FDA 510(k) Applications Received During April, 2012

FDA 510(k) Number Submission Date Device Name Applicant Contact
K121265 04/26/2012 AMPHIRION PLUS PTA CATHETER MEDTRONIC INC. NAINESH SUREJA
K121290 04/30/2012 AQUAMANTRYS3 BSC 9.1S MEDTRONIC INC. TARA N TURNEY
K121219 04/23/2012 ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER MEDTRONIC INC. WENDY SAUNDERS
K120987 04/02/2012 DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF MEDTRONIC INC. EMILY BLUS
K120988 04/02/2012 DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT MEDTRONIC INC. JACQUELINE HAUGE
K121075 04/09/2012 NERVEVISION SOFTWARE SYSTEMS 3D IMAGING PARTNERS INC. CAROLYN PRIMUS
K121069 04/09/2012 3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK 3M COMPANY JIZHONG JIN
K121003 04/02/2012 ABBOTT PLEX-ID FLU ASSAY ABBOTT LABORATORIES DARREN CLARKE
K121015 04/04/2012 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM ABBOTT VASCULAR IVALEE COHEN
K121222 04/25/2012 TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER ABBOTT VASCULAR SUZANNE REDMAN
K121161 04/17/2012 EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER ACTA MEDICAL LLC AARON COMPTON
K121282 04/30/2012 MICROLUX/DL MICROLUX/BLU BIO/SCREEN ADDENT, INC. JOSHUA FRIEDMAN
K121253 04/27/2012 MERIDIAN CRANIAL PERFORATOR ADEOR MEDICAL TECHNOLOGIES GMBH FABIO VON ZEPPELIN
K121095 04/11/2012 DX-D IMAGING PACKAGE AGFA HEALTHCARE N.V. DAVID LEDWIG
K121272 04/27/2012 PROTECH DENT AKERVALL TECHNOLOGIES INC SASSA AKERVALL
K121031 04/05/2012 WAVELIGHT FS200 PATIENT INTERFACE 1505 ALCON RESEARCH, LTD. MICHAEL BUENGER
K121181 04/18/2012 SWANNSHIDI BONE MARROW ASPIRATION NEEDLE ALLIANCE PARTNERS, LLC JENNIFER PALINCHIK
K121150 04/16/2012 ALMA LASERS FAMILY OF PIXEL RF TIPS ALMA LASERS INC. KATHY MAYNOR
K121022 04/10/2012 AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV AMERIWATER BRIAN BOWMAN
K121218 04/23/2012 HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA, ANDREW TECHNOLOGIES, LLC HERBERT CRANE
K121004 04/06/2012 APEX KIRSCHNER WIRES AND STEINMANN PINS APEX TOOLS & ORTHOPEDICS CO. HOLLACE SAAS RHODES
K120814 04/02/2012 PADLOCK CLIP-12 APONOS MEDICAL CORP. JOHN FEE
K121168 04/17/2012 APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH APTUS ENDOSYSTEMS, INC. BURT GOODSON
K121124 04/13/2012 ARTHREX MIXING AND DELIVERY SYSTEM ARTHREX, INC. CHRISTINA FLORES
K121261 04/26/2012 ASAP MUITISCOPE ASAP ENDOSCOPIC PRODUCTS GMBH ANGELIKA SCHERP
K121101 04/11/2012 SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT ASTORIA-PACIFIC,INC. CHARLES A PETERSON
K121070 04/10/2012 C-QUR RPM MESH ATRIUM MEDICAL CORP. JOSEPH DEPAOLO
K121177 04/18/2012 BOND APATITE AUGMA BIOMATERIALS, LTD. KEVIN A THOMAS
K120971 04/02/2012 ATLAS PTA BALLOON DILATATION CATHETER BARD PERIPHERAL VASCULAR, INC. MEGAN BROWN
K121092 04/10/2012 FLOWEASE [SUBCUTANEOUS] INFUSION SET BAXTER HEALTHCARE CORP. NIEDRE M HECKMAN
K121087 04/10/2012 CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM BAYER HEALTHCARE ROGER SONNENBURG
K121190 04/19/2012 CONTOUR NEXT BLOOD GLUCOSE METER BAYER HEALTHCARE LLC CHARLES RYAN
K121165 04/17/2012 BEAM BRUSH/BEAM APP BEAM TECHNOLOGIES, LLC ALEX CURRY
K121214 04/23/2012 ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM BECKMAN COULTER, INC. KERRIE OETTER
K121050 04/06/2012 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE BECTON DICKINSON & CO. JOHN ROBERTS
K120994 04/02/2012 BD BACTEC PLUS PRIME AEROBIC/F BECTON, DICKINSON AND COMPANY PAUL SWIFT
K121283 04/30/2012 BD EMERALD SAF-T SINGLE USE, HYPODERMIC BECTON, DICKINSON AND COMPANY KIMBERLY LANE
K121284 04/30/2012 CHABNER XRT GARMENTS BFFL CO. INC EVAN P PHELPS
K121198 04/19/2012 BW685, BW685S BIEGLER GMBH PAUL DRYDEN
K121268 04/26/2012 WANDY DISPERSVIE ELECTRODE BIO-MED USA INC. YOUNG CHI
K121143 04/16/2012 LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) BIO-RAD LABORATORIES SUZSNNE PARSONS
K121122 04/13/2012 DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL BIOCHEMICAL DIAGNOSTIC, INC. ALLEN PANETZ
K121270 04/26/2012 BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM BIOJECT MEDICAL TECHNOLOGIES INC. CHRISTINE BREITBACH
K121002 04/10/2012 ETEST CEFTAROLINE BIOMERIEUX, INC. JENNIFER CHIA-HSUAN LIN
K121100 04/16/2012 VITEK 2 AST STREPTOCOCUS VANCOMYCIN BIOMERIEUX, INC. JOCELYN JENNINGS
K121149 04/16/2012 VANGUARD SSK 360 REVISION KNEE SYSTEM BIOMET MANUFACTURING CORP. GARY BAKER, M.S. RAC
K121130 04/13/2012 POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS BIOMET SPINE VIVIAN KELLY
K121113 04/12/2012 BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER BIOPSY SCIENCES, LLC SHARON ROCKWELL
K121267 04/26/2012 BT-200V VASCULAR DOPPLER BISTOS CO., LTD. YOUNG CHI
K121196 04/19/2012 EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) BOSTON SCIENTIFIC CORP. VICKY L HAGENS
K121186 04/18/2012 RADIAL JAW 4 PULMONARY BIOPSY FORCEPS BOSTON SCIENTIFIC CORP. CORRIE GOODING
K121048 04/06/2012 ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED BOSTON SCIENTIFIC CORP. JANIS F TARANTO
K120983 04/02/2012 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM BOSTON SCIENTIFIC CORPORATION JANIS F TARANTO
K121073 04/09/2012 POWERGLIDE MIDLINE CATHETER C.R. BARD, INC. JESSICA AGNELLO
K121167 04/17/2012 CAIRE COMPANION 5 OXYGEN CONCENTRATOR CAIRE INC. BEN KADRLIK
K121254 04/25/2012 CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE CAMBER SPINE TECHNOLOGIES DAN PONTECORVO
K121176 04/18/2012 STGC CARDINAL SPINE, LLC KEVIN A THOMAS
K121009 04/03/2012 HEARTCHECK ECG PEN WITH GEMS HOME CARDIO COMM SOLUTIONS, INC. JONATHAN WARD
K120979 04/02/2012 CAREFUSION NICOLET EDX CAREFUSION 209, INC. CURTIS TRUESDALE
K121247 04/25/2012 ALCO-SCREEN CHEMATICS, INC. CARL REYNOLDS
K121256 04/25/2012 ALCO-SCREEN 02 CHEMATICS, INC. CARL REYNOLDS
K121208 04/20/2012 OBIX PERINATAL DATA SYSTEM 7.0 CLINICAL COMPUTER SYSTEMS, INC. CYNTHIA BELL
K121237 04/24/2012 BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE CLINIQA CORPORATION DAWN GAST
K121263 04/26/2012 TAPER SET HIP SYSTEM RDP STEM CONSENSUS ORTHOPEDICS, INC.
K121275 04/27/2012 AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER CONVATEC INC KATRINA FIEDLER
K121039 04/05/2012 COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM COPAN FLOCK TECHNOLOGIES CYNTHIA SINCLAIR
K121037 04/05/2012 LOSPA TIBIAL BASE PLATE CORENTEC CO., LTD J.S. DANIEL
K121194 04/19/2012 ENDO CLIP III 5MM CLIP APPLIER COVIDIEN ANGELA VAN ARSDALE
K121139 04/16/2012 ACCUMESH DEPLOYMENT SYSTEM COVIDIEN LLC JAMES MCMAHON
K120997 04/02/2012 BAROSTAT SOFTWARE OPTION CROSPON, LTD. PAUL DRYDEN
K121127 04/13/2012 SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS CYNOSURE, INC. IRINA KULINETS
K121287 04/30/2012 HT-WEDGE D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L SUSAN PAVELKO
K121215 04/23/2012 DEKA ARM SYSTEM DEKA INTEGRATED SOLUTIONS CORPORATION ROGER LEROUX
K121007 04/03/2012 NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 DELTA MED SRL HARRY BONTRAGER
K121020 04/04/2012 VIPER SYSTEM DEPUY SPINE, INC. KIRSTEN LEHMULLER
K121027 04/04/2012 DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH DIAMOND DIAGNOSTICS, INC KATHY CRUZ
K121140 04/16/2012 PROLYTE ELECTROLYTE ANALYZER DIAMOND DIAGNOSTICS, INC KATHY CRUZ
K121040 04/05/2012 SMARTLYTE ELECTROLYTE ANALYZER DIAMOND DIAGNOSTICS, INC. KATHY CRUZ
K121053 04/06/2012 DIAZYME HOMOCYSTEINE POC TEST KIT DIAZYME LABORATORIES ABHIJIT DATTA
K121093 04/10/2012 D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 DXM CO., LTD. JIGAR SHAH
K121185 04/23/2012 EDWARDS PERCUTANEOUS SHEATH INTRODUCER EDWARDS LIFESCIENCES, LLC. SPENCER WALKER
K121119 04/12/2012 BNA ANALYSIS SYSTEM EIMINDA LTD. DALIA DICKMAN
K121024 04/04/2012 LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8; ENCORE MEDICAL, L.P. WILLIAM GARZON
K121174 04/17/2012 XPRESS MULTI-SINUS DILATION TOOL ENTELLUS MEDICAL, INC. KAREN E PETERSON
K121207 04/20/2012 EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. CYNTHIA HUNG
K120995 04/02/2012 ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT ERAD, INC. JILLIAN M REED
K113375 04/24/2012 ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE ESWALLOW USA WILLIAM INGRAM
K121028 04/05/2012 ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM)) ETVIEW LTD. YORAM LEVY
K121220 04/23/2012 EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT EXACTECH, INC. LINDY KNISELY
K121067 04/11/2012 EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE EXACTECH, INC. LINDY KNISELY
K121142 04/16/2012 CRAWFORD BIOCANALICULUS INTUBATION FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) BARBARA FANT
K121125 04/13/2012 FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM FLEXIBLE STENTING SOLUTIONS, INC. JOSEPH C GRIFFIN III
K120986 04/02/2012 STRATIFY JCV DXSELECT FOCUS DIAGNOSTICS, INC. TARA VIVIANI
K121118 04/12/2012 FORA COMFORTSCAN EAR THERMOMETER FORA CARE INC. PINJUNG CHEN
K121206 04/20/2012 DETECT FORUM ENGINEERING TECHNOLOGIES LTD YULIYA YUKEVICH
K121154 04/16/2012 ULTRASONIC NEBULIZER FOSHAN GAUNYING ELECTRONICS CO., LTD. GUENTER GINSBERG
K121035 04/05/2012 FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US FUJIFILM MEDICAL SYSTEM U.S.A., INC. GINA WALLJASPER
K121251 04/25/2012 ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK GALIL MEDICAL LTD. LYNNE DAVIES
K121274 04/27/2012 PIXEL APP GAUSS SURGICAL, INC. PEGGY MCLAUGHLIN
K121200 04/19/2012 FLIGHTPLAN FOR LIVER GE HEALTHCARE CAROL ALLOIAN
K121019 04/04/2012 OPTIMA NM/CT 640 GE HEALTHCARE ELI WERNER
K121062 04/06/2012 VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM GE MEDICAL SYSTEM ISRAEL LTD. BRYAN BEHN
K121063 04/06/2012 VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM GE MEDICAL SYSTEM ISRAEL LTD. BRYAN BEHN
K121049 04/06/2012 UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM GLOBUS MEDICAL INC. MERIAM YOUSSEF
K121107 04/12/2012 FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R) GLOBUS MEDICAL, INC. SARAH M FITZGERALD
K121166 04/17/2012 WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL GUANGZHOU WONDFO BIOTECH CO., LTD. JOE SHIA
K121225 04/23/2012 HAMILTON-C2 HAMILTON MEDICAL AG RALPH AGUILA
K121005 04/03/2012 ADIPREP ADIPOSE TRANSFER SYSTEM HARVEST TECHNOLOGIES, CORP. GABRIEL J MURACA, JR.
K121278 04/30/2012 HERMES MEDICAL IMAGING SUITE V5.2 HERMES MEDICAL SOLUTIONS, AB JOAKIM ARWIDSON
K121085 04/11/2012 HET BIPOLAR LIGATOR SYSTEM HET SYSTEMS, LLC SHELLEY TRIMM
K121280 04/30/2012 MYOSURE INTRUMENT TRAY HOLOGIC, INC. DANIEL F PHELAN
K121032 04/05/2012 PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP HOSPIRA, INC. YULIYA MATLIN
K121132 04/13/2012 EZSENSOR P DIGITAL INTRAORAL SENSOR HUMANRAY CO,LTD DAVE KIM
K121108 04/12/2012 DOPPLEX ABILITY HUNTLEIGH HEALTHCARE DAVID MOYNHAM
K121133 04/13/2012 CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM I-SENS, INC. HYUN JOON OH
K121034 04/05/2012 IOI TOTAL HIP ICONACY ORTHOPEDIC IMPLANTS, LLC ROY Y HORI, PHD
K121077 04/09/2012 NHANCER IMDS OPERATIONS B.V. E SCHULTING
K121231 04/24/2012 IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST IND NDIAGNOSTIC INC. KAI LOU
K121021 04/04/2012 INOMAX DS (DELIVERY SYSTEM) INO THERAPEUTICS DAVID TRUEBLOOD
K121012 04/03/2012 FLEXLAB 3.6, ACCELERATOR A3600 INPECO S.P.A. ROBERTO TAMBORRA
K121159 04/16/2012 INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER INTEGRA LIFESCIENCE CORPORTATION STEVEN PELTIER
K120977 04/02/2012 DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC INTERNATIONAL TECHNIDYNE CORP. LAWRENCE PICCIANO
K121026 04/04/2012 FLO-GUARD BREATHING FILTER INTERSURGICAL, INC. MICHAEL ZALEWSKI
K121023 04/04/2012 SPECTRUM V.0 INTRINSIC MEDICAL IMAGING STEPHEN J GOLDNER, JD, RAC
K121128 04/13/2012 MULTIPURPOSE HANDLING MEDIUM IRVINE SCIENTIFIC SALES CO., INC. JAYME YAMAGUCHI-OWENS
K121171 04/17/2012 CUROS TIP IVERA MEDICAL, INC. DON CANAL
K121230 04/24/2012 IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE IVOCLAR VIVADENT AG SANDRA CAKEBREAD
K121152 04/16/2012 SURGICAL GOWN, SMS JIANGSU GUANGDA MEDICAL MATERIAL, CO., LTD DARREN REEVES
K121016 04/05/2012 RANGE SPINAL SYSTEM (MESA AND DENALI) K2M, INC. NANCY GIEZEN
K121232 04/24/2012 K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR KAMIYA BIOMEDICAL COMPANY SHAWN KAPLAN
K121187 04/19/2012 KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES KATALYST SURGICAL, LLC MICHELLE MCDONOUGH
K120985 04/02/2012 KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING KIMBERLY-CLARK CORP. MARCIA JOHNSON
K121098 04/11/2012 HERO I DENTAL IMPLANT SYSTEM KJ MEDITECH CO., LTD PRISCILLA CHUNG
K121047 04/06/2012 HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM KJ MEDITECH CO., LTD PRISCILLA CHUNG
K121109 04/12/2012 AERODR X70 KONICA MINOLTA MEDICAL & GRAPHIC, INC. SHIGEYUKI KOJIMA
K121046 04/06/2012 STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. HEATHER VIELE
K121096 04/11/2012 VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM L & K BIOMED CO., LTD KI HYANG KIM
K121103 04/11/2012 LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S LDR SPINE USA INC. BRADLEY W STRASSER
K121116 04/12/2012 PLATEAU SPACER SYSTEM LIFE SPINE RANDY LEWIS
K120998 04/02/2012 SOLSTICE CROSS CONNECTOR LIFE SPINE RANDY LEWIS
K121151 04/16/2012 PRO-LINK CERVICAL SPACER SYSTEM LIFE SPINE, INC RANDY LEWIS
K121289 04/30/2012 LTM-LABAROSCOPIC SURGICAL MESH LIFECELL CORP. MARK R JAKUBOWSKI
K121227 04/23/2012 MANUKA FILL LINKS MEDICAL PRODUCTS, INC. JAMES SMITH
K120976 04/02/2012 MANUKA IG LINKS MEDICAL PRODUCTS, INC. JAMES SMITH
K121083 04/10/2012 TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA LOMA VISTA MEDICAL TIFFINI DIAGE
K121064 04/06/2012 MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM MAKO SURGICAL CORPORATION DIONNE SANDERS
K120984 04/02/2012 MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR MASIMO CORPORATION PATRICIA MILBANK
K121203 04/20/2012 BOSTON KERATOPROSTHESIS OR BOSTON KPRO MASSACHUSETTS EYE & EAR INFIRMARY BRIAN J EDWARDS
K121243 04/25/2012 ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER MEDA CO. LTD. KAI CHEN
K121011 04/03/2012 AMISTEM AND QUADRA - LINE EXTENSION MEDACTA INTERNATIONAL ADAM GROSS
K121115 04/12/2012 M.U.S.T PEDICLE SCREW SYSTEM MEDACTA INTERNATIONAL ADAM GROSS
K121262 04/26/2012 MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY MEDEFIL, INC. PRADEEP AGGARWAL
K120980 04/02/2012 1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC MEDICAL COMPONENTS INC JEAN CALLOW
K120981 04/02/2012 2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC MEDICAL COMPONENTS INC JEAN CALLOW
K121094 04/10/2012 MEDCOMP VASCU-PICC & MIDLINE CATHETERS MEDICAL COMPONENTS INC JEAN CALLOW
K121148 04/16/2012 SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D MEDICAL DESIGN LLC. KRISTI VONDRA
K121014 04/03/2012 SOLAR GI MEDICAL MEASUREMENT SYSTEMS,B.V. K. OGINK SOMHORST
K120982 04/02/2012 DIGITAL EYE-FUNDUS CAMERA MEDIMAGING INTEGRATED SOLUTIONS, INC. (MIIS) CHIH-LU HSU
K121191 04/19/2012 VERTEX RCCONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. CLAIRE EVANS
K121264 04/26/2012 TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE MEDTRONIC SURGICAL TECHNOLOGIES RISHI SINHA
K121246 04/25/2012 MEDYSSY LT CAGE SYSTEM MEDYSSEY CO., LTD. MICHAEL KVITNISKY
K120978 04/02/2012 OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR MERETE MEDICAL GMBH EMMANUEL ANAPLIOTIS
K121044 04/06/2012 ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM MERIDIAN BIOSCIENCE, INC. MICHELLE L SMITH
K121051 04/06/2012 CONCIERGE GUIDING CATHETER MERIT MEDICAL SYSTEMS, INC. MICHAELA RIVKOWICH
K121269 04/26/2012 TBA MIGADA PLANT YOSSI SHACHAR
K121248 04/25/2012 LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC MOLLER MEDICAL GMBH GRANT GECKELER
K121117 04/12/2012 NDX ABUTMENTS NATIONAL DENTEX CORP LINDA K SCHULZ
K121089 04/10/2012 NMI PICC III NAVILYST MEDICAL, INC. LORRAINE M HANLEY
K121184 04/18/2012 SENSUS NEUROMETRIX, INC. RAINER MAAS
K121276 04/27/2012 NEURO VENTION LAMINPLASTY PLATING SYSTEM NEUROVENTION LLC MEREDITH MAY
K121285 04/30/2012 ORAVAN OSA NEW JERSEY SNORING SOLUTIONS DEBORAH STEIN
K121195 04/19/2012 NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER NINEPOINT MEDICAL, INC CINDY DOMECUS
K120989 04/02/2012 TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM NIPRO DIAGNOSTICS, INC. KAREN DEVINCENT
K121001 04/02/2012 COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002) NOVITAS MEDICAL, LLC MARSHAL FRYMAN
K121241 04/25/2012 MALE LATEX CONDOM NULATEX SDN. BHD. TEO AI SIANG
K121173 04/17/2012 CHORD-X EPTFE SUTURE ON-XLIFETECHNOLOGIES JOHN ELY
K121091 04/10/2012 CATALYS PRECISION LASER SYSTEM OPTIMEDICA CORPORATION ALAN MARQUARDT
K121239 04/24/2012 MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE OPTOACOUSTICS LTD PAUL DRYDEN
K121043 04/05/2012 OPTOS OCT/SLO MICROPERIMETER OPTOS PLC RANDY J PREBULA
K121250 04/25/2012 OP SPINE SYSTEM ORTHOPEDIATRICS, CORP. MARK FOX
K121102 04/11/2012 OSTEOSYMBIONICS PEEK CRANIAL IMPLANT OSTEOSYMBIONICS, LLC ELAINE DUNCAN
K121175 04/18/2012 FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM OSTIAL CORPORATION KAITLIN VON HOFFMANN
K120996 04/02/2012 FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN PARAGON VISION SCIENCES WILLIAM E MEYERS
K121249 04/25/2012 MULTIARRAY KIT PARAMED SRL LUISELLA DE BENEDETTI
K121156 04/16/2012 AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES PHADIA AB MARTIN MANN
K121296 04/30/2012 INTERVENTIONAL WORKSPOT PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. FRANS JACOBS
K121223 04/23/2012 QLAB WITH FHN AND VPQ PLUG-IN PHILIPS ULTRASOUND, INC. PENNY GRECO
K121065 04/06/2012 POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE POLYMED THERAPEUTICS, INC JJ XIA
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