FDA 510(k) Decisions During September, 2011  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K111759 09/09/2011 .DECIMAL ELECTRON APERTURE .DECIMAL, INC. DANIEL L BENNETT
K111697 09/27/2011 AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM ABBOTT MEDICAL OPTICS INC OPHELIA BIGGS
K102938 09/23/2011 ACQPOINT THERMAJADE MASSAGE TABLE ACQPOINT, INC. MORRIS SHEPPARD
K112159 09/21/2011 CMS-1000FM CENTRAL MONITORING SYSTEM ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K112022 09/22/2011 DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K112187 09/21/2011 FM-1000 PLUS FETAL MONITOR ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K111934 09/22/2011 PD-100 SERIES ULTRASONIC POCKET DOPPLER ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K112465 09/14/2011 VITAL SIGNS MONITOR ADVANCED INSTRUMENTS, INC. JORGE MILLAN
K110713 09/12/2011 WATERPAP VALVE AIRWAYS DEVELOPMENT, LLC RICHARD J LARKIN
K103615 09/08/2011 ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ
K112031 09/13/2011 ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION ALMA LASERS, INC. ANNE WORDEN
K112047 09/13/2011 AMCOM COMMTECH MESSENGER AMCOM SOFTWARE,INC. THOMAS KROENKE
K102359 09/16/2011 PICASSO/ PICASSO LITE/ PICASSO PERIO AMD LASERS, LLC AMY SZENTES
K112738 09/30/2011 ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE ANDON MEDICAL CO., LTD. YI LIN
K111139 09/02/2011 DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U ANSELL HEALTHCARE PRODUCTS, INC. NEIL BURRIS
K111462 09/08/2011 FIXATE TISSUE BAND ANULEX TECHNOLOGIES, INC RACHEL KENNEDY
K102816 09/15/2011 GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE
K112237 09/02/2011 MICROSUTURE ANCHORS ARTHREX, INC. COURTNEY SMITH
K101986 09/09/2011 ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE ASAHI INTECC CO., LTD. YOSHI TERAI
K111287 09/26/2011 ASTRA TECH IMPLANT SYSTEM ASTRA TECH AB LINDA K SCHULZ
K112209 09/08/2011 PREFILLED CATHETER INFLATION SYRINGE AVAIL MEDICAL PRODUCTS, INC. STEVEN A HOWELL
K111704 09/09/2011 AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX AVINGER, INC. SEVRINA CIUCCI, RAC
K111989 09/22/2011 CORONIS FUSION 4MP DL BARCO NV LIEVEN DE WANDEL
K112434 09/29/2011 BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION BD MEDICAL SURGICAL JOHN ROBERTS
K111366 09/30/2011 BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM BECTON DICKINSON AND COMPANY (BD) RACHEL LEBLANC
K111270 09/13/2011 REUSABLE STIMULATING ELECTRODES BIO PROTECH, INC. JUDY BURTON
K111003 09/15/2011 BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL BIODENTA SWISS AG DAVID EILER
K111951 09/27/2011 ISOAMP HSV ASSAY BIOHELIX CORPORATION FRAN WHITE
K112324 09/06/2011 CERALAS 980NM DIODE LASER FAMILY BIOLITEC MEDICAL DEVICES, INC HARRY HAYES
K112442 09/30/2011 RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM BIOLITEC MEDICAL DEVICES, INC HARRY HAYES
K112253 09/20/2011 CERALAS 147NM DIODE LASER SYSTEM BIOLITEC, INC. HARRY HAYES
K111809 09/26/2011 SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS BIOMATERIALS KOREA INC. Kevin Walls
K112075 09/15/2011 VITEK 2 STRPTOCOCCUS AMPICILLIN BIOMERIEUX, INC. JOLYN TENLLADO
K112129 09/27/2011 VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN BIOMERIEUX, INC. JOLYN TENLLADO
K110565 09/01/2011 ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE BIOMET 3I, INC. JOSE E CABRERA
K110400 09/30/2011 TAPERLOC COMPLETE MICROPLASTY STEM BIOMET MANUFACTURING CORP. BECKY EARL
K112356 09/19/2011 GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE BIONOSTICS, INC. RANDY BYRD
K102633 09/09/2011 BIOTEQ ANGIOGRAPHIC CATHETER BIOTEQUE CORP. JENNIFER REICH
K111839 09/26/2011 SELECTRA ACCESSORY KIT BIOTRONIK, INC. Jon Brumbaugh
K112482 09/26/2011 SELECTRA SLITTER TOOL BIOTRONIK, INC. Jon Brumbaugh
K103426 09/14/2011 LITE PELVIC FLOOR REPAIR KITS BOSTON SCIENTIFIC CORP. MICHELLE BERRY
K112198 09/14/2011 EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE Boston Scientific Corporation ASHLEY PYLE
K112609 09/30/2011 DESARA MESH CALDERA MEDICAL, INC. VICKI GAIL
K111346 09/09/2011 RESOLUTIONMD MOBILE MODEL RMB-MOB-2X CALGARY SCIENTIFIC, INC. KYLE PETERSON
K101769 09/13/2011 EPISIL CAMURUS AB MAUREEN O'CONNELL
K111694 09/15/2011 ASTRA CANDELIS, INC. VINCENT CIPOLLA
K111612 09/14/2011 DIGITAL RETINAL CAMERA CANON, INC. KOJI KUBO
K111682 09/02/2011 DIGITAL RADIOGRAPHY CANON, INC.-MEDICAL EQUIPMENT GROUP KOJI KUBO
K112309 09/02/2011 DIGITAL RADIOGRAPHY CANON, INC.-MEDICAL EQUIPMENT GROUP KOJI KUBO
K111710 09/20/2011 FULL AUTO TONOMETER MODEL TX-20 CANON, INC.-MEDICAL EQUIPMENT GROUP KOJI KUBO
K111115 09/13/2011 CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM CAPTIVA SPINE, INC JOHN SANDERS
K112372 09/15/2011 CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC HELDER A SOUSA
K112327 09/09/2011 SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC HELDER A SOUSA
K110493 09/20/2011 TANDEMHEART PUMP CARDIACASSIST INC. ROBERT BOLLINGER
K111878 09/29/2011 PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES CARDINAL HEALTH, INC. TATYANA BOGDAN
K111868 09/21/2011 STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES TATYANA BOGDAN
K111649 09/23/2011 CS 7600 CARESTREAM HEALTH, INC. DANIEL HOEFER
K112067 09/16/2011 NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) CARTICEPT MEDICAL INC Tanya Eberle
K112474 09/23/2011 CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE CEDARS-SINAI MEDICAL CENTER GEOFF POLLARD
K102778 09/16/2011 CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION CELLAVISION AB CONSTANCE G BUNDY
K111390 09/12/2011 SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA.. CENDRES & METAUX SA TANJA BONGNI
K111322 09/14/2011 CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD CHEMTRON BIOTECH, INC. Jane Zhang
K110637 09/07/2011 ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM CILAG GMBH INTERNATIONAL FIONA LEEPER
K103461 09/13/2011 COLGATE DESENSITIZING DENTAL CREAM COLGATE-PALMOLIVE CO. CHARLES P IRELAND
K112386 09/08/2011 EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM COLOPLAST CORP. TIM CRABTREE
K112096 09/30/2011 IMAGELINK COMPUTER PROGRAMS AND SYSTEMS, INC. MICHAEL HUNT
K111916 09/29/2011 CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA S SHAH
K101273 09/30/2011 DYNAMIC ECG SYSTEM MODEL TLC5000 CONTEC MEDICAL SYSTEM CO., LTD. Diana Hong
K111966 09/15/2011 PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC COOPERVISION, INC. LISA HAHN
K111578 09/23/2011 CORELEADER COLLA-ALGI FIBER MODEL CAW CORELEADER BIOTECH CO., LTD. IAN LI
K102944 09/07/2011 CORELEADER HEMO-PAD MODEL CPII 02030 CORELEADER BIOTECH CO., LTD. IAN LI
K111733 09/22/2011 CORELEADER SCAR-DIMMER CORELEADER BIOTECH CO., LTD. IAN LI
K111887 09/09/2011 CLOSUREFAST RADIOFREQUENCY CATHETER COVIDIEN Daniel Campion
K112477 09/28/2011 PALINDROME H, SI, HSI CHRONIC CATHETER COVIDIEN WING NG
K112349 09/01/2011 VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H ANGELA V ARSDALE
K110754 09/09/2011 CRYOPEN CRYOSURGICAL SYSTEM, K102214 CRYOPEN, INC. MIKE HAAS, M.D.
K112311 09/01/2011 ALP 501 RB PUMP SYSTEM CURRIE MEDICAL SPECIALTIES, INC. BERNICE NAVARRO
K112196 09/14/2011 OCTOTMPORT DALIM SURGNET CORPORATION APRIL LEE
K111876 09/21/2011 Z BOND, PRELUDE ONE DANVILLE MATERIALS, INC. LINDSAY TILTON
K111116 09/09/2011 ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000 DATEX-OHMEDA MONICA MORRISON
K100806 09/16/2011 DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM DELBIO INCORPORATION NICKY PAN
K111833 09/21/2011 VIRTUE DIAGNOSOFT, INC. JEFFREY ROBERTS
K103290 09/19/2011 EDLEN IMAGING - GEMINI DUSB EDLEN IMAGING LLC FELIX HOVSEPIAN
K112645 09/22/2011 RADIFORCE LARGE MONITOR SYSTEM EIZO GMBH BERND HOMBERG
K111676 09/30/2011 APEX Elekta Limited Patrick Hull
K111996 09/14/2011 ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 ELITECHGROUP DEBRA K HUTSON
K112421 09/01/2011 EMG SUCTION UNIT EMG TECHNOLOGY CO., LTD. PAUL CHO
K111629 09/16/2011 TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001 ENCORE MEDICAL, L.P. TEFFANY HUTTO
K110913 09/23/2011 ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH TAMER IBRAHIM
K111763 09/15/2011 PATHASSIST LIGHT FIBER Entellus Medical, Inc. KAREN E PETERSON
K112272 09/07/2011 EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. YC LEI
K111728 09/16/2011 EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. YC LEI
K111845 09/26/2011 THE ESPINER SAC OR E SAC ESPINER MEDICAL LIMITED EDWIN LINDSAY
K111490 09/16/2011 MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS EV3 INC DANIEL CHER, MD
K111720 09/16/2011 AVIAFIT FLOWMEDIC LTD. AHAVA STEIN
K110429 09/02/2011 PROSIM 4, PROSIM 6, PROSIM 8 FLUKE BIOMEDICAL JOHN NELSON
K110165 09/30/2011 FREERIDER MODEL LUGGIE MODEL 168-4IT FREERIDER LUGGIE SCOOTERS INC JEFFREY L DAVIS
K111865 09/30/2011 WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE FUJIFILM MEDICAL SYSTEM U.S.A., INC. DEBBIE PEACOCK
K110729 09/01/2011 ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM FUJIFILM MEDICAL SYSTEMS, USA INC. PETER ALTMAN
K103358 09/01/2011 ROMA (HE4 EIA + ARCHITECT CA 125 II) FUJIREBIO DIAGNOSTICS, INC. DIANA L DICKSON
K111791 09/23/2011 LUMAGEM MOLECULAR BREAST IMAGING SYSTEM GAMMA MEDICA-IDEAS INCORPORATED Albert Boniske
K111731 09/15/2011 MOLECULAR BREAST IMAGING SOFTWARE GAMMA MEDICA-IDEAS INCORPORATED Albert Boniske
K112371 09/27/2011 LOGIQ P3 GE HEALTHCARE BRYAN BEHN
K112122 09/23/2011 VENUE 40 GE HEALTHCARE BRYAN BEHN
K112213 09/01/2011 VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM GE HEALTHCARE BRYAN BEHN
K111614 09/26/2011 CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE GE HEALTHCARE INTEGRATED IT SOLUTIONS JEME WALLACE
K103327 09/30/2011 DISCOVERY MR750W 3.0T GE HEALTHCARE JAPAN CORPORATION TORU SHIMIZU
K102933 09/02/2011 GEM-TONE BODY TRAINING SYSTEM GEMORE TECHNOLOGY CO., LTD. BODEN S LAI
K103489 09/09/2011 GE VEO RECONSTRUCTION OPTION GENERAL ELECTRIC CO. ANDREW J MENDEN
K112071 09/23/2011 WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
K112310 09/08/2011 WONDFO METHADONE URINE TEST,OPIATE TEST Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
K112236 09/19/2011 WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
K112395 09/09/2011 WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
K111059 09/01/2011 GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) GYRUS ACMI, INC. LORRAINE CALZETTA
K112320 09/30/2011 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR HEALTH & LIFE CO., LTD. SARAH SU
K111832 09/29/2011 PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID HERAEUS KULZER, LLC CHERYL ZIMMERMAN
K112502 09/19/2011 PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 HILL-ROM CO. CHAD HODSON
K110673 09/27/2011 HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K112556 09/28/2011 ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS HOWMEDICA OSTEONICS CORP VALERIE GIAMBANCO
K110290 09/27/2011 EXETER HIP STEM HOWMEDICA OSTEONICS CORP VALERIE GIAMBANCO
K112455 09/22/2011 AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS STEPHANIE FITTS
K103396 09/27/2011 COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION i-SENS, Inc. STANLEY R GOODMAN
K110033 09/15/2011 FEEL-DRCS IMFOU CO., LTD Ho Dong Yang
K111650 09/06/2011 IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS... IMMUNODIAGNOSTIC SYSTEMS LTD. MICK FENTON
K111660 09/13/2011 XELIS CARDIAC INFINITT CO., LTD. CARL ALLETTO
K111613 09/08/2011 XELIS FUSION INFINITT CO., LTD. CARL ALLETTO
K112329 09/08/2011 OMNI PATIENT MONITOR INFINIUM MEDICAL JOHN O'BRIEN
K111857 09/21/2011 SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE INMED GLOVES FACTORY XIAOBING LI
K103648 09/14/2011 COLLAGEN POWDER INNOCOLL PHARMACEUTICALS LTD AARON WYSE
K111060 09/09/2011 MRGFUS PELVIC PA COIL MODEL 1.0 INSIGHTECH, LTD ORI LUBIN
K110086 09/09/2011 IFS PROFILE PLATES, SCREWS, AND WASHERS INTERNAL FIXATION SYSTEMS, INC. CHRIS ENDARA
K111484 09/12/2011 DISCOVERY INTUITIVE SPINE, LLC JENNIFER PALINCHIK
K112584 09/29/2011 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT INTUITIVE SURGICAL, INC. KIM T SERVANCE
K101185 09/20/2011 NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY IRIS MOLECULAR DIAGNOSTICS ROBERT KLEM
K111838 09/26/2011 INQU PASTE MIX ISTO TECHNOLOGIES, INC. PATSY J TRISLER
K111743 09/14/2011 THE INSYNC CERAMIC SYSTEM JENSEN INDUSTRIES, INC. GARY PHELPS
K111177 09/12/2011 JUELL HARD CURE JUELL DENTAL ANGELA BLACKWELL
K111178 09/12/2011 JUELL SOFT CURE JUELL DENTAL ANGELA BLACKWELL
K111370 09/21/2011 ODALYS PEDICLE SCREW SYSTEM KALITEC DIRECT, LLC J.D. WEBB
K110462 09/26/2011 KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE KEPLER MEDTEC SHARYN ORTON, PHD
K103150 09/23/2011 KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK KIMBERLY-CLARK ANN WATERHOUSE
K103810 09/14/2011 KJ SUBMERGED SYSTEM KJ MEDITECH CO., LTD Priscilla Chung
K110766 09/15/2011 KOLPLUX SYSTEM KOLPLAST CI LTDA E.J. Smith
K112136 09/29/2011 TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD. Glen Feye
K110327 09/30/2011 LDR SPINE ROI-A INTERBODY FUSION SYSTEM LDR SPINE USA MARITZA ELIAS
K110891 09/13/2011 THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER LEMAITRE VASCULAR INC. ANDREW HODGKINSON
K111837 09/27/2011 RADIAL ARTERY COMPRESSION TOURNIQUET LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD SHAN ZHAO
K112524 09/26/2011 HAIRMAX LASERCOMB LEXINGTON INTERNATIONAL, LLC DAVID MICHAELS
K111729 09/07/2011 PILOT SPINAL SYSTEM LIFE SPINE, INC RANDY LEWIS
K111355 09/16/2011 ECHOBRIGHT LIFE-TECH, INC. SKIP RIMER
K110370 09/15/2011 Q-CLEAR LIGHT AGE, INC. ELIZABETH REDDINGTON
K111516 09/27/2011 NMR LIPOPROFILE (R) TEST AND NMR PROFILER LIPOSCIENCE, INC SUZETTE M WARNER
K103217 09/28/2011 LITE-MED LM-9200 ELMA LITE-MED INC WALT HSU
K111816 09/29/2011 EQUIMATRIX LUITPOLD PHARMACEUTICALS, INC. MARSHA SIMON
K112199 09/01/2011 XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1) LUMINEX MOLECULAR DIAGNOSTICS, INC. LUBNA SYED
K110606 09/29/2011 MV INTRADERMIC NEEDLES; MAGIC NEEDLE; MAGIC NEEDLE M.V. S.R.L. ENRICO BISSON
K112360 09/15/2011 QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K111888 09/23/2011 MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS MASIMO CORPORATION ANIL BHALANI
K111641 09/26/2011 SURGICASE ORTHOGNATHIC SOFTWARE WIZARD MATERIALISE N.V. OLIVER CLEMENS
K110659 09/13/2011 MEDICAL CONCEPTS INTERBODY FUSION SYSTEM MEDICAL CONCEPTS, INC. CHRISTOPHER CANIS
K111734 09/06/2011 MYSAFETY SYRINGE MEDICALCHAIN INTL. CORP. ROBIN HWANG
K111350 09/29/2011 MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM MEDICAM INC. PHILIPPE AMAR
K110497 09/26/2011 PASS LP SPINAL SYSTEM MEDICREA INTERNATIONAL J.D. WEBB
K110062 09/01/2011 MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG MEDIPURPOSE PTE. LTD. JULIE STEPHENS
K111577 09/08/2011 MEDLINE VIAL DECANTER MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K111457 09/15/2011 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK LEE GRANT
K112555 09/27/2011 CD HORIZON(R) SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. CHRIS MCKEE
K111510 09/15/2011 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. KEVIN FORD
K112226 09/29/2011 HYDROCOIL EMBOLIC SYSTEM (HES) MICROVENTION, INC. LARAINE PANGELINA
K111451 09/20/2011 MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX MICROVENTION, INC. LARAINE PANGELINA
K110741 09/29/2011 SCEPTER C OCCLUSION BALLOON CATHETER MICROVENTION, INC. Naomi Gong
K103089 09/15/2011 SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS MIS - IMPLANT TECHNOLOGIES LTD. IMAN KHORSHID
K112257 09/20/2011 BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE MOLNLYCKE HEALTH CARE US, LLC ANGELA L BUNN
K111802 09/08/2011 SV BRAIN ARRAY, SIEMENS 3T MRI INTERVENTIONS, INC. E.F. WADDELL
K111687 09/29/2011 EMG SYSTEM MYOTRONICS-NOROMED, INC. F. ADIB
K111019 09/30/2011 SURGIMAP (TM) SPINE NEMARIS INC KEITH A BARRITT
K111666 09/07/2011 EVADYNE TEMPORARY CROWN AND BRIDGE RESIN NEO DENTAL CHEMICAL PRODUCTS CO., LTD. ROBERT SEIPLE
K112131 09/29/2011 NEODYNE DRESSING NEODYNE BIOSCIENCES, INC. PEGGY MCLAUGHLIN
K111767 09/15/2011 NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS MONICA STACHURA,JD
K111576 09/20/2011 NT 2000 LESIONING GENERATOR NEUROTHERM, INC. F. DAVID ROTHKOPF
K110140 09/30/2011 NEUROVISION NERVE LOCATOR MONITOR NEUROVISION MEDICAL PRODUCTS, INC. CHRISTINE VERGELY
K111973 09/21/2011 VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET NUCLETRON MICHAEL PAUL
K103515 09/15/2011 EQUAL DOSE NUCLETRON CORPORATION MANAL YOUSOF
K111329 09/06/2011 NM-7000 NUGA MEDICAL CO., LTD CHARLIE MACK
K112400 09/12/2011 SMARTSHEARS NUSCIENCE CONSULTING AND MANAGEMENT GROUP, LLC NIKOLE GOLDSMITH
K111174 09/19/2011 NXSTAGE PUREFLOW SL NXSTAGE MEDICAL, INC. MARY LOU STROUMBOS
K112176 09/15/2011 SILICONE SPHERES OCULO PLASTIK, INC. SYLVAIN DESROSIERS
K103132 09/08/2011 FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI OCULUS PRIVATE LIMITED Kevin Walls
K110860 09/02/2011 COMP A-I-R OMRON HEALTHCARE, INC. PAUL DRYDEN
K111505 09/08/2011 RTVUE CAM WITH CORNEAL POWER UPGRADE OPTOVUE, INC. JOHN TALARICO
K103808 09/01/2011 SAPPHIRE NC ORBUSNEICH MEDICAL, INC. JOHN PAZIENZA
K110309 09/14/2011 FOB ONE STEP RAPID TEST ORIENT GENE BIOTECH Gary Lehnus
K111936 09/21/2011 ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD ORTHO DEVELOPMENT TOM HAUETER
K111069 09/22/2011 OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT OSTEOSYMBIONICS, LLC ELAINE DUNCAN
K111278 09/16/2011 Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE OTTO BOCK HEALTHCARE, LP WILLIAM KABITZ
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