FDA 510(k) Applications Received During December, 2010

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
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K103841 12/22/2010 BELIMED STEAM STERILIZER MST-V SAUTER AG HANS STADLER
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K103522 12/01/2010 SEDECAL SEDECAL S.A. DANIEL KAMM, P.E.
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K103560 12/03/2010 SHASER IPL HAIR REMOVAL SYSTEM SHASER, INC. GLEN EMELOCK
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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
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K103548 12/03/2010 ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491 SIEMENS HEALTHCARE DIAGNOSTICS INC. SANDRA D WHITE
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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
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K103654 12/15/2010 VELA XL STARMEDTEC GMBH GREGOR WEIDEMANN
K103536 12/01/2010 IBED WIRELESS WITH IBED AWARENESS STRYKER CORPORATION DIANE HORWITZ
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K103822 12/30/2010 SYNTHES HEMOSTATIC BONE PUTTY (HBP) SYNTHES USA PRODUCTS, LLC JEFFREY L DOW
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K103659 12/15/2010 CS 9300, CS 9300C TROPHY MARIE-PIERRE LABAT-CAMY
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K103773 12/27/2010 ZENOFLEX DIMENSION WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
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