| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K052366 |
10/13/2005 |
ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA |
AB BIODISK |
ANNE BOLMSTROM |
| K051501 |
10/19/2005 |
ZIRACE |
ACUCERA, INC. |
KYUNG-BIN LEE |
| K051544 |
10/07/2005 |
VITALCAREGIVING SYSTEM |
ADVANCED MONITORING CAREGIVING INC. |
GEORGE MYERS |
| K051589 |
10/31/2005 |
SLIMMANAGER, MODEL SM-X, SM-E |
AIIA COMMUNICATION INC. |
JOHN MYUNG |
| K051056 |
10/20/2005 |
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR |
ALBERT BROWNE LTD. |
CYNTHIA J M. NOLTE |
| K050985 |
10/07/2005 |
GLUCODR SUPERSENSOR SYSTEM |
ALL MEDICUS CO., LTD |
JE YOUNG CHANG |
| K051912 |
10/11/2005 |
COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B |
ALSIUS CORP. |
KENNETH A COLLINS |
| K052443 |
10/17/2005 |
ICY CATHETER, MODEL IC-3893A |
ALSIUS CORP. |
KENNETH A COLLINS |
| K051044 |
10/07/2005 |
ARCTEC SEMIRIGID PLATING SYSTEM |
ALTIVA CORP. |
JOHN KAPTIAN |
| K052124 |
10/17/2005 |
ACTICLOT, MODEL 824 |
AMERICAN DIAGNOSTICA, INC. |
LEIGH AYRES |
| K052336 |
10/11/2005 |
SPECTRAQUATTRO PULSED LIGHT SYSTEM |
AMJET DISTRIBUTION, LLC |
STEVE TRINTER |
| K052686 |
10/05/2005 |
ARTHROCARE ARTHROWANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K050373 |
10/11/2005 |
UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS |
ARTHROSURFACE, INC. |
STEVEN EK |
| K052482 |
10/17/2005 |
ARTELON SURGICAL SUTURE |
ARTIMPLANT AB |
MARIE MARLOW |
| K051783 |
10/04/2005 |
ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES |
ARTSANA S.P.A. |
LARA N SIMMONS |
| K052085 |
10/14/2005 |
STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES |
ASIA-MED GMBH AND CO KG |
Kevin Walls |
| K050425 |
10/20/2005 |
AURA-PSG |
ASTRO-MED, INC. |
MICHAEL J SULLIVAN |
| K052070 |
10/14/2005 |
ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT IN ZIRCONIA, ATLANTIS GEMEINI + ABUTMENT IN ZIRCONIA |
ATLANTIS COMPONENTS, INC. |
BETSY A BROWN |
| K052893 |
10/25/2005 |
ATRICURE TRANSPOLAR SYSTEM |
ATRICURE, INC. |
ELSA CHI ABRUZZO |
| K052491 |
10/07/2005 |
AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR |
AXYA MEDICAL, INC. |
HOWARD L SCHRAYER |
| K052242 |
10/03/2005 |
ADVIA CHEMISTRY MICROALBUMIN CONTROLS |
BAYER HEALTHCARE LLC |
ANDRES HOLLE |
| K052163 |
10/11/2005 |
ADVIA IMS GLUCOSE ASSAY |
BAYER HEALTHCARE, LLC |
ANDRES HOLLE |
| K052270 |
10/05/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (STREP) 0.125 - 4UG/ML |
BECTON, DICKINSON & CO. |
Monica Giguere |
| K052269 |
10/03/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -CIPROFLOXACIN GN |
BECTON, DICKINSON & CO. |
Monica Giguere |
| K052547 |
10/13/2005 |
BELMONT BUDDY FLUID WARMER |
BELMONT INSTRUMENT CORP. |
URAIWAN P LABADINI |
| K043341 |
10/27/2005 |
BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
BIO-RAD LABORATORIES, INC. |
CHRISTOPHER BENTSEN |
| K042352 |
10/17/2005 |
BIODERM SCIENCES WOUND CREAM |
BIODERM SCIENCES, INC. |
EDWARD R GUBISH |
| K050286 |
10/03/2005 |
FIDIS CONNECTIVE 8 |
BIOMEDICAL DIAGNOSTICS (BMD) SA |
COURIVAUD CHRISTELLE |
| K052685 |
10/27/2005 |
ORTHOPEDIC SALVAGE SYSTEM- OSS |
BIOMET, INC. |
ALLISON KOSKEY |
| K050124 |
10/04/2005 |
POROUS COATED ACETABULAR COMPONENTS |
BIOMET, INC. |
PATRICIA BERES |
| K052433 |
10/18/2005 |
PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM |
BIOPTICS, INC. |
JEFFREY ORACH |
| K051480 |
10/12/2005 |
ENTERAL FEEDING TUBE |
BIOSEARCH MEDICAL PRODUCTS, INC. |
GENE BOYD |
| K052757 |
10/28/2005 |
PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER |
BIOTRONIK AG |
Jon Brumbaugh |
| K052190 |
10/04/2005 |
FETAL MONITOR, MODELS BT-300 AND BT-200 |
BISTOS CO., LTD. |
CHARLIE MACK |
| K052028 |
10/28/2005 |
BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS) |
BONART CO. LTD. |
ERIC L ONG |
| K052783 |
10/27/2005 |
MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX |
BOSTON SCIENTIFIC CORP. |
Diane Brinza |
| K050192 |
10/20/2005 |
BRC SOFTWARE PRODUCT |
BRC OPERATIONS PTY LIMITED |
CARRI GRAHAM |
| K052155 |
10/20/2005 |
BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED |
C.R. BARD, INC. |
LUCINDA L FOX |
| K051991 |
10/20/2005 |
POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINE |
C.R. BARD, INC. |
LYNN M KIRCHOFF |
| K052161 |
10/21/2005 |
POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A) |
CARDIAC SCIENCE, INC. |
KENNETH F OLSON |
| K051641 |
10/20/2005 |
ALARIS SYSTEM PC UNIT, MODEL 8001 |
CARDINAL HEALTH, ALARIS PRODUCTS |
STACY L LEWIS |
| DEN050006 |
10/28/2005 |
CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM |
CARDIOMEMS INC |
CAROL VIERLING |
| K052240 |
10/19/2005 |
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002 |
CARDIONET, INC |
JACK GAIKWAD |
| K052528 |
10/11/2005 |
AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE |
CEREMED, INC. |
TADEUSZ WELLISZ |
| K050689 |
10/26/2005 |
SURGICAL FACE MASK |
CHINA SURGICAL DRESSINGS CENTER CO.,LTD |
MICHAEL F. L CHANG |
| K050265 |
10/14/2005 |
CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 |
CHRONO-LOG CORP. |
NICHOLAS J VERIABO |
| K052046 |
10/19/2005 |
BLOOD PRESSURE METER, MODEL CH-432 |
CITIZEN WATCH CO., LTD. |
JOSEPH EDMONDSON |
| K051089 |
10/26/2005 |
GII SPINAL FIXATION SYSTEM |
CO-LIGNE AG |
DAVID W SCHLERF |
| K052449 |
10/17/2005 |
CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MODELS 80-1163, 80-1189 |
Codman & Shurtleff, Inc. |
JOAN Q BARTLE |
| K052041 |
10/25/2005 |
COLLAGEN BONE HEALING PROTECTIVE SHEET |
COLLAGEN MATRIX, INC. |
PEGGY HANSEN |
| K052010 |
10/04/2005 |
HBA1C LINEARITY SET |
CONE BIOPRODUCTS |
WILLIAM CONE |
| K052104 |
10/21/2005 |
ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185; ULTRACLEAN FOOTCONTROLLED SUCTION |
CONMED CORPORATION |
PAMELA VETTER |
| K052740 |
10/17/2005 |
NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM |
CONMED INTEGRATED SYSTEMS (CMIS) |
C. JEFF LIPPS |
| K052279 |
10/11/2005 |
COOK IRELAND ECHOBRUSH |
COOK IRELAND LTD |
EMMETT DEVEREUX |
| K052501 |
10/21/2005 |
MULTIPLE RESIN TOOTH BONDING AGENT |
COSMEDENT, INC. |
JAMES L SANDRIK |
| K052040 |
10/18/2005 |
QUICKSMILE |
COSMETIC DENTAL MATERIALS INC |
ROBERT BOWERS |
| K052558 |
10/27/2005 |
VCS, MODEL S4T |
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER/CHC |
CHANG W LAN |
| K052346 |
10/26/2005 |
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
| K052498 |
10/17/2005 |
FRAGMENT SPECIFIC FIXATOR |
DAVID J. SLUTSKY MD |
DAVID J SLUTSKY |
| K052436 |
10/06/2005 |
PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 |
DENVER BIOMEDICAL, INC. |
JEFF HILL |
| K052630 |
10/17/2005 |
ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
DENISE LUCIANO |
| K052631 |
10/21/2005 |
SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
DENISE LUCIANO |
| K052178 |
10/21/2005 |
DEPUY CAS HIP INSTRUMENTATION |
DEPUY ORTHOPAEDICS, INC. |
RANDA FRANKLIN |
| K052472 |
10/06/2005 |
DEPUY GLOBAL SHOULDER CROSSLINK GLENOID |
DEPUY ORTHOPAEDICS, INC. |
Natalie Heck |
| K052079 |
10/21/2005 |
PINNACLE CONSTRAINED ACETABULAR LINERS |
DEPUY ORTHOPAEDICS, INC. |
KELI K HANKEE |
| K052746 |
10/21/2005 |
CONCORDE VBR SPINAL SYSTEM |
DEPUY SPINE, INC. |
LISA GILMAN |
| K052552 |
10/13/2005 |
HYBRID ANTERIOR CERVICAL PLATE SYSTEM |
DEPUY SPINE, INC. |
LIZ LAVELLE |
| K052717 |
10/20/2005 |
D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER |
DIDECO S.R.L. |
BARRY SALL |
| K052430 |
10/04/2005 |
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM |
DIGIRAD CORP. |
Joel Tuckey |
| K052754 |
10/27/2005 |
WRIST FUSION PLATE |
DVO EXTREMITY SOLUTIONS, LLC |
DINA L WEISSMAN |
| K051680 |
10/11/2005 |
DYNATRON DX2 TRACTION UNIT |
DYNATRONICS CORP. |
RON HATCH |
| K043520 |
10/21/2005 |
EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR |
EMG TECHNOLOGY CO., LTD. |
LEONARD FRIER |
| K051806 |
10/03/2005 |
CARE FECAL OCCULT BLOOD TEST, MODEL KT313 |
EPITOPE DIAGNOSTICS, INC. |
PING GAO |
| K052549 |
10/06/2005 |
LEADCARE II BLOOD LEAD TESTING SYSTEM |
ESA BIOSCIENCES INC. |
HAROLD ASP |
| K052805 |
10/17/2005 |
MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150 |
ESAOTE S.P.A. |
CARRI GRAHAM |
| K051534 |
10/05/2005 |
CARDIOLINE AR 600, AR 1200, AR 2100 |
ET MEDICAL DEVICES SPA |
ATTILIO CASTELLI |
| K051950 |
10/07/2005 |
INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321 |
ETHICON ENDO-SURGERY, INC. |
KIMBERLY SHOEMAKER |
| K052358 |
10/05/2005 |
ETIAM STAR PACS COMPONENTS |
ETIAM, S.A. |
CARL ALLETTO |
| K052112 |
10/28/2005 |
XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 |
EXCEL TECH. LTD. |
NICOLE LANDREVILLE |
| K052103 |
10/19/2005 |
EXEL SECURE TOUCH II SAFETY SYRINGE |
EXELINT INTL. CO. |
ARMAND HAMID |
| K052849 |
10/26/2005 |
INFRARED THERMOMETER, FDIR-V1 |
FAMIDOC TECHNOLOGY CO., LTD |
MR. STEELJIN |
| K052714 |
10/26/2005 |
RAVE COMPOSITE BRACKET |
FDA AGENTS |
STEVE KLAMIC |
| K050997 |
10/07/2005 |
EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE |
FLEXUSPINE, INC. |
COREY HARBOLD |
| K051580 |
10/31/2005 |
VP SHEATH |
FLOWCARDIA, INC. |
RICHARD SPANO |
| K052000 |
10/25/2005 |
ARCHITECT CA 19-9XR ASSAY |
FUJIREBIO DIAGNOSTICS, INC. |
DIANA L WOLANIUK |
| K052462 |
10/20/2005 |
G-COAT |
GC AMERICA, INC. |
TERRY L JORITZ-LYONS |
| K052755 |
10/13/2005 |
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT |
GE HEALTHCARE |
JOEL KENT |
| K052582 |
10/14/2005 |
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES |
GE HEALTHCARE |
JOEL KENT |
| K052855 |
10/28/2005 |
STARSPEED SERIES CT SCANNER SYSTEMS |
GE HEALTHCARE |
LEKSHMI NAIR |
| K052581 |
10/20/2005 |
LUNAR IDXA |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
JAMES P RASKOB |
| K051508 |
10/05/2005 |
MED FLASH II INTENSE PULSED LIGHT SYSTEM. |
GENERAL PROJECT S.R.L. |
MAUREEN O'CONNELL |
| K051727 |
10/26/2005 |
AIMSTICK URINE REAGENT STRIPS |
GERMAINE LABORATORIES, INC. |
MARTIN O'CONNOR |
| K051721 |
10/26/2005 |
GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM |
GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. |
CARL KNOBLOCH |
| K050460 |
10/25/2005 |
GYRUS PLASMACISION AND PLASMABLEND ELECTRODES |
GYRUS MEDICAL, INC. |
MARK A JENSON |
| K052626 |
10/05/2005 |
SMARTSUCTION HARMONY DEVICE |
HAEMONETICS CORP. |
GABRIEL J MURACA |
| K052416 |
10/25/2005 |
PERIPRO PATCH |
HANCOCK/JAFFE LABORATORIES |
SUE MONTOYA |
| K052294 |
10/21/2005 |
SHOULDER NAIL PLATE |
HAND INNOVATIONS, LLC. |
ERNESTO HERNANDEZ |
| K052543 |
10/25/2005 |
HERACERAM ZIRKONIA |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K051948 |
10/21/2005 |
AVON PATELLO-FEMORAL JOINT PROSTHESIS |
HOWMEDICA OSTEONICS CORP |
VIVIAN KELLY |
| K051977 |
10/12/2005 |
SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS |
HOWMEDICA OSTEONICS CORP |
KAREN ARIEMMA |
| K052718 |
10/27/2005 |
V40 BIOLOX DELTA CERAMIC FEMORAL HEADS |
HOWMEDICA OSTEONICS CORP |
KAREN ARIEMMA |
| K051514 |
10/04/2005 |
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002 |
HYPOGUARD USA, INC. |
BRUCE A MACFARLANE |
| K052368 |
10/17/2005 |
OLECRANONPLATE WITH ANGULAR STABILITY |
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
AL LIPPINCOTT |
| K051969 |
10/03/2005 |
TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA |
IBL GMBH |
Gary Lehnus |
| K051579 |
10/21/2005 |
IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS |
Immunalysis Corporation |
MICHAEL VINCENT |
| K051577 |
10/04/2005 |
IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS |
Immunalysis Corporation |
MICHAEL VINCENT |
| K051626 |
10/13/2005 |
IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS |
Immunalysis Corporation |
MICHAEL VINCENT |
| K051476 |
10/28/2005 |
UNI-VENT MODEL 73X |
IMPACT INSTRUMENTATION, INC. |
LESLIE H SHERMAN |
| K052648 |
10/20/2005 |
MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS |
IMPLANT INNOVATIONS, INC. |
JIM BANIC |
| K051800 |
10/21/2005 |
IN6 SAFETY SYRINGE, MODEL 3ML |
IN6 INCUVESTOR INC. |
JENNIFER REICH |
| K052284 |
10/17/2005 |
REFORMAT GATEWAY |
INFINITT CO., LTD. |
CARL ALLETTO |
| K052244 |
10/13/2005 |
IISIS, VERSION 1.0 |
INNOVISION MEDICAL TECHNOLOGIES, LLC |
PATRICIA L ANDREWS |
| K051742 |
10/07/2005 |
OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH |
INNTEC, INC. |
Gary Syring |
| K052143 |
10/04/2005 |
QUANTA LITE GLIADIN IGA II |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K052142 |
10/04/2005 |
QUANTA LITE GLIADIN IGG II |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K052262 |
10/27/2005 |
QUANTA LITE M2 EP (MIT3) ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K052121 |
10/21/2005 |
GEM PREMIER 3000 |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K052468 |
10/05/2005 |
YK9000 SERIES MANUAL WHEELCHAIR |
INTCO METAL PRODUCTS (ZHENJIANG) CO., LTD. |
JOHN ZHAO |
| K052473 |
10/28/2005 |
CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000 |
INTER MEDICAL MEDIZINTECHNIK GMBH |
HANS GUENTER OSIEK |
| K050970 |
10/14/2005 |
MILO DENTAL IMPLANT SYSTEM |
INTRA-LOCK INTERNATIONAL |
JEFFREY SAKOFF |
| K051943 |
10/04/2005 |
SUREFLOW SAFETY INFUSION DEVICE |
INTRASAFE MEDICAL, LLC |
SHEPARD G BENTLEY |
| K052497 |
10/12/2005 |
NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A |
INVIVO CORP. |
TOM SCHUBERT |
| K051548 |
10/24/2005 |
IRRADIA MID - LASER (S3) |
IRRADIA AB |
THEO RUSSO-LARSSON |
| K052979 |
10/31/2005 |
1125 XSB XENON FIBER-OPTIC LIGHT SOURCE |
ISOLUX LLC |
NILCOLAOS ANDREOULAKIS |
| K051705 |
10/14/2005 |
IPS E.MAX CAD/IPS E.MAX ZIRCAD |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
| K052341 |
10/07/2005 |
AJEX 9015/135H PORTABLE X-RAY |
JPI AMERICA, INC. |
ABE ELGOHARY |
| K051531 |
10/17/2005 |
TECTONIC CERVICAL PLATE SYSTEM |
K2M, LLC |
RICH WOODS |
| K051909 |
10/21/2005 |
DIAGNODENT |
KAVO AMERICA |
DENIEL KAMM |
| K051584 |
10/06/2005 |
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY |
KENDALL |
JAMES WELSH |
| K052673 |
10/17/2005 |
KING I POWERED SCOOTER, MODEL CTL-11 |
KING I TECH CORPORATION |
Ke-Min Jen |
| K052203 |
10/20/2005 |
AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600 |
KIRWAN SURGICAL PRODUCTS, INC. |
KEVIN P PRARIO |
| K043213 |
10/06/2005 |
KOWA VX-10 |
KOWA CO. LTD. |
RICHARD N PHILLIPS |
| K051812 |
10/21/2005 |
TGO SPRAY |
LABORATOIRES CARILENE S.A.S. |
EMALEE MURPHY |
| K052384 |
10/07/2005 |
LANX VBR SYSTEM |
LANX, LLC |
DAVID W SCHLERF |
| K052359 |
10/03/2005 |
IBL CORTISOL LIA TEST KIT |
Lehnus & Associates Consulting |
Gary Lehnus |
| K051214 |
10/24/2005 |
ALUMA SKIN RENEWAL SYSTEM |
LUMENIS, INC. |
Connie Hoy |
| K043494 |
10/04/2005 |
MASTEL LASER CLEAN ROOM, MODEL EBS-100 |
MASTEL PRECISION SURGICAL INSTRUMENTS, INC. |
MERLE GOERINGER |
| K052061 |
10/21/2005 |
MODUS IMF SCREWS 2.0 |
MEDARTIS, INC. |
FLOYD G LARSON |
| K052563 |
10/24/2005 |
INOGEN SATELLITE CONSERVER, MODEL SC-100 |
MEDICAL ELECTRONIC DEVICES, INC. |
THOMAS WENZEL |
| K052495 |
10/11/2005 |
ATRILAZE MALLEABLE ABLATION PROBE |
MEDICALCV, INC. |
DENNY STEGER |
| K052911 |
10/31/2005 |
ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
SHIM KYUNG-AM |
| K052720 |
10/20/2005 |
MEDLINE IODOFORM PACKING STRIPS |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
| K050394 |
10/25/2005 |
SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS |
MEDTOX DIAGNOSTICS, INC. |
ALAN MORRIS |
| K052609 |
10/21/2005 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K052734 |
10/21/2005 |
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K052747 |
10/28/2005 |
MODIFICATION TO:CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K052261 |
10/07/2005 |
MODIFICATION TO: VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD TREHARNE |
| K052440 |
10/11/2005 |
MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER |
MENTOR CORPORATION |
DONNA A CRAWFORD |
| K052351 |
10/17/2005 |
HDR IORT SHIELDED APPLICATOR |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
FELIX MICK |
| K052379 |
10/31/2005 |
MIM 3.5 (CIRCA) |
MIMVISTA CORP. |
PETER SIMMELINK |
| K052721 |
10/27/2005 |
MINXRAY, MODEL HF100H+ |
MINXRAY, INC. |
DANIEL KAMM |
| K051872 |
10/03/2005 |
MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011 |
MK-DENT GMBH |
MARTINA GUNDEROTH |
| K051869 |
10/07/2005 |
NEOBLUE COZY LED PHOTOTHERAPY SYSTEM |
NATUS MEDICAL, INC. |
LUANNE NG |
| K052633 |
10/17/2005 |
DUAL SHOT - CONTRAST DELIVERY SYSTEM |
NEMOTO KYORINDO CO., LTD. |
TOSHIO KANETAKA |
| K052571 |
10/17/2005 |
MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0 |
NEUROGNOSTICS, INC. |
Hrishikesh Gadagkar |
| K041704 |
10/17/2005 |
NEWGEL AND NEWGEL PLUS E |
NEWMEDICAL TECHNOLOGY, INC. |
HAITHAM MATLOUB |
| K051607 |
10/07/2005 |
NOVASPINE CEMENT RESTRICTOR NSCR |
NOVASPINE LLC |
HAMID KHOSROWSHAHI |
| K052361 |
10/24/2005 |
SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM |
NUCLETRON CORPORATION |
LISA DIMMICK |
| K051959 |
10/12/2005 |
NV CORMED SOLAS SPINAL SYSTEM |
NV CORMED |
CARL KNOBLOCH |
| K051645 |
10/13/2005 |
EVIS EXERA 160A SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K050233 |
10/28/2005 |
OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI |
OMRON HEALTHCARE, INC. |
JIM LI, PH.D. |
| K052538 |
10/07/2005 |
S-BONE HIP TOOL |
ORTHOPEDIC SCIENCES, INC |
JAMES K BRANNON |
| K052173 |
10/19/2005 |
VITAGEL SURGICAL HEMOSTAT SPRAY SET |
ORTHOVITA, INC. |
GINA M NAGVAJARA |
| K051656 |
10/25/2005 |
OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM |
OSTEOBIOLOGICS, INC. |
GABRIELE G NIEDERAUER |
| K052681 |
10/06/2005 |
START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI) |
OTTO BOCK HEALTH CARE, LP |
BOB CLARKE |
| K052770 |
10/31/2005 |
PATHFORMER |
PATH SCIENTIFIC, LLC |
PATSY J TRISLER |
| K052349 |
10/21/2005 |
AVANTE LED CURING UNIT, MODEL N44 |
PENTRON CLINICAL TECHNOLOGIES |
GREG MOREAU |
| K052106 |
10/31/2005 |
SIMILE FLOW |
PENTRON CLINICAL TECHNOLOGIES |
GREG MOREAU |
| K052707 |
10/20/2005 |
M3046B COMPACT PORTABLE PATIENT MONITORS |
PHILIPS MEDICAL SYSTEMS |
MICHAEL J DOYLE |
| K051632 |
10/05/2005 |
PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A |
PHILIPS MEDICAL SYSTEMS |
TAMARA YOUNT |
| K052640 |
10/07/2005 |
GEMINI RAPTOR |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
MELINDA NOVATNY |
| K043383 |
10/27/2005 |
N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110 |
PHYSION, INC. |
ERIC J NEMETH, ESQ. |
| K051646 |
10/07/2005 |
ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH |
POINTE SCIENTIFIC, INC. |
WILLIAM F WALTERS |
| K051844 |
10/07/2005 |
EQUATOR PLUS ACETABULAR CUP SYSTEM |
PORTLAND ORTHOPAEDICS PTY. LTD. |
ELAINE DUNCAN |
| K052378 |
10/07/2005 |
PROASIA, MODEL L3402 |
PROASIA LIMITED |
JEFF CHANG |
| K052486 |
10/07/2005 |
PROASIA, MODEL L4501 |
PROASIA LIMITED |
JEFF CHANG |
| K052463 |
10/14/2005 |
PROMETAL HN86 |
PROMETAL TECHNOLOGIES |
DONNA MARIE HARTNETT |
| K051987 |
10/06/2005 |
FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE |
PT. MANDIRI INTI BUANA |
SASITHARAN NAIR |
| K051928 |
10/12/2005 |
AUTOCHECK6+ |
RADIOMETER MEDICAL APS |
LENE M MARNAES |
| K052658 |
10/12/2005 |
SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET |
RENASCENCE MEDICAL, INC. |
DANIEL DYAR |
| K052227 |
10/28/2005 |
RESPCARE FACE MASK |
RESPCARE INC. |
FRANK PELC |
| K052110 |
10/20/2005 |
M-SERIES PRO CPAP SYTEM |
RESPIRONICS, INC. |
ZITA A YURKO |
| K051176 |
10/05/2005 |
FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K051276 |
10/28/2005 |
HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K052193 |
10/03/2005 |
ISE COMPENSATOR |
Roche Diagnostics |
CORINA HARPER |
| K052982 |
10/28/2005 |
ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET |
Roche Diagnostics |
RANDY JOHNSON |
| K051543 |
10/17/2005 |
ELECSYS PRECICONTROL BONE |
ROCHE DIAGNOSTICS CORP. |
CORINA HAPER |
| K052365 |
10/17/2005 |
CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE |
ROCKET MEDICAL PLC |
TRACY CHARLTON |
| K052105 |
10/31/2005 |
WATER FILLED TEETHER |
ROYAL INDUSTRIES (THAILAND) PUBLIC CO. LTD. |
ANDREW SIMS |
| K052506 |
10/06/2005 |
RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108 |
RUBICOR MEDICAL, INC. |
ROBERT J CHIN |
| K051888 |
10/18/2005 |
TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013 |
SCANTIBODIES LABORATORY, INC. |
MICHAEL NORDSTROM |
| K052073 |
10/26/2005 |
FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000 |
SCHUTZ-DENTAL GMBH |
MICHAEL WIERZ |
| K052189 |
10/17/2005 |
REVENEER CERAMIC REPAIR SYSTEM |
SCHUTZ-DENTAL GMBH |
MICHAEL WIERZ |
| K052367 |
10/05/2005 |
SCIENT'X CEMENT RESTRICTOR |
SCIENT'X |
J.D. WEBB |
| K052904 |
10/27/2005 |
VIRTUAL MEDICAL SYSTEMS MODEL VT3000 |
SCIENTIFIC IMAGING, INC. |
CHRIS JOHNSON |
| K052713 |
10/28/2005 |
MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER |
SECHRIST INDUSTRIES, INC. |
GREG GODFREY |
| K052857 |
10/21/2005 |
ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000 |
SENORX, INC. |
AMY BOUCLY |
| K051456 |
10/21/2005 |
SENTINEL CERULOPLASMIN |
SENTINEL CH. SRL |
DAVIDE SPADA |
| K051452 |
10/25/2005 |
SENTINEL CLIN CHEM CAL |
SENTINEL CH. SRL |
DAVIDE SPADA |
| K052500 |
10/17/2005 |
DAR-8000F |
SHIMADZU MEDICAL SYSTEMS |
RANDAL WALKER |
| K052890 |
10/31/2005 |
NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VITAMIN E |
SIAM SEMPERMED CORP. LTD. |
WILLIAM E HARRIS |
| K052775 |
10/31/2005 |
SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP) |
SIEMENS AG, MEDICAL SOLUTIONS |
SIEGLINDE WEST |
| K052895 |
10/27/2005 |
FOURSIGHT VIEWTOOL IMAGE VIEWER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICK J LYNCH |
| K052164 |
10/04/2005 |
MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JUDITH CAMPBELL |
| K052792 |
10/07/2005 |
ANTHOLOGY HIP STEM |
SMITH & NEPHEW, INC. |
JANET AKIL |
| K052652 |
10/21/2005 |
SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE |
SMITH & NEPHEW, INC. |
DEANA BOUSHELL |
| K052183 |
10/07/2005 |
SORING GMBH SONOCA LIPO |
SORING GMBH MEDIZINTECHNIK |
CARL ALLETTO |
| K052514 |
10/19/2005 |
CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001 |
SPECTRANETICS CORP. |
NEIL BURRIS |
| K051976 |
10/17/2005 |
PROVEN REVISION MODULAR TIBIAL TRAY |
STELKAST COMPANY |
DONALD A STEVENS |
| K052516 |
10/03/2005 |
STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137 |
STERITEC PRODUCTS, INC. |
LINDA NELSON |
| K051871 |
10/27/2005 |
STOMA BONE SCREW |
STORZ AM MARK GMBH |
FRANZ MENEAN |
| K052141 |
10/06/2005 |
STRYKER STILETTO ELECTROSURGICAL PROBE |
Stryker Endoscopy |
CRYSTAL ONG |
| K052761 |
10/11/2005 |
MODIFICATION TO: XIA 4.5 SPINAL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
| K052409 |
10/20/2005 |
SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL |
SULTAN CHEMISTS, INC. |
CLARK SMITH |
| K051879 |
10/05/2005 |
SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS |
SYNTHES (USA) |
KATHY ANDERSON |
| K052390 |
10/07/2005 |
SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION |
SYNTHES (USA) |
Lisa Boyle |
| K052677 |
10/12/2005 |
SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP) |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K052634 |
10/11/2005 |
TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE |
TEH LOONG CORP. |
CHIEN LIN |
| K051562 |
10/20/2005 |
NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE SURGICAL GLOVE - ALOE VERA COATED GREEN COLOUR |
TERANG NUSA SDN BHD |
CHIN-GUAN LOW |
| K052286 |
10/21/2005 |
DEUTSCH ANTI-BLOCKAGE WOUND DRAIN |
THE CATHETER EXCHANGE, INC. |
GEORGE P TEITELBAUM |
| K052660 |
10/17/2005 |
MODEL 672-BD, HOME UVB LIGHT SOURCE (JORDAN LIGHT); MODEL 2400, 4 (6 FOOT) HO UV LIGHT SOURCE; MODEL 2600, 6 (6 FOOT) HO |
THE RICHMOND LIGHT CO. |
ALEX M CLARKE |
| K051066 |
10/07/2005 |
THERATEST EL-ANA PROFILES |
THERATEST LABORATORIES, INC. |
MARIUS TEDORESCU |
| K052778 |
10/20/2005 |
THERMAGE THERMACOOL SKIN MARKETING |
THERMAGE, INC. |
PAMELA M BUCKMAN |
| K052859 |
10/25/2005 |
AQUAMANTYS PUMP GENERATOR SYSTEM |
TISSUELINK MEDICAL, INC. |
VICKI ANASTASI |
| K052884 |
10/26/2005 |
MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
MICHAELA MAHL |
| K051587 |
10/25/2005 |
TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470 |
TRACOE MEDICAL GMBH |
MICHAEL A WARREN |
| K052043 |
10/17/2005 |
3.8MM CS FACET COMPRESSION DEVICE |
TRIAGE MEDICAL, INC. |
GAYLE HIROTA |
| K051805 |
10/13/2005 |
KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE |
TYCO HEALTHCARE/KENDALL |
BRIDGET GARDNER |
| K051637 |
10/31/2005 |
DSNARE, MODEL 00711087 |
UNITED STATES ENDOSCOPY GROUP, INC. |
GRETCHEN Y COHEN |
| K052175 |
10/17/2005 |
I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000 |
UROPLASTY, INC. |
MICHAEL MORRELL |
| K052025 |
10/17/2005 |
URGENT PC NEUROMODULATION SYSTEM |
UROPLASTY, INC. |
MICHAEL MORRELL |
| K052584 |
10/07/2005 |
1.5T 12 CHANNEL BODY ARRAY |
USA INSTRUMENTS, INC. |
ROBERT B SMITH |
| K052621 |
10/07/2005 |
1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL |
USA INSTRUMENTS, INC. |
ROBERT B SMITH |
| K052585 |
10/04/2005 |
3T HD BREAST ARRAY |
USA INSTRUMENTS, INC. |
DAVID BROWN |
| K052191 |
10/27/2005 |
MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT |
VERIDEX, LLC |
DEBRA J RASMUSSEN |
| K051815 |
10/17/2005 |
MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM |
VERTEBRON, INC. |
LUIS NESPRIDO |
| K051992 |
10/20/2005 |
POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM |
VIDACARE CORPORATION |
GRACE HOLLAND |
| K052003 |
10/11/2005 |
VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40) |
VNUS MEDICAL TECHNOLOGIES, INC. |
SAM NANAVATI |
| K051248 |
10/27/2005 |
VYGON MICRO-ACCESS SAFETY INTRODUCER KIT |
VYGON CORP. |
COURTNEY SMITH |
| K052806 |
10/17/2005 |
BURANE |
WAVELIGHT LASER TECHNOLOGIE AG |
ALEXANDER POPP |
| K052312 |
10/07/2005 |
WIDE 5MP (MAMMO) LCD MONITOR SYSTEM |
WIDE CORPORATION |
CARL ALLETTO |
| K052292 |
10/21/2005 |
SPIDER CERVICAL PLATING (SCP) SYSTEM |
X-SPINE SYSTEMS, INC. |
DAVID KIRSCHMAN |
| K033405 |
10/18/2005 |
LONGFEI LFY-I-5 OXYGEN CONCENTRATOR |
ZHEJIANG LONGFEI INDUSTRIAL CO., LTD. |
COCO WANG |
| K052600 |
10/13/2005 |
ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED) |
ZIMMER DENTAL INC. |
ERIN MCVEY |
| K052171 |
10/13/2005 |
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE |
ZIMMER, INC. |
CINDY J DICKEY |
