FDA 510(k) Decisions During March, 2011  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K101374 03/16/2011 AAXTER A3 POSTERIOR SPINAL SYSTEM AAXTER CO., LTD JACK CHEN
K063817 03/31/2011 MANDOMETER III AB MANDO KIM BLOOM
DEN070014 03/31/2011 MANDOMETER III AB MANDO KIM BLOOM
K101422 03/22/2011 THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER ACCESS SCIENTIFIC, INC. ALBERT MISAJON
K110218 03/31/2011 INSPIRA AIR BALLOON DILATION SYSTEM ACCLARENT, INC. KERI YEN
K103471 03/14/2011 UBM PLUS ACCUTOME, INC. BRIAN T.S. BARRETT
K103499 03/31/2011 A SCOPE ACTIVE SIGNAL TECHNOLOGIES, INC. HARVEY KNAUSS
K110458 03/14/2011 SILVER ANTIMICROBIAL WOUND GEL ADVANCED MEDICAL SOLUTIONS LIMITED CLAIRE RYAN
K092622 03/04/2011 STERRAD 100NX STERILIZER EXPRESS CYCLE ADVANCED STERILIZATION PRODUCTS NANCY CHU
K101154 03/28/2011 CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L AIRSEP CORP. PETER WEISENBORN
K110503 03/10/2011 AIRSTRIP REMOTE PATIENT MONITORING (RPM) AIRSTRIP TECHNOLOGIES, LP ANDY MILLER
K102402 03/30/2011 SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM ALPHATEC SPINE, INC. MARY STANNERS
K110108 03/16/2011 MODALIXX AMPRONIX, INC. ASAL NAMINI
K110018 03/15/2011 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO., LTD LIU YI
K101913 03/11/2011 ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM ANTHOGYR SAS ERIC GENEVE
K102241 03/23/2011 ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT ANTHOGYR SAS BRAYETTE SABINE
K102825 03/02/2011 BLOOD PRESSURE CUFF APK TECHNOLOGY CO., LTD Diana Hong
K102636 03/03/2011 ZENITH PEDICLE SYSTEM APOLLO SPINE, INC. CHRISTINE SANTAGATE
K110660 03/31/2011 ARTHREX BIOCOMPOSITE SUTURETAK ARTHREX, INC. COURTNEY SMITH
K103705 03/18/2011 LOW PROFILE SCREWS ARTHREX, INC. COURTNEY SMITH
K101985 03/07/2011 ASAHI GUIDE WIRE EXTENSION 165CM ASAHI INTECC CO., LTD. YOSHI TERAI
K110553 03/18/2011 ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE ASAHI INTECC USA, INC. YOSHI TERAI
K103828 03/29/2011 BILI-THERAPY SPOT TYPE ATOM MEDICAL CORPORATION PAUL DRYDEN
K102554 03/03/2011 AVITA SCANEO IR THERMOMETER MODEL TS4X SERIES AVITA CORPORATION JENNIFER REICH
K103679 03/03/2011 AXIS PACS, HMS PACS AXIS HEALTH CARE, LLC RONALD W GRAHAM
K103546 03/17/2011 AYCAN WORKSTATION OSIRIX PRO AYCAN DIGITALSYSTEME GMBH MATTHIAS BROENNER
K103792 03/04/2011 BARCO MAMMO TOMOSYNTHESIS BARCO NV LIEVEN DE WANDEL
K103245 03/23/2011 CELSTAT BAXTER HEALTHCARE CORP. SAMUEL MATHEW
K102936 03/30/2011 HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R BAXTER HEALTHCARE CORP. DAVID E CURTIN
K103551 03/25/2011 INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS, BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K102064 03/07/2011 BD FACS SAMPLE PREP ASSISTANT III (SPA III) BECTON DICKINSON & CO. Katy Campbell
K103798 03/18/2011 BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS BECTON DICKINSON & CO. Thalia Charles
K101901 03/08/2011 IPL THERAPY SYSTEM BEIJING STARLIGHT SCIENCE & TECHNOLOGY DEVELOPMENT Diana Hong
K110796 03/31/2011 SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE BIOMERS PRODUCTS, LLC DARYL WISDAHL
K101607 03/11/2011 BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTS BIOMET 3I, INC. JOSE E CABRERA
K101608 03/11/2011 BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS BIOMET 3I, INC. JOSE E CABRERA
K110555 03/24/2011 ARCOMXL ACTIVE ARTICULATION BIOMET MANUFACTURING CORP. BEKCY EARL
K102580 03/03/2011 VANGUARD REMOVABLE MOLDED POLY TIBIA BIOMET MANUFACTURING CORP. TAMARA J WEST
K110145 03/04/2011 BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR BIOMET, INC. ELIZABETH WRAY
K103751 03/22/2011 MUSTANG BALLOON DILATATION CATHETERS BOSTON SCIENTIFIC ANNE V ROSSI
K110686 03/28/2011 ACCUTRAC BOSTON SCIENTIFIC CORP. LAUREN ANDERSON
K110685 03/29/2011 FLEXIVA TRACTIP BOSTON SCIENTIFIC CORP. LAUREN ANDERSON
K110295 03/03/2011 INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM BOSTON SCIENTIFIC CORP. SHANNON PETTIT
K102912 03/03/2011 INTERLOCK FIBERED IDC OCCLUSION SYSTEM BOSTONSCIENTIFIC DEBBIE MCINTIRE
K103246 03/16/2011 IPLAN RT BRAINLAB, AG ALEXANDER SCHWIERSCH
K103640 03/22/2011 MIDMARK IQECG BRENTWOOD MEDICAL TECHNOLOGY CORP. GREG HOLLAND
K101928 03/23/2011 VENTRALEX ST HERNIA PATCH C.R. BARD, INC. MICHELLE GODIN
K101920 03/23/2011 VENTRIO ST HERNIA PATCH C.R. BARD, INC. MICHELLE GODIN
K103591 03/29/2011 DIGITAL RADIOGRAPHY CANON, INC.-MEDICAL EQUIPMENT GROUP KOJI KUBO
K110585 03/25/2011 CAPTIVA SPINE FUSELOX CERVICAL CAGE CAPTIVA SPINE, INC JOHN SANDERS
K100698 03/14/2011 STCC CARDINAL SPINE, LLC DAVID J COLLETTE
K110389 03/11/2011 STEALTH 360 ORBITAL PAD SYSTEM CARDIOVASCULAR SYSTEMS, INC. MEGAN M BRANDT
K103106 03/30/2011 CHLORASHIELD TM ANTIMICROBIAL DRESSING CARE FUSION 213 LLC ARLEN JOHNSON
K103410 03/30/2011 NEOPAP SYSTEM CHILDRENS MEDICAL VENTURES LLC SCOTT WRIGHT
K103172 03/11/2011 CIV-OB (PLUS) CIVNET COMMUNICATION LTD NATHAN BEN-NATHAN
K110332 03/24/2011 CLEARCANVAS RIS / PACS CLEARCANVAS INC. CLINTON CHAU
K103038 03/29/2011 DUET DRF CMT MEDICAL TECHNOLOGIES, LTD. SHLOMI DINES
K101830 03/31/2011 ZMACHINE, MODEL DT-100 CONSOLIDATED RESEARCH OF RICHMOND, INC RICHARD KAPLAN
K101530 03/29/2011 EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D COOK IRELAND LTD Jacinta Kilmartin
K110347 03/16/2011 DOPPLER MONITOR COOK VASCULAR, INC. JIM FERGUSON
K103518 03/09/2011 TRINITY ACETABULAR SYSTEM CORIN U.S.A. LUCINDA GERBER, BA (HONS)
K102635 03/22/2011 APOLONIA LASER IMPLANT SYSTEM CSM IMPLANT CO., LTD JOYCE BANG
K103709 03/10/2011 CERACELL DENTAL CURASAN AG ROGER GRAY
K110511 03/11/2011 E4D COMPASS D4D TECHNOLOGIES Allison Scott
K102320 03/04/2011 COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7) DAESUNG MAREF CO., LTD. BRANDON CHOI
K100424 03/21/2011 DANMEDICAL ANALYSIS SYSTEM, MODEL D-MAS DANMEDICAL LIMITED IAN DRYSDALE
K103371 03/11/2011 COUDE/ OR TIEMANN DEGANIA SILICONE, LTD. ZOYA LEE
K103712 03/11/2011 GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KRISTINE CHRISTO
K103756 03/15/2011 DEPUY ATTUNE TOTAL KNEE SYSTEM DEPUY ORTHOPAEDICS, INC. NANCY FRIDDLE
K093736 03/10/2011 DEPUY CORAIL HIP SYSTEM, REVISION STEM DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K103146 03/11/2011 ISOGRAY TREATMENT PLANNING SYSTEM DOSISOFT SA ROBERT J MORTON
K102474 03/04/2011 FLAATZ 750E DRTECH CORP. BEOM-JIN MOON
K110393 03/04/2011 EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W EKF-DIAGNOSTIC GMBH STEPHEN GORSKI
K101482 03/31/2011 EM-9000 ELITE MEDICAL INC STEVEN J DE BROCK
K102647 03/24/2011 ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE... ELITECHGROUP VITAL SCIENTIFIC BV DEBRA K HUTSON
K103696 03/22/2011 ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES ERBE USA, INC. JOHN TARTAL
K110699 03/25/2011 LIGAMAX 5 ETHICON ENDO-SUGERY, LLC EMILY KRUETZKAMP
K110385 03/25/2011 ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER ETHICON ENDO-SURGERY, INC. ASIFA VONHOF
K103786 03/24/2011 ZEST PETITE NASAL MASK FISHER & PAYKEL HEALTHCARE, LTD. TINA MASON
K092433 03/10/2011 DYSIS FORTH PHOTONICS HELLAS SA JUAN CARLOS SERNA
K101552 03/14/2011 FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001 FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. S.DAVID PIPER, PE
K110721 03/30/2011 GAUNYING INFRARED LAMP FOSHAN GAUNYING ELECTRONICS CO., LTD. LADI LEE
K103687 03/04/2011 SYNAPSE 3D CEREBRAL ANALYSIS FUJIFILM MEDICAL SYSTEM U.S.A., INC. DEBBIE PEACOCK
K103720 03/16/2011 SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS FUJIFILM MEDICAL SYSTEMS U.S.A., INC. KIMERLY A SHARP
K103596 03/29/2011 WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR FUJIFILM MEDICAL SYSTEMS U.S.A., INC. KATHERINE Y CHOI
K103134 03/11/2011 FUKUDA DENSHI FUKUDA DENSHI USA, INC. DOUG BLAKELY
K103335 03/07/2011 GEM OPTION FOR 1.5 MRI SYSTEMS GE HEALTHCARE MICHAEL S PRETO
K103458 03/04/2011 VIEWPOINT 6 GE HEALTHCARE NICOLE LANDREVILLE
K103649 03/09/2011 VOLUSON S6, VOLUSON S8 GE HEALTHCARE BRYAN BEHN
K103411 03/22/2011 IDEAL IQ SOFTWARE OPTION GE MEDICAL SYSTEMS TRACEY FOX
K103480 03/07/2011 THORACIC VCAR GE MEDICAL SYSTEMS, LLC STEPHEN SLAVENS
K110601 03/18/2011 SENTINELLA 102 GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A SEVERINE MOINE
K103425 03/29/2011 ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM GENORAY AMERICA INC. JAE KIM
K102299 03/18/2011 CPR FACE MASK GENUINE FIRST AID LLC Gary Lehnus
K103504 03/16/2011 GETINGE 400HC/500HC SERIES STEAM STERILIZER GETINGE SOURCING, LLC BARB SMITH
K101250 03/07/2011 GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES GIVEN IMAGING LTD. Tim Thomas
K102172 03/01/2011 MSA HIP SYSTEM GLOBAL MANUFACTURING TECHNOLOGY HOLLACE S RHODES
K103072 03/17/2011 REVERE SACRAL PLATES GLOBUS MEDICAL, INC. KELLY J BAKER
K110299 03/21/2011 DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM10 SERIES GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED PATRICK CHOW
K102964 03/07/2011 EU-TTG IGA AND EU-TTG IGG GRIFOLS USA, INC. CATHERINE L WONG
K102692 03/11/2011 SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO HANGZHOU JINCHENG MEDICAL SUPPLIER MANUFACTURE CO. CHENGYU SHEN
K103585 03/04/2011 BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP HARRY J. BOSWORTH CO. GARY CHUVEN
K103537 03/10/2011 ET III SA ULTRA WIDE SYSTEM HIOSSEN INC. PATRICK LIM
K103265 03/16/2011 NHANES WHOLE BODY DXA REFERENCE DATABASE HOLOGIC, INC. CHRISTINA HURTON
K102019 03/03/2011 RESTORATION ACETABULAR WEDGE AUGMENTS HOWMEDICA OSTEONICS KAREN ARIEMMA
K103613 03/02/2011 INPECTRA STO2 SPOT CHECK HUTCHINSON TECHNOLOGY, INC. COLIN M MCGRAW
K110412 03/16/2011 IDS-ISYS IFG-I CONTROL SET IMMUNODIAGNOSTIC SYSTEMS LTD. MICK FENTON
K103493 03/11/2011 HEAD FIATION DEVICE (HFD 100) IMRIS, INC. THOMAS M TSKERIS
K103416 03/17/2011 NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM INFIMED, INC. JIGAR SHAH
K103670 03/31/2011 NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR) INNOVATIVE GLOVES CO; LTD RAJEEV SOOD
K101644 03/23/2011 QUANTA FLASH H-TTG IGG INOVA DIAGNOSTICS, INC. RUFUS BURLINGAME
K102164 03/17/2011 HEMOSIL PROTEIN S ACTIVITY ASSAY INSTRUMENTATION LABORATORY CO. Jacqueline Emery
K103742 03/17/2011 ACCELL EVO3 (FORMERLY ACCELL A2I) INTEGRA LIFESCIENCES JENNY FAM
K103741 03/02/2011 SURGISURE TISSUE REMOVAL SYSTEM INTERLACE MEDICAL, INC. JOHN J VOZELLA
K103700 03/15/2011 ESSENTIAL MRI PATIENT MONITOR INVIVO CORPORATION RUSTY KELLY
K103586 03/30/2011 IOS FASTSCAN SPRAY IOS TECHNNOLOGIES, INC. DUANE DURBIN
K101852 03/23/2011 CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT IRIS INTERNATIONAL INC., A DIVISION OF IRIS IRIS I DAVID W GATES
K102704 03/10/2011 EASY CUFF JOAN SPIEGEL, MD PAUL DRYDEN
K102190 03/17/2011 WINSTIM JOHARI DIGITAL HEALTHCARE, LTD. NISHA JOHARI
K103743 03/17/2011 CONCORDE CURVE SYSTEM JOHNSON & JOHNSON EUGENE BANG
K103488 03/02/2011 CONCORDE BULLET CAGE SYSTEM JOHNSON AND JOHNSON KEVIN G STEVENS
K103169 03/07/2011 ALEUTTIAN K2M, INC. NANCY GIEZEN
K103440 03/17/2011 EVEREST SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K102229 03/04/2011 PULMOTRACK 2020 SYSTEM KARMELSONIX YORAM LEVY
K103156 03/14/2011 V.A.C. VERAFLO CLEANSE DRESSING SYSTEM KCI USA, INC. (KINETIC CONCEPTS, INC.) MARGARET MARSH
K102574 03/07/2011 PALLA M SPINAL SYSTEM KOREA BONE BANK CO., LTD JOYCE BANG
K103026 03/29/2011 ELECTRO SENSOR -BODY COMPOSITION L.D. TECHNOLOGY, LLC RICHARD CLEMENT
K103498 03/31/2011 LAKONG ULTRASONIC SCALER LAKONG MEDICAL DEVICE COMPANY, LTD DANNY WANG
K103666 03/23/2011 LANX LATERAL LANX, INC. ALAN BRUKHOLDER
K103237 03/25/2011 LANX SPINAL SYSTEM LANX, INC. DAMON BELLONI
K110036 03/28/2011 FX 222-02 POWERED WHEELCHAIR LANZHOU WANLI AVIATION ELECTROMECHANICAL INC. JUNNATA CHANG
K103686 03/15/2011 STAR 50 N LARSEN & TOUBRO LIMITED E. J SMITH
K103763 03/11/2011 STELLAR 300 LARSEN & TOUBRO LIMITED E.J. Smith
K102727 03/16/2011 LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY LENSAR, INC. SHIRLEY MCGARVEY
K101458 03/11/2011 LINA XCISE MODEL MOR-1515 LINA MEDICAL APS WALT BRITTLE
K101792 03/18/2011 LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706 LINDE GAS NORTH AMERICA LLC MICHAEL PIACENZA
K110042 03/24/2011 MANUKATEX MANUKA MEDICAL LIMITED James Smith
K102919 03/11/2011 NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K102464 03/04/2011 QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K103191 03/08/2011 QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K102533 03/22/2011 ROTATING GAMMA SYSTEM INFINI (INFINI) MASEP MEDICAL SCIENCE & TECH.DEVELOPMENT (SHENZHEN SUSAN D GOLDSTEIN-FALK
K110028 03/17/2011 MASIMO RADICAL Y PULSE CO-OXIMETER MASIMO CORPORATION SHELLY HARRIS
K103136 03/18/2011 SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE MATERIALISE N.V. Alexandra Razzhivina
K110343 03/11/2011 TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP MAYBORN BABY AND CHILD / JACKEL INTERNATIONAL LTD NEIL HEWITT
K103721 03/21/2011 MPACT ACETABULAR SYSTEM MEDACTA INTERNATIONAL NATALIE J KENNEL
K103170 03/24/2011 GMK REVISION KNEE SC LINERS MEDACTA INTERNATIONAL, SA NATALIE J KENNEL
K093830 03/03/2011 MEDLINE ANGIOGRAPHIC CONTROL SYRINGE MEDLINE INDUSTRIES, INC. MATT CLASEN
K101560 03/25/2011 MEDLINE RETRACTABLE SAFETY SYRINGE MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K103375 03/16/2011 PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL MEDTEK DEVICES, INC. GREG PEPE
K102588 03/18/2011 ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE MEDTRONIC ABLATION FRONTIERS, LLC BRENDA CLAY
K101930 03/15/2011 MEMOMETAL NAVIS BONE PLATING SYSTEM MEMOMETAL TECHNOLOGIES GILES AUDIC
K103427 03/24/2011 MOBILEECG SYSTEM MEMTEC CORP. DENNIS GARBOSKI
K100569 03/11/2011 MERIT EMBOLECTOMY CATHETER MODEL ASAP100 MERIT MEDICAL SYSTEMS, INC. LINDSAY MARTIN
K103123 03/10/2011 APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES) MICRO-MEGA SOCIETE ANONYME CONCHE PHILIPPE
K103656 03/24/2011 THERMO SCIENTIFIC MAS R DOA TOTAL Microgenics Corporation LISA CHARTER
K102563 03/15/2011 SINGLE CANNULA EXTENDED APPLICATOR MICROMEDICS, INC. TOM LOPAC
K110591 03/29/2011 MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL MR INSTRUMENTS, INC. JOSHUA J HOLWELL
K110322 03/04/2011 OLECRA INTRAMEDULLARY FIXATION SYSTEM MYLAD ORTHOPEDIC SOLUTIONS SCOTT G EDWARDS
K093584 03/04/2011 EZ-MISTER N.M. BEALE CO. INC. PAMELA PAPINEAU
K103126 03/03/2011 TROPHON CHEMICAL INDICATOR NANOSONICS LIMITED RON WEINBERGER
K102677 03/24/2011 BODYTOM NL 4000 NEUROLOGICA CORPORATION DONALD D FICKETT
K102874 03/28/2011 NEW STETIC ACRYLICS NEW STETIC ARTHUR WARD
K110445 03/17/2011 FLEXFUSION (TM) FIXATION IMPLANT NEXTREMITY SOLUTIONS, LLC ARTHUR A ALFARO
K110058 03/31/2011 BPA-FREE PIT AND FISSURE SEALANT NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC CORA BRACHO-TROCONIS
K103750 03/03/2011 NUVASIVE TRAVERSE PLATE SYSTEM NUVASIVE, INC. Elias Ketchum
K102115 03/30/2011 ODFS PACE ODSTOCK MEDICAL LTD STEVEN CROOK
K101699 03/31/2011 WIDEXLINK IN CLEAR SERIES HEARING AIDS OFFICE RESEARCH IN CLINICAL AMPLIFICTION FRANCIS KUK
DEN100025 03/31/2011 WIDEXLINK IN CLEAR SERIES HEARING AIDS OFFICE RESEARCH IN CLINICAL AMPLIFICTION FRANCIS KUK
K102578 03/25/2011 APEX PS KNEE SYSTEM OMNI LIFE SCIENCE, INC. RADHIKA PONDICHERRY
K110501 03/21/2011 HEM-4030 OMRON HEALTHCARE, INC. PAUL DRYDEN
K103650 03/23/2011 NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM OON CORP. RESOURCES JANNA P TUCKER
K103837 03/24/2011 BALANCED KNEE SYSTEM REVISION OFFSET TIBIA ORTHO DEVELOPMENT TOM HAUETER
K103384 03/16/2011 ESCALADE ACETABULAR CUP SYSTEM ORTHO DEVELOPMENT TOM HAUETER
K103111 03/23/2011 FORZA SPACER SYSTEM ORTHOFIX INC. DARLA CHEW
K103114 03/14/2011 OSSPRAY SYLC CR OSSPRAY LTD IAN THOMPSON
K103105 03/25/2011 ORTHODONTIC SCREW OSSTEM IMPLANT CO.,LTD PATRICK LIM
K103664 03/17/2011 PRIMUS AESTHETIC PLATFORM PALOMAR MEDICAL TECHNOLOGIES, INC. Sharon Timberlake
K103148 03/11/2011 AIDA DIAGNOSTIC ULTRASOUND SYSTEM PANASONIC HEALTHCARE CO., LTD. RAM BEDI
K110371 03/17/2011 ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY PANORAMIC CORP. DANIEL KAMM
K103477 03/03/2011 PERMOBIL M300 / M400 PERMOBIL AB JAN ASTROM
K110456 03/02/2011 PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM PHARMAJET, INC. MICHAEL J RYAN
K110151 03/22/2011 ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T PHILIPS HEALTHCARE LYNN HARMER
K102958 03/18/2011 PHILIPS AVALON FETAL MONITOR PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH MICHAEL ASMALSKY
K110622 03/31/2011 INTELLIVUE PATIENT MONITOR PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HERBERT VAN DYK
K102821 03/11/2011 DISCOVRED PHOENIX DENTAL, INC. JEFFREY S COX
K103748 03/02/2011 LAGUNA PEDICLE SCREW SYSTEM PHYGEN, LLC HARTMUT LOCH
K103567 03/22/2011 LIFEPAK 15 MONITOR/DEFIBRILLATOR PHYSIO-CONTROL, INC. MICHELLE ACKERMANN
K101790 03/07/2011 QUANTUM SPINAL SYSTEM, QUANTUM MIS PIONEER SURGICAL TECHNOLOGY BARRY E SANDS
K110367 03/23/2011 PIONEER SPINAL PROCESS FUSION PLATE PIONEER SURGICAL TECHNOLOGY, INC EMILY M DOWNS
K103689 03/17/2011 PLANMECA PROMAX 3D MID PLANMECA OY LARS MORING
K110491 03/16/2011 BACKSTOP CATHETER PLUROMED, INC. JAMES WILKIE
K103339 03/31/2011 TDS ABUTMENT FOR FRIADENT XIVE POU YU BIOTECHNOLOGY CO., LTD. DANIEL TSAO
K110416 03/24/2011 ABL835 FLEX ANALYZER WITH PLEURAL PH RADIOMETER MEDICAL APS SOREN BOGESTRAND
K092275 03/01/2011 RANDOX ECSTASY (MDMA) ASSAY RANDOX LABORATORIES, LTD. P. ARMSTRONG
K103206 03/04/2011 RAUMEDIC- ICP-MONITORING SYSTEM RAUMEDIC AG REINER THIEM
K101721 03/24/2011 WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA REGULATORY AND MARKETING SERVICES, INC. ARTHUR WARD
K103167 03/01/2011 STELLAR 150 RESMED GERMANY INC. SANDRA GRUNWALD
K110444 03/16/2011 MIRAGE MICRO RESMED LTD. DAVID D'CRUZ
K102586 03/18/2011 S9 VPAP ADAPT WITH H5I RESMED LTD. DAVID D'CRUZ
K102465 03/24/2011 BIPAP AVAPS VENTILATORY SUPPORT SYSTEM RESPIRONICS, INC. ELAINE LARKIN
K103395 03/24/2011 PERFORMAX TOTAL FACE MASK RESPIRONICS, INC. MICHELLE BRINKER
K103661 03/23/2011 RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE RUBBERCARE PROTECTION PRODUCTS SDN BHD LIM KWEE SHYAN
K102403 03/03/2011 SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL SAM MEDICAL PRODUCTS JACK N MCCUTCHEON
K103841 03/15/2011 BELIMED STEAM STERILIZER MST-V SAUTER AG HANS STADLER
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