FDA 510(k) Applications Received During July, 2012

FDA 510(k) Number Submission Date Device Name Applicant Contact
K121985 07/06/2012 ARCHITECT TOTAL BILIRUBIN ABBOTT LABORATORIES LINDA MORRIS
K122137 07/18/2012 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM ACCURAY INCORPORATED ANNE SCHLAGENHAFT
K121934 07/16/2012 TOMOTHERAPY TREATMENT SYSTEM ACCURAY INCORPORATED GREG BANGE
K122110 07/17/2012 ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM ACON LABORATORIES, INC. QIYI XIE
K122076 07/16/2012 PERSONAL HEALTH CENTER (PHC) ADFLOW HEALTH NETWORKS INC GLEN FEYE
K122044 07/12/2012 STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR ADVANCED STERILIZATION PRODUCTS NANCY CHU
K121991 07/06/2012 ENTEROCOCCUS QUICKFISH BC ADVANDX, INC. BENJAMIN S CRYSTAL
K121976 07/05/2012 AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE AESCULAP, INC. KATHY A RACOSKY
K122119 07/17/2012 DX-D FULL LEG FULL SPINE AFGA HEALTHCARE N.V. DAVID LEDWIG
K122162 07/20/2012 AGGREGUIDE AGGREDYNE, INC. J. HARBEY KNAUSS
K122133 07/18/2012 AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING AIRSTRIP TECHNOLOGIES, LP
K122298 07/31/2012 AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR AJEX MEDITECH., LTD WILLIAM LITTLE
K122047 07/12/2012 ALAMO P ALLIANCE PARTNERS, LLC JENNIFER PALINCHIK
K121937 07/02/2012 E-CUBE INNO ALPINION MEDICAL SYSTEMS CO., LTD DONGHWAN KIM
K122098 07/16/2012 APPS-HEALTH01 ANDON HEALTH CO., LTD YI LIU
K122054 07/13/2012 LIFESTYLES NATURAL PERSONAL LUBRICANT ANSELL HEALTHCARE PRODUCTS, LLC DONNA DIGANGI
K122248 07/27/2012 IGROW II HAIR GROWTH SYSTEM APIRA SCIENCE, INC. RAYMOND R BLANCHE
K122130 07/18/2012 WINX SLEEP THERAPY SYSTEM APNICURE, INC. CHRIS DANIEL
K122270 07/30/2012 OVERTUBE ENDOSCOPIC ACCESS SYSTEM APOLLO ENDOSURGERY, INC. HEATHER CRAWFORD, RAC
K121942 07/11/2012 ADENOVIRUS R-GENE US ARGENE SA ERIC BRISSON
K121941 07/02/2012 ARROW PICC POWERED BY ARROW VPS STYLET ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) ELIZABETH DUNCAN
K122027 07/11/2012 ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER ARROW INTERNATIONAL, INC. PAUL AMUDALA
K122078 07/16/2012 LOFRIC PRIMO, LOFRIC HYDRO-KIT ASTRA TECH, INC. ALLISON C KOMIYAMA
K122129 07/18/2012 SPHYGMOCOR XCEL ATCOR MEDICAL JOHN ABRAM
K122022 07/10/2012 ATHEROEDGE ATHEROPOINT LLC JASJIT S SURI
K122276 07/31/2012 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICURE, INC. JAMES LUCKY
K122138 07/19/2012 ATRIUM FLIXENE IFG VASCULAR GRAFT ATRIUM MEDICAL CORP. MEGAN MCCAGH
K121964 07/05/2012 MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML AUGMENIX , INC. ERIC ANKERUD
K121946 07/03/2012 AXIS-SHIELD ACVTIVE-B12 AXIS-SHIELD DIAGNOSTICS, LTD. SIMON JOHN RICHARDS
K122260 07/27/2012 AYCAN MOBILE AYCAN DIGITALSYSTEME GMBH MATTHIAS BROENNER
K122297 07/31/2012 ENLUXTRA HUMIFIBER WOUND DRESSING BASF VENTURE CAPITAL AMERICA INC. NADI ERGENC, PH.D.
K122278 07/30/2012 BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR BAYLIS MEDICAL COMPANY INC. MEGHAL KHAKHAR
K121790 07/03/2012 ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM BECKMAN COULTER, INC. KERRIE OETTER
K122046 07/12/2012 WRIST PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. LEI CHEN
K121983 07/06/2012 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRA BENQ MEDICAL TECHNOLOGY CORPATION BOB LEIKER
K122112 07/17/2012 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM BIO COMPRESSION SYSTEMS, INC. MAUREEN GARNER
K122187 07/24/2012 VRESELECT CULTURE MEDIUM BIO-RAD FRAN WHITE
K122281 07/30/2012 PADNET 2.0 BIOMEDIX, INC. GREG HOCKING
K121863 07/13/2012 VITEK 2 AST-ST CEFOTAXIME BIOMERIEUX, INC. ELIZABETH LANDON
K122300 07/31/2012 T3 DENTAL IMPLANT BIOMET 3I TAMARA WEST
K122277 07/30/2012 OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM BIOMET MANUFACTURING CORP. ELIZABETH WRAY
K122160 07/20/2012 VANGUARD XP KNEE SYSTEM BIOMET MANUFACTURING CORP. TRACY BICKEL JOHNSON
K122237 07/26/2012 BIOPHOTAS LIFELIGHT BIOPHOTAS, INC. SHEPARD G BENTLEY, RAC
K121973 07/05/2012 BIOPRO HEMI-EDGE TOE SYSTEM BIOPRO, INC. AL LIPPINCOTT
K122196 07/24/2012 CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY BLACKROCK NEUROMED, LLC JOHN ZIOBRO
K121936 07/02/2012 NAVIOPFS BLUE BELT TECHNOLOGIES, INC. RICHARD G CONFER
K122052 07/12/2012 MINIFIX BALL MINIFIX ONE BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC JUAN TEZAK
K122203 07/25/2012 TRUETOME BOSTON SCIENTIFIC CORP. LAURIE PANNELLA
K122072 07/16/2012 WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE BOSTON SCIENTIFIC CORPORATION LAURIE PANNELLA
K122011 07/09/2012 NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP BRAINLAB AG ALEXANDER SCHWIERSCH
K122225 07/25/2012 STERILE RADIOLUCENT SKULL PINS BRAINLAB AG ALEXANDER SCHWIERSCH
K122288 07/30/2012 BRAINSWAY DEEP TMS SYSTEM BRAINSWAY, LTD AHAVA STEIN
K121928 07/02/2012 DESARA SL CALDERA MEDICAL, INC. VICKI GAIL
K122184 07/23/2012 ECG CHECK CARDIAC DESIGNS, LLC KARIM MARROUCHE
K122285 07/30/2012 TABLET COMMANDER CARDIOCOM LLC DANIEL L COSENTINO
K122241 07/27/2012 IMAGEN3D CARDIOVASCULAR IMAGING TECHNOLOGIES MELANIE HASEK
K122215 07/25/2012 NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) CARTICEPT MEDICAL, INC. TANYA EBERLE
K122246 07/27/2012 MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12 CELLERATION, INC. KATHY SIMPSON
K122282 07/30/2012 QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS CENTERS FOR DISEASE CONTROL AND PREVENTION ELIZABETH HAMELIN
K122000 07/10/2012 HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER CHANGZHOU HOLYMED PRODUCTS CO LTD ALAN YU
K121998 07/10/2012 HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED CHANGZHOU HOLYMED PRODUCTS CO LTD ALAN YU
K122208 07/25/2012 EXTERNAL FIXATOR SYSTEM CHRISTOPHER D. ENDARA CHRISTOPHER ENDARA
K122118 07/17/2012 HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM CODMAN & SHURTLEFF, INC. KATHY STRANGE
K122115 07/17/2012 COLLAGEN DENTAL WOUND DRESSINGS COLLAGEN MATRIX, INC. PEGGY HANSEN
K122179 07/23/2012 VASOPRESS DVT LEG GARMENTS (STERILE) VASOPRESS DVT FOOT GARMENTS (STERILE) COMPRESSION THERAPY CONCEPTS LEONARD NASS
K121974 07/09/2012 CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA S SHAH
K122033 07/16/2012 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA S SHAH
K121935 07/09/2012 TAPERSET HIP SMALL STEMS CONSENSUS ORTHOPEDICS, INC. MATTHEW M HULL
K122091 07/16/2012 COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK, INC. SEAN SPENCE
K122295 07/31/2012 CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS CORE 3D PROTECH, S.L. ANNA CORTINA
K122099 07/16/2012 BENCOX II STEM, BENCOX METAL HEAD CORENTEC CO., LTD J.S. DANIEL
K122280 07/31/2012 IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM CYDEN LIMITED AUSTIN SPEIER
K122030 07/11/2012 LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON DEGANIA SILICONE, LTD. ZOYA LEE
K122268 07/30/2012 ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS DENTSPLY INTERNATIONAL HELEN LEWIS
K122123 07/18/2012 6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY JULIE VAFIDES
K121929 07/02/2012 ZEPHYR 'X-SERIES" PATIENT TRANSFER SLED DIACOR, INC. KEVIN ANDERSON
K121944 07/03/2012 LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT DIASORIN, INC. MARI MEYER
K121951 07/03/2012 LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3 DIASORIN, INC. KELLY R SAUER
K121915 07/03/2012 BRIGHT RESTORATIVE MATERIALS DMP LTD DIMITRIS PRANTSIDIS
K122159 07/20/2012 DORNIER MEDILAS H30 SOLVO DORNIER MEDTECH AMERICA, INC. JOHN HOFFER
K121938 07/02/2012 MEDILAS H RFID LASER FIBER DORNIER MEDTECH AMERICA, INC. JOHN HOFFER
K121999 07/09/2012 GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE DRAEGER MEDICAL GMBH BETH ZIS
K121996 07/09/2012 BE PLUS LTM AMPLIFIER GWI AMPLIFIER EB NEURO, S.P.A. ALLISON SCOTT
K122125 07/18/2012 ASA LASER SH1 EL.EN. ELECTRONIC ENGINEERING SPA PAOLO PERUZZI
K122083 07/16/2012 ELITECH CLINICAL SYSTEMS CK NAC SL ELITECHGROUP DEBRA K HUTSON
K122177 07/23/2012 ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL ELITECHGROUP DEBRA K HUTSON
K122202 07/25/2012 ELLEX 2RT ELLEX MEDICAL PTY. LTD. KEVIN HOWARD
K122095 07/12/2012 ICP TRIAGEMANAGER EMERGO EUROPE CONSULTING BV RACHIDA ZIANI
K122239 07/27/2012 FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING ENCORE MEDICAL, L.P. TEFFANY HUTTO
K121943 07/03/2012 XPRESS MULTI-SINUS DILATION TOOL ENTELLUS MEDICAL, INC. KAREN E PETERSON
K122290 07/30/2012 ENVITEC MYSIGN O OXYGEN MEASURING DEVICE ENVITEC-WISMAR GMBH STEPHEN GORSKI
K122006 07/09/2012 G-SCAN BRIO ESAOTE, S.P.A. ALLISON SCOTT, RAC
K122194 07/24/2012 LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE EVERYWAY MEDICAL INSTRUMENTS CO., LTD. ROBERT TU
K121919 07/02/2012 SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV EXACT MEDICAL MANUFACTURING, INC ROBERT O DEAN
K121989 07/06/2012 OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC, EXACTECH, INC. GINA CASSIDY
K122205 07/25/2012 EXINI EXINI DIAGNOSTICS AB ALLISON SCOTT
K121950 07/03/2012 MICROTARGETING XL STAR DRIVE SYSTEM FHC, INC. KERI SEITZ
K122154 07/20/2012 POWERPLAY MUSCLE MASSAGER FIG, LLC JOE ADKINS
K121975 07/05/2012 AIRVO HUMIDIFIER MYAIRO HUMIDIFIER FISHER & PAYKEL HEALTHCARE, LTD. BRETT WHISTON
K122206 07/25/2012 GARAVENTA X3 INCLINED PLATFORM LIFT GARAVENTA (CANADA) LTD [DBA GARAVENTA LIFT] JAY MANSOUR
K122114 07/17/2012 LOGIQ S7 EXPERT, LOGIQ S7 PRO GE HEALTHCARE BRYAN BEHN
K122174 07/23/2012 PEDIATRIC POSITIONER PAD SET GE HEALTHCARE COILS (USA INSTRUMENTS INC.) MICHELLE HUETTNER
K122234 07/26/2012 OEC 9900 ELITE GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC GERALD BUSS
K122253 07/27/2012 PROCARE MONITOR B20 GE MEDICAL SYSTEMS CHINA CO., LTD. ROBERT CASARSA
K122164 07/20/2012 MR VESSELLQ XPRESS GE MEDICAL SYSTEMS SCS HELEN PENG
K122062 07/13/2012 APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER GEN-PROBE, INC. MARIA CARMELITA S BALUYOT
K122272 07/30/2012 CARDIOMEM GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG SUSAN D GOLDSTEIN-FALK
K122071 07/16/2012 GETINGE 400HC-E / SERIES STEAM STERILIZER GETINGE SOURCING LLC BARB SMITH
K121922 07/02/2012 BEACON STABILIZATION SYSTEM GLOBUS MEDICAL INC. MERIAM YOUSSEF
K122226 07/26/2012 REVERE STABILIZATION SYSTEM GLOBUS MEDICAL INC. MERIAM YOUSSEF
K122097 07/16/2012 PATRIOT SPACERS GLOBUS MEDICAL, INC. MERIAM YOUSSEF
K122142 07/19/2012 GLOOKO LOGBOOK CHARTS GLOOKO, INC. SHILPA MYDUR
K122028 07/10/2012 AURICAL HIT GN OTOMETRICS DANIEL KAMM
K122067 07/16/2012 TYPE 1077 ACCUSCREEN GN OTOMETRICS TOM RINIKER
K121987 07/06/2012 WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST GUANGZHOU WONDFO BIOTECH CO., LTD. JOE SHIA
K122262 07/27/2012 ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM HAEMONETICS CORP. ERICA DIAZ
K122259 07/27/2012 BLOOD PRESSURE MONITOR WITH STETHOSCOPE HANGZHOU RELI-ON CO., LTD CHARILE MACK
K122275 07/30/2012 ARTISAN EXTEND CONTROL CATHETER HANSEN MEDICAL HASSAN LABAY
K121993 07/09/2012 SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT HEIDELBERG ENGINEERING GMBH DIANE HORWITZ, PH.D.
K122015 07/10/2012 DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE HOWMEDICA OSTEONICS CORP. CHRISTIE PENCINGER
K122141 07/19/2012 IDS-ISYS IGF-I CALIBRATION VERIFIERS IMMUNODIAGNOSTIC SYSTEMS LTD. MICK FENTON
K121997 07/09/2012 IMRIS ONCOLOGY PACKAGE IMRIS, INC. SANJAY SHAH
K122008 07/09/2012 INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE INCITE INNOVATION LLC JOHN KIRWAN
K122075 07/17/2012 DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER INTERSURGICAL, INC. MICHAEL ZALEEWSKI
K122077 07/17/2012 MANOMETER INTERSURGICAL, INC. MICHAEL ZALEWSKI
K121921 07/02/2012 INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS INTUITIVE SURGICAL, INC. CHERECE L JONES
K122040 07/12/2012 INVOTEC LARYNGEAL ELECTRODE INVOTEC INTERNATIONAL, INC. JEFFREY L AULL
K122061 07/13/2012 K-Y BRAND LIQUIBEADS JOHNSON & JOHNSON HEALTHCARE PRODUCTS LORNA-JANE BREMER
K122096 07/16/2012 KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC. LEIGH SPOTTEN
K121883 07/09/2012 PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT KCI USA, INC. (KINETIC CONCEPTS, INC.) SHANNON SCOTT
K122039 07/11/2012 KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B KETTENBACH GMBH & CO KG JUERGEN BERGER
K122049 07/12/2012 NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM KINAMED, INC. HEATHER NEELY
K122025 07/11/2012 BRIGHTGLASS BRIGHTGLASS M KTK MEDICAL SUPPLIES GMBH THOMAS LOTTERMOSER
K121980 07/06/2012 ZIRPRIME KURARAY NORITAKE DENTAL INC. IVAN WASSERMAN
K122050 07/12/2012 CPRMETER CPR FEEDBACK DEVICE LAERDAL MEDICAL A/S DAN DILLION
K122069 07/16/2012 STORM MINI SCREW LANCER ORTHODONTICS, INC. LARRY WALKER
K121940 07/03/2012 LANX SPINAL FIXATION SYSTEM LANX, INC. PATRICK HUNT
K122145 07/19/2012 LANX SPINAL FIXATION SYSTEM LANX, INC. MICHAEL FUNK
K121839 07/09/2012 UNBALLOON NON-OCCLUSIVE MODELING CATHETER LEMAITRE VASCULAR INC. ANDREW HODGKINSON
K122247 07/27/2012 LIDCORAPID V2 MONITOR LIDCO LTD. GREGORY SPELLER
K121933 07/02/2012 NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM) MARVAO MEDICAL DEVICES, LTD. MARYBETH GAMBER
K121912 07/02/2012 E1 EAR SENSORS MASIMO CORPORATION DAVID COLLETTE
K121914 07/02/2012 MASIMO SET USPO2 PULSE OXIMETRY CABLE MASIMO CORPORATION DAVID COLLETTE
K122131 07/18/2012 POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY) MATANG MFG. SDN. BHD. LESLIE LEONG
K122042 07/12/2012 CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES MAUNA KEA TECHNOLOGIES MICHAEL DANIEL
K122201 07/25/2012 PROTURA COUCH SOFTWARE MED-TEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS AMANDA STAHLE
K122232 07/26/2012 GMK NARROW MEDACTA INTERNATIONAL ADAM GROSS
K122252 07/27/2012 SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS MEDICAL DEVELOPMENTS INTERNATIONAL TRACEY BULLIVANT
K121979 07/06/2012 PASS OCT SPINAL SYSTEM MEDICREA INTERNATIONAL LAURA AVIRON-VIOLET
K122023 07/11/2012 MIXJECT WITH SPRAY HEAD MEDIMOP MEDICAL PROJECTS, LTD. LLANIT GOLDGRABER
K122092 07/16/2012 MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM MEDRANGE CORPORATION KUOFANG HUANG
K121982 07/06/2012 SOVEREIGN SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK LAUREN KAMER
K122037 07/11/2012 ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST MEDTRONIC SOFAMOR DANEK, INC. BECKY RONNER
K122240 07/27/2012 BONE PLUS BCP EAGLE EYE MEGAGEN IMPLANT CO., LTD APRIL LEE
K122231 07/26/2012 XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM MEGAGEN IMPLANT CO., LTD APRIL LEE
K121962 07/05/2012 PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B MEGO AFEK AC LTD ALEX RAPEL
K122273 07/30/2012 MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS MENICON CO. LTD. ELLEN M BEUCLER
K122019 07/10/2012 STREPTOCOCCUS APP. SEROLOGICAL REAGENTS MERIDIAN BIOSCIENCE, INC. MICHELLE L SMITH
K122088 07/16/2012 MERIT ONE SNARE SYSTEM MERIT MEDICAL SYSTEMS, INC. MARK MULLANEY
K122089 07/16/2012 OSTIAL PRO STENT POSITIONING SYSTEM MERIT MEDICAL SYSTEMS, INC. DAVID THOMAS
K122190 07/24/2012 PRELUDE 7F SHORT SHEATH INTRODUCER MERIT MEDICAL SYSTEMS, INC. DAN CLARK
K122016 07/10/2012 REXTAR, REXTAR LCD META BIOMED, INC. BLIX WINSTON
K122291 07/31/2012 THERMO SCIENTIFIC MAS OMNI-CARDIO MICROGENICS CORPORATION KAREN LEE
K122013 07/10/2012 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M) MICROLIFE CORP. SUSAN D GOLDSTEIN-FALK
K122086 07/16/2012 THERMAL LIGATING SHEARS MICROLINE SURGICAL, INC WILLIAM MCCALLUM
K122132 07/18/2012 AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM MOLNLYCKE HEALTH CARE ANGELA L BUNN
K122073 07/16/2012 ELI 280 ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC. AMY YANG
K122294 07/31/2012 PRESSURIZED INFUSION PUMP MUI SCIENTIFIC TAMMY MUI
K121954 07/03/2012 NMI MICROCATHETER NAVILYST MEDICAL, INC. WANDA CARPINELLA
K121990 07/06/2012 PICC CONVENIENCE KIT NAVILYST MEDICAL, INC. MARION W GORDON
K121931 07/09/2012 NONDISPOSABLE STIMULATING INSTRUMENTS NEUROVISION MEDICAL PRODUCTS, INC. CHRISTINE VERGELY
K122217 07/25/2012 CERTUS 140 2.45GHZ ABLATION SYSTEM NEUWAVE MEDICAL, INC DAN KOSEDNAR
K122031 07/11/2012 NEXTRA TI HAMMERTOE CORRECTION SYSTEM NEXTREMITY SOLUTIONS, LLC ARTHUR A ALFARO
K122214 07/25/2012 TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T) NIHON KOHDEN CORP. STEVE GEERDES
K121926 07/02/2012 BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM NORTHSTAR HEALTHCARE HOLDINGS WESLEY TOAVS
K121947 07/03/2012 ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES NORTHSTAR HEALTHCARE HOLDINGS WESLEY TOAVS
K122012 07/10/2012 Z-MED Z-MED II NUMED, INC. NICHELLE LAFLESH
K122081 07/16/2012 NUVASIVE LONG LATERAL SPINAL SYSTEM NUVASIVE, INC. ELIAS KETCHUM
K122051 07/12/2012 NXSTAGE SYSTEM ONE NXSTAGE MEDICAL, INC. MARY LUO STROUMBOS
K122198 07/24/2012 6.00MM X 6.00MM MACRO EXTERNAL IMPLANT SYSTEM OCO BIOMEDICAL JACK BLOOM
K122267 07/30/2012 GIRAFFE AND PANDA WARMERS OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC., AGATA ANTHONY
K121959 07/05/2012 EVIS EXERA III VIDEO SYSTEM OLYMPUS MEDICAL SYSTEMS CORP. LAURA STORMS-TYLER
K122180 07/23/2012 HIGH FLOW INSUFFLANTION UNIT OLYMPUS MEDICAL SYSTEMS CORPORATION DAPHNEY GERMAIN-KOLAWOLE
K122085 07/16/2012 STINGRAY CERVICAL CAGE OMNI SURGICAL, LP DBA SPINE360 DAVE LAMB
K121932 07/02/2012 HEM-7200-Z (BP742) OMRON HEALTHCARE, INC. PAUL DRYDEN
K121902 07/16/2012 NATRATONE ORELLE CORPORATION LTD PATRICIA COOMBES
K121927 07/02/2012 MICROSTREAM FILTERLINE ICU ORIDION MEDICAL 1987 LTD. DALIA GIVONY
K122065 07/13/2012 DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE ORMCO CORP. WENDY GARMAN
K121953 07/03/2012 HEMASORB APPLY ORTHOCON, INC. RICHARD KRONENTHAL, PHD
K122156 07/20/2012 ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY ORTHOCON, INC. RICHARD KRONENTHAL
K122005 07/09/2012 MAXLOCK EXTREME SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. DEREK LEWIS
K122084 07/16/2012 INTRODUCER SET, MODEL ADELANTE-S SERIES OSCOR INC. MILA DOSKOCIL
K122171 07/23/2012 MS SA IMPLANT SYSTEM OSSTEM IMPLANT CO LTD PATRICK LIM
K122124 07/18/2012 PORTABLE X-RAY SYSTEM OSSTEM IMPLANT CO.,LTD PATRICK LIM
K121995 07/18/2012 TS FIXTURE SYSTEM OSSTEM IMPLANT CO.,LTD PATRICK LIM
K122178 07/23/2012 FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1 OSTIAL CORPORATION KAITLIN VON HOFFMANN
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K122018 07/10/2012 OP300 PALODEX GROUP OY MATTI TULIKOURA
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K122197 07/24/2012 AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES PHADIA US INC. MARTIN MANN
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K122158 07/20/2012 PBP TOTAL HIP SYSTEM PIPELINE BIOMEDICAL PRODUCTS, LLC TERRY POWELL
K121963 07/05/2012 PLANMED NUANCE DIGIGUIDE PLANMED OY LARS MORING
K121977 07/05/2012 PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM PLASMA SURGICAL LIMITED PETER GIBSON
K122200 07/25/2012 A3F FRATIONAL POLLOGEN LTD YORAM LEVY
K121948 07/03/2012 CR 10-X DIGITIZER PRACTICAL COMPLIANCE, LLC
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K122251 07/27/2012 VITRA MULTISPOT QUANTEL MEDICAL MAUREEN O'CONNELL
K122189 07/24/2012 QUIDEL MOLECULAR RSV + HMPV ASSAY QUIDEL CORP. RONALD H LOLLAR
K122126 07/18/2012 DIRECT LDL/HDL CHOLESTEROL CALIBRATOR RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG
K122182 07/23/2012 DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC RAYENCE CO., LTD DAVE KIM
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K122216 07/25/2012 RELIANCE ANTERIOR CERVICAL PLATE SYSTEM RELIANCE MEDICAL SYSTEMS, LLC BRET M BERRY
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K122003 07/09/2012 RENEW INSERT RENEW MEDICAL, INC. VICTORIA MACKINNON
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K121955 07/03/2012 COUGHASSIST T70 DEVICE RESPIRONICS, INC. COLLEEN WITT
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K122010 07/09/2012 Z6 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD YANG ZHAOHUI
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K121981 07/06/2012 ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY SIEMENS HEALTHCARE DIAGNOSTICS PHILIP LIU
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K122059 07/13/2012 ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS SMITH & NEPHEW, INC. KARIN DESJARDINS
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K122105 07/17/2012 SMI CARDIOVASCULAR PATCH SOLINAS MEDICAL INC JAMES HONG
K122254 07/27/2012 INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR SORIN GROUP ITALIA S.R.L. SCOTT LIGHT
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K122168 07/23/2012 VISUALIF CHALLENGING ACCESS PLATE SPINE SMITH PARTNERS L.P. CLIFTON NAIVAR
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K122235 07/26/2012 RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET TELEFLEX MEDICAL, INC. LORI PFOHL
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K122064 07/17/2012 FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE TIANJIN NEW BAY BIORESEARCH CO., LTD. ROGER DE BOCK
K122289 07/30/2012 IMAGE-COM 5.0 TOM TEC IMAGING SYSTEMS GMBH BERNHARD MUMM
K122229 07/26/2012 VICEROY SPINAL SYSTEM TORREY SPINE MEREDITH MAY
K122109 07/17/2012 AQUILION ONE VISION, V4.90 TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K122299 07/31/2012 SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR TRANSENTERIX, INC. TAMMY B CARREA
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K122183 07/23/2012 AUGMENT AND SCREW, PSA TYPE UNITED ORTHOPEDIC CORP. FANG-YUAN HO
K122185 07/23/2012 U-MOTION II ACETABULAR SYSTEM UNITED ORTHOPEDIC CORP. FANG-YUAN HO
K122236 07/26/2012 VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K122155 07/20/2012 PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM VATECH CO., LTD. DAVE KIM
K122106 07/17/2012 SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE VERAN MEDICAL TECHNOLOGIES, INC. SCOTT WRIGHTSTONE
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K122269 07/30/2012 ENAMIC VITA ZAHNFABRIK H. RAUTER GMBH & CO. ELIZABETH WOLFSEN
K122136 07/18/2012 VITREAVIEW VITAL IMAGES, INC. IAN NEMEROV
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K122218 07/25/2012 ADVANCE TOTAL KNEE SYSTEM-PATELLA WRIGHT MEDICAL TECHNOLOGY, INC. DANIELLE MUELLER
K122163 07/20/2012 CERTEX SPINAL IMPLANT SYSTEM X-SPINE SYSTEMS, INC DAVID KIRSCHMAN
K121992 07/06/2012 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR XINWEI (SHANDONG) PLASTIC AND RUBBER PRODUCTS CO., LTD FRANK LIU
K122265 07/30/2012 VIALOK SINGLE VIAL ACCESS DEVICE VENTED YUKON MEDICAL, LLC
K121971 07/05/2012 WITHINGS, SMART BODY SCALE ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. LEO WANG
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