| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K072824 |
10/23/2007 |
FOX SV PTA CATHETER |
ABBOTT LABORATORIES |
GEORGE J PRENDERGAST |
| K070296 |
10/03/2007 |
VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM |
ACE VISION GROUP |
IAN GORDON |
| K063295 |
10/12/2007 |
ACON UTI URINARY TRACT INFECTION TEST STRIPS |
ACON LABORATORIES, INC. |
JINN-NAN LIN |
| K072519 |
10/23/2007 |
ACTIVATOR V SPINAL ADJUSTING INSTRUMENT |
ACTIVATOR METHODS INTERNATIONAL, LTD. |
DEBBIE KOENEMAN |
| K071230 |
10/03/2007 |
APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600 |
ADVANCED BRAIN MONITORING, INC. |
DANIEL J LEVENDOWSKI |
| K072462 |
10/11/2007 |
WIDE SPACED QUATTRODE LEADS |
ADVANCED NEUROMODULATION SYSTEMS |
MIA M WARE |
| K072680 |
10/25/2007 |
DRYSTAR AXYS, MODEL EYZ4E |
AGFA HEALTHCARE CORPORATION |
PATRICK J LYNCH |
| K062932 |
10/19/2007 |
AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER |
AHLSTROM MOUNT HOLLY SPRINGS LLC |
HEATHER MOWERS |
| K072035 |
10/16/2007 |
RESOLVE UVB PHOTOTHERAPY SYSTEM |
ALLUX MEDICAL |
LLOYD H GRIESE |
| K072699 |
10/05/2007 |
ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS: ACCENT, ACCENT XL |
ALMA LASERS LTD. |
A WORDEN |
| K072081 |
10/24/2007 |
ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM |
ALPHATEC SPINE, INC. |
MARY STANNERS |
| K071990 |
10/29/2007 |
VALEO CERVICAL PLATE SYSTEM |
AMEDICA CORP. |
Glenn Stiegman |
| K070411 |
10/01/2007 |
AMSURE NEBULIZER |
AMSINO INTERNATIONAL, INC. |
CHING C SEAH |
| K072225 |
10/12/2007 |
ANGIOSCULPT PTA SCORING BALLOON CATHETER |
ANGIOSCORE, INC. |
MELINDA SWANSON |
| K071128 |
10/10/2007 |
SCANSCOPE XT SYSTEM |
APERIO TECHNOLOGIES |
PERRY JOHNSTON |
| K070865 |
10/23/2007 |
EXPANDING VASCULAR SHEATH |
APPLIED MEDICAL |
CHERYL BLAKE |
| K072674 |
10/05/2007 |
KII TROCAR SYSTEM |
APPLIED MEDICAL RESOURCES CORP. |
FRANS VANDENBROEK |
| K071398 |
10/04/2007 |
SCANVIEW, MODEL SC-300 |
APPLIED SPECTRAL IMAGING, LTD. |
SILVIA STOLARSKI |
| K071491 |
10/10/2007 |
ARROW INTERNATIONAL, INC., SURGICAL DRAPES |
ARROW INTL., INC. |
KARL J NITTINGER |
| K072865 |
10/23/2007 |
MODIFICATON TO: ARTHROCARE ARTHROWANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K072705 |
10/23/2007 |
ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301J |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K063788 |
10/15/2007 |
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS |
ASCENT HEALTHCARE SOLUTIONS |
KATIE BRAY |
| K070059 |
10/02/2007 |
REPROCESSED TROCARS |
ASCENT HEALTHCARE SOLUTIONS |
MOIRA BARTON |
| K072624 |
10/01/2007 |
ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT |
ASTRA TECH AB |
LINDA SCHULZ |
| K071946 |
10/05/2007 |
ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS |
ATLANTIS COMPONENTS, INC. |
BETSY A BROWN |
| K072426 |
10/19/2007 |
ATLAS SPINE PEDICLE SCREW SYSTEM |
ATLAS SPINE LLC |
JEANETTE G DAILEY |
| K070773 |
10/11/2007 |
AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR |
AXYA MEDICAL, INC. |
HOWARD L SCHRAYER |
| K071909 |
10/18/2007 |
PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R |
BARKEY GMBH & CO. KG |
THOMAS BARKEY |
| K072612 |
10/26/2007 |
ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647 |
BECKMAN COULTER, INC. |
RACHELLE PARSONS |
| K071681 |
10/04/2007 |
CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554 |
BECKMAN COULTER, INC. |
LOURDES COBA |
| K071561 |
10/12/2007 |
HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D |
BEIJING NORTH POLE DENTAL HANDPIECE CO., LTD |
Diana Hong |
| K072087 |
10/05/2007 |
BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24 |
BELIMED SAUTER AG |
HANS STADLER |
| K072294 |
10/25/2007 |
SYSTEM-MINI, MODELS: 390, E30 |
BIO-MEDICAL RESEARCH, LTD. |
ANNE-MARIE KEENAN |
| K072358 |
10/31/2007 |
BIOPLEX VASCULITIS KIT |
Bio-Rad Laboratories |
PRIYA BONDRE |
| K071638 |
10/10/2007 |
BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
LINDA K SCHULZ |
| K070520 |
10/23/2007 |
PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES) |
BIOLIFE, LLC |
Karen O'Toole |
| K071146 |
10/11/2007 |
VIDAS B.R.A.H.M.S. PCT ASSAY |
BIOMERIEUX, INC. |
NIKITA S MAPP |
| K072668 |
10/15/2007 |
VITEK 2 GRAM POSITIVE VANCOMYCIN |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K071934 |
10/11/2007 |
MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT |
BIOMET MANUFACTURING CORP. |
MARY L VERSTYNEN |
| K071271 |
10/23/2007 |
BIOMET CABLE SYSTEM |
BIOMET MANUFACTURING, INC. |
BECKY EARL |
| K070955 |
10/12/2007 |
ACID ETCHED LAG SCREWS |
BIOMET ORTHOPEDICS, INC. |
BECKEY EARL |
| K072298 |
10/29/2007 |
BIOPRO MEMORY STAPLE, MODELS 18062-18073 |
BIOPRO, INC. |
DAVID MRAK |
| K071981 |
10/26/2007 |
BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS) |
BONART CO. LTD. |
ERIC L ONG |
| K072008 |
10/03/2007 |
BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER |
BRAEMAR, INC. |
DARREN DERSHEM |
| K072046 |
10/17/2007 |
EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM |
BRAINLAB AG |
RAINER BIRKENBACH |
| K072506 |
10/26/2007 |
EXACTRAC 5.5 |
BRAINLAB AG |
RAINER BIRKENBACH |
| K072716 |
10/12/2007 |
VECTOR VISION HIP |
BRAINLAB AG |
BENJAMIN WAGNER |
| K072573 |
10/11/2007 |
VECTORVISION HIP AND HIP SR |
BRAINLAB AG |
BENJAMIN WAGNER |
| K070195 |
10/15/2007 |
BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B |
BROADSOUND CORPORATION |
JIANN HWA JENG, PHD |
| K072230 |
10/05/2007 |
POWERPICC SOLO |
C.R. BARD, INC. |
LYNN M KIRCHOFF |
| K072800 |
10/25/2007 |
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM |
CARDIOVASCULAR SYSTEMS, INC. |
JOHN CARLINE |
| K071904 |
10/25/2007 |
DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M) |
CARLETON LIFE SUPPORT SYSTEMS INC. |
GARY BYRD |
| K071796 |
10/19/2007 |
CAPSEW PLICATION SYSTEM |
CAYENNE MEDICAL, INC. |
DAVID J COLLETTE |
| K071313 |
10/26/2007 |
TROJAN-ENZ BRAND |
CHURCH & DWIGHT CO., INC. |
STEPHEN C KOLAKOWSKY |
| K072402 |
10/19/2007 |
FLEX-STAR V |
CMP INDUSTRIES LLC. |
DEVON O HOWE |
| K071931 |
10/22/2007 |
CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 |
Codman & Shurtleff, Inc. |
EMILY E VALERIO |
| K070798 |
10/04/2007 |
ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS |
COEUR, INC. |
DEBRA F MANNING |
| K072397 |
10/18/2007 |
SYNOSS SYNTHETIC BONE GRAFT MATERIAL |
COLLAGEN MATRIX, INC. |
PEGGY HANSEN |
| K071632 |
10/18/2007 |
PERFECT TISSUE CONTOURING SYSTEM II |
COLTENE/WHALEDENT INC. |
GLENN PERSELLO |
| K072712 |
10/31/2007 |
COMFORT ELECTRIC SCOOTER, LY-EW408 |
COMFORT ORTHOPEDIC CO. LTD. |
Ke-Min Jen |
| K072711 |
10/31/2007 |
COMFORT POWERED WHEELCHAIR, LY-EB 206 |
COMFORT ORTHOPEDIC CO. LTD. |
Ke-Min Jen |
| K071100 |
10/15/2007 |
AMNISCREEN HOME DETECTION LINER KIT |
COMMON SENSE, LTD. |
NATASHA LESKOVSEK |
| K071938 |
10/01/2007 |
MONACO RTP SYSTEM |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
KATHRYN STINSON |
| K071907 |
10/05/2007 |
VCARE RETRACTOR/ELEVATOR |
CONMED CORPORATION |
BRIAN KILLORAN |
| K072706 |
10/24/2007 |
MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL |
CONMED LINVATEC |
SUE F DAUTERMAN |
| K070405 |
10/17/2007 |
MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT |
COOK BIOTECH, INC. |
DANIEL J DILLON |
| K072148 |
10/03/2007 |
CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER |
COOK, INC. |
SUSANNE GALIN |
| K072620 |
10/31/2007 |
GAME READY CLASSIC SYSTEM, MODEL 550550 |
COOLSYSTEMS, INC. |
MARIANNE BALDWIN |
| K070749 |
10/24/2007 |
ESTECH PERCUTANEOUS INSERTION DILATOR KIT |
COOMBS MEDICAL DEVICE CONSULTING |
CRAIG COOMBS |
| K072011 |
10/18/2007 |
COPD LIQUID OXYGEN PORTABLE, MODEL 300P |
COPD PARTNERS, INC. |
PAUL DRYDEN |
| K072229 |
10/05/2007 |
MONOSWIFT |
CP MEDICAL |
BETSY CORTELLONI |
| K072422 |
10/24/2007 |
CYBERWAND STERILE PADS, MODEL: CW-RBPBX |
CYBERSONICS, INC. |
WILLIAM A STOLL |
| K072086 |
10/26/2007 |
INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM |
D B ORTHODONTICS LTD |
ANNA M DYSON |
| K072435 |
10/17/2007 |
DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H |
DADE BEHRING, INC. |
KATHLEEN ENNIS |
| K072512 |
10/03/2007 |
MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) |
DATEX-OHMEDA, INC. |
AGATA SMIEJA |
| K072713 |
10/12/2007 |
ION DENTAL RESIN SYSTEM |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K072342 |
10/03/2007 |
SULTAN TOOTH ROOT DESENSITIZER |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K072083 |
10/25/2007 |
SMALL FRAGMENT LOCKING PLATING SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K072546 |
10/05/2007 |
SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM |
DEPUY SPINE,INC |
FRANK S JURCZAK |
| K072496 |
10/05/2007 |
MODIFICATION TO SPACE CPSXL BONE CEMENT |
DFINE, INC. |
ROBERT POSER |
| K070265 |
10/24/2007 |
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000 |
DIAGNOSTIC HYBRIDS, INC. |
GAIL GOODRUM |
| K071480 |
10/01/2007 |
LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIMEN DILUENT SET, MODELS 310600, 310601 AND 310602 |
DIASORIN, INC. |
CHARLES D KAFADER II |
| K072529 |
10/26/2007 |
TRACKPORT |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
| K071787 |
10/26/2007 |
BEMITT, MODEL 0001 |
DJA DISTRIBUTORS, LLC |
BETH BROMBERG |
| K071737 |
10/25/2007 |
GENERAL SEMEN ANALYSIS KIT |
DYN-BIOSHAF (2006) LTD. |
THOMAS M TSAKERIS |
| K072507 |
10/04/2007 |
ENDOWAVE INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
| K072126 |
10/02/2007 |
HABIB VESEAL |
EMCISION, LTD. |
NAGY HABIB |
| K072789 |
10/19/2007 |
DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES |
ENCISION, INC. |
JUDITH V KING |
| K072404 |
10/31/2007 |
ERBE ERBEJET 2 SYSTEM |
ERBE USA, INC. |
JOHN TARTAL |
| K071445 |
10/29/2007 |
TERRAQUANT MQ2000 V.5 WITH THE TQ-1TENS |
ESCADA INTERNATIONAL, INC. |
Kevin Walls |
| K072636 |
10/23/2007 |
A-BSM BONE SUBSTITUTE MATERIAL |
ETEX CORP. |
PAMELA W ADAMS |
| K072557 |
10/30/2007 |
FAXITRON SPECIMEN RADIOGRAPHY SYSTEM, MODEL MX-20 |
FAXITRON X-RAY CORP. |
DOUGLAS WIEGMAN |
| K071511 |
10/05/2007 |
PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G |
FOCUS DIAGNOSTICS, INC. |
SID MATHUR |
| K071330 |
10/31/2007 |
GALTSTICK INTRODUCER SYSTEM |
GALT MEDICAL CORP. |
DAVID CATLIN |
| K070414 |
10/12/2007 |
GAMBRO CARTRIDGE BLOOD SETS |
GAMBRO RENAL PRODUCTS |
THOMAS B DOWELL |
| K071097 |
10/10/2007 |
NAVIGATOR APPLICATIONS SUITE |
GE HEALTHCARE FINLAND OY |
ADRIENNE LENZ |
| K072797 |
10/17/2007 |
GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K072655 |
10/23/2007 |
ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR |
Genesee BioMedical, Inc. |
JOHN T WRIGHT, PH.D. |
| K072465 |
10/04/2007 |
NIKO CORPECTOMY SPACER |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
| K071484 |
10/10/2007 |
PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040 |
GLUSTITCH, INC. |
DON BLACKLOCK |
| K072191 |
10/25/2007 |
CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM |
GVI TECHNOLOGY PARTNERS |
KEVIN M MURROCK |
| K071194 |
10/18/2007 |
RAPHAEL COLOR ASV VENTILATOR |
HAMILTON MEDICAL AG |
JOERG SCHNEIDER |
| K071851 |
10/18/2007 |
HDC STERILE SPIDER SCREW |
HDC S.R.L. |
GUIDO BONAPACE |
| K071652 |
10/25/2007 |
HEMOCUE WBC SYSTEM |
HEMOCUE AB |
ALLAN WHITE |
| K072727 |
10/26/2007 |
INRATIO 2 PT MONITORING SYSTEM |
HEMOSENSE, INC. |
DOUG RUNDLE |
| K072900 |
10/26/2007 |
EXCELARREST FOAM |
HEMOSTASIS, LLC |
KEITH ROBERTS |
| K070146 |
10/12/2007 |
ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP |
HORIBA ABX |
PASCAL MACZIOLA |
| K072020 |
10/18/2007 |
RESTORATION ADM SYSTEM |
HOWMEDICA OSTEONICS CORP |
KAREN ARIEMMA |
| K071881 |
10/09/2007 |
TRIATHLON PKR SYSTEM |
HOWMEDICA OSTEONICS CORP |
VIVIAN KELLY |
| K072221 |
10/15/2007 |
MODIFICATION TO TRIATHLON TS KNEE SYSTEM |
HOWMEDICA OSTEONICS CORP. |
TIFFANI ROGERS |
| K070856 |
10/05/2007 |
ICU MEDICAL SINGLE-USE SYRINGE |
ICU MEDICAL, INC |
TRACY S BEST |
| K070998 |
10/11/2007 |
INION BIORESTORE |
INION OY |
KATI MARTTINEN |
| K072120 |
10/11/2007 |
PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE |
INNOVATIVE SPINAL TECHNOLOGIES INC |
GINA YEH |
| K071516 |
10/03/2007 |
INOMAX DS |
INO THERAPEUTICS LLC |
RICHARD K BOURNE |
| K072679 |
10/12/2007 |
P.004 ABUTMENTS |
INSTITUT STRAUMANN AG |
ELAINE ALAN |
| K072113 |
10/10/2007 |
INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301 |
INTEGRA LIFESCIENCES CORP. |
DIANA M BORDON |
| K072454 |
10/16/2007 |
INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS |
INTEGRA RADIONICS, INC. |
KEVIN J O'CONNELL |
| K070354 |
10/05/2007 |
IMD'S ANESTHESIA NEEDLES (TUOHY, QUINCKE AND PENCIL POINT) |
INTERNATIONAL MEDICAL DEVELOPMENT, INC |
WALTER ZOHMANN |
| K070601 |
10/12/2007 |
MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM |
INTRA-LOCK INTERNATIONAL |
JEFFREY SAKOFF |
| K072130 |
10/31/2007 |
PTFE PEEL AWAY MICROINTRODUCER |
INTROMED |
PHIL TRIOLO |
| K071405 |
10/09/2007 |
PROBE HOLDER SYSTEM |
INTUITIVE SURGICAL, INC. |
MICHAEL H YRAMATEGUI |
| K070751 |
10/15/2007 |
ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY |
ISOTIS ORTHOBIOLOGICS, INC |
KARON MORELL |
| K071799 |
10/02/2007 |
MODIFICATION TO BIOSTAR OIA SHIGATOX |
IVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS |
ROBIN C HART |
| K072262 |
10/26/2007 |
GENTLERAY 980 DIODE LASER SYSTEM |
KAVO AMERICA |
JOHN MILLER |
| K071070 |
10/23/2007 |
OLYMPUS DENTAL IMPLANT SYSTEM |
KEYSTONE DENTAL, INC. |
FLOYD G LARSON |
| K072063 |
10/26/2007 |
KFX TISSUE FIXATION SYSTEM AND ACCESSORIES |
KFX MEDICAL |
M D HEAVEN |
| K072630 |
10/03/2007 |
FORU, MODEL EQ30 |
KWANG YANG MOTOR CO., LTD. |
JUANNATA CHANG |
| K063631 |
10/05/2007 |
POLYPERF / POLYPERF SAFE |
LABORATOIRES PEROUSE |
MARIE NOELLE EROUT |
| K072233 |
10/05/2007 |
SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS |
LEONHARD LANG GMBH |
ELAINE DUNCAN |
| K072050 |
10/18/2007 |
PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS |
LIFE-TECH, INC. |
JEFF KASOFF |
| K071986 |
10/19/2007 |
LTM-RC SURGICAL MESH |
LIFECELL CORP. |
LORRAINE T MONTEMURRO |
| K072572 |
10/05/2007 |
PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS |
LIFECORE BIOMEDICAL, INC. |
KAREN CLEMENT |
| K072768 |
10/23/2007 |
RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS |
LIFECORE BIOMEDICAL, INC. |
KAREN CLEMENT |
| K072543 |
10/05/2007 |
ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM |
LIFESCAN, INC. |
Alison Wilson |
| K070315 |
10/30/2007 |
LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 |
LINA MEDICAL APS |
WALT BRITTLE |
| K071713 |
10/12/2007 |
CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR |
MEDICAL DECISIONS NETWORK |
JONATHAN KAHAN |
| K072898 |
10/25/2007 |
HEXAPOD EVO RT COUCH TOP |
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
MICHAEL WOLFF |
| K072097 |
10/30/2007 |
BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1 |
MEDICAL SELECT, INC. |
AMY JONES |
| K072525 |
10/05/2007 |
ZIPKNOT, MODEL 1017-3000 |
MEDICINELODGE, INC. |
MARY SINNOTT |
| K070530 |
10/18/2007 |
MODIFICATION TO PASSMED SPINAL SYSTEM |
MEDICREA TECHNOLOGIES |
J.D. WEBB |
| K071740 |
10/04/2007 |
CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES |
MEDTEXX MANUFACTURING SDN. BHD. |
OOI LOON SENG |
| K072990 |
10/31/2007 |
GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID |
MEDTRONIC INC. |
KAREN A BROZOWSKI |
| K072155 |
10/05/2007 |
PIONEER CATHETER |
MEDTRONIC INC. |
CATHERINE PRIESTLEY |
| K070438 |
10/17/2007 |
MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305 |
MEDTRONIC MINIMED, INC. |
JODIE ROGERS |
| K062447 |
10/15/2007 |
TRAVERSE OCT SPINAL FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
ED CHIN |
| K072559 |
10/05/2007 |
SUCTION COAGULATOR |
MEGADYNE MEDICAL PRODUCTS, INC. |
RONDA MAGNESON |
| K071899 |
10/22/2007 |
BIS MODULE FOR ENVOY PATIENT MONITOR |
MENNEN MEDICAL LTD. |
IFAT OREN |
| K071101 |
10/18/2007 |
TRU RSV |
MERIDIAN BIOSCIENCE, INC. |
SUSAN ROLIH |
| K072569 |
10/31/2007 |
METOXIT CAM-BLANKS |
Metoxit AG |
IAN GORDON |
| K071085 |
10/03/2007 |
E3-80 PORTABLE ECG RECORDER & ANALYZER |
MICRO-STAR INTERNATIONAL CO., LTD. |
ALBUM D TSAI |
| K072200 |
10/26/2007 |
STIMLAB |
MICROPACE PTY. LTD. |
MICHAEL CEJNAR |
| K072526 |
10/05/2007 |
MICRUS COURIER ENZO MICROCATHETER 0.0190 |
MICRUS ENDOVASCULAR CORPORATION |
MICHAEL CROMPTON |
| K072173 |
10/05/2007 |
MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE, MODEL CRC; CASHMERE-SR, MODEL SRC |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
| K072516 |
10/18/2007 |
MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR |
MIDMARK DIAGNOSTICS GROUP |
TONY CAPPARELLI |
| K071814 |
10/16/2007 |
LIGHT SABRE SPINAL ACCESS DEVICE |
MINRAD, INC. |
JOHN MCNEIRNEY |
| K072255 |
10/18/2007 |
MINRAD INC. NASAL SCAVENGING CIRCUIT |
MINRAD, INC. |
JOHN MCNEIMEY |
| K072438 |
10/05/2007 |
MEDICAL MAGGOTS, CREATURE COMFORTS |
MONARCH LABS, LLC. |
RONALD S SHERMAN |
| K072931 |
10/30/2007 |
MC 3003G-32R HEAD COIL |
MR INSTRUMENTS, INC. |
MARK WATSON |
| K072685 |
10/19/2007 |
NGARDE SYSTEM |
N SPINE, INC. |
JUDE V PAGANELLI |
| K070597 |
10/11/2007 |
VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST |
NANOSPHERE, INC |
SUE KENT |
| K072125 |
10/18/2007 |
ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT |
NDO SURGICAL, INC. |
JOHN J VOZELLA |
| K071838 |
10/19/2007 |
NEOSS VARIOUS TITANIUM ABUTMENTS |
NEOSS LTD |
FREDRIK ENGMAN |
| K072841 |
10/16/2007 |
NEUVIZ SPIRAL CT SCANNER SYSTEM |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
TIAN TANFANG |
| K072029 |
10/15/2007 |
PHENIX VERTEBRAL BODY REPLACEMENT |
NEW BUSINESS DEVELOPMENT, LLC |
TIM B LUSBY |
| K072424 |
10/03/2007 |
COOLTOUCH, MODEL LC215,COOLLIPO |
NEW STAR LASERS, INC. |
NATALIE VOLLRATH |
| K071384 |
10/09/2007 |
MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901 |
NIHON SEIMITSU SOKKI CO., LTD. |
KOJI KUBO |
| K072024 |
10/04/2007 |
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 |
NIPRO MEDICAL CORP. |
JESSICA OSWALD |
| K072362 |
10/23/2007 |
NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG |
NOVALUNG GMBH |
ROSINA ROBINSON |
| K072715 |
10/16/2007 |
REALHAND HIGH DEXTERITY INSTRUMENTS |
NOVARE SURGICAL SYSTEMS, INC. |
DAVID W SCHLERF |
| K072499 |
10/30/2007 |
NOVOFLO CATHETER LT |
NOVOSCI, INC. |
DAVID MAKANANI |
| K072343 |
10/29/2007 |
NEUROVISION JJB SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K072339 |
10/19/2007 |
NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K071764 |
10/24/2007 |
REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360 |
OBTECH MEDICAL SARL |
ELIZABETH MILLER |
| K071617 |
10/19/2007 |
ORAL NEUTRALIZER |
ORAL BIOTECH |
ROBERT BOWERS |
| K072665 |
10/03/2007 |
SUNIRAY 5.2 |
ORANGEDENTAL GMBH & CO. KG |
MARC FIEBER |
| K072295 |
10/11/2007 |
CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE |
ORIDION CAPNOGRAPHY, INC. |
RACHEL WEISSBROD |
| K072076 |
10/31/2007 |
CYTOPLAST PTFE SUTURE |
OSTEOGENICS BIOMEDICAL, INC. |
DUSTYN WEBB |
| K070212 |
10/12/2007 |
CITOP10 GUIDEWIRE, 0.014(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014(1.0MM TIP), CITOP SUPPORT ACCESSORY, 0.023(126CM) |
OVALUM LTD. |
KEN RAICHMAN |
| K072591 |
10/10/2007 |
CARDIOP-B SYSTEM, VERSION 2.1 |
PAIEON, INC. |
RAVIT BARKAMA |
| K071912 |
10/29/2007 |
APACERAM BONE GRAFT SUBSTITUTE |
PENTAX CORP. |
PATSY J TRISLER |
| K072545 |
10/26/2007 |
ARTISTE SE FLOWABLE COMPOSITE, MODEL N280 |
PENTRON CLINICAL TECHNOLOGIES |
GREG MOREAU |
| K071993 |
10/17/2007 |
T-PORT HP INFUSION PORT |
PFM MEDICAL, INC |
SALVADORE PALOMARES |
| K072299 |
10/04/2007 |
POWRSYRINGE ASPIRATOR |
PINYONS MEDICAL TECHNOLOGY, INC. |
SHAWN P FOJTIK |
| K072187 |
10/12/2007 |
PIONEER LOWTOP SPINAL ROD SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN M GILBERT |
| K071593 |
10/15/2007 |
PTS PANELS CHOL+HDL PANEL TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K071421 |
10/04/2007 |
PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET |
PROMEPLA |
PATSY J TRISLER |
| K072735 |
10/18/2007 |
PULSION PICCO-2, MODEL 8500 |
PULSION MEDICAL SYSTEMS AG |
Jamie Sulley |
| K072935 |
10/31/2007 |
SPEEDER 1.5T WRIST ARRAY COIL |
QUALITY ELECTRODYNAMICS |
CHRISTIE ZYDYK |
| K070484 |
10/22/2007 |
QUANTRX FEMALE FERTILITY TEST |
QUANTRX BIOMEDICAL CORPORATION |
LORRAINE C COGAN |
| K070502 |
10/04/2007 |
RADIUS SNARE |
RADIUS MEDICAL TECHNOLOGIES, INC. |
RICHARD DEMELLO |
| K071013 |
10/18/2007 |
REDSENSE |
REDSENSE MEDICAL AB |
CONSTANCE G BUNDY |
| K072327 |
10/24/2007 |
CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON |
REGENERATION TECHNOLOGIES, INC. |
Lisa Simpson |
| K071621 |
10/09/2007 |
RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES |
RELIANT TECHNOLOGIES, INC. |
DAN MARINSIK |
| K070443 |
10/05/2007 |
INTRACEPT BI-POLAR RF PROBE, MODEL 04814 |
RELIEVANT MEDSYSTEMS, INC. |
Mark Smutka |
| K071808 |
10/10/2007 |
MIRAGE MICRO |
RESMED LTD. |
DAVID D'CRUZ |
| K072026 |
10/26/2007 |
RNK ELECTRONIC STETHOSCOPE |
RNK PRODUCTS, INC. |
CHARLES R ABBRUSCATO |
| K070788 |
10/05/2007 |
ELECSYS CORTISOL TEST SYSTEM |
Roche Diagnostics |
KAY TAYLOR |
| K072638 |
10/19/2007 |
ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 |
ROCHE DIAGNOSTICS CORP. |
KERWIN L KAUFMAN |
| K072051 |
10/03/2007 |
NOVATOME, MODEL: SU101-50 |
SCHOLTEN SURGICAL INSTRUMENTS, INC. |
JIM VAN ANDEL |
| K071726 |
10/23/2007 |
ZUMA |
SEASPINE, INC. |
ETHEL BERNAL |
| K072488 |
10/19/2007 |
LANFAN POWDER-FREE VINYL EXAM GLOVES |
SHANGHAI LANFAN CO., LTD. |
BEI KAIFENG |
| K072235 |
10/19/2007 |
PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K071382 |
10/16/2007 |
SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77, |
SHIN CHANG MEDICAL CO., LTD. |
JAN J FRANK |
| K071947 |
10/12/2007 |
VACU-MED BLOOD COLLECTION NEEDLES |
SHINA CORP. |
CAROLE STAMP |
| K072909 |
10/31/2007 |
1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL |
SIEMENS AG, MEDICAL SOLUTIONS |
LUTZ MAHN |
| K072204 |
10/05/2007 |
ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
PHILIP LIU |
| K071466 |
10/09/2007 |
DCA VANTAGE, MODEL 5075 |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
NOOR MALKI |
| K072237 |
10/10/2007 |
MAGNETOM VERIO |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JUDITH CAMPBELL |
| K072567 |
10/30/2007 |
SYMBIA-E, MODEL 10275879 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALAINE MEDIO |
| K072365 |
10/17/2007 |
SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
ROBERT LAWRENCE |
| K072767 |
10/15/2007 |
QUASAR BLUE LIGHT THERAPY SYSTEM |
SILVER BAY, LLC |
GARY MOCNIK |
| K071160 |
10/05/2007 |
REFLECTION, TANDEM UNIPOLAR |
SMITH & NEPHEW, INC. |
MEGAN BEVILL |
| K072675 |
10/15/2007 |
SMITH & NEPHEW ARTHROSCOPE |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
| K071527 |
10/04/2007 |
PNEUPAC VR1 AIR MIX |
SMITHS MEDICAL INTERNATIONAL, LTD. |
DONALD ALEXANDER |
| K072667 |
10/10/2007 |
SHARPS AWAY DISPOSABLE CONTAINER |
SOLUTIONS, INC. |
JERRI ANDERSON |
| K072091 |
10/29/2007 |
D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
| K070845 |
10/12/2007 |
SOUNMED COLOPOSCOPE COLPO-99/99PLUS |
SOUNMED, INC. |
RUBEN OLIVARES |
| K072468 |
10/01/2007 |
MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM |
SPECTRUM DYNAMICS LTD. |
AHAVA STEIN |
| K071914 |
10/12/2007 |
MERCURY SPINAL SYSTEM |
SPINAL ELEMENTS, INC. |
KERRI DIMARTINO |
| K071833 |
10/23/2007 |
MOSAIC DEVICES |
SPINAL ELEMENTS, INC. |
KERRI DIMARTINO |
| K070930 |
10/18/2007 |
REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS |
STERILMED, INC. |
DENNIS TOUSSAINT |
| K072072 |
10/05/2007 |
HARMONY LED-1 SURGICAL LIGHTING SYSTEM |
STERIS Corporation |
JOHN SCOVILLE |
| K062297 |
10/04/2007 |
VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM |
STERIS Corporation |
PATRICK J MCCULLAGH |
| K070769 |
10/05/2007 |
VHP 136 TRAY |
STERIS Corporation |
PATRICK MCCULLAGH |
| K071087 |
10/16/2007 |
VIS-U-ALL II HEAT-SEAL POUCH AND TUBING |
STERIS Corporation |
JOHN R SCOVILLE |
| K070765 |
10/12/2007 |
VIS-U-ALL II SELF SEAL POUCH |
STERIS Corporation |
PATRICK MCCULLAGH |
| K071888 |
10/15/2007 |
STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES |
STRAUMANN USA |
ELAINE ALAN |
| K072568 |
10/05/2007 |
MODIFICATION TO OASYS SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
| K071397 |
10/01/2007 |
DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES |
SUNRISE MEDICAL |
JOSEPH E OLSAVSKY |
| K072787 |
10/31/2007 |
GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111 |
SYNCRO MEDICAL INNOVATIONS, INC. |
WILLIAM MCLAIN |
| K071046 |
10/23/2007 |
SYNTHES CHRONOS COMPOSITE |
SYNTHES (USA) |
JEFFREY DOW |
| K072253 |
10/12/2007 |
SYNFIX-LR SPACER |
SYNTHES SPINE CO.LP |
SUSAN LEWANDOWSKI |
| K072039 |
10/03/2007 |
ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4223E; TD-4223F |
TaiDoc Technology Corporation |
ERICA LI |
| K071493 |
10/26/2007 |
CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-4225 |
TaiDoc Technology Corporation |
ERICA LI |
| K072574 |
10/18/2007 |
ALPHARD CONE BEAM CT, MODEL X178 |
TAKARA BELMONT CORP. |
DANIEL KAMM |
| K072016 |
10/19/2007 |
CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE |
TECHNOMED EUROPE |
MAURICE ROOST |
| K063131 |
10/05/2007 |
CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS |
THERMO ELECTRON OY |
PAIVI SORMUNEN |
| K063705 |
10/09/2007 |
LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL |
THERMO ELECTRON OY |
PAIVI SORMUNEN |
| K063145 |
10/17/2007 |
PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS |
THERMO ELECTRON OY |
PAIVI SORMUNEN |
| K071580 |
10/03/2007 |
AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL |
THERMO FISHER SCIENTIFIC OY |
PAIVI SORMUNEN |
| K071340 |
10/05/2007 |
CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL |
THERMO FISHER SCIENTIFIC OY |
PAIVI SORMUNEN |
| K071057 |
10/05/2007 |
COLONIC & ENEMA NOZZLE |
TILLER MIND BODY, INC. |
HAROLD L JONES |
| K071948 |
10/18/2007 |
AEQUALIS REVERSED ADAPTER |
TORNIER |
Mireille Lemery |
| K072826 |
10/24/2007 |
APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K072606 |
10/02/2007 |
AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
|
| K072737 |
10/05/2007 |
CSCS-001A CALCIUM SCORING PACKAGE |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K072918 |
10/29/2007 |
MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K063035 |
10/01/2007 |
SLEUTH IMPLANTABLE ECG MONITORING SYSTEM |
TRANSNOMA MEDICAL, INC. |
ANGELA RAUN |
| K070870 |
10/10/2007 |
SKIN CARE LIGHT |
TRANSVERSE INDUSTRIES CO. |
HO K LIANG |
| K071049 |
10/16/2007 |
DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR |
TYCO HEALTHCARE |
WEI ZHAO |
| K072117 |
10/05/2007 |
THROMBIX PATCH THROMBIN HEMOSTASIS PATCH |
VASCULAR SOLUTIONS, INC. |
JAMES CHAPMAN |
| K071347 |
10/05/2007 |
VAX-D GENESIS G2 SYSTEM |
VAX-D MEDICAL TECHNOLOGIES LLC |
LAWRENCE DYER |
| K072323 |
10/10/2007 |
MASTERSCREEN & OXYCON CPX |
VIASYS HEALTHCARE GMBH |
Yvette Lloyd |
| K072045 |
10/22/2007 |
ONCONTROL BONE MARROW BIOPSY SYSTEM |
VIDACARE CORPORATION |
GRACE HOLLAND |
| K072171 |
10/01/2007 |
GATECT-RT |
VISION RT LIMITED |
ROBERT J MORTON, M.S. |
| K071937 |
10/19/2007 |
BONALIVE GRANULES AND BONALIVE PLATES |
VIVOXID LTD. |
CONSTANCE G BUNDY |
| K072597 |
10/15/2007 |
PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
RYAN M BELANEY |
| K070592 |
10/05/2007 |
SMALL BONE WEDGE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
WESLEY L REED |
| K072401 |
10/15/2007 |
DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR |
XUZHOU FULL SUN MEDICAL PRODUCTS LTD. |
HSUN-HUI HUANG |
| K072472 |
10/25/2007 |
DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED |
XUZHOU FULL SUN MEDICAL PRODUCTS LTD. |
HSUN-HUI HUANG |
| K072474 |
10/16/2007 |
QUIKCLOT EX |
Z-MEDICA CORPORATION |
RONALD E PETERSON |
| K062542 |
10/29/2007 |
Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX |
Z-Systems AG |
FLOYD G LARSON |
| K072589 |
10/04/2007 |
TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16 |
ZIMMER DENTAL INC. |
WILLIAM FISHER |
| K071880 |
10/05/2007 |
Optima ZS Transition Screw |
ZIMMER SPINE, INC |
NICOLE BOWDEN |
| K071879 |
10/05/2007 |
ZIMMER DTO IMPLANT |
ZIMMER SPINE, INC |
NICOLE BOWDEN |
| K071545 |
10/31/2007 |
Z-800 VOLUMETRIC INFUSION PUMP |
ZYNO MEDICAL LLC |
CHAOYOUNG LEE |
