FDA 510(k) Decisions During April, 2012  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K110629 04/27/2012 RESMART CPAP, RESMART AUTO-CPAP AND RESMART HUMIDIFIER 3B PRODUCTS, INC. NORMA F ESTRIN, PH.D.
K112440 04/18/2012 AB DENTAL DEVICES IMPLANTS AND ACCESSORIES A.B. DENTAL DEVICES, LTD. CHARLES HURWITZ
K120662 04/24/2012 PICCOLO HDL-CAPILLARY TEST SYSTEM ABAXIS, INC. DENNIS M BLEILE
K120664 04/24/2012 PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM ABAXIS, INC. DENNIS M BLEILE
K113719 04/20/2012 SAFETY SCREW CONNECTOR ABBOTT LABORATORIES ELIZABETH M ZOLA
K113332 04/18/2012 ON CALL CHOSEN LANCING DEVICE ACON LABORATORIES, INC. AARON FRIDAY
K112653 04/09/2012 ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS ACON LABORATORIES, INC. QIYI XIE
K120300 04/13/2012 CT-GUIDE NEEDLE GUIDANCE SYSTEM ACTIVIEWS LTD JOHN J SMITH, M.D., J.D.
K112094 04/24/2012 BRAIN BIOPSY NEEDLE AD-TECH MEDICAL INSTRUMENT CORP. GARY J SYRING
K113371 04/03/2012 STAPHYLOCOCCUS QUICKFISH BC ADVANDX, INC. BENJAMIN S CRYSTAL
K120939 04/26/2012 AERONEB PRO AEROGEN LTD MARTHA FOLAN
K120032 04/13/2012 MECHANICAL WHEELCHAIR AIKIN HEALTHCARE CO., LTD KEVIN WALLS
K120209 04/12/2012 PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE AMERICAN I.V. PRODUCTS, INC. MAJDI SHOMALI
K120805 04/13/2012 PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE ANGIOSLIDE, LTD CLAY ANSELMO
K120448 04/06/2012 MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL APEX BIOTECHNOLOGY CORP. LISA LIU
K121004 04/24/2012 APEX KIRSCHNER WIRES AND STEINMANN PINS APEX TOOLS & ORTHOPEDICS CO. HOLLACE SAAS RHODES
K112734 04/24/2012 APLAN A.V. FISTULA NEEDLE SET APLAN WELL ENTERPRISE CO., LTD JEN KE-MIN
DEN100016 04/27/2012 PROSTATE MECHANICAL IMAGER ARTANN LABORATORIES, INC GERARD J PRUD'HOMME
K093579 04/27/2012 PROSTATE MECHANICAL IMAGER ARTANN LABORATORIES, INC GERARD J PRUD'HOMME
K112899 04/06/2012 ARTHREX BIO-SUTURE ARTHREX, INC. SALLY FOUST
K112481 04/09/2012 FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT ASCENSION ORTHOPEDIC BRADLEY W STRASSER
K112438 04/11/2012 TITAN MODULAR TOTAL SHOULDER SYSTEM ASCENSION ORTHOPEDIC SUSAN WALTON
K110481 04/05/2012 TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE ASI MEDICAL, INC. JOHN MCPEEK
K113424 04/17/2012 LOFRIC SINGLE USE URINARY CATHETER ASTRA TECH AB FLOYD G LARSON
K111547 04/12/2012 BILI-THERAPY PAD TYPE ATOM MEDICAL CORPORATION PAUL DRYDEN
K121070 04/26/2012 C-QUR RPM MESH ATRIUM MEDICAL CORP. JOSEPH DEPAOLO
K113831 04/19/2012 PRIMUS HEARING INSTRUMENT TEST UNIT AUDITDATA A/S DAN HAUGBOL
K120971 04/19/2012 ATLAS PTA BALLOON DILATATION CATHETER BARD PERIPHERAL VASCULAR, INC. MEGAN BROWN
K120722 04/19/2012 RIVAL PTA DILATATION CATHETER BARD PERIPHERAL VASCULAR, INC. MARK JOB
K112909 04/30/2012 OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION BAUSCH & LOMB, INC. TRICIA GARRETT
K113533 04/11/2012 NEURO CHECK DEVICE WITH IO-FLEX WIRE BAXANO, INC. EDWARD SINCLAIR
K120037 04/20/2012 BLUWHITE DIAMOND DENTAL BURS MODIFIED BEAVERS DENTAL, DIV. SYBRON CANADA, LTD. WENDY GARMAN
K103230 04/24/2012 AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION BESTGEN BIOTECH CORP. STEVEN SHEN
K120231 04/24/2012 EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL) BIOLITEC MEDICAL DEVICES, INC HARRY HAYES, PH.D
K120437 04/26/2012 TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM BIOLITEC SIA (LATVIA) HARRY HAYES
K113593 04/17/2012 NEXTGEN ALTIUS OCT SYSTEM BIOMET SPINE (AKA EBI, LLC) VIVIAN KELLY
K120853 04/20/2012 NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, BIONESS, INC. KIM TOMPKINS
K120694 04/03/2012 ENCORE 26 ADVANTAGE KIT BOSTON SCIENTIFIC CORP. ADRIENNE HOTCHKISS
K103227 04/11/2012 ORATECT ORAL FLUID DRUG SCREEN DEVICES BRANAN MEDICAL CORPORATION HUIYING WANG
K120881 04/18/2012 MANTARAY GUIDEWIRES BRIDGEPOINT MEDICAL JILL MUNSINGER
K113119 04/27/2012 ENDOGATOR ADVANTAGE IRRIGATION PUMP BYRNE MEDICAL, INC. BRENT GEIGER
K120076 04/19/2012 RESOLUTIONMD WEB CALGARY SCIENTIFIC, INC. KYLE PETERSON
K111924 04/10/2012 FINESSE PERSONAL INSULIN DELIVERY PATCH CALIBRA MEDICAL, INC. RICHARD J MEADER
K111824 04/23/2012 FLAT PANEL DETECTOR CANON, INC.-MEDICAL EQUIPMENT GROUP DIANE RUTHERFORD
K120746 04/27/2012 DISPOSABLE POWDER FREE VINYL EXAM GLOVES CANOPUS MEDICAL SUPPLY CO., LTD. GLORIA CHANG
K120292 04/13/2012 CAPLOX II PEDICLE SCREW SYSTEM CAPTIVA SPINE, INC RICH JANSEN
K113707 04/27/2012 STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES TATYANA BOGDAN
K120086 04/24/2012 CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM CARDIOSOLUTIONS MICHELE LUCEY
K120979 04/25/2012 CAREFUSION NICOLET EDX CAREFUSION 209, INC. CURTIS TRUESDALE
K112535 04/27/2012 GENESIS REUSABLE RIGID CONTAINER SYSTEM CAREFUSION 2200, INC. KATE FULLER
K113096 04/13/2012 MICRO I CAREFUSION GERMANY 234 GMBH ELMAR NIEDERMEYER
K120062 04/13/2012 DRX-REVOLUTION MOBILE X-RAY SYSTEM CARESTREAM HEALTH, INC. CAROLYN WAGNER
K110590 04/13/2012 INTRABEAM NEEDLE APPLICATOR CARL ZEISS SURGICAL GMBH JUDITH A BRIMACOMBE, MA
K120830 04/16/2012 NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) CARTICEPT MEDICAL INC TANYA EBERLE
K112141 04/13/2012 SMARTEPIL,DEPILASE YAG LASE PLUS CASTLE LASER SYSTEMS, LIMITED RAYMOND R BLANCHE
K120570 04/05/2012 CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM CHOICE SPINE, LP MARK BEKKALA
K120757 04/24/2012 SLEEPWEAVER ELAN NASAL CPAP MASK CIRCADIANCE LLC DAVID GROLL
K120117 04/16/2012 CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM CODMAN & SHURTLEFF, INC. MEGAN HERMAN
K120686 04/04/2012 ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM CODMAN & SHURTLEFF, INC. KIM FONDA
K113585 04/25/2012 NASAL/EPISTAXIS PACK COGENT THERAPEUTICS, LLC ANNE WORDEN
K120828 04/05/2012 BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES COLOPLAST A/S REBEKA STOLTMAN
K120316 04/19/2012 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA S SHAH
K112342 04/26/2012 FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM CONVATEC INC KATRINA FIEDLER
K111695 04/02/2012 HYBRID GRAFT COOK BIOTECH, INC. MARY A FADERAN, PHD, RAC
K113759 04/03/2012 AVAIRA (ENFILCON A) CONTACT LENS COOPERVISION, INC. KARIN GASTINEAU
K120696 04/02/2012 TIGER SPINE SYSTEM CORELINK LLC J.D. WEBB
K120674 04/04/2012 MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER COVIDIEN WING NG
K112536 04/19/2012 SONICISION STERILIZATION TRAY COVIDIEN DAVID M HORTON
K120863 04/19/2012 WHOLEY GUIDE WIRE SYSTEM COVIDIEN LLC DAVID RBERTSON
K120043 04/27/2012 CSM INTERNAL-R IMPLANT SYSTEM CSM IMPLANT APRIL LEE
K113361 04/03/2012 SECURIS SPINAL FIXATION CUMTOM SPINE DAVID BRUMFIELD
K113548 04/10/2012 PEDCAT CURVEBEAM, LLC DAVID W COWAN
K120868 04/20/2012 MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER DATASCOPE CORP., CARDIAC ASSIST DIVISION HELDER A SOUSA
K120589 04/24/2012 MILAGRO INTERFERENCE SCREWS DEPUY MITEK, A JOHNSON & JOHNSON COMPANY DEEP PAL
K120095 04/06/2012 SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND DEPUY MITEK, A JOHNSON & JOHNSON COMPANY SUSAN KAGAN
K120591 04/17/2012 DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 DIAMOND DIAGNOSTICS, INC KATHY CRUZ
K111464 04/19/2012 PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES DIPPED PRODUCTS (THAILAND) LTD L.G.S. GUNAWARDANA
K111250 04/27/2012 DRY MOUTH MOUTHWASH DR. FRESH, INC. CAMILLE THORNTON
K112992 04/20/2012 EARLOGIC OAE TESTER EARLOGIC CORPORATION SHIN KUK YOO
K113796 04/26/2012 SOLITAIRE-C CERVICAL SPACER SYSTEM EBI, LLC MARGARET CROWE
K113170 04/06/2012 CERVICAL PLATE EISERTECH, LLC LUKAS EISERMANN
K120407 04/19/2012 2MP MONOCHROME LCD MONITOR, RADIFORCE GX240 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K113240 04/20/2012 3.7 MP COLOR LCD MONITOR, RADIFORCE MX270W EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K120962 04/27/2012 PATHASSIST LIGHT FIBER ENTELLUS MEDICAL, INC. GARRETT P AHLBORG
K120735 04/02/2012 PATHASSIT LIGHT SEEKER ENTELLUS MEDICAL, INC. GARRETT P AHLBORG
K120721 04/06/2012 EOS EOS IMAGING JOHN J SMITH
DEN110016 04/30/2012 PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS ETHICON ENDO-SURGERY THOMAS BOSTICCO
K110431 04/30/2012 PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS ETHICON ENDO-SURGERY THOMAS BOSTICCO
K103767 04/16/2012 DUAL HEATED INFANT VREATHING CIROUITS FISHER & PAYKEL HEALTHCARE LTD. ROBERT PETRY
K120452 04/24/2012 FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM FLEXIBLE STENTING SOLUTIONS, INC. JOSEPH C GRIFFIN III
K113433 04/04/2012 SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT FOCUS DIAGNOSTICS, INC. SHARON YOUNG
K110333 04/12/2012 NATURALASE CO2 LASER SYSTEM FOCUS MEDICAL, LLC. JOHN LEE
K120361 04/06/2012 SYNAPSE 3D BASE TOOLS FUJIFILM MEDICAL SYSTEMS USA, INC. DEBBIE PEACOCK
K112398 04/12/2012 TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT GALT MEDICAL BETSY CORTELLONI
K120473 04/09/2012 PIXEL APP GAUSS SURGICAL, INC. PEGGY MCLAUGHLIN
K121019 04/19/2012 OPTIMA NM/CT 640 GE HEALTHCARE ELI WERNER
K120741 04/27/2012 VOLUSON S6, VOLUSON S8 GE HEALTHCARE BRYAN BEHN
K120613 04/06/2012 OEC 9900 ELITE GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC GERALD BUSS
K113286 04/27/2012 ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS GE MEDICAL SYSTEMS LUNAR TRISHIA DWYER
K120201 04/19/2012 GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM GE VINGMED ULTRASOUND AS BRYAN BEHN
K110835 04/26/2012 GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS GEO MEDICAL CO., LTD. ALBERT REGO
K120092 04/13/2012 PLYMOUTH THORACOLUMBAR PLATE SYSTEM GLOBUS MEDICAL INC. SARAH M FITZGERALD
K113847 04/11/2012 BORRELIA BURGDORFERI IGG BLOT TEST GOLD STANDARD DIAGNOSTICS NAPOLEON MONCE
DEN120013 04/30/2012 PORTRAIT ANALYZER GREAT BASIN SCIENTIFIC LARRY REA
K113358 04/30/2012 PORTRAIT ANALYZER GREAT BASIN SCIENTIFIC LARRY REA
K111636 04/03/2012 REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM GUNNELL, INC. ANDREW EVANCHO
K120670 04/03/2012 HAMILTON-T1 HAMILTON MEDICAL AG RALPH AGUILA
K120055 04/24/2012 HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS HAMILTON THORNE, INC. DIARMAID H DOUGLAS-HAMILTON
K113674 04/05/2012 SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT HANDPIECE HEADQUARTERS INC. - HPR INC. TINA STEFFANIE-OAK
K111999 04/17/2012 HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL HEALGEN SCIENTIFIC, LLC YONGQUAN WANG
K113837 04/27/2012 POWDER FREE VINYL PATIENT EXAMINATION GLOVES HEBEI CHANGSHENG PLASTIC PRODUCTS CO., LTD. RICHARD LU
K112215 04/12/2012 HEMCON HEMOSTATIC GEL HEMCON MEDICAL TECHNOLOGIES EUROPE, LTD. KENDRA RATHKEY
K102428 04/18/2012 WUNDER TEST HIEN HELEN NGUYEN HIEN NGUYEN
K120388 04/06/2012 INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM HOLOGIC, INC. EILEEN M BOYLE
K110530 04/30/2012 ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL HORIBA ABX S.A.S. CAROLINE FERRER
K113760 04/25/2012 VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS VALERIE GIAMBANCO
K120187 04/06/2012 MULTI-MODALITY IMAGE FUSION IGT LLC DBA EIGEN WILLIAM MANDEL
K113662 04/20/2012 FENESTRATED NERVE BLOCK NEEDLE IMD INC WALTER ZOHMANN
K103037 04/17/2012 IND URINARY TRACT INFECTION (UTI) TEST STRIPS IND DIAGNOSTIC, INC. KAI LOU
K120935 04/27/2012 SECURACATH INTERRAD MEDICAL INC SEW-WAH TAY
K120215 04/30/2012 SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE INTUITIVE SURGICAL, INC. KIM T SERVANCE
K111274 04/04/2012 JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038 JETPREP, LTD. JOHN SMITH
K112110 04/10/2012 STERILE LUBRICATING JELLY JIANERKANG MEDICAL DRESSING COMPANY JORDON CHU
K102327 04/13/2012 CLEARVISION DR 7000F JPI HEALTHCARE CO., LTD WILLIAM LITTLE
K120492 04/30/2012 K2 MEDICAL VASCULAR CLAMPS K2 MEDICAL GMBH & CO. KG PETER FETZER
K120656 04/04/2012 EVEREST SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K111997 04/06/2012 IMAGE1 GI CCU MODEL 22203020-114 KARL STORZ ENDOSCOPY-AMERICA, INC. WINKIE WONG
K120264 04/11/2012 KONAN SPECULAR MICROSCOPE XIV KONAN MEDICAL, INC. DAVID S FERNQUIST
K120477 04/09/2012 AEROSYNC FOR AERODR SYSTEM KONICA MINOLTA MEDICAL & GRAPHIC, INC. RESSELL MUNVES
K120063 04/19/2012 VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM L&K BIOMED CO., LTD HEE KYEONG JOO
K120234 04/19/2012 EZONO 3000 LIFE-TECH, INC. SKIP RIMER
K113115 04/03/2012 EPICARE YAG LIGHT AGE, INC. ELIZABETH REDDINGTON
K113616 04/27/2012 ACCUDXA2 LONE OAK MEDICAL TECHNOLOGIES, LLC DAVID COMLEY
K113502 04/05/2012 ADVANTAGE LASER SYSTEM LUTRONIC CORPORATION MAUREEN O'CONNELL
K112470 04/05/2012 2GC HIP/KNEE MODULAR SPACER MANDELL HORWITZ CONSULTANTS LLC DIANE M HORWITZ
K113599 04/27/2012 SURGICASE CONNECT MATERIALISE N.V. ALEXANDRA RAZZHIVINA
K113829 04/02/2012 ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE MATERIALISE N.V. ALEXANDRA RAZZHIVINA
K120208 04/20/2012 CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES MAUNA KEA TECHNOLOGIES MICHAEL A DANIEL
K113633 04/20/2012 MCKESSON ANESTHESIA CARE MCKESSON TECHNOLOGIES INC. JANICE M HOGAN
K120531 04/18/2012 VERSAFITCUP CC TRIO-ADDITIONAL LINERS MEDACTA INTERNATIONAL ADAM GROSS
K120108 04/27/2012 APTUS PROXIMAL HUMERUS SYSTEM MEDARTIS AG KEVIN A THOMAS
K120718 04/19/2012 INSTAPACS/INSTARISPACS MEDDIFF TECHNOLOGIES PVT. LTD CARL ALLETTO
K113583 04/12/2012 CURAD ANTIBACTERIAL BANDAGE MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K120069 04/03/2012 MEDLINE STOPCOCK AND MANIFOLD MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K120517 04/26/2012 DEPUY PULSE CERVICAL CAGE SYSTEM MEDOS INTERNATIONAL SARL EUGENE BANG
K113677 04/05/2012 GRINDCARE MEASURE MEDOTECH A/S CALLEY HERZOG
K120368 04/09/2012 CAPSTONE CONTROL SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. JULIE BASSETT
K120207 04/23/2012 VISIA MEVIS MEDICAL SOLUTIONS AG THOMAS E TYNES
K120908 04/25/2012 HYDROCOIL EMBOLIC SYSTEM (HES) MICROVENTION, INC. LARAINE PANGELINA
K112666 04/20/2012 SALINE WOUND WASH NANOPLAS, INC. RYAN LYTLE
K120279 04/06/2012 NANOFUSE DBM NANOTHERAPEUTICS GREGG RITTER
K120880 04/19/2012 ORBIT NATIONAL BIOMEDICAL LLC DBA QRS DIAGNOSTIC MARY KAY JENSEN
K112247 04/02/2012 A BAER WITH ABAER I/O FUNCTION NATUS MEDICAL INCORPORATED CHARLES L MORIN
K120709 04/06/2012 THE DOME GX4MP COLOR NONITOR NDS SURGICAL IMAGING JIM LENG
K113554 04/05/2012 CMI IMPLANT IS SYSTEM NEOBIOTECH CO., LTD. APRIL LEE
K120764 04/27/2012 EPIFLO(R) NEOGENIX, LLC SRINIVASAN SARANGAPANI
K120182 04/19/2012 NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES NEOMED, INC. PENNY NORTHCUTT
K120051 04/20/2012 SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML NEPHRON PHARMACEUTICALS CORP. MARCUS JULIANO
K112314 04/27/2012 NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER NEPHROS, INC. GREG COLLINS
K112286 04/19/2012 NOVAC 11 NEW RADIANT TECHNOLOGY S.P.A. MAUREEN O'CONNEL
K112315 04/23/2012 HOME PREGNANCY TEST NEWSCEN COAST BIO-PHARMACEUTICAL CO., LTD CHANDRAVADAN PATEL
K113398 04/18/2012 NEXUS TKO-6, LUER-ACTIVATED DEVICE NEXUS MEDICAL, LLC HEATHER TURNER
K113494 04/19/2012 NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA NOBLES MEDICAL TECHNOLOGIES II, INC. MARIA HATEGAN
K112843 04/19/2012 PULSE OXIMETER NONIN MEDICAL, INC. BRODIE PEDERSON
K113221 04/27/2012 NAMSA BIOLOGICAL INDICATOR SPORE STRIPS NORTH AMERICAN SCIENCE ASSOC., INC. JULIE WHEELER
K121001 04/17/2012 COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002) NOVITAS MEDICAL, LLC MARSHAL FRYMAN
K112717 04/13/2012 NUVASIVE NVJJB SYSTEM NUVASIVE, INC. ELIAS KETCHUM
K113608 04/10/2012 DEFLEX NUXEN S.R.L. HERNAN ILARI
K113687 04/30/2012 EQUINOX RELIEVE O-TWO MEDICAL TECHNOLOGIES, INC. DAVID ZHANG
K120196 04/19/2012 OLEA SPHERE OLEA MEDICAL KRISTI GUSMAN
K111425 04/20/2012 OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190 OLYMPUS MEDICAL SYSTEMS CORP. SHERI MUSGNUNG
K120238 04/03/2012 RTVUE XR OCT OPTOVUE, INC. JOHN J TALARICO
K120034 04/17/2012 RADIOGRAPHIC X-RAY SYSTEM ORICH MEDICAL EQUIPMENT (TIANJIN CO., LTD. JUN PENG
K120165 04/17/2012 INTRAOSSEOUS FIXATION SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. DEREK LEWIS
K120157 04/10/2012 MINI MAXLOCK EXTREME PLATING SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. DEREK LEWIS
K120291 04/16/2012 OP SPINE SYSTEM ORTHOPEDIATRICS, CORP. MARK FOX
K120015 04/24/2012 OSTEOMED WRIST PLATING SYSTEM OSTEOMED LP SUZANNE CHEANG
K112795 04/20/2012 PALTOP DENTAL IMPLANT SYSTEM PALTOP ADVANCED DENTAL SOLUTIONS LTD TAL HAMMER-TOPAZ
K120942 04/20/2012 PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC PARCUS MEDICAL, LLC PAUL VAGTS
K113839 04/12/2012 RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE PARKELL, INC. DANIEL R SCHECHTER
K120028 04/17/2012 AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES PEGAVISION CORPORATION TONY HSU
K120330 04/02/2012 PENUMBRA COIL SYSTEM/PENUMBRA COIL 400 PENUMBRA, INC. EMILLY T NURTHEN
K120255 04/19/2012 PHILIPS MICRODOSE PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB GUSTAV LINS
K113144 04/03/2012 PAGEWRITER TC 20, 30, 50, 70 PHILIPS MEDICAL SYSTEMS PAUL SCHRADER
K120367 04/17/2012 3MENSIO WORKSTATION PIE MEDICAL IMAGING B.V. FLORIE DANIELS
K120313 04/20/2012 NEO CR KNEE SYSTEM PIPELINE ORTHOPEDICS TERRY POWELL
K120065 04/03/2012 PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES PLAXTRON INDUSTRIAL (M) SDN. BHD. MING-YIE JAN
K113488 04/18/2012 JAZZY ELITE 6 PRIDE MOBILITY PRODUCT CORPORRATION KIMBERLY BLAKE
K111453 04/05/2012 STEAM DOT BLU PROCESS INDICATOR PROPPER MFG. CO., INC. ANDREW SHARAVARA
K120003 04/05/2012 NUCAL PULPDENT CORPORATION KENNETH J BERK
K112696 04/18/2012 TWIN PEAKS LUMBAR CAGE QUALGENIX LLC RICHARD DESLAURIERS
K120859 04/19/2012 PRE-LOADED GOLD VISICOIL CK MARKER RADIOMED CORPORATION GORDON ROBERTS
K120161 04/13/2012 ALPHAPOINT IMAGING SOFTWARE RADLOGICS, INC. MOSHE BECKER
K120252 04/11/2012 RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM RAUMEDIC AG REINER THIEM
K120387 04/06/2012 RAYSTATION RAYSEARCH LABORATORIES AB DAVID HEDFORS
K112505 04/06/2012 ETHEREA REGULATORY INSIGHT, INC. KEVIN WALLS
K111085 04/25/2012 SHARPS TANK REUSABLE SHARPS CONTAINER REHRIG PACIFIC COMPANY DAVID OLMSTEAD
K113640 04/05/2012 STELLAR 150 RESMED GERMANY INC. DAVID D'CRUZ
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