| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K103491 |
12/10/2010 |
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM |
A JOHNSON & JOHNSON COMPANY |
FRANK S JURCZAK |
| K103601 |
12/08/2010 |
AUDIT MICROCV IMMUNOASSAY LINEARITY SET |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
| K103627 |
12/13/2010 |
ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS |
ABBOTT LABORATORIES |
JUDITH R WALLACH |
| K103595 |
12/10/2010 |
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM |
ACCLARENT, INC. |
GURVINDER SINGH NANDA |
| K103790 |
12/27/2010 |
ACE TRIMARK TRICAM DENTAL IMPLANT |
ACE SURGICAL SUPPLY COMPANY INC. |
DENISE WILLIAMS |
| K103772 |
12/27/2010 |
VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE) |
ADVANCED MEDICAL DEVICES FACTORY |
XINGYUAN WANG |
| K103533 |
12/01/2010 |
ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
JULIE GLENDRANGE |
| K103635 |
12/13/2010 |
CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S |
AEROGEN LTD |
MARTHA FOLAN |
| K103544 |
12/10/2010 |
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D |
AGAMATRIX INC |
WILLIAM H MCGRAIL |
| K103597 |
12/08/2010 |
DX-D 100 |
AGFA HEALTHCARE N.V. |
PHIL CUSCUNA |
| K103058 |
12/02/2010 |
MULTIFUNCTION KEITO |
AGUIFLAI IBERICA S.L. |
XAVIER CASALS |
| K103616 |
12/10/2010 |
PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER |
AKTINA MEDICAL PHYSICS CORP. |
TONY SPACCAROTELLA |
| K103610 |
12/09/2010 |
CLEARVIEW EXACT II INFLUENZA A & B TEST |
ALERE SCARBOROUGH, INC D/B/A BINAX, INC. |
ANNE JEPSON |
| K103615 |
12/09/2010 |
ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
HYMAN KATZ |
| K103714 |
12/21/2010 |
ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA |
ANSELL HEALTHCARE PRODUCTS, LLC |
MARY L ARMSTRONG |
| K103535 |
12/01/2010 |
VACPLUS SUCTION UNIT |
APEX MEDICAL CORP. |
|
| K103706 |
12/20/2010 |
THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR |
APPLIED CARDIAC SYSTEMS, INC. |
R. BEN GHADIMI |
| DEN100026 |
12/14/2010 |
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE |
APTUS ENDOSYSTEMS, INC. |
BURT GOODSON |
| K103705 |
12/20/2010 |
LOW PROFILE SCREWS |
ARTHREX, INC. |
COURTNEY SMITH |
| K103634 |
12/13/2010 |
ASCOM CLINICALCONNEX CARDIOMAX |
ASCOM (US), INC. |
THOMAS KROENKE |
| K103643 |
12/13/2010 |
ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS) |
ASCOT TECHNOLOGIES, INC. |
MARY E RANDALL |
| K103759 |
12/23/2010 |
ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT |
ASTRA TECH, INC. |
BETSY A BROWN |
| K103828 |
12/28/2010 |
BILI-THERAPY SPOT TYPE |
ATOM MEDICAL CORPORATION |
PAUL DRYDEN |
| K103679 |
12/22/2010 |
AXIS PACS, HMS PACS |
AXIS HEALTH CARE, LLC |
RONALD W GRAHAM |
| K103546 |
12/02/2010 |
AYCAN WORKSTATION OSIRIX PRO |
AYCAN DIGITALSYSTEME GMBH |
MATTHIAS BROENNER |
| K103792 |
12/27/2010 |
BARCO MAMMO TOMOSYNTHESIS |
BARCO NV |
LIEVEN DE WANDEL |
| K103551 |
12/02/2010 |
INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS, |
BAXTER HEALTHCARE CORP. |
NANETTE HEDDEN |
| K103842 |
12/30/2010 |
UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 |
BECKMAN COULTER, INC. |
MARINE BOYAJIAN |
| K103798 |
12/27/2010 |
BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS |
BECTON DICKINSON & CO. |
THALIA CHARLES |
| K103685 |
12/17/2010 |
PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA |
BEIJING RONGRUI-CENTURY SCIE. & TECH. CO., LTD. |
DIANA HONG |
| K103631 |
12/13/2010 |
SLEEPMINDER BREATHING FREQUENCY INDICATOR |
BIANCAMED LIMITED |
PAUL PHILLIPS |
| K103684 |
12/17/2010 |
VRESELECT CULTURE MEDIUM |
BIO-RAD |
FRAN WHITE |
| K103834 |
12/30/2010 |
BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS |
BIO-RAD LABORATORIES |
JUANG WANG |
| K103691 |
12/17/2010 |
BIOHORIZONS ABUTMENTS FOR ZIMMER |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
MICHAEL DAVIS |
| K103755 |
12/23/2010 |
TAPERLOC COMPLETE, SIZE 5 AND 6 |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
| K103553 |
12/03/2010 |
LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION |
BIONOSTICS, INC. |
RANDY BYRD |
| K103746 |
12/23/2010 |
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD) |
BIOSENSE WEBSTER, INC. |
WAYNE R HOHMAN |
| K103545 |
12/17/2010 |
BT-350 |
BISTOS CO., LTD. |
STEVE KOHN |
| K103668 |
12/16/2010 |
BNX FINE NEEDLE ASPIRATION SYSTEM |
BOSTON ENDOSCOPIC ENGINEERING |
ANNETTE M FAGNANT |
| K103751 |
12/23/2010 |
MUSTANG BALLOON DILATATION CATHETERS |
BOSTON SCIENTIFIC |
ANNE V ROSSI |
| K103640 |
12/23/2010 |
MIDMARK IQECG |
BRENTWOOD MEDICAL TECHNOLOGY CORP. |
GREG HOLLAND |
| K103591 |
12/07/2010 |
DIGITAL RADIOGRAPHY |
CANON, INC.-MEDICAL EQUIPMENT GROUP |
KOJI KUBO |
| K103651 |
12/14/2010 |
CARDIOMED |
CARDIO MEDICAL PRODUCTS, INC. |
NICK MENDISE |
| K103734 |
12/22/2010 |
POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE |
CENTRAL MEDICARE SDN BHD |
NICK WANG |
| K103562 |
12/06/2010 |
CENTURION PRESSURE INJECTABLE EXTENSION SET |
CENTURION MEDICAL PRODUCTS CORPORATION |
MATTHEW K PRICE |
| K103766 |
12/23/2010 |
XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0 |
CEPHEID |
KERRY J FLOM |
| K103820 |
12/30/2010 |
REPROBONE DENTAL GRAFTING MATERIAL |
CERAMISYS LTD |
HILLARD W WELCH |
| K103675 |
12/16/2010 |
CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE |
CHIENMAX VIETNAM CO. LTD |
JIGAR SHAH |
| K103695 |
12/17/2010 |
PREPEX SYSTEM |
CIRC MEDTECH |
SHOSHANA FRIEDMAN |
| K103568 |
12/06/2010 |
RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH |
COLOPLAST A/S |
JANELL A COLLEY |
| K103791 |
12/27/2010 |
PHYSIOGLOVE ES WITH ECG ANALYSIS |
COMMWELL LTD. |
IRVING LEVY |
| K102940 |
12/23/2010 |
VASCOPRESS SEQUENTIAL DVT PUMP |
COMPRESSION THERAPY CONCEPTS |
LEONARD NASS |
| K103665 |
12/16/2010 |
CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT; CONED R SABRE GENESIS TM ELECTROSURGICAL UNIT (230V); CONMED HYFRESURG O |
CONMED CORPORATION |
SHAWN RIEDEL |
| K103709 |
12/20/2010 |
CERACELL DENTAL |
CURASAN AG |
ROGER GRAY |
| K103626 |
12/14/2010 |
CUTERA GENESISPLUS LASER SYSTEM |
CUTERA, INC. |
CONNIE HOY |
| K103667 |
12/15/2010 |
SAPPHIRE ST PORTABLE DIODE LASER |
DEN-MAT HOLDINGS, LLC |
ALAN B MATTHEWS |
| K103549 |
12/03/2010 |
DENOVO TEDDY GEL INFANT HEEL WARMER |
DENOVO PRODUCTS LLC |
DALE WALTERS |
| K103653 |
12/13/2010 |
E3 TORQUE CONTROL MOTOR |
DENTSPLY INTERNATIONAL INC. |
HELEN LEWIS |
| K103831 |
12/30/2010 |
DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
DEEP PAL |
| K103712 |
12/20/2010 |
GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
KRISTINE CHRISTO |
| K103756 |
12/23/2010 |
DEPUY ATTUNE TOTAL KNEE SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
NANCY FRIDDLE |
| K103529 |
12/01/2010 |
LIAISON XL ANALYZER MODEL 10050 |
DIASORIN, INC. |
MARI MEYER |
| K103557 |
12/02/2010 |
DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET |
DIAZYME LABORATORIES |
ABHIJIT DATTA |
| K103600 |
12/08/2010 |
PORTABLE X-RAY SYSTEM |
DIGIMED CORPORATION |
KIM ANTOL |
| K103736 |
12/22/2010 |
DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE |
DMC MEDICAL LTD. |
TRACY BEST |
| K103625 |
12/10/2010 |
OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE |
DRAEGER MEDICAL SYSTEMS, INC. |
JOYCE KILROY |
| K103738 |
12/22/2010 |
H-WAVE |
ELECTRONIC WAVEFORM LABORATORY, INC. |
RYAN P HEANEY |
| K103747 |
12/23/2010 |
ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS |
ELITECHGROUP SEPPIM S.A.S. |
DEBRA K HUTSON |
| K103608 |
12/09/2010 |
I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND |
ELLEX, INC. |
JONATHAN STRAWN |
| K103801 |
12/28/2010 |
HYPOTHERMX INTRAVENOUS FLUID WARMER |
EMIT CORPORATION |
DARLA J ELKIN |
| K103554 |
12/03/2010 |
METRON-CP/MD |
EPONATECH LLC |
K. BRIAN MATLOCK |
| K103696 |
12/17/2010 |
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES |
ERBE USA, INC. |
JOHN TARTAL |
| K103637 |
12/13/2010 |
ERKA. PERFECT-ANEROID |
ERKA KALLMEYER MEDIZINTECHNIK GMBH |
JAN WEISS |
| K103672 |
12/16/2010 |
REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET |
ETHICON ENDO-SURGERY, LLC |
DENNIS HAHN |
| K103618 |
12/10/2010 |
TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM |
EV3 INC |
BRENDA JOHNSON |
| K103719 |
12/21/2010 |
LIFECARE CONDUCTIVE GARMENTS |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
JAY MANSOUR |
| K103699 |
12/20/2010 |
EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC |
EXACTECH, INC. |
SHING JEN TAI, PHD |
| K103655 |
12/17/2010 |
OCTANE-C INTERBODY FUSION DEVICE SYSTEM |
EXACTECH, INC. |
PATRICK HUGHES |
| K103783 |
12/27/2010 |
EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC |
FIAB S.P.A. |
ALBERTO CALABRO |
| K103767 |
12/23/2010 |
DUAL HEATED INFANT VREATHING CIROUITS |
FISHER & PAYKEL HEALTHCARE LTD. |
ROBERT PETRY |
| K103786 |
12/27/2010 |
ZEST PETITE NASAL MASK |
FISHER & PAYKEL HEALTHCARE, LTD. |
TINA MASON |
| K103550 |
12/03/2010 |
YOBOSHI DENTAL UNIT |
FOSHAM YOBOSHI MEDICAL EQUIPMENT CO., LTD |
SABRINA WEI |
| K103687 |
12/17/2010 |
SYNAPSE 3D CEREBRAL ANALYSIS |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
DEBBIE PEACOCK |
| K103596 |
12/08/2010 |
WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
KATHERINE Y CHOI |
| K103676 |
12/16/2010 |
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL |
FUJIREBIO DIAGNOSTICS, INC. |
DIANA LYN DICKSON |
| K103832 |
12/30/2010 |
PHOENIX HEMODIALYSIS DELIVERY SYSTEM |
GAMBRO RENAL PRODUCTS, INC. |
KAE MILLER |
| K103458 |
12/20/2010 |
VIEWPOINT 6 |
GE HEALTHCARE |
NICOLE LANDREVILLE |
| K103649 |
12/15/2010 |
VOLUSON S6, VOLUSON S8 |
GE HEALTHCARE |
BRYAN BEHN |
| K103802 |
12/28/2010 |
TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR |
GE HEALTHCARE FINLAND OY |
TATJA PASANEN |
| K103678 |
12/16/2010 |
CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH |
ALBRECHT MALKMUS |
| K103730 |
12/21/2010 |
GE LUNAR VISCERAL FAT SOFTWARE |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
CHRIS PAULIK |
| K103671 |
12/16/2010 |
GENESYS SPINE TILOCK SYSTEM |
GENESYS SPINE |
BRIAN J BERGERON |
| K103745 |
12/23/2010 |
BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF |
GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) |
WENDY A MCMANUS |
| K103757 |
12/23/2010 |
IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT |
GRIFOLS |
GARY LEHNUS |
| K103803 |
12/28/2010 |
HAMILTON-G5 |
HAMILTON MEDICAL AG |
FREDERIKE BRUEHSCHWEIN |
| K103538 |
12/02/2010 |
HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939 |
HARDY DIAGNOSTICS |
WENDY HADLEY |
| K103585 |
12/07/2010 |
BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP |
HARRY J. BOSWORTH CO. |
GARY CHUVEN |
| K103641 |
12/13/2010 |
GUARDACARE |
HEMCON MEDICAL TECHNOLOGIES, INC. |
KEVIN HAWKINS |
| K103537 |
12/02/2010 |
ET III SA ULTRA WIDE SYSTEM |
HIOSSEN INC. |
PATRICK LIM |
| K103788 |
12/29/2010 |
PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT |
HORIBA ABX SAS |
CAROLINE FERRER |
| K103224 |
12/21/2010 |
HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING |
HOSPIRA, INC. |
KAREN KEENER |
| K103835 |
12/30/2010 |
REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N |
HOWMEDICA OSTEONICS CORP |
AVITAL MERL-MARGULIES |
| K103613 |
12/09/2010 |
INPECTRA STO2 SPOT CHECK |
HUTCHINSON TECHNOLOGY, INC. |
COLIN M MCGRAW |
| K103737 |
12/22/2010 |
OMNI II PATIENT MONITOR |
INFINIUM MEDICAL |
JOHN OBRIEN |
| K103648 |
12/14/2010 |
COLLAGEN POWDER |
INNOCOLL PHARMACEUTICALS LTD |
AARON WYSE |
| K103670 |
12/16/2010 |
NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR) |
INNOVATIVE GLOVES CO; LTD |
RAJEEV SOOD |
| K103742 |
12/28/2010 |
ACCELL EVO3 (FORMERLY ACCELL A2I) |
INTEGRA LIFESCIENCES |
JENNY FAM |
| K103726 |
12/22/2010 |
JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS |
INTEGRA LIFESCIENCES CORPORATION |
STEPHANIE SHEESLEY |
| K103760 |
12/23/2010 |
TITAN |
INTERACOUSTICS A/S |
ERIK NIELSEN |
| K103741 |
12/23/2010 |
SURGISURE TISSUE REMOVAL SYSTEM |
INTERLACE MEDICAL, INC. |
JOHN J VOZELLA |
| K103523 |
12/01/2010 |
185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX |
INTERNATIONAL BIOMEDICAL, LTD. |
AMY PIEPER |
| K103525 |
12/01/2010 |
A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX |
INTERNATIONAL BIOMEDICAL, LTD. |
AMY PIEPER |
| K103527 |
12/01/2010 |
AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX |
INTERNATIONAL BIOMEDICAL, LTD. |
AMY PIEPER |
| K103524 |
12/01/2010 |
VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX |
INTERNATIONAL BIOMEDICAL, LTD. |
AMY PIEPER |
| K103700 |
12/20/2010 |
ESSENTIAL MRI PATIENT MONITOR |
INVIVO CORPORATION |
RUSTY KELLY |
| K103586 |
12/07/2010 |
IOS FASTSCAN SPRAY |
IOS TECHNNOLOGIES, INC. |
DUANE DURBIN |
| K103799 |
12/28/2010 |
INQU PASTE MIX PLUS |
ISTO TECHNOLOGIES, INC. |
PATSY J TRISLER, JD, RAC |
| K103556 |
12/02/2010 |
IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE) |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
| K103697 |
12/20/2010 |
TORQTECH |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K103817 |
12/29/2010 |
POSEY BED |
J. T. POSEY CO. |
ROBERT KELLEHER |
| K103778 |
12/27/2010 |
LEFORTE NEURO SYSTEM BONE PLATE |
JEIL MEDICAL CORPORATION |
PAUL SUMNER |
| K103830 |
12/30/2010 |
JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK) |
JIANGSU SHENLI MEDICAL PRODUCTION FACTORY |
DARREN REEVES |
| K103743 |
12/23/2010 |
CONCORDE CURVE SYSTEM |
JOHNSON & JOHNSON |
EUGENE BANG |
| K103490 |
12/10/2010 |
EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM |
JOHNSON & JOHNSON |
KEVIN STEVENS |
| K103488 |
12/10/2010 |
CONCORDE BULLET CAGE SYSTEM |
JOHNSON AND JOHNSON |
KEVIN G STEVENS |
| K103617 |
12/10/2010 |
DIGITAL FOREHEAD THERMOMETER |
K-JUMP HEALTH CO., LTD. |
JASON CHENG |
| K103797 |
12/27/2010 |
K2M COCR WIRE |
K2M, INC. |
NANCY GIEZEN |
| K103800 |
12/28/2010 |
BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS |
KAZ USA, INC (A SUBSIDIARY OF KAZ INC) |
RAJ KASBEKAR |
| K103839 |
12/30/2010 |
BEHIND EAR GENTLE TOUCH THERMOMETER |
KAZ, INC. |
RAJ S KASBEKAR |
| K103787 |
12/27/2010 |
MEDEOR MATRIX |
KENSEY NASH CORP. |
LORI BURNS |
| K103810 |
12/29/2010 |
KJ SUBMERGED SYSTEM |
KJ MEDITECH CO., LTD |
PRISCILLA CHUNG |
| K103703 |
12/20/2010 |
REGUIS SIGMA |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
RUSSELL MUNVES |
| K103660 |
12/15/2010 |
LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM |
LANX, INC. |
WILLIAM SANDUL |
| K103666 |
12/15/2010 |
LANX LATERAL |
LANX, INC. |
ALAN BRUKHOLDER |
| K103686 |
12/17/2010 |
STAR 50 N |
LARSEN & TOUBRO LIMITED |
E. J SMITH |
| K103763 |
12/23/2010 |
STELLAR 300 |
LARSEN & TOUBRO LIMITED |
E.J. SMITH |
| K103574 |
12/06/2010 |
PREGNANCY ONE STEP RAPID TEST |
LEHNUS & ASSOCIATES CONSULTING |
GARY LEHNUS |
| K103771 |
12/27/2010 |
LOTUS BLAKE ESTEEM SCOOTER |
LETRIX POWER HANGZHOU PTY LTD |
ROBERT DUNN |
| K103547 |
12/02/2010 |
LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM |
LIGHTMED CORP. |
JOCELYN LIU |
| K103776 |
12/27/2010 |
XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
LUBNA SYED |
| K103721 |
12/21/2010 |
MPACT ACETABULAR SYSTEM |
MEDACTA INTERNATIONAL |
NATALIE J KENNEL |
| K103530 |
12/01/2010 |
SPIRODOC |
MEDICAL INTERNATIONAL RESEARCH USA, INC. |
ED KOHERE |
| K103805 |
12/28/2010 |
MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE |
MEDICAL WIRE & EQUIPMENT COMPANY (BATH) LTD |
DAVID ELLIS |
| K103722 |
12/21/2010 |
THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
PARK KYEONG-MI |
| K103735 |
12/22/2010 |
MEDILED MINI |
MEDIX I.C.S.A. |
JAMES H KNAUSS |
| K103718 |
12/21/2010 |
DYNACOR LUBRICATION GEL |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K103602 |
12/08/2010 |
EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K103764 |
12/23/2010 |
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 |
MEDTRONIC INC. |
YUKIKO CORSON |
| K103731 |
12/22/2010 |
CAPSTONE R SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
THAO PHAN |
| K103565 |
12/06/2010 |
MEDVOXEL HEARTPRO SOFTWARE APPLICATION |
MEDVOXEL SYSTEMS INC |
BONNIE SEWLOCHAN |
| K103561 |
12/06/2010 |
MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS |
MENICON CO. LTD. |
BEVERLEY D VENUTI |
| K103599 |
12/08/2010 |
UNIVERSAL DIGITAL INTERFACE (UDI) 1717 |
MERIDIAN MEDICAL SYSTEMS, LLC |
ARIEL MARCIANO |
| K103656 |
12/15/2010 |
THERMO SCIENTIFIC MAS R DOA TOTAL |
MICROGENICS CORPORATION |
LISA CHARTER |
| K103680 |
12/17/2010 |
MICROLIFE DIGITAL UNDERARM THERMOMETER |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K103780 |
12/27/2010 |
MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
| K103576 |
12/06/2010 |
MIM 5.2 (BRACHY) |
MIM SOFTWARE INC. |
LYNN HANIGAN |
| K103785 |
12/27/2010 |
MOBILE MIM |
MIM SOFTWARE INC. |
LYNN HANIGAN |
| K103715 |
12/21/2010 |
COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE |
MIRADOR BIOMEDICAL, INC. |
JUSTIN HULVERSHORN |
| K103784 |
12/27/2010 |
DBX DEMINERALIZED BONE MATRIX PUTTY |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY JOY |
| K103795 |
12/27/2010 |
DBX DEMINERALIZED BONE MATRIX PUTTY |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY JOY |
| K103589 |
12/07/2010 |
NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM |
NATUS MEDICAL INCORPORATED |
JULIE FREED |
| K103833 |
12/30/2010 |
NEOPIP PATIENT CIRCUIT WITH PEEP |
NEOFORCE GROUP, INC. |
MONICA FERRANTE |
| K103623 |
12/10/2010 |
NEWDEAL INTERPHALANGEAL IMPLANT |
NEWDEAL SAS |
MARILYSE LATOUR |
| K103750 |
12/23/2010 |
NUVASIVE TRAVERSE PLATE SYSTEM |
NUVASIVE, INC. |
ELIAS KETCHUM |
| K103650 |
12/14/2010 |
NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM |
OON CORP. RESOURCES |
JANNA P TUCKER |
| K103266 |
12/08/2010 |
ISTAND |
OPTOVUE, INC. |
JOHN J TALARICO |
| K103657 |
12/15/2010 |
SAPPHIRE |
ORBUSNEICH MEDICAL, INC. |
JOHN PAZIENZA |
| K103808 |
12/29/2010 |
SAPPHIRE NC |
ORBUSNEICH MEDICAL, INC. |
JOHN PAZIENZA |
| K103829 |
12/30/2010 |
KNEEALIGN SYSTEM |
ORTHALIGN, INC |
AMY WALTERS |
| K103837 |
12/30/2010 |
BALANCED KNEE SYSTEM REVISION OFFSET TIBIA |
ORTHO DEVELOPMENT |
TOM HAUETER |
| K103594 |
12/08/2010 |
PONTO PRO POWER |
OTICON MEDICAL AB |
ULRIKA NIELSEN |
| K103664 |
12/16/2010 |
PRIMUS AESTHETIC PLATFORM |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
SHARON TIMBERLAKE |
| K103775 |
12/27/2010 |
PEAK SUCTION COAGULATOR |
PEAK SURGICAL, INC. |
LOIS NAKAYAMA |
| K103604 |
12/09/2010 |
ISA CO2, ISA AX+, ISA OR+ |
PHASEIN AB |
DAVID WEISSBURG |
| K103652 |
12/14/2010 |
SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8 |
PHILIPS MEDICAL SYSTESMS |
LAWRENCE MILANA |
| K103815 |
12/29/2010 |
Q-STATION |
PHILIPS ULTRASOUND, INC. |
NANCY P BURKE |
| K103646 |
12/14/2010 |
INTELLIVUE MX40 PATIENT MONITOR |
PHILLIPS MEDICAL SYSTEMS |
CLAIRE ARAKAKI |
| K103748 |
12/23/2010 |
LAGUNA PEDICLE SCREW SYSTEM |
PHYGEN, LLC |
HARTMUT LOCH |
| K103567 |
12/06/2010 |
LIFEPAK 15 MONITOR/DEFIBRILLATOR |
PHYSIO-CONTROL, INC. |
MICHELLE ACKERMANN |
| K103729 |
12/22/2010 |
INFILL INTERVERTEBRAL BODY FUSION DEVICE |
PINNACLE SPINE GROUP, LLC |
REBECCA K PINE |
| K103689 |
12/17/2010 |
PLANMECA PROMAX 3D MID |
PLANMECA OY |
LARS MORING |
| K103575 |
12/06/2010 |
SPIRO PD |
PMD HEALTHCARE |
E.J. SMITH |
| K103563 |
12/14/2010 |
PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150 |
PRECISION MEDICAL, INC. |
JAMES PARKER |
| K103838 |
12/30/2010 |
FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM |
PRECISION SURGERY LTD. |
KAREN E WARDEN, PHD. |
| K103819 |
12/30/2010 |
PSL ANTERIOR CERVICAL PLATE SYSTEM |
PRECISION SURGERY LTD. |
KAREN E WARDEN |
| K103540 |
12/02/2010 |
PSORIA-LIGHT |
PSORIA-SHIELD INC. |
WAYNE GLOVER |
| K103539 |
12/02/2010 |
QUANTA SYSTEM DUOLITE |
QUANTA SYSTEM, S.P.A. |
ISABELLA CARRER |
| K103564 |
12/06/2010 |
VENOFER PUMP |
RENAL SOLUTIONS, INC. |
DAVID VANELLA |
| K103578 |
12/06/2010 |
PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST |
RESPIRONICS NOVAMETRIX, LLC |
KEVIN MADER |
| K103716 |
12/21/2010 |
ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET |
ROCHE DIAGNOSTICS |
KATHIE J GOODWIN |
| K103661 |
12/16/2010 |
RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE |
RUBBERCARE PROTECTION PRODUCTS SDN BHD |
LIM KWEE SHYAN |
| K103841 |
12/22/2010 |
BELIMED STEAM STERILIZER MST-V |
SAUTER AG |
HANS STADLER |
| K103812 |
12/29/2010 |
MITRA-LIFT |
SCIENCITY CO., LTD |
JOYCE BANG |
| K103522 |
12/01/2010 |
SEDECAL |
SEDECAL S.A. |
DANIEL KAMM, P.E. |
| K103619 |
12/10/2010 |
SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (GREEN/ BLUE / WHITE / MAGENTA / CLEAR - NON COLORED) |
SHANDONG BLUE SAIL INNOVATION CO., LTD. |
YONGCHEN ZHANG |
| K103560 |
12/03/2010 |
SHASER IPL HAIR REMOVAL SYSTEM |
SHASER, INC. |
GLEN EMELOCK |
| K103542 |
12/02/2010 |
GENSTRIP TEST STRIP MODEL 100-201 |
SHASTA TECHNOLOGIES, LLC |
CAROLINE TONTINI |
| K103584 |
12/07/2010 |
ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS |
SHENZHEN ENVISEN INDUSTRY CO. LIMITED |
STEPHEN H GORSKI |
| K103583 |
12/07/2010 |
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
ZHAI PEI |
| K103677 |
12/16/2010 |
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
ZHAI PEI |
| K103723 |
12/21/2010 |
SICAT IMPLANT V1.2 |
SICAT GMBH & CO. KG |
MARK W SHEEHAN |
| K103683 |
12/17/2010 |
IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) |
SIEMENS HEALTHCARE DIAGNOSTICS |
GARO MIMARYAN |
| K103612 |
12/09/2010 |
DIMENSION VISA ENZ 2 CAL |
SIEMENS HEALTHCARE DIAGNOSTICS INC |
ANNA MARIE K ENNIS |
| K103836 |
12/30/2010 |
ENZYME II CALIBRATOR |
SIEMENS HEALTHCARE DIAGNOSTICS INC |
ANNA MARIE KATH ENNIS |
| K103548 |
12/03/2010 |
ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491 |
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
SANDRA D WHITE |
| K103701 |
12/20/2010 |
ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
KIRA GORDON |
| K103606 |
12/09/2010 |
ARTISTE SOLUTION WITH SYS_VB50 UPDATE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CHRISTINE DUNBAR |
| K103711 |
12/20/2010 |
ORTHOPHOS XG 3D / CEPH |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
| K103753 |
12/23/2010 |
SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
| K103579 |
12/06/2010 |
INTRA SKAN DC |
SKANRAY TECHNOLOGIES |
PARASURAMAPPA BELUR |
| K103793 |
12/27/2010 |
DURAFIBER AG |
SMITH & NEPHEW, INC |
TERRY MCMAHON |
| K103682 |
12/17/2010 |
PARIETEX PROGRIP |
SOFRADIM PRODUCTION |
JAMES MCMAHON |
| K103813 |
12/29/2010 |
SOPRO 281 |
SOPRO |
RICK ROSATI |
| K103762 |
12/23/2010 |
SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON, RN, MED, RAC |
| K103383 |
12/01/2010 |
SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM |
SPARTEK MEDICAL, INC. |
HENRY KLYCE |
| K103740 |
12/27/2010 |
SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE |
SPECTRA MEDICAL DEVICES, INC. |
DAVID L ROSEN, B.S. PHARM., J.D. |
| K103781 |
12/27/2010 |
MED-LOK SAFETY NEEDLE |
STA-MED, LLC |
RANDALL MAY |
| K103654 |
12/15/2010 |
VELA XL |
STARMEDTEC GMBH |
GREGOR WEIDEMANN |
| K103536 |
12/01/2010 |
IBED WIRELESS WITH IBED AWARENESS |
STRYKER CORPORATION |
DIANE HORWITZ |
| K103807 |
12/29/2010 |
IVAS 2-10MM (10 GUAGE) BALLON CATHETER |
STRYKER CORPORATION |
MELISSA KANN |
| K103693 |
12/17/2010 |
VANTAGE ABI |
SUMMIT DOPPLER SYSTEMS, INC. |
KEN JARRELL |
| K103692 |
12/17/2010 |
SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 |
SURGIQUEST, INC. |
DANIEL DONOVAN |
| K103713 |
12/21/2010 |
ELTA WOUND CLEANSER |
SWISS AMERICAN PRODUCTS, INC. |
ERIC LUO |
| K103770 |
12/27/2010 |
SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL |
SYNTEX HEALTHCARE PRODUCTS CO., LTD |
KATHY LIU |
| K103558 |
12/02/2010 |
SYNTHES SCOUT VESSEL GUARD |
SYNTHES SPINE |
HEATHER GUERIN |
| K103822 |
12/30/2010 |
SYNTHES HEMOSTATIC BONE PUTTY (HBP) |
SYNTHES USA PRODUCTS, LLC |
JEFFREY L DOW |
| K103673 |
12/16/2010 |
GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK |
TECHLAB INC., CORPORATE RESEARCH CENTER |
DONNA T LINK |
| K103698 |
12/20/2010 |
TENSCARE ITOUCH SURE MODEL ITS |
TENSCARE LTD. |
ANDREW BROWN |
| K103647 |
12/13/2010 |
THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES |
THD SPA |
GUIDO BONAPACE |
| K103824 |
12/30/2010 |
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS |
THE BINDING SITE |
SUZANNE HORNE |
| K103708 |
12/20/2010 |
ML24000 UVA-1 PHOTOTHERAPY UNIT |
THE DAAVLIN DISTRIBUTING COMPANY |
MICHAEL THIEL |
| K103761 |
12/23/2010 |
VISUALIZE: VASCULAR |
THE MEDIPATTERN CORPORATION |
ERIN WALSH |
| K103531 |
12/01/2010 |
PRESTIGE 24I; BIOLIS 24I; MGC 240 |
TOKYO BOEKI MEDISYS INC. |
JAMES M CLINTON |
| K103782 |
12/27/2010 |
4D MV-ASSESSMENT 2.0 |
TOMTEC IMAGING SYSTEMS, GMBH |
INGE SCHEIDT |
| K103629 |
12/13/2010 |
PET-512MC TRANSESOPHAGEAL TRANSDUCER |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K103645 |
12/13/2010 |
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM |
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN |
PAUL BIGGINS |
| K103532 |
12/01/2010 |
AUTOREADER 2 |
TREK DIAGNOSTIC SYSTEMS |
CYNTHIA KNAPP |
| K103534 |
12/01/2010 |
GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014" / 0.018" GUIDE WIRE |
TRIREME MEDICAL, INC. |
SHIVA ARDAKANI |
| K103659 |
12/15/2010 |
CS 9300, CS 9300C |
TROPHY |
MARIE-PIERRE LABAT-CAMY |
| K103814 |
12/29/2010 |
PEZO INTERBODY CAGES SYSTEM |
ULRICH GMBH & CO. KG |
HANS STOVER |
| K103710 |
12/20/2010 |
WBR XPRESS PET |
ULTRASPECT LTD. |
DAN LAOR |
| K103733 |
12/22/2010 |
"UNITED" U2 XPE TOTAL KNEE SYSTEM |
UNITED ORTHOPEDIC CORPORATION |
FANG-YUAN HO |
| K103694 |
12/17/2010 |
TISSUE SAMPLING NEEDLE |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL L MARTIN |
| K103611 |
12/09/2010 |
UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL L MARTIN |
| K103688 |
12/17/2010 |
G-PROX EZ ENDOSCOPIC GRASPER |
USGI MEDICAL |
MARY LOU MOONEY |
| K103825 |
12/30/2010 |
V-GO INSULIN DELIVERY SYSTEM |
VALERITAS, INC. |
SCOTT HUIE |
| K103707 |
12/20/2010 |
VECTEC DISPOSABLE MONOPOLAR CONNECTOR CABLE |
VECTEC |
DIANE MANDELL HORWITZ |
| K110215 |
12/29/2010 |
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY |
VENTANA MEDICAL SYSTEMS, INC. |
ROXANE BONNER |
| K103818 |
12/29/2010 |
CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY |
VENTANA MEDICAL SYTEMS, INC |
GEORGE DE LA ROSA |
| K103555 |
12/03/2010 |
MULTIPLATE 5.0 AGGREGOMETER |
VERUM DIAGNOSTICA GMBH |
MAXIMILIAN ZUCKER |
| K103580 |
12/06/2010 |
GRANDIO SO FLOW |
VOCO GMBH |
MANFRED THOMAS PLAUMANN |
| K103639 |
12/13/2010 |
VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
JAMES LEE |
| K103587 |
12/07/2010 |
DISPOSABLE BLLOD COLLECTION NEEDLE |
WEIHAI HONGYU MEDICAL DEVICES CO., LTD. |
DIANA HONG |
| K103773 |
12/27/2010 |
ZENOFLEX DIMENSION |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K103598 |
12/08/2010 |
PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SARAH HOLTGREWE |
| K103704 |
12/20/2010 |
REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP |
ZEPHYR SLEEP TECHNOLOGIES INC |
SABINA BRUCHLMANN |
| K103603 |
12/14/2010 |
ZEUS ELISA HSV GG-2 IGG TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
EWA NADOLCZAK |
| K103662 |
12/15/2010 |
CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS; LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LI |
ZIMMER, INC. |
REBECCA BROOKS |
