| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K061849 |
06/30/2006 |
MESODERM |
AA ADVANCED TECHNOLOGY INC. |
E.J. Smith |
| K061667 |
06/14/2006 |
CELL-DYN RUBY SYSTEM |
ABBOTT LABORATORIES |
MICHELLE ROEDING |
| K061559 |
06/05/2006 |
ACON URINALYSIS REAGENT STRIPS |
ACON LABORATORIES CO. |
MARTIN O'CONNOR |
| K061522 |
06/02/2006 |
TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM |
ACTIVA TEK INC |
DAVID SCOFIELD |
| K061661 |
06/13/2006 |
STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20 |
ADVANCED INFUSION, INC. |
JAMES CHRISTENSEN |
| K061699 |
06/16/2006 |
EXCIA |
AESCULAP, INC. |
LISA M BOYLE |
| K061704 |
06/16/2006 |
OPTILENE MESH |
AESCULAP, INC. |
LISA M BOYLE |
| K061732 |
06/20/2006 |
TAP-T |
AIRWAY MANAGEMENT INC. |
DARREN HENDERSON |
| K061538 |
06/02/2006 |
ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200 |
ALARA, INC. |
DIANE KING |
| K061738 |
06/20/2006 |
ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD |
ALBERT BROWNE LTD. |
CYNTHIA J.M. NOLTE |
| K061556 |
06/05/2006 |
AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020 |
AMEDICA BIOTECH, INC. |
Jeff Chen |
| K061850 |
06/30/2006 |
MINI-YAG LASER |
AMERICAN LASERS, INC. |
DAVID K QUON |
| K061812 |
06/26/2006 |
COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005 |
ANALYTICON BIOTECHNOLOGIES AG |
KLAUS LANGER |
| K061846 |
06/26/2006 |
COMBI SCAN100 |
ANALYTICON BIOTECHNOLOGIES AG |
KLAUS LANGER |
| K061555 |
06/05/2006 |
ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM |
ANCHOR PRODUCTS CO. |
ROBERT H THRUN |
| K061733 |
06/20/2006 |
ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K061651 |
06/13/2006 |
FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 |
APPLE MEDICAL CORP. |
JOHN C PULFORD |
| K061763 |
06/22/2006 |
ARC SURGICAL BIOTRAK SCREW |
ARC SURGICAL LLC. |
ED BOEHMER |
| K061665 |
06/14/2006 |
ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT |
ARTHREX, INC. |
ANN WATERHOUSE |
| K061863 |
06/30/2006 |
ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY |
ARTHREX, INC. |
ANN WATERHOUSE |
| K061801 |
06/26/2006 |
2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS |
ARTHROTEK, INC. |
SUSAN ALEXANDER |
| K061776 |
06/23/2006 |
ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE |
ARTHROTEK, INC. |
PATRICIA SANDBORN BERES |
| K061657 |
06/13/2006 |
HITCH LACTOSORB SUTURE ANCHOR |
ARTHROTEK, INC. |
LESTER F PADILLA |
| K061601 |
06/08/2006 |
ASAHI PRECIOUS GUIDE CATHETER |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K061759 |
06/22/2006 |
REPROCESSED EXTERNAL FIXATION DEVICE |
ASCENT HEALTHCARE SOLUTIONS |
AMANDA BABCOCK |
| K061856 |
06/30/2006 |
V-2200 INFANT INCUBATOR |
ATOM MEDICAL INC |
MARY STANIEWICZ |
| K061593 |
06/08/2006 |
ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1 |
ATRICURE, INC. |
ELSA C ABRUZZO |
| K061680 |
06/15/2006 |
ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER |
ATRIUM MEDICAL CORP. |
JOSEPH P DEPAOLO |
| K061862 |
06/30/2006 |
AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM |
AXIOM ORTHOPAEDICS, INC. |
MARY MCNAMARA-CULLINANE |
| K061639 |
06/12/2006 |
ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON |
AXON SYSTEMS, INC. |
HOWARD BAILIN |
| K061515 |
06/01/2006 |
RENALSOFT |
BAXTER HEALTHCARE CORP. |
DAVID E CURTIN |
| K061574 |
06/07/2006 |
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 |
BECKMAN COULTER, INC. |
NANCY NADLER |
| K061616 |
06/08/2006 |
COULTER LH 780 HEMATOLOGY ANALYZER |
BECKMAN COULTER, INC. |
NANCY NADLER |
| K061673 |
06/14/2006 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE(GP) 0.25/0.12 -32/16 UG/ML |
BECTON, DICKINSON & CO. |
VICKI L KENNEDY |
| K061638 |
06/12/2006 |
BEST STRAND AND BEST SPACER |
BEST MEDICAL INTERNATIONAL, INC. |
MICHAEL J PHELAN |
| K061857 |
06/30/2006 |
MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR |
BIO COMPRESSION SYSTEMS, INC. |
JAMES JOCHEN ROGERS |
| K061744 |
06/21/2006 |
COCHLEA-SCAN / COCHLEA-SCAN PLUS |
BIO-LOGIC SYSTEMS CORP. |
NORMAN BRUNNER |
| K061799 |
06/26/2006 |
QUADRATENS, MODEL QT-42 |
BIO-RESEARCH ASSOCIATES, INC. |
JOHN C RADKE |
| K061603 |
06/08/2006 |
SMOOTHSHAPES |
BIOCELLULASE, INC. |
ROBERT NAGEL |
| K061567 |
06/06/2006 |
BIOHORIZONS CERAMIC ABUTMENT |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON GREER |
| K061794 |
06/26/2006 |
FIDIS TM THYRO, MODEL MX002 |
BIOMEDICAL DIAGNOSTICS (BMD) SA |
CHRISTELLE COURIVAUD |
| K061681 |
06/15/2006 |
REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT |
BIOMET MANUFACTURING CORP. |
LESTER F PADILLA |
| K061798 |
06/26/2006 |
BIOPRO MEMORY STAPLE |
BIOPRO, INC. |
DAVID MRAK |
| K061602 |
06/08/2006 |
DUET SYSTEM |
BIOVIEW LTD. |
DORIT WINITZ |
| K061599 |
06/08/2006 |
PIN SCREW |
BK MEDITECH CO., LTD. |
BYUNGJUN PARK |
| K061788 |
06/26/2006 |
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM |
BOEHRINGER LABORATORIES |
CHRISTOPHER RADL |
| K061787 |
06/26/2006 |
MAXFORCE TTS SINGLE-USE BALLOON DILATOR |
BOSTON SCIENTIFIC CORP. |
WING NG |
| K061764 |
06/22/2006 |
MEDIBYTE, MODEL MP8 |
BRAEBON MEDICAL CORP. |
RICHARD A BONATO |
| K061514 |
06/01/2006 |
BRUNO VERTICAL PLATFORM LIFT, MODEL VPL-3100 |
BRUNO INDEPENDENT LIVING AIDS, INC. |
TERRENCE O'BRIEN |
| K061570 |
06/06/2006 |
I-STYLE BONE MARROW ASPIRATION NEEDLE |
BUSSE HOSPITAL DISPOSABLES, INC. |
MUHAMAD ANSARI |
| K061705 |
06/16/2006 |
CADWELL EASYNET NASAL PRESSURE MODULE |
CADWELL LABORATORIES, INC. |
CHRIS BOLKAN |
| K061706 |
06/16/2006 |
CADWELL EASYNET OXIMETER MODULE |
CADWELL LABORATORIES, INC. |
CHRIS BOLKAN |
| K061528 |
06/02/2006 |
SELFCHECK GLUCO |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K061762 |
06/22/2006 |
TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N |
CARDINAL HEALTH, INC. |
LAVENIA FORD |
| K061539 |
06/05/2006 |
GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE |
CLINICAL INNOVATIONS, LLC |
WM DEAN WALLACE |
| K061568 |
06/06/2006 |
CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738 |
Codman & Shurtleff, Inc. |
JOCELYN RAPOSO |
| K061516 |
06/01/2006 |
STAODYN MAX PRESET, MODEL 4470 |
COMPEX TECHNOLOGIES, INC. |
CARL BEAURLINE |
| K061814 |
06/27/2006 |
VASOPRESS DVT SYSTEM, MODEL VP500D |
COMPRESSION THERAPY CONCEPTS, INC. |
LEONARD NASS |
| K061711 |
06/19/2006 |
OASIS WOUND MATRIX |
COOK BIOTECH, INC. |
PERRY W GUINN |
| K061855 |
06/30/2006 |
NEUROQUANT |
CORTECHS LABS, INC |
ALLAN GREEN |
| K061722 |
06/19/2006 |
BLOXX RAPID CLOTTING AGENT |
CROSSLINK-D, INC |
LOUIS J MAZZARESE |
| K061503 |
06/01/2006 |
DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) |
DADE BEHRING, INC. |
ANDREA M TASKER |
| K061825 |
06/28/2006 |
DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
| K061852 |
06/30/2006 |
DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
| K061802 |
06/27/2006 |
DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
| K061838 |
06/29/2006 |
DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110 |
DADE BEHRING, INC. |
VICTOR M CARRIO |
| K061703 |
06/16/2006 |
DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120) |
DADE BEHRING, INC. |
VICTOR M CARRIO |
| K061839 |
06/29/2006 |
DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125 |
DADE BEHRING, INC. |
GEORGE M PLUMMER |
| K061792 |
06/26/2006 |
DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI |
DADE BEHRING, INC. |
LORRAINE H PIESTRAK |
| K061655 |
06/13/2006 |
DIMENSION VISTA FLEX REAGENT CARTRIDGES |
DADE BEHRING, INC. |
LORRAINE H PIESTRAK |
| K061845 |
06/29/2006 |
DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
| K061793 |
06/26/2006 |
DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR |
DADE BEHRING, INC. |
ANDREA M TASKER |
| K061795 |
06/23/2006 |
DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR |
DADE BEHRING, INC. |
PAMELA A JUNGA |
| K061818 |
06/28/2006 |
DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330) |
DADE BEHRING, INC. |
VICTOR M CARRIO |
| K061702 |
06/16/2006 |
DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340) |
DADE BEHRING, INC. |
VICTOR M CARRIO |
| K061750 |
06/21/2006 |
DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220 |
DADE BEHRING, INC. |
VICTOR M CARRIO |
| K061751 |
06/21/2006 |
DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260 |
DADE BEHRING, INC. |
VICTOR M CARRIO |
| K061719 |
06/19/2006 |
DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212 |
DADE BEHRING, INC. |
GEORGE W PLUMMER |
| K061536 |
06/02/2006 |
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS |
DADE BEHRING, INC. |
MAUREEN MENDE |
| K061687 |
06/15/2006 |
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS |
DADE BEHRING, INC. |
MAUREEN MENDE |
| K061808 |
06/27/2006 |
DARCO LOCKING BONE PLATE SYSTEM |
DARCO INTERNATIONAL, INC. |
MARK S COOPER |
| K061609 |
06/09/2006 |
GE DATEX-OHMEDA AISYS |
DATEX-OHMEDA, INC. |
DAN KOSEDNAR |
| K061754 |
06/21/2006 |
BARD COMPOSITE L/P MESH |
DAVOL INC., SUB. C.R. BARD, INC. |
GAIL DOW |
| K061658 |
06/13/2006 |
SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L |
DENTALL CORP. |
EDWIN FIRST |
| K061580 |
06/07/2006 |
ECLIPSE WAX REMOVER |
DENTSPLY INTERNATIONAL |
HELEN LEWIS |
| K061833 |
06/29/2006 |
DEPUY AML HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
ANNE SCHULER |
| K061648 |
06/13/2006 |
DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) |
DEPUY ORTHOPAEDICS, INC. |
NANCY FRIDDLE |
| K061520 |
06/02/2006 |
VIPER SPINE SYSTEM |
DEPUY SPINE, INC. |
MARY GRAY |
| K061531 |
06/02/2006 |
SPACE CPSXL BONE CEMENT |
DFINE, INC. |
ROBERT D POSER |
| K061758 |
06/22/2006 |
ACTIVE RENIN IRMA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
SCOTT BISHOP |
| K061803 |
06/27/2006 |
STA - CONTROL LA 1+2 |
DIAGNOSTICA STAGO, INC. |
LAURA WORFOLK |
| K061805 |
06/27/2006 |
STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM |
DIAGNOSTICA STAGO, INC. |
LAURA WORFOLK |
| K061820 |
06/28/2006 |
DIASORIN LIAISON VZV IGG |
DIASORIN, INC. |
Mari Meyer |
| K061797 |
06/26/2006 |
SM IMPLANT SYSTEMS |
DIO DEPARTMENT DSI, INC. |
DAE KYU CHANG |
| K061713 |
06/19/2006 |
MAGIS1;MAGIS2 |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
| K061632 |
06/12/2006 |
GLOBUS PREMIUM MUSCLE STIMULATOR |
DOMINO S.R.L. |
GIOVANNI CIRIANI |
| K061563 |
06/05/2006 |
EBI ARRAY SPINAL SYSTEM |
EBI, L.P. |
JENNIFER P HARAKAL |
| K061696 |
06/14/2006 |
IQQA-LIVER SOFTWARE |
EDDA TECHNOLOGY, INC. |
XIAOLAN ZENG |
| K061540 |
06/05/2006 |
LEKSELL GAMMAPLAN |
ELEKTA INSTRUMENT AB |
LOUISE LINGBLAD |
| K061721 |
06/19/2006 |
PEDI-SPIDER STRAP |
EMERGENCY PRODUCTS AND RESEARCH |
MARK MOEHLER |
| K061650 |
06/13/2006 |
SELECT TENS, MODEL 4600S |
EMPI |
CARL BEAURLINE |
| K061597 |
06/08/2006 |
EPOC BLOOD ANALYSIS SYSTEM |
EPOCAL, INC. |
ROY LAYER |
| K061755 |
06/21/2006 |
MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM |
ESAOTE EUROPE B.V. |
CARRI GRAHAM |
| K061614 |
06/09/2006 |
TERRAQUANT MQ2000 V. 5 AND HANDYRX MQ2007 LASERS |
ESCADA INTERNATIONAL, INC. |
MARY MCNAMARA-CULLINANE |
| K061770 |
06/23/2006 |
ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM |
ETHICON ENDO-SURGERY, INC. |
TOM BOSTICCO |
| K061533 |
06/02/2006 |
PROCEED VENTRAL PATCH |
ETHICON, INC. |
BRYAN A LISA |
| K061804 |
06/27/2006 |
ZERION ALPHA, ; ZERION BETA |
ETKON INTERNATIONAL GMBH |
MATTHIAS ZITZMANN |
| K061566 |
06/06/2006 |
PRIMUS GPS BILIARY STENT SYSTEM |
EV3 INC |
MELISSA SOMMERFELD |
| K061668 |
06/14/2006 |
OPTECURE +CCC |
EXACTECH, INC. |
MARITZA ELIAS |
| K061693 |
06/15/2006 |
FORYOU POWERED WHEELCHAIR, MODEL FC-100 |
FORYOU TECHNOLOGY CO., LTD. |
Ke-Min Jen |
| K061672 |
06/14/2006 |
SYNAPSE MIP/MPR IMAGE VISUALIZATION SOFTWARE OBLIQUUS |
FUJIFILM MEDICAL SYSTEMS USA, INC. |
DEBBIE PEACOCK |
| K061782 |
06/26/2006 |
GAMBRO POSICLEAR |
GAMBRO SERVICES, INC. |
JEFFERY R SHIDEMAN |
| K061535 |
06/02/2006 |
GC XLC-100 CAPSULE |
GC AMERICA, INC. |
TERRY L JORITZ-LYONS |
| K061625 |
06/12/2006 |
AUTOBONE2 |
GE HEALTHCARE |
LARRY A KROGER |
| K061587 |
06/08/2006 |
FULLCARD ANALYSIS |
GE HEALTHCARE |
LARRY A KROGER |
| K061741 |
06/20/2006 |
MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM |
GE HEALTHCARE |
ALLEN TABOR |
| K061817 |
06/28/2006 |
LIGHTSPEED 7.1 CT SCANNER SYSTEM |
GE MEDICAL SYSTEMS, LLC |
LEKSHMI NAIR |
| K061509 |
06/01/2006 |
TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 |
GEN-PROBE, INC. |
BRIAN J SHEA |
| K061686 |
06/15/2006 |
IDI-VANR ASSAY |
GENEOHM SCIENCES CANADA, INC. |
Judi Smith |
| K061525 |
06/02/2006 |
GE VIVID - I |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K061682 |
06/15/2006 |
GE VOLUSON E8 ULTRASOUND SYSTEM |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K061508 |
06/01/2006 |
OSOM INFLUENZA A&B TEST |
GENZYME CORP. |
FRED D LASKY |
| K061735 |
06/20/2006 |
INFIBRA, MODEL 1200 |
GLOBAL DENTAL PRODUCTS, INC. |
JERRY BARTICK |
| K061791 |
06/26/2006 |
FOCUS VNG/ENG TYPE 1068 |
GN OTOMETRICS A/S |
MICHAEL HAMACHER |
| K061853 |
06/30/2006 |
GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES |
Grace Medical, Inc. |
JEFF COBB |
| K061562 |
06/05/2006 |
VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR |
GRAND WORK PLASTIC PRODUCTS CO., LTD. |
KATHY LIU |
| K061690 |
06/15/2006 |
SURGICAL HEADLIGHT |
GULF MEDICAL FIBEROPTICS |
MARCELINO AFANADOR |
| K061748 |
06/21/2006 |
FRAGMENT PLATE SYSTEM |
HAND INNOVATIONS, LLC. |
NATALIE S HECK |
| K061611 |
06/09/2006 |
BOSWORTH DENTIN RESIN |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K061608 |
06/09/2006 |
MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER |
HITACHI MEDICAL CORP. |
DOUG THISTLETHWAITE |
| K061561 |
06/05/2006 |
HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS |
HOLOGIC, INC. |
JEANETTE SCHIER-PUGSLEY |
| K061585 |
06/07/2006 |
OPTICATH CENTRAL VENOUS OXIMETRY CATHETER |
HOSPIRA, INC. |
NICOHL WILDING |
| K061573 |
06/07/2006 |
TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT |
HOSPIRA, INC. |
THOMAS KOZMA |
| K061677 |
06/15/2006 |
SOLAR PUREFIX HA SHOULDER |
HOWMEDICA OSTEONICS CORP |
TIFFANI ROGERS |
| K061521 |
06/02/2006 |
TRIATHLON METAL BACKED PATELLA |
HOWMEDICA OSTEONICS CORP |
TIFFANI ROGERS |
| K061654 |
06/13/2006 |
TRIDENT CONSTRAINED ACETABULAR INSERT |
HOWMEDICA OSTEONICS CORP |
JOSEPH VIOLA |
| K061619 |
06/09/2006 |
INSPECTRA STO2 TISSUE OXYGENATION MONITOR |
HUTCHINSON TECHNOLOGY, INC. |
THOMAS A DOLD |
| K061848 |
06/30/2006 |
HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1 |
HYPERMED, INC. |
CHAS BURR |
| K061595 |
06/08/2006 |
XAMINER |
IMAGING DYNAMICS COMPANY LTD. |
SHIRANTHA SAMARAPPULI |
| K061629 |
06/12/2006 |
CERTAIN PREVAIL DENTAL IMPLANT |
IMPLANT INNOVATIONS, INC. |
JIM BANIC |
| K061784 |
06/26/2006 |
INSORB ABSORBABLE STAPLE, MODEL 1020 |
INCISIVE SURGICAL, INC. |
JAMES PETERSON |
| K061746 |
06/21/2006 |
COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID |
INNOCOLL PHARMACEUTICALS |
AARON WYSE |
| K061718 |
06/19/2006 |
INNOVACON SPECTRUM II TEST CARD |
INNOVACON, INC. |
EDWARD TUNG |
| K061841 |
06/29/2006 |
QUANTA LITE INTRINSIC FACTOR ELISA |
INOVA DIAGNOSTICS, INC. |
GARY L NORMAN |
| K061842 |
06/29/2006 |
QUANTA LITE PBC SCREEN IGG/IGA ELISA |
INOVA DIAGNOSTICS, INC. |
GARY L NORMAN |
| K061859 |
06/30/2006 |
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS |
INOVEL LLC |
WILLIAM WAWRZYNIAK |
| K061715 |
06/19/2006 |
MRGFUS GENERAL PURPOSE AND BREAST COIL |
INSIGHTEC TXSONICS, INC. |
Nadir Alikacem |
| K061598 |
06/08/2006 |
HEMOSIL HOMOCYSTEINE AND CONTROLS |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K061640 |
06/12/2006 |
INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM |
INTEGRA LIFESCIENCES CORPORATION |
JON CAPAROTTA |
| K061607 |
06/09/2006 |
STORM OPERATING KIT, MODEL 1-10-0 |
INTELLIGENT ORTHOPAEDICS LTD |
NEIL MC LACHLAN |
| K061620 |
06/09/2006 |
IFS CANNULATED BONE SCREW |
INTERNAL FIXATION SYSTEMS, INC. |
STEVE HERNANDEZ |
| K061542 |
06/05/2006 |
BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX |
INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS-BINAX |
ANNE JEPSON |
| K061675 |
06/14/2006 |
VISION VXC CENTRAL STATION, MODEL 4300 |
INVIVO CORPORATION |
MARIA KEELAN |
| K061549 |
06/05/2006 |
AMNIOSTAT-FLM-PG |
IRVINE SCIENTIFIC SALES CO., INC. |
WENDELL LEE, PHARM. D |
| K061679 |
06/15/2006 |
WALLACE ARTIFICIAL INSEMINATION CATHETER |
IRVINE SCIENTIFIC SALES CO., INC. |
WENDELL LEE |
| K061781 |
06/26/2006 |
MULTILINK SPRINT |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
| K061664 |
06/14/2006 |
FORMCORE DC, MODEL 28-700100 |
J. MORITA USA, INC. |
TAKESHI INOUE |
| K061701 |
06/16/2006 |
HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K061760 |
06/22/2006 |
ARM BLOOD PRESSURE MONITOR, MODEL KP-7600 |
K-JUMP HEALTH CO., LTD. |
DANNY WANG |
| K061772 |
06/23/2006 |
TRIACTIV FX EMBOLIC PROTECTION SYSTEM |
KENSEY NASH CORP. |
ROBIN M FATZINGER |
| K061749 |
06/21/2006 |
ECLIPSE TOTAL ANKLE IMPLANT |
KINETIKOS MEDICAL, INC. |
JOHN G STAMPINATO |
| K061507 |
06/01/2006 |
SONICWELD RX ENDOBROW FIXATION |
KLS-MARTIN L.P. |
JENNIFER DAMATO |
| K061541 |
06/05/2006 |
KSEA BIPOLAR ELECTROTOME |
KSEA |
JAMES A LEE |
| K061860 |
06/30/2006 |
CLEARFIL MAJESTY ESTHETIC |
KURARAY MEDICAL INC. |
KOJI NISHIDA |
| K061816 |
06/28/2006 |
GALAXY |
LARSEN & TOUBRO LIMITED |
HARRY P GUGNANI |
| K061656 |
06/09/2006 |
LASER-D68 |
LASER PAIN CLINICS LP |
HOLLY WRIGHT |
| K061646 |
06/12/2006 |
LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES |
LASERSCOPE |
PAUL HARDIMAN |
| K061600 |
06/08/2006 |
ARX SPINAL SYSTEM |
LIFE SPINE |
ERIN MALLOY |
| K061698 |
06/16/2006 |
MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR |
LIFE SPINE |
ERIN MALLOY |
| K061726 |
06/19/2006 |
LSC, MODEL 3 |
LIFESTAND |
STEFANIE D BANKSTON |
| K061504 |
06/01/2006 |
POWDER FREE NITRILE BLUE EXAMINATION GLOVE |
LIWE TRADING |
K M LEE |
| K061505 |
06/01/2006 |
POWERED NITRILE BLUE EXAMINATION GLOVES |
LIWE TRADING |
K M LEE |
| K061828 |
06/28/2006 |
LORENZ BIOTECH APTIVA, VERSION 2.13 |
LORENZ BIOTECH S.P.A. |
ROSINA ROBINSON |
| K061742 |
06/20/2006 |
URYXXON RELAX URINE ANALYZER |
MACHEREY-NAGEL GMBH & CO., KG. |
ARMOND WELCH |
| K061832 |
06/29/2006 |
JOSTRA HLM TUBING SETS WITH SAFELINE COATING |
MAQUET CARDIOPULMONARY AG |
JAMES COLLIE |
| K061628 |
06/12/2006 |
JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030 |
MAQUET CARDIOPULMONARY AG |
JAMES COLLIE |
| K061546 |
06/05/2006 |
QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140 |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
| K061743 |
06/21/2006 |
VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001 |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
| K061666 |
06/14/2006 |
CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX |
MAUNA KEA TECHNOLOGIES |
FOUAD TARABAH |
| K061694 |
06/15/2006 |
MEDCARE MECHANICAL WHEELCHAIR, MODELS MC-281S & MC-200S |
MEDCARE MANUFACTURING INC. |
Ke-Min Jen |
| K061831 |
06/28/2006 |
MEDCHANNEL HTS SYSTEM |
MEDCHANNEL, LLC |
FREDERICK TOBIA |
| K061684 |
06/15/2006 |
MEDI-GLOBE ROTA-CUT SPHINCTEROTOME |
MEDI-GLOBE CORPORATION |
SCOTT KARLER |
| K061606 |
06/09/2006 |
DEFIBRILLATOR CABLE TESTER, MODEL DT2200 |
MEDICAL DEVICES/PADPRO, INC. |
DANIEL KAMM |
| K061731 |
06/20/2006 |
MEDGRAPHICS ULTIMA SYSTEM |
MEDICAL GRAPHICS CORP. |
LYNN BROSIOUS |
| K061560 |
06/05/2006 |
SONOMARK |
MEDICAL PRODUCTS MANUFACTURING, INC. |
THERON E JOHNSON |
| K061551 |
06/05/2006 |
POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS) |
MEDIPURE CORPORATION (M) SDN. BHD. |
TERENCE LIM SIN KOOI |
| K061579 |
06/07/2006 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD W TREHARNE |
| K061635 |
06/12/2006 |
MSD BIPOLAR FORCEPS |
MEDTRONIC SOFAMOR DANEK |
RICHARD W TREHARNE |
| K061591 |
06/08/2006 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K061592 |
06/08/2006 |
MODIFICATION TO CD HORIZON SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K061557 |
06/05/2006 |
FUSION |
MEDWAVE, INC. |
DONNA R LUNAK |
| K061809 |
06/27/2006 |
ARTEGRAL IMCROWN |
MERZ DENTAL GMBH |
RICHARD G HUNTER |
| K061530 |
06/02/2006 |
MD-TEMP |
META BIOMED CO., LTD. |
TAE-HOON KIM |
| K061558 |
06/05/2006 |
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BU1-4U |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K061615 |
06/09/2006 |
INTERDRY TEXTILE WITH SILVER |
MILLIKEN CHEMICAL |
MARY MCNAMARA-CULLINANE |
| K061712 |
06/19/2006 |
SPIROBANK II |
MIR MEDICAL INTL. RESEARCH SRL |
SIMON FOWLER |
| K061554 |
06/05/2006 |
MEPILEX AG ABSORBENT SILICONE-COATED DRESSING |
MOLNLYCKE HEALTH CARE |
STEVEN DOWDLEY |
| K061774 |
06/23/2006 |
NFIX II PEDICLE SCREW SYSTEM |
N SPINE, INC. |
R. STEPHEN REITZLER |
| K061700 |
06/16/2006 |
NEOTRACT ANCHOR |
NEOTRACT, INC. |
KEVIN MACDONALD |
| K061829 |
06/28/2006 |
ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES |
NEW LEAF MEDICAL, INC. |
RICHARD T NOCK |
| K061618 |
06/09/2006 |
COOLTOUCH, MODEL CTEV |
NEW STAR LASERS, INC. |
DONALD V JOHNSON |
| K061765 |
06/22/2006 |
KALIX II IMPLANT |
NEWDEAL S.A. |
JUDITH E O'GRADY |
| K061594 |
06/08/2006 |
LARGE UNI-CLIP STAPLE |
NEWDEAL S.A. |
JUDITH E O'GRADY |
| K061768 |
06/23/2006 |
MP-1 MICROPERIMETER |
NIDEK TECHNOLOGIES SRL |
ALDO COCCHIGLIA |
| K061519 |
06/01/2006 |
MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM |
NIKKISO CO. LTD. |
FUMIAKI KANAI |
| K061529 |
06/02/2006 |
PROCERA ZIRCONIA ABUTMENT FOR CAMLOG IMPLANT SYSTEM |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
| K061830 |
06/28/2006 |
STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K061789 |
06/26/2006 |
LATERAL PLATE SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K061778 |
06/26/2006 |
NUVASIVE SPHERX II SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K061837 |
06/29/2006 |
NXSTAGE CARTRIDGE EXPRESS |
NXSTAGE MEDICAL, INC. |
NORMA LEMAY |
| K061575 |
06/07/2006 |
OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 |
OLYMPUS AMERICA, INC. |
BEV HARDING |
| K061822 |
06/28/2006 |
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3 |
OMRON HEALTHCARE, INC. |
DONNA DJINOVICH |
| K061524 |
06/02/2006 |
ISS INTEGRATED SPINE SYSTEM |
ORTHO DEVELOPMENT CORP. |
WILLIAM J GRIFFIN |
| K061588 |
06/08/2006 |
VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
MICHAEL BYRNE |
| K061581 |
06/07/2006 |
EXCEL HIGH SPEED DENTAL HANDPIECE |
ORTHOSOURCE, INC. |
LLOYD TAYLOR |
| K061730 |
06/20/2006 |
OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 |
OSMETECH, INC. |
BERNIE HEITZ |
| K061652 |
06/13/2006 |
PALOMAR LUX1540 HANDPIECE |
PALOMAR MEDICAL PRODUCTS, INC. |
Sharon Timberlake |
| K061695 |
06/15/2006 |
LED PROLUX 770 |
PENG LIM ENTERPRISE CO., LTD. |
C.S. WANG |
| K061720 |
06/19/2006 |
COSMELIGHT |
PENNTACK ENTERPRISES INC. |
PABLO PENA |
| K061766 |
06/22/2006 |
EXPRESSWAY INTERMITTENT CATHETER |
PERCUTANEOUS SYSTEMS, INCORPORATED |
THOMAS LAWSON |
| K061707 |
06/16/2006 |
HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS |
PHILIPS MEDICAL SYSTEMS |
SONGHUA ZHANG |
| K061685 |
06/15/2006 |
PULSERA |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
JOSEPH S ARNAUDO |
| K061610 |
06/09/2006 |
PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
HAUKE SCHIK |
| K061622 |
06/12/2006 |
PS SERIES |
PHOTONIC OPTISCHE GERATE GESMBH & COKG |
DIETER FEGER |
| K061564 |
06/05/2006 |
PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD |
PORTLAND ORTHOPAEDICS PTY. LTD. |
ELAINE DUNCAN |
| K061649 |
06/13/2006 |
POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
| K061716 |
06/19/2006 |
PRESTIGE AMERITECH FACE MASK |
Prestige Ameritech |
DAN REESE |
| K061517 |
06/01/2006 |
PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES |
PRIME HERBS CORPORATION |
GENEVIEVE HSIA |
| K061678 |
06/15/2006 |
PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI-MAP-25 |
PRORHYTHM |
JOHN J TALARICO |
| K061790 |
06/26/2006 |
PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES |
PROTEIN POLYMER TECHNOLOGIES, INC. |
RADINE POBUDA |
| K061689 |
06/15/2006 |
AQUATINE EC ENDODONTIC CLEANSER |
PURICORE, INC. |
HOWARD MANN |
| K061576 |
06/07/2006 |
MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM |
QUANTUM ORTHOPEDICS, INC. |
JASON BLAIN |
| K061511 |
06/01/2006 |
R&D CBC-3D + CRP HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
RALPH E HOGANCAMP |
| K061810 |
06/27/2006 |
COUGAR WHEELCHAIR |
R82 A/S |
KIRK MACKENZIE |
| K061532 |
06/02/2006 |
GENTLE COLON (REVISION 2.0) |
RENDOSCOPY, INC. |
MIRA PATTANAYAK |
| K061785 |
06/23/2006 |
CYL-FIL OXYGEN SYSTEM |
RESPONSIVE RESPIRATORY INC. |
THOMAS BANNON |
| K061737 |
06/20/2006 |
LOSS OF RESISTANCE SYRINGE |
ROBERT BUSSE & CO., INC. |
MUHAMAD ANSARI |
| K061683 |
06/15/2006 |
TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
THERESA AMBROSE BUSH |
| K061780 |
06/26/2006 |
TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS + |
ROZINN ELECTRONICS, INC. |
MARK ROSOFF |
| K061663 |
06/05/2006 |
ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES |
RTC INC.-MEMCATH TECHNOLOGIES LLC |
MARC JAKER |
| K061510 |
06/01/2006 |
SANARUS VISICA TREATMENT SYSTEM |
SANARUS MEDICAL, INC. |
TRENA DEPEL |
| K061571 |
06/06/2006 |
ASTRA 300 |
SDI DIAGNOSTICS, INC. |
COSIMO CARIOLO |
| K061756 |
06/21/2006 |
TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP |
SHEN WEI (USA), INC. |
CYNTHIA LIU |
| K061641 |
06/12/2006 |
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO |
SHIMADZU MEDICAL SYSTEMS |
RANDAL WALKER |
| K061643 |
06/12/2006 |
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO |
SHIMADZU MEDICAL SYSTEMS |
RANDAL WALKER |
| K061637 |
06/12/2006 |
ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO |
SHIMADZU MEDICAL SYSTEMS |
RANDAL WALKER |
| K061671 |
06/14/2006 |
SYNGO TRUED, MODEL VC10A |
SIEMENS MEDICAL SOLUTIONS |
JAMES E KUHN |
| K061590 |
06/08/2006 |
SMDIE DEVICE INTERFACING SYSTEM |
SIEMENS MEDICAL SOLUTIONS HEALTH SERVICES CORPORAT |
IAN GORDON |
| K061545 |
06/05/2006 |
SCENIUM 1.1 |
SIEMENS MOLECULAR IMAGING LTD |
FRANK POKROP |
| K061577 |
06/07/2006 |
OVALTWIST PEDICLE SCREW SYSTEM |
SIGNUS MEDIZINTECHNIK GMBH |
MIKE ENSIGN |
| K061724 |
06/19/2006 |
POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE) |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
| K061779 |
06/26/2006 |
COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE |
SMITH & NEPHEW, INC. |
GINO ROUSS |
| K061783 |
06/26/2006 |
KNEE FUSION NAIL |
SMITH & NEPHEW, INC. |
JOHN REABE |
| K061569 |
06/06/2006 |
SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS |
SMITH & NEPHEW, INC. |
JASON SELLS |
| K061513 |
06/01/2006 |
LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET |
SMITHS MEDICAL ASD, INC. |
TIMOTHY J TALCOTT |
| K061589 |
06/08/2006 |
SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY |
SOLARC SYSTEMS, INC. |
BRUCE ELLIOTT |
| K061527 |
06/02/2006 |
CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
| K061578 |
06/07/2006 |
SSP VERTEBRAL BODY REPLACEMENT |
SPECIALTY SPINE PRODUCTS, LLC |
FLOYD G LARSON |
| K061752 |
06/21/2006 |
SPINAL USA VBR SYSTEM |
SPINAL USA |
JEFFREY JOHNSON |
| K061710 |
06/19/2006 |
CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLS |
ST. JUDE MEDICAL |
ADELE SHOUSTAL |
| K061843 |
06/30/2006 |
VENTURE WIRE CONTROL CATHETER, MODEL WCC |
ST. JUDE MEDICAL |
SHANNON SPRINGER |
| K061544 |
06/05/2006 |
STELLARTECH 100 COAGULATION SYSTEM |
STELLARTECH RESEARCH CORP. |
JAMES R SANTOS |
| K061548 |
06/05/2006 |
STRYKER URETERAL ILLUMINATION SYSTEM IV |
STRYKER CORP. |
ERICA A WALTERS |
| K061725 |
06/19/2006 |
STRYKER ARIA PNEUMATIC SYSTEM |
STRYKER INSTRUMENTS |
VALERIE FRANCK |
| K061660 |
06/13/2006 |
STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLE |
STRYKER INSTRUMENTS |
JENNIFER HOFFMAN |
| K061835 |
06/29/2006 |
STRYKER SILVERGLIDE BIPOLAR FORCEPS REUSABLE CABLE; DISPOSABLE CABLE |
STRYKER INSTRUMENTS |
JEAN W SHEPPARD |
| K061836 |
06/29/2006 |
AVS ASL PEEK SPACER SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
| K061813 |
06/27/2006 |
MANTIS SPINAL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
| K061854 |
06/30/2006 |
XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
| K061626 |
06/12/2006 |
VASORING* VRC VASCULAR RING CONNECTOR |
SUNWEI TECH CO. LTD. |
JOSEPH J CHANG |
| K061526 |
06/02/2006 |
ENSEAL PTC TISSUE SEALING DEVICE |
SURGRX INC |
LINDA OLESON |
| K061621 |
06/12/2006 |
SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS |
SYNTHES (USA) |
DEBORAH L JACKSON |
| K061753 |
06/21/2006 |
SYNTHES (USA) CLAVICLE HOOK PLATES |
SYNTHES (USA) |
DEBORAH JACKSON |
| K061800 |
06/26/2006 |
CLEVER TD-1112 EAR/SKIN/SURFACE IR THERMOMETER |
TaiDoc Technology Corporation |
PI-SHIOU LI |
| K061674 |
06/14/2006 |
RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER |
TALIA TECHNOLOGY LTD. |
JONATHAN S KAHAN |
| K061662 |
06/12/2006 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
TANGSHAN LUXIONG PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K061659 |
06/12/2006 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
TANGSHAN LUXIONG PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K061736 |
06/20/2006 |
COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA |
TELEFLEX MEDICAL |
LORI HAYS |
| K061807 |
06/27/2006 |
SPI ART ABUTMENTS |
THOMMEN MEDICAL, AG |
Floyd Larson |
| K061617 |
06/09/2006 |
FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST |
Tianjin New Bay Bioresearch Co., Ltd. |
RODRIGO BERTIE |
| K061688 |
06/15/2006 |
ANTI-SNORING / SLEEP APNEA DEVICE |
TOMED DR. TOUSSAINT GMBH |
WINFRIED TOUSSAINT |
| K061645 |
06/12/2006 |
MAGPRO, MODEL R30 |
TONICA ELEKTRONIK A/S |
LISE TERKELSEN |
| K061824 |
06/28/2006 |
TORNIER CEMENT RESTRICTOR |
TORNIER |
Mireille Lemery |
| K061605 |
06/09/2006 |
NEMIO XG, SAA-580A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K061613 |
06/09/2006 |
VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) |
TRIPATH IMAGING |
BRYAN J TUCKER |
| K061827 |
06/28/2006 |
SONIX ULTRASOUND SCANNER |
UltraSonix Medical Corporation |
LULIA NUCA |
| K061769 |
06/23/2006 |
E.P.T. CERTAINTY 1-STEP PREGNANCY TEST |
UNIPATH LTD. |
Louise Roberts |
| K061676 |
06/14/2006 |
RIGIDOMETER, MODEL DIR-4U |
UROAN 21 |
ANABEL ROSSELLO |
| K061582 |
06/07/2006 |
VARISOURCE 200 HDR AFTERLOADER |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K061565 |
06/05/2006 |
LANGSTON DUAL LUMEN CATHETER |
VASCULAR SOLUTIONS, INC. |
JULIE TAPPER |
| K061627 |
06/12/2006 |
MODIFICATION TO I VENT 201 |
VERSAMED MEDICAL SYSTEMS, INC. |
JERRY KORTEN |
| K061771 |
06/23/2006 |
EZ-CONNECT |
VIDACARE CORPORATION |
GRACE HOLLAND |
| K061624 |
06/12/2006 |
VITREA, VERSION 3.9 |
VITAL IMAGES, INC. |
TIMOTHY J KAPPERS |
| K061823 |
06/28/2006 |
ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE |
VOCO GMBH |
MICHAEL SUS |
| K061796 |
06/26/2006 |
HEPATOSTAT SET, MODEL 760X |
VYGON CORP. |
STEPHEN GOLDNER |
| K061727 |
06/19/2006 |
GORE PRECLUDE VESSEL GUARD |
W.L. GORE & ASSOCIATES,INC |
Michael Ivey |
| K061775 |
06/23/2006 |
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR |
WAKO CHEMICALS, USA, INC. |
LORI CREASY |
| K061653 |
06/13/2006 |
SOYALA FULL FACE MASK |
WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG |
ECKHARDT ABERS |
| K061815 |
06/27/2006 |
COOK CELECT VENA CAVA FILTER |
WILLIAM COOK EUROPE APS |
THALIA BRINE |
| K061670 |
06/14/2006 |
LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE |
WILLIAM COOK EUROPE APS |
TINA H ANDERSON |
| K061844 |
06/29/2006 |
DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MATT PAUL |
| K061547 |
06/05/2006 |
DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MATT PAUL |
| K061834 |
06/29/2006 |
XCAT; XCAT FOR NEURO |
XORAN TECHNOLOGIES, INC. |
JIM BERTOLINA |
| K061553 |
06/05/2006 |
NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVES |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
JANNA P TUCKER |
| K061767 |
06/23/2006 |
QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+ |
Z-MEDICA CORPORATION |
ROBERT V PACKARD |
| K061534 |
06/02/2006 |
ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM |
ZIEHM IMAGING, INC. |
RICHARD WESTRICH |
| K061847 |
06/30/2006 |
ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KRA451S, ZRA452S |
ZIMMER DENTAL INC. |
WILLIAM FISHER |
| K061717 |
06/19/2006 |
ZIMMER ONE-PIECE IMPLANT, 3.7 MM, ANGLED |
ZIMMER DENTAL INC. |
ERIN MCVEY |
| K061786 |
06/26/2006 |
VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS |
ZIMMER, INC. |
PATRICIA JENKS |
| K061851 |
06/30/2006 |
ZIRKONZAHN ICE |
ZIRKONZAHN GMBH |
DONNA M HARTNETT |
