
| K081824 |
06/27/2008 |
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY |
BECTON, DICKINSON & CO. |
KATHRYN B CARR |
| K081825 |
06/27/2008 |
BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY |
BECTON, DICKINSON & CO. |
KATHRYN B CARR |
| K081547 |
06/02/2008 |
BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC |
BIO-MED U.S.A., INC. |
YOUNG CHI |
| K081729 |
06/18/2008 |
MODIFICATION TO GFX NERVE ABLATION SYSTEM |
BIOFORM MEDICAL, INC. |
LORI HAYS |
| K081818 |
06/27/2008 |
BIOLOK MICRO-LOK IMPLANT SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
MICHAEL DAVIS |
| K081835 |
06/27/2008 |
ACTICARE IC AND TSE |
BIOINDUCTION LIMITED |
KRISTA OAKES |
| K081589 |
06/05/2008 |
WATERLASE, VERSION 3.0 |
BIOLASE TECHNOLOGY, INC. |
IOANA RIZOIU |
| K081636 |
06/11/2008 |
PEEK-OPTIMA ALIF SPACER |
BIOMET SPINE |
VIVIAN KELLY |
| K081787 |
06/24/2008 |
CAMLAB CRANIAL ORTHOSIS HELMET |
BIOSCULPTOR CORPORATION |
MARK MAZLOFF |
| K081656 |
06/12/2008 |
VISUALASE THERMAL THERAPY SYSTEM |
BIOTEX, INC. |
ROGER MCNICHOLS |
| K081684 |
06/17/2008 |
BLACKSTONE PEDICLE SCREW SYSTEM |
BLACKSTONE MEDICAL, INC. |
WHITNEY G TORNING |
| K081849 |
06/30/2008 |
BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE |
BLACKSTONE MEDICAL, INC. |
WHITNEY G TORNING |
| K081550 |
06/03/2008 |
BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO |
BONART CO. LTD. |
ERIC L ONG |
| K081733 |
06/19/2008 |
10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890 |
BOSTON SCIENTIFIC CORP. |
WING NG |
| K081739 |
06/19/2008 |
2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT |
BOSTON SCIENTIFIC CORP. |
Marybeth Gamber |
| K081576 |
06/05/2008 |
BLAZER DX-20 DIAGNOSTIC CATHETER |
BOSTON SCIENTIFIC CORP. |
RONALD C ALLEN |
| K081777 |
06/23/2008 |
VENTRIO HERNIA PATCH |
C.R. BARD, INC. |
STEPHANIE BAKER |
| K081855 |
06/30/2008 |
IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) |
CANADA, INC. |
FEDERICO FORERO |
| K081648 |
06/12/2008 |
DIGITAL RADIOGRAPHY CXDI-60G |
CANON, INC. |
SHEILA DRISCOLL |
| K081837 |
06/30/2008 |
AVEA VENTILATOR |
CARDINAL HEALTH 207, INC. |
ANDRE VON MULLER |
| K081670 |
06/13/2008 |
THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK |
CARDINAL HEALTH 207, INC. |
ANDRE VON MULLER |
| K081836 |
06/30/2008 |
CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM |
CARESTREAM HEALTH,INC. |
CHRISTINE EHMANN |
| K081531 |
06/02/2008 |
AOC SOLUBLE IMPLANT MATERIAL |
CEREMED, INC. |
TADEUSZ WELLISZ |
| K081619 |
06/09/2008 |
CHROMOLITE EP |
CHROMOGENEX TECHNOLOGIES LIMITED |
PETER R BEVAN |
| K081677 |
06/17/2008 |
SAVI APPLICATOR KIT |
CIANNA MEDICAL, INC. |
GARY MOCNIK |
| K081602 |
06/06/2008 |
DIZZYFIX |
CLEARWATER CLINICAL LIMITED |
MATTHEW BROMWICH |
| K081606 |
06/06/2008 |
BAHA INTENSO |
COCHLEAR AMERICAS |
SEAN BUNDY |
| K081537 |
06/02/2008 |
CFS FLEXIBLE |
COMFORT AND FLEXIBLE SYSTEMS |
JAY MANSOUR |
| K081556 |
06/03/2008 |
CADSTREAM, VERSION 5.0 |
CONFIRMA, INC. |
BRENT LEWIS |
| K081644 |
06/12/2008 |
BEAMER ARGON PROBE |
CONMED CORPORATION |
KAREN PROVENCHER |
| K081580 |
06/05/2008 |
BEAMER ARGON SNARE PROBE |
CONMED CORPORATION |
KAREN PROVENCHER |
| K081634 |
06/11/2008 |
CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL |
CONMED CORPORATION |
SHAWN RIEDEL |
| K081768 |
06/20/2008 |
COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES |
COOK INCORPORATED |
SUSANNE GALIN |
| K081690 |
06/17/2008 |
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER |
COOK, INC. |
NATHAN SIMON |
| K081564 |
06/04/2008 |
CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTENSION |
CREASPINE |
CYNTHIA J NOLTE |
| K081762 |
06/20/2008 |
CURBELL PATIENT MONITORING CABLES |
CURBELL ELECTRONICS INC. |
Kevin Walls |
| K081816 |
06/26/2008 |
VOCALIS AND VOCALIS SM |
CYTOPHIL INC |
Greg Johnson |
| K081815 |
06/26/2008 |
VOCALIS GEL |
CYTOPHIL INC |
Greg Johnson |
| K081829 |
06/27/2008 |
CAPIMAGE |
DANISH DIAGNOSTIC DEVELOPMENT A/S |
NIELS SORENSEN |
| K081842 |
06/30/2008 |
ENGSTROM CARESTATION, ENGSTROM PRO |
DATEX-OHMEDA, INC. |
ADRIENNE LENZ |
| K081844 |
06/30/2008 |
GE DATEX-OHMEDA AVANCE |
DATEX-OHMEDA, INC. |
ADRIENNE LENZ |
| K081669 |
06/13/2008 |
IMPROVED COMFORT-FIT NIGHTGUARD |
DENTEK ORAL CARE, INC. |
HOWARD M HOLSTEIN |
| K081620 |
06/09/2008 |
MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
| K081546 |
06/02/2008 |
SMALL BONE LOCKING PLATING SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K081758 |
06/20/2008 |
HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015 |
DEPUY SPINE, INC. |
HANDE TUFAN |
| K081584 |
06/05/2008 |
DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY |
DERMA SCIENCES, INC. |
MARY MCNAMARA-CULLINANE |
| K081746 |
06/19/2008 |
D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT |
DIAGNOSTIC HYBRIDS, INC. |
GAIL R GOODRUM |
| K081685 |
06/17/2008 |
LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG |
DIASORIN, INC. |
CAROL A DEPOUW |
| K081687 |
06/17/2008 |
LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG |
DIASORIN, INC. |
CAROL A DEPOUW |
| K081743 |
06/19/2008 |
CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS |
DRAEGER MEDICAL AG & CO. KG |
KARIN LUEBBERS |
| K081694 |
06/17/2008 |
DENJECTOR |
DXM CO., LTD. |
MARIA GRIFFIN |
| K081569 |
06/04/2008 |
DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS |
DYNAREX CORPORATION |
VIJAY SACHDEV |
| K081847 |
06/30/2008 |
PICASSO MASTER, ECT AND MASTER 3D |
E-WOO TECHNOLOGY |
DAVE KIM |
| K081652 |
06/12/2008 |
CLAROS NANO DENTAL LASER SYSTEM |
ELEXXION AG |
HOLGER ERNST |
| K081565 |
06/04/2008 |
INTEGRE PRO, MODEL L2RY |
Ellex Medical Pty. Ltd. |
KEVIN HOWARD |
| K081679 |
06/17/2008 |
REVELATION HIP STEM, MODELS, 427-01, 427-02; LINEAR HIP STEM, MODELS 425-00, 425-05 |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K081542 |
06/02/2008 |
MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM |
Entellus Medical, Inc. |
Sew-Wah Tay |
| K081703 |
06/17/2008 |
MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS |
ENTRA HEALTH SYSTEMS, LTD. |
CARLOS GONZALEZ |
| K081796 |
06/25/2008 |
EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM |
EPS BIO TECHNOLOGY CORP. |
Y.C. LEI |
| K081794 |
06/25/2008 |
MODEL 7340 ULTRASOUND SYSTEM |
ESAOTE, S.P.A. |
CARRI GRAHAM |
| K081741 |
06/19/2008 |
NEUROLINK IP, MODEL PK1113 |
EXCEL-TECH LTD. (XLTEK) |
GOLDY SINGH |
| K081578 |
06/05/2008 |
ACCELA SYSTEM |
GENESIS BIOSYSTEMS, INC. |
STEPHEN J MACDONALD |
| K081640 |
06/11/2008 |
GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS |
GIMMI GMBH |
KEN BLAKE |
| K081838 |
06/30/2008 |
GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING |
GISH BIOMEDICAL, INC. |
MARTIN SELLERS |
| K081821 |
06/27/2008 |
D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP) |
GLOBAL PATHOGEN SOLUTIONS INC. |
CARSON LINKER |
| K081712 |
06/17/2008 |
FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700 |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
Diana Hong |
| K081766 |
06/20/2008 |
PKS OMNI INSTRUMENT |
GYRUS-ACMI L.P. |
LORRAINE CALZETTA |
| K081738 |
06/19/2008 |
ULTRASONIC NEBULIZER SYSTEM, MODEL HL100 |
HEALTH & LIFE CO., LTD. |
SAMUEL PIPER |
| K081603 |
06/06/2008 |
DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 |
HEARTFORCE MEDICAL, INC. |
ARTHUR WARD |
| K081745 |
06/19/2008 |
ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLEWAITE |
| K081572 |
06/04/2008 |
SMARTSIGNS MINPULSE |
HUNTLEIGH HEALTHCARE LTD. |
ROBERT MCCARTHY |
| K081806 |
06/26/2008 |
IDI IMPLANT SYSTEM |
IDI BIOMEDICAL LLC |
ANGELA BLACKWELL |
| K081630 |
06/11/2008 |
MAMMO WORKSTATION |
IMAGE DIAGNOST INTERNATIONAL GMBH |
PETER HEINLEIN |
| K081698 |
06/17/2008 |
MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) |
IMAGE STREAM MEDICAL, INC. |
CHAS BURR |
| K081653 |
06/12/2008 |
MDI MII ONE-PIECE IMPLANT, 2.9MM |
IMTEC CORP. |
GLENN GEE |
| K081788 |
06/24/2008 |
INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200 |
INNOCHIPS TECHNOLOGY CO., LTD. |
BRANDON CHOI |
| K081782 |
06/23/2008 |
COLLIEVA |
INNOCOLL PHARMACEUTICALS |
AARON WYSE |
| K081740 |
06/19/2008 |
HEMOBAND, MODELS HB-NS AND HB-NSXL |
INNOVATIONS FOR ACCESS, INC. |
HAL J OIEN |
| K081691 |
06/17/2008 |
INOMAX DS (DELIVERY SYSTEM) |
INO THERAPEUTICS LLC |
DAVID TRUEBLOOD |
| K081651 |
06/12/2008 |
INSTRUMED RONGEUR |
INSTRUMED INTERNATIONAL, INC. |
MICHAEL MASSONG |
| K081693 |
06/17/2008 |
NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS |
INSTRUMENTATION INDUSTRIES, INC. |
DORIS F WALTER |
| K081778 |
06/23/2008 |
NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS |
INSTRUMENTATION INDUSTRIES, INC. |
DORIS F WALTER |
| K081635 |
06/11/2008 |
INTEGRA MESHED BILAYER WOUND MATRIX |
INTEGRA LIFESCIENCES CORP. |
DIANA M BORDON |
| K081773 |
06/23/2008 |
OSV II |
INTEGRA NEUROSCIENCES IMPLANTS S.A. |
JON CAPAROTTA |
| K081614 |
06/09/2008 |
ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES |
INTERBODY INNOVATIONS, LLP |
J.D. WEBB |
| K081579 |
06/05/2008 |
INVENTUS IMPLANT SYSTEM |
INVENTUS CO., LTD |
ROSHANA AHMED |
| K081673 |
06/13/2008 |
DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE |
IONICS MEDICAL CORP. |
M. LAINE MASHBUM |
| K081817 |
06/26/2008 |
ACCELL TBM-R |
ISOTIS ORTHOBIOLOGICS, INC |
JUDITH E O'GRADY |
| K081557 |
06/03/2008 |
PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER |
JDDB MANUFACTURING, INC |
JACQUIN C YOUNGBLOOD-JOHNSON |
| K081658 |
06/12/2008 |
POWDER-FREE VINYL EXAMINATION GLOVES |
JIANGSU ALFA GLOVE CO., LTD |
CHU XIAOAN |
| K081655 |
06/12/2008 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (LIGHT YELLOW) |
JIANGSU CUREGUARD GLOVE CO., LTD. |
CHU XIAOAN |
| K081657 |
06/12/2008 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW) |
JIANGSU CUREGUARD GLOVE CO., LTD. |
CHU XIAOAN |
| K081755 |
06/20/2008 |
FUSION MEDICAL STI |
JOHN RICCIO |
JOHN RICCIO |
| K081695 |
06/17/2008 |
DMC COMPOSITE |
KERR CORP. |
Wendy Garman |
| K081598 |
06/06/2008 |
SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE |
KFX MEDICAL |
GAYLE HIROTA |
| K081678 |
06/17/2008 |
CONMED BEAMER SYSTEM C600 |
KLS MARTIN GMBH + CO. KG |
BERNHARD HUG |
| K081797 |
06/25/2008 |
IMAGE STORAGE SYSTEM, MODEL KSS-400 |
KONAN MEDICAL, INC. |
GEORGE MYERS |
| K081637 |
06/11/2008 |
LASER IMAGER DRYPRO MODEL 873 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
RUSSELL MUNVES |
| K081587 |
06/05/2008 |
KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530 |
KRELL PRECISION (YANG ZHOU) CO., LTD. |
CHARLIE MACK |
| K081583 |
06/05/2008 |
CLEARFIL SA CEMENT |
KURARAY MEDICAL INC. |
KOJI NISHIDA |
| K081781 |
06/24/2008 |
NUWAV |
LABORIE MEDICAL TECHNOLOGIES, CORP |
BARBARA MORNET |
| K081708 |
06/17/2008 |
TAXI ENDOSCOPIC GUIDEWIRE |
LAKE REGION MFG., INC. |
DEEP PAL |
| K081705 |
06/17/2008 |
LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN |
LANG DENTAL MFG. CO., INC. |
CHAH M SHEN |
| K081552 |
06/03/2008 |
SKYLINE 55 |
LARSEN & TOUBRO LIMITED |
A B DESHPANDE |
| K081570 |
06/04/2008 |
DPL THERAPY SYSTEM |
LED TECHNOLOGIES, LLC |
LEWIS WARD |
| K081848 |
06/30/2008 |
LIPOSE FAT TRANSFER SYSTEM |
LIPOSE CORP. |
ALAN CURTIS |
| K081704 |
06/17/2008 |
SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS |
LUMENIS, INC. |
TINA MAYER |
| K081659 |
06/12/2008 |
RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K081672 |
06/13/2008 |
C-INSIGHT |
MAZOR SURGICAL TECHNOLOGIES LTD. |
AHAVA STEIN |
| K081775 |
06/23/2008 |
THE MEDCOMP .010 VASCULAR GUIDEWIRES |
MEDCOMP |
LISA WEIKERT |
| K081593 |
06/06/2008 |
POWER ASPIRATOR, MODEL LS2 OR LS2DP |
MEDICAL DEVICE RESOURCE CORP. |
MEL KIMSEY |
| K081639 |
06/11/2008 |
ICSI CUMULASE |
MEDICULT A/S |
RONALD G LEONARDI |
| K081559 |
06/03/2008 |
GENESIS |
MEDISISS |
BRANDI JAMES |
| K081536 |
06/02/2008 |
MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED |
MEDISIZE BV |
|
| K081676 |
06/17/2008 |
SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
KYUNG-AM SHIM |
| K081594 |
06/06/2008 |
MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K081804 |
06/26/2008 |
PIONEER PLUS CATHETER |
MEDTRONIC INC. |
CATHERINE PRIESTLEY |
| K081784 |
06/24/2008 |
MASTERGRAFT PUTTY |
MEDTRONIC SOFAMOR DANEK |
MICHELLE OBENAUER |
| K081573 |
06/05/2008 |
MEDTRONIC EXPORT AP CATHETER |
MEDTRONIC VASCULAR |
TARA N TURNEY |
| K081791 |
06/25/2008 |
E-Z CLEAN ELECTROSURGICAL ELECTRODE |
MEGADYNE MEDICAL PRODUCTS, INC. |
RONDA K MAGNESON |
| K081527 |
06/02/2008 |
LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT |
MILLIPORE CORPORATION |
ALISHA VU |
| K081800 |
06/25/2008 |
T12S TELEMETRY TRANSMITTER |
MORTARA INSTRUMENT, INC. |
LAURA SPIEGELHOFF |
| K081811 |
06/26/2008 |
CARE3 PLUS |
NAKANISHI, INC. |
KEITH BARRITT |
| K081553 |
06/03/2008 |
AED BIPOLAR FORCEPS, MODEL 13-1646 |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
GAYLE M BUTLER |
| K081851 |
06/30/2008 |
NEOSS ACCESS ABUTMENTS |
NEOSS, LTD. |
FREDRIK ENGMAN |
| K081628 |
06/10/2008 |
MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO |
NEW STAR LASERS, INC. |
NATALIE R VOLLRATH |
| K081665 |
06/13/2008 |
MILLENIUM II |
NEXT MOBILITY, LLC |
JOSEPH AZARY |
| K081792 |
06/25/2008 |
SPY ANALYSIS TOOLKIT, MODEL SA9000 |
NOVADAQ TECHNOLOGIES, INC. |
ALLISON MANNERS |
| K081680 |
06/17/2008 |
NUCLEUS-X, MODEL 230X |
NUMED, INC. |
NICHELLE LAFLESH |
| K081611 |
06/09/2008 |
NUVASIVE COROENT SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K081615 |
06/09/2008 |
OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN |
OLYMPUS AMERICA, INC. |
STEPHANIE G DONNELLY |
| K081709 |
06/17/2008 |
OLYMPUS AFP - ALPHA-FETOPROTEIN |
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) |
STEPHANIE G DONNELLY |
| K081561 |
06/03/2008 |
OSFERION D |
OLYMPUS TERUMO BIOMATERIALS CORPORATION |
STACY A KLUESNER |
| K081776 |
06/23/2008 |
CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM |
OMEGA CRITICAL CARE LIMITED |
ALAN SHORT |
| K081770 |
06/23/2008 |
BLACK WIDOW ANTERIOR BUTTRESS PLATE |
OMNI SURGICAL, L.P. |
JOSHUA KAUFMAN |
| K081654 |
06/12/2008 |
HEM-9000AI |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
| K081744 |
06/19/2008 |
PASCAL SYNTHESIS DELIVERY SYSTEM |
OPTIMEDICA CORPORATION |
JUDY F GORDON |
| K081543 |
06/02/2008 |
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM |
Ortho-Clinical Diagnostics, Inc. |
LEAH VAN DE WATER |
| K081786 |
06/24/2008 |
ZIOCERA & CONVERTIBLE SYSTEM |
OSSTEM IMPLANT CO LTD |
MINJOO KIM |
| K081575 |
06/05/2008 |
HU/HS/HG PROSTHETIC SYSTEM |
OSSTEM IMPLANT CO.,LTD |
MINJOO KIM |
| K081749 |
06/19/2008 |
AVANTE Z ZIRCONIA (AS)3 BLOCKS |
PENTRON CERAMICS, INC. |
CINDY SALTER |
| K081540 |
06/02/2008 |
ZEGRA POSTURE TRAINER |
PETER FISCHER |
PETER FISCHER |
| K081830 |
06/30/2008 |
IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1 |
PHADIA AB |
MARTIN MANN |
| K081532 |
06/02/2008 |
PHARMAJET NEEDLE-FREE INJECTION SYSTEM |
PHARMAJET, INC. |
RON BAUER |
| K081601 |
06/06/2008 |
VEO MULTIGAS MONITOR FOR POCKET PC |
PHASEIN AB |
DAVID WEISSBURG |
| K081793 |
06/25/2008 |
PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841A INTELLIVUE TELEMETRY SYSTEM TRANSCEIVER |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
MARKUS STACHA |
| K081802 |
06/26/2008 |
CX50 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
ROB BUTLER |
| K081661 |
06/13/2008 |
HD15 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
|
| K081558 |
06/03/2008 |
PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN GILBERT |
| K081699 |
06/17/2008 |
PLANMECA SOVEREIGN |
PLANMECA USA, INC. |
BOB PIENKOWSKI |
| K081826 |
06/27/2008 |
INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
| K081720 |
06/18/2008 |
PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS |
PRIME HERBS CORPORATION |
GENEVIEVE HSIA |
| K081633 |
06/11/2008 |
PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS |
PRIMED MEDICAL PRODUCTS INC. |
RAYMOND G MARUSYK |
| K081555 |
06/03/2008 |
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED |
PROCTER & GAMBLE CO. |
LENORE FAULHABER |
| K081810 |
06/26/2008 |
PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL |
PULPDENT CORPORATION |
KENNETH J BERK |
| K081592 |
06/06/2008 |
POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES |
QUALITY GALLANT SDN. BHD. |
SEAH BEE HOON |
| K081756 |
06/20/2008 |
OCULAR RESPONSE ANALYZER |
REICHERT INC. |
SANDRA BROWN |
| K081779 |
06/23/2008 |
GOLOX-93 |
RESPIRONICS, INC. |
ZITA A YURKO |
| K081539 |
06/02/2008 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR |
RICH MOUNTAIN MEDICAL PRODUCTS, INC. |
MICHELLE SHIH |
| K081535 |
06/02/2008 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR |
RICH MOUNTAIN MEDICAL PRODUCTS, INC. |
MICHELLE SHIH |
| K081538 |
06/02/2008 |
TUTOPATCH, TUTOMESH |
RTI BIOLOGICS, INC. |
TRAVIS AROLA |
| K081702 |
06/17/2008 |
CARBOXYLATE CEM, PHOSPHATE CEM |
S & C POLYMER GMBH |
CHRISTIAN BOETTCHER |
| K081548 |
06/02/2008 |
ANTERIOR BUTTRESS PLATE |
SCIENT'X USA, INC. |
JOHN SANDERS |
| K081533 |
06/02/2008 |
SENTINEL PLASMAPROTEINS CAL 3X |
SENTINEL CH. SpA |
FABIO ROTA |
| K081734 |
06/19/2008 |
SYNGO IMAGING (VERSION V31) |
SIEMENS AG, MEDICAL SOLUTIONS |
|
| K081731 |
06/19/2008 |
DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32 |
SIEMENS HEALTHCARE DIAGNOSTICS |
VICTOR M CARRIO |
| K081643 |
06/12/2008 |
DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 |
SIEMENS HEALTHCARE DIAGNOSTICS |
YUK-TING LEWIS |
| K081769 |
06/23/2008 |
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 |
SIEMENS HEALTHCARE DIAGNOSTICS |
RADAMES RIESGO |
| K081732 |
06/19/2008 |
INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS |
SIEMENS HEALTHCARE DIAGNOSTICS |
KATHLEEN A DRAY-LYONS |
| K081683 |
06/17/2008 |
LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 |
SIEMENS HEALTHCARE DIAGNOSTICS |
YUK-TING LEWIS |
| K081716 |
06/18/2008 |
ADVIA CENTAUR HAVM ASSAY |
Siemens Healthcare Diagnostics Inc. |
MARY SEEGER |
| K081789 |
06/25/2008 |
DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR |
Siemens Healthcare Diagnostics Inc. |
HELEN M LEE |
| K081808 |
06/26/2008 |
ACUNAV V ULTRASOUND CATHETER |
SIEMENS MEDICAL SOLUTIONS USA INC. |
SHELLY PEARCE |
| K081722 |
06/18/2008 |
YSIO |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
GARY JOHNSON |
| K081631 |
06/11/2008 |
SINTEA BIOTECH PLS MULTI-AXIAL SCREWS |
SINTEA BIOTECH, INC. |
DANIELLE WERNIKOWSKI |
| K081566 |
06/04/2008 |
SMITH & NEPHEW OXINIUM DH FEMORAL HEADS |
SMITH & NEPHEW, INC. |
JASON SELLS |
| K081774 |
06/23/2008 |
SOLX 790 TITANIUM SAPPHIRE LASER |
SOLX INC. |
DOUG ADAMS |
| K081832 |
06/27/2008 |
ENSPLINTCMX CLAVICLE PIN |
SONOMA ORTHOPEDIC PRODUCTS, INC. |
CHARLES NELSON |
| K081524 |
06/02/2008 |
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 |
| K081711 |
06/17/2008 |
LUCENT MAGNUM+ |
SPINAL ELEMENTS, INC. |
KERRI DIMARTINO |
| K081645 |
06/12/2008 |
AGILIS NXT STEERABLE INTRODUCER, MODEL G408324 |
ST. JUDE MEDICAL |
MAC MCKEEN |
| K081803 |
06/26/2008 |
ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM |
ST. JUDE MEDICAL |
ANDREA HUDACK |
| K081719 |
06/18/2008 |
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM |
STANBIO LABORATORY |
KIRK JOHNSON |
| K081814 |
06/26/2008 |
REPROCESSED ENT SHAVERS |
STERILMED, INC. |
JOSHUA CLARIN |
| K081586 |
06/05/2008 |
REPROCESSED EXTERNAL FIXATION DEVICE |
STERILMED, INC. |
JOSHUA CLARIN |
| K081600 |
06/06/2008 |
STERIS RESERT XL TEST STRIP |
STERIS Corporation |
JOHN SCOVILLE |
| K081805 |
06/26/2008 |
CUFFALERT |
SUNMED |
PAUL DRYDEN |
| K081747 |
06/19/2008 |
MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM |
SYNTHES (USA) |
ANDREA M TASKER |
| K081700 |
06/17/2008 |
SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION |
SYNTHES (USA) |
AMNON TALMOR |
| K081623 |
06/10/2008 |
SYNTHES RIB FIXATION SYSTEM |
SYNTHES (USA) |
AMNON TALMOR |
| K081568 |
06/04/2008 |
ANTEGRA-T |
SYNTHES SPINE CO.LP |
KIRSTEN STOWELL |
| K081610 |
06/09/2008 |
SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER |
SYSMEX AMERICA, INC. |
NINA GAMPERLING |
| K081609 |
06/09/2008 |
CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237 |
TaiDoc Technology Corporation |
Yuhua Chen |
| K081714 |
06/18/2008 |
FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM |
TaiDoc Technology Corporation |
Yuhua Chen |
| K081715 |
06/18/2008 |
FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM |
TaiDoc Technology Corporation |
Yuhua Chen |
| K081674 |
06/17/2008 |
BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG) |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K081827 |
06/27/2008 |
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K081760 |
06/20/2008 |
RSVP PHANTOM PELVIS, MODEL TLP260 |
THE PHANTOM LABORATORY, INC. |
JOSHUA LEVY |
| K081608 |
06/09/2008 |
PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS) |
TOBY ORTHOPAEDICS, LLC |
AL WEISENBORN |
| K081554 |
06/03/2008 |
TOKUYAMA TISSUECARE |
TOKUYAMA DENTAL CORPORATION |
KEITH BARRITT |
| K081707 |
06/17/2008 |
AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS |
TORNIER, INC. |
JEFF ONDRLA |
| K081621 |
06/09/2008 |
INFX-8000C (INFINIX CC-I AND VC-I) |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K081624 |
06/10/2008 |
INFX-8000F (INFINIX CSI AND INFINIX DPI) |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K081582 |
06/05/2008 |
INFX-8000V, INFINIX-CFI AND INFINIX VFI |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K081790 |
06/25/2008 |
MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM |
TRINITY ORTHOPEDICS, LLC |
KEVIN A THOMAS |
| K081852 |
06/30/2008 |
TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11 |
TRULY INSTRUMENT LIMITED |
YANG JIANHAO |
| K081726 |
06/18/2008 |
TYSONBIO LINK HEALTH MANAGEMENT SYSTEM |
TYSON BIORESEARCH, INC. |
WEN-HAI TSAI |
| K081813 |
06/26/2008 |
UNIVERSAL COMPRESSION FRACTURE REPAIR SYSTEM |
U.S. IMPLANT SOLUTIONS, LLC |
SCOTT GARRETT |
| K081846 |
06/30/2008 |
GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951 |
VASCULAR SOLUTIONS, INC. |
CHARMAINE SUTTON |
| K081560 |
06/03/2008 |
VASCUTEK CANNULA GRAFT, MODEL CGS2008S |
VASCUTEK LTD. |
KAREN KELSO |
| K081626 |
06/10/2008 |
FLOWPICC CONSOLE |
VASONOVA INC. |
SORIN GRUNWALD |
| K081625 |
06/10/2008 |
FLOWPICC STYLET |
VASONOVA INC. |
SORIN GRUNWALD |
| K081591 |
06/06/2008 |
NEUCODIA |
VERISCI CORPORATION |
GEORGE HU |
| K081757 |
06/20/2008 |
VERISTA IMAGING ISOCAM II GAMMA CAMERA |
VERISTA IMAGING INC. |
SUSAN D GOLDSTEIN-FALK |
| K081754 |
06/20/2008 |
OVA1 TEST |
VERMILLION |
GILLIAN CRUTCHER |
| K081845 |
06/30/2008 |
IVENT101 |
VERSAMED MEDICAL SYSTEMS, INC. |
JERRY KORTEN |
| K081597 |
06/06/2008 |
MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM |
VERTEBRON, INC. |
LUIS NESPRIDO |
| K081567 |
06/04/2008 |
VERTEBRON SSP CERVICAL PLATING SYSTEM |
VERTEBRON, INC. |
LUIS NESPRIDO |
| K081823 |
06/27/2008 |
MASTERSCREEN PAED - BABY BODY |
VIASYS HEALTHCARE GMBH |
THOMAS RUST |
| K081725 |
06/18/2008 |
ENTERAL PUMP SET, MODEL 20-1010 |
VIASYS MEDSYSTEMS |
STEPHANIE WASIELEWSKI |
| K081713 |
06/17/2008 |
VERTEBRAL ACCESS SYSTEM BY VIDACARE |
VIDACARE CORPORATION |
GRACE HOLLAND |
| K081585 |
06/05/2008 |
ENDOSCOPY VIDEO CAMERA SYSTEM |
VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS |
CHRISTINE E NICHOLS |
| K081799 |
06/25/2008 |
GORE TRI-LOBE BALLOON CATHETER |
W. L. GORE & ASSOCIATES, INC. |
KANU H VADODARIA |
| K081748 |
06/19/2008 |
ONEPLANT DENTAL IMPLANT SYSTEM |
WARANTEC CO., LTD. |
DANIEL KAMM |
| K081647 |
06/12/2008 |
ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS |
XODUS MEDICAL, INC. |
BRENDA NIEL |
| K081590 |
06/06/2008 |
YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J |
YA HORNG ELECTRONIC CO., LTD. |
STEVEN CHANG |
| K081759 |
06/20/2008 |
NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES, ZIMMER UNIVERSAL LOCKING SYSTEM, 3.5MM TIVANIUM TI-6AL-4V |
ZIMMER GMBH |
ERIC S PITTMAN |
| K081850 |
06/30/2008 |
BISQUE ZIRCONIA BLANKS, TYPE BYZ |
ZIRCAR ZIRCONIA, INC. |
STUART R GOLDMAN |
| K081574 |
06/05/2008 |
ZOLL R SERIES |
ZOLL MEDICAL CORPORATION |
EILEEN M BOYLE |
| K081828 |
06/27/2008 |
ZOLL R SERIES BLS DEFIBRILLATOR |
ZOLL MEDICAL CORPORATION |
EILEEN M BOYLE |
