FDA 510(k) Decisions During August, 2014  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K141435 08/27/2014 OPAL CHIRO, 20/20 P-DR 2020 IMAGING DANIEL KAMM, P.E.
K133769 08/25/2014 3B RESMART BPAP 25A, BMC RESMART BPAP 25A 3B MEDICAL, INC ALEX LUCIO
K140392 08/13/2014 3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER 3M COMPANY SUZANNE LEUNG
K140330 08/18/2014 3M STERI-DRAPE FABRIC SURGICAL DRAPES 3M HEALTH CARE MARK BURVILLE
K141823 08/07/2014 AAP LOQTEC CLAVICLE PLATES 2.7/3.5 AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K141782 08/07/2014 HI-TORQUE VERSATURN GUIDE WIRE Abbott Vascular VIVEK THAKKAR
K141215 08/21/2014 SURGISEAL TWIST TOPICAL SKIN ADHESIVE Adhezion Biomedical, LLC RICHARD JONES
K141065 08/22/2014 CONSTELLATION VISION SYSTEM ALCON RESEARCH, LTD. ROBERT LUNDBERG
K140933 08/15/2014 ALIVECOR HEART MONITOR ALIVECOR, INC. Albert Boniske
K140009 08/29/2014 SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM ALMA LASERS LTD. KATHY MAYNOR
K133991 08/06/2014 ISY ALTATEC GMBH LINDA SCHULZ
K133685 08/13/2014 0.9% SODIUM CHLORIDE FLUSH SYRINGE AMUSA ALEX FERRI
K141567 08/21/2014 IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM APIRA SCIENCE, INC. RAYMOND R BLANCHE
K141288 08/22/2014 VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE APPLIED MEDICAL RESOURCES JESSICA CHO
K141573 08/28/2014 SILVERLON ISLAND WOUND DRESSING ARGENTUM MEDICAL RICH FOSTER
K140723 08/19/2014 NOMAD MD 75K V HANDHELD X-RAY SYSTEM ARIBEX, INC. CHRISTOPHER DODGE
K141735 08/15/2014 ARTHREX ANKLE FUSION PLATING SYSTEM ARTHREX, INC. LAURA MEDLIN
K140476 08/13/2014 ARTHREX FIBERTAK SUTURE ANCHOR ARTHREX, INC. COURTNEY SMITH
K140944 08/22/2014 1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP ATHEROMED INC JEAN CHANG
K142120 08/28/2014 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICURE, INC. JONATHAN MCELWEE
K133981 08/15/2014 AVACEN 100 AVACEN INC. THOMAS G MUEHLABUER
K142036 08/25/2014 INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS B. BRAUN MEDICAL, INC. TRACY MADDOCK
K131407 08/12/2014 BAHADIR STERILIZATION TRAYS BAHADIR USA CORP. ISMAIL KILIC
K142011 08/18/2014 SOLUTION SET/EXTENSION SET BAXTER HEALTHCARE CORPORATION TIFFANY LIN
K141128 08/13/2014 FINGERTIP PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. LEI CHEN
K141141 08/14/2014 KIVA VCF TREATMENT SYSTEM BENVENUE MEDICAL, INC. CINDY DOMECUS, R.A.C.
K141581 08/06/2014 ASTROGLIDE NATURAL BIOFILM, INC. Sherry Castello
K142097 08/29/2014 SELEC-3 I.V.ADMINISTRATION SET BIOMEDIX, INC. MYRA J BENDER
K133817 08/05/2014 VITEK 2 AST - YEAST FLUCONAZOLE BIOMERIEUX, INC. JOCELYN JENNINGS
K133952 08/19/2014 VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE BIOMERIEUX, INC. CHARLENE FERRAND
K141653 08/18/2014 BIOLOX DELTA CERAMIC OPTION HEADS BIOMET, INC. BECKY EARL
K141762 08/27/2014 PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM BIOMET, INC. LONNIE WITHAM
K140210 08/22/2014 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720 BIONIME CORPORATION Feng-Yu Lee
K134037 08/07/2014 PREMVIA BIOTIME, INC. DAVID C FURR
K132892 08/01/2014 TEBCO-W BOMED INC B. BO SRAMEK, PH.D
K141597 08/22/2014 MUSTANG BALLOON DIALATION CATHETER Boston Scientific Corporation MELANIE RASKA
K141521 08/21/2014 MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER Boston Scientific Corporation MELANIE RASKA
K141236 08/07/2014 NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) Boston Scientific Corporation ADRIENNE HOTCHKISS
K140999 08/06/2014 TANDEMHEART VENO-VENOUS CANNULA CARDIACASSIST INC. Greg Johnson
K140850 08/27/2014 GENESIS REUSABLE RIGID CONTAINER SYSTEM CAREFUSION 2200, INC. JANE WEBER
K133532 08/21/2014 ALARIS SYSTEM WITH GUARDRAILS SUITE MX CAREFUSION 303, INC. CHRISTINE CATON
K133925 08/22/2014 VYNTUS/ SENTRYSUITE PRODUCT LINE CAREFUSION GERMANY 234 GMBH ELMAR NIEDERMEYER
K140782 08/13/2014 ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR CELLERATION, INC. KATHY SIMPSON
K141209 08/07/2014 EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES CELONOVA BIOSCIENCES, INC. NICOLE BARBER
K141859 08/01/2014 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING CENTERS FOR DISEASE CONTROL AND PREVENTION Yon Yu, Pharm.D.
K132049 08/15/2014 THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS CHOICE SPINE KIM FINCH
K141318 08/27/2014 CIANNA MEDICAL SGS SYSTEM CIANNA MEDICAL, INC. GARY MONCNIK
K140703 08/19/2014 OPA 30 SOLUTION CIDEN TECHNOLOGIES LLC COURTNEY CLARK
K141480 08/22/2014 CVI42 CIRCLE CARDIOVASCULAR IMAGING INC SHIRANTHA SAMARAPPULI
K140490 08/29/2014 CIVA SHEET PD-103 CIVATECH ONCOLOGY, INC. BLIX WINSTON
K141364 08/29/2014 CLIMB MAMMOGRAPHY VIEWER SOFTWARE CLIMB MEDICAL SYSTEMS, INC. KENNETH WADE
K140748 08/20/2014 ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD CO-INNOVATION BIOTECH CO.,LTD. HONG FENG
K133703 08/18/2014 PHYSIOGLOVE ET SYSTEM COMMWELL R&D LTD. JONATHON KAHAN
K140945 08/22/2014 COMPACTCATH INTERMITTENT URINARY CATHETER COMPACTCATH INC GREGORY MATHISON
K140953 08/01/2014 GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER CONVATEC LTD. CLARE WILLIAMSON
K141818 08/05/2014 TURBO-JECT PICC SETS COOK CORPORATED SEAN SPENE
K140306 08/15/2014 CORMATRIX PROTECT ECM ENVELOPE CORMATRIX CARDIOVASCULAR, INC. BRYAN BROSSEAU
K141858 08/05/2014 CLOSURERFG RADIOFREQUENCY GENERATOR COVIDIEN Laura Moen-Ftacek
K141153 08/14/2014 LIGASURE; CURVED SMALL JAW SEALER/DIVIDER, 5MM BLUNT TIP SEALER/DIVIDER, MARYLAND JAW ONE STEP STEALER/DIVIDERS, CURVED COVIDIEN
K141357 08/21/2014 BARRX FLEX RFA ENERGY GENERATOR COVIDIEN IIC Tim Thomas
K141371 08/07/2014 SONICISION CORDLESS ULTRASONIC DISSECTOR COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H DAVID HORTON
K140338 08/27/2014 CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE) CREGANNA-TACTX MEDICAL NIALL FOX
K140620 08/07/2014 SPORVIEW PLUS BI TEST PACK CROSSTEX INTERNATIONAL MICHAEL G NOLAN
K140585 08/18/2014 CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM CUREXO TECHNOLOGY CORPORATION GLEN EMELOCK
K133945 08/11/2014 CUTERA PICOSECOND LASER SYSTEM CUTERA, INC. BRADLEY RENTON
K141264 08/21/2014 TENSYN BAND, TENSYN FRACTURE PLATES DALLEN MEDICAL, INC. AL MEMMOLO
K140175 08/05/2014 INTRAVASCULAR ADMINISTRATION SET DELTA MED SPA ROGER GRAY
K140537 08/20/2014 TENURE4G DEN-MAT HOLDINGS, LLC HELEN RAGUS
K133255 08/12/2014 ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLANT SYSTEMS DENTALPOINT AG ROSHANA AHMED
K140347 08/20/2014 ANKYLOS C/X IMPLANT SYSTEM DENTSPLY INTL., INC. HELEN LEWIS
K140896 08/05/2014 VAPR ARCTIC SUCTION ELECTRODE DEPUY MITEK, A JOHNSON & JOHNSON COMPANY SUSAN KAGAN
K140880 08/04/2014 DEVILBISS SMARTLINK II SYSTEM DEVILBISS HEALTHCARE LLC BETTY MILLER
DEN140016 08/19/2014 STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE DEXCOM, INC. ANDREW BALO
K133751 08/08/2014 DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS DIAMOND DIAGNOSTICS, INC KATHY CRUZ
K133803 08/06/2014 DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT DIAZYME LABORATORIES Abhijit Datta
K140458 08/26/2014 DIOTECH LASER FIBER DIOTECH CO PETER CHUNG
K121886 08/08/2014 SAVINA 300 SAVINA 300, COUNTRY VARIANTS DRAEGER MEDICAL GMBH BETH ZIS
K140168 08/28/2014 EASYSTIM TN28_OTC EASYMED INSTRUMENTS CO., LTD. JEFFERY WU
K142080 08/28/2014 NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED ECOLAB, INC. JENNIFER WILLNER
K140381 08/08/2014 SENSILIGHT/ SENSILIGHT PLUS EL GLOBAL TRADE LTD. SHLOMIT SEGMAN
K141916 08/07/2014 PATHASSIST LED LIGHT FIBER Entellus Medical, Inc. GARRETT P AHLBORG
K140689 08/22/2014 IKNEE DISTAL FEMORAL CUTTING GUIDE EVERGREEN ORTHOPEDIC RESEARCH LAB JEFF STEPANIAN
K141821 08/28/2014 ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET EXACTECH, INC. THOMAS MCNAMARA
K141129 08/15/2014 EXACTECH CERVICAL SPACER SYSTEM EXACTECH, INC. MEREDITH MAY MS, RAC
K133638 08/21/2014 GEKO FIRSTKIND LIMITED SHEILA HEMEON-HEYER
K141281 08/14/2014 CRIT-LINE CLIP (CLIC) BLOOD CHAMBER FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC DENISE OPPERMANN
K140149 08/22/2014 EPX-4440HD DIGITAL VIDEO PROCESSOR FUJIFILM MEDICAL SYSTEMS U.S.A., INC. MARY K MOORE
K142017 08/22/2014 X-PORTE ULTRASOUND SYSTEM FUJIFILM SonoSite, Inc. Patricia Liau
K140028 08/21/2014 GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER GALT MEDICAL CORP. DAVID DERRICK
K141768 08/04/2014 LOGIQ V5/LOGIQ V3 GE HEALTHCARE BRYAN BEHN
K133695 08/07/2014 TITAN 11 GEMSS MEDICAL SYSTEMS CO., LTD DAVE KIM
K140086 08/22/2014 PERSONAL KINETIGRAPH (PKG) SYSTEM GKC MANUFACTURING PTY LTD. MARIE SCHROEDER
K133678 08/26/2014 CONFIRM BIOACTIVE GLOBUS MEDICAL, INC. CHRISTINA KICHULA
K142044 08/25/2014 CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
K133222 08/06/2014 SAAD PATIENT MONITOR (SPM) HANIN MEDICAL SERVICES CO. LTD RAYMOND J KELLY
K141614 08/07/2014 MAGELLAN ROBOTIC SYSTEM Hansen Medical KATE W LEE
K141822 08/05/2014 SENSEI X ROBOTIC CATHETER SYSTEM HANSON MEDICAL, INC. TODD MILHOLLAND
K140270 08/20/2014 NEXUS MIDLINE CT CATHETER HEALTH LINE INTERNATIONAL CORPORATION JOHN E LINCOLN
K132855 08/29/2014 HEARTWAY POWER MOBILITY SCOOTER HEARTWAY MEDICAL PRODUCTS CO., LTD. JEN KE-MIN
K140988 08/12/2014 POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE) HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD CHARLES SHEN
K141021 08/26/2014 POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR HL RUBBER INDUSTRIES SDN BHD NOORZALIZA AHMAD
K140366 08/15/2014 ENDLESSFIBER REUSABLE SURGICAL LASER FIBER HOGUE SURGICAL LLC ROGER S HOGUE, MD
K141642 08/22/2014 VAPRO INTERMITTENT CATHETER HOLLISTER, INCORPORATED JEANNE LEE
K133108 08/05/2014 FIT BELT HONG QIANG XING (SHENZHEN) ELECTRONICS LIMITED XU JIAN HUA
K142135 08/28/2014 REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC JAN TRIANI
K141451 08/26/2014 VixWin Platinum IMAGING SCIENCES INTERNATIONAL (DBA GENDEX LLC) SANJAY AHUJA
K131348 08/05/2014 ORTOMED INFOMED SERVICIOS INFORMATICOS S.L. SANTIAGO SOLA
K141443 08/28/2014 INFRONT LUMBAR INTERBODY FUSION SYSTEM INFRONT MEDICAL, LLC JOHN KUCZYNSKI
K140886 08/08/2014 WALKAIDE SYSTEM INNOVATIVE NEUROTRONICS INC. GLEN NEALLY
K133582 08/15/2014 HEMOSIL D-DIMER HS 500 CONTROL INSTRUMENTATION LABORATORY CAROL MARBLE
K141841 08/01/2014 INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP INTEGRA LIFESCIENCE CORPORTATION NICOLE C HARLAN
K133942 08/01/2014 ENDOSCOPE STERILIZATION TRAY INTUITIVE SURGICAL BRANDON HANSEN
K141077 08/12/2014 DA VINCI FIREFLY IMAGING SYSTEM INTUITIVE SURGICAL, INC. MELISSA S GONZALEZ
K141848 08/29/2014 IOGYN SYSTEM IOGYN, INC. RICH CHRISTENSEN
K131290 08/06/2014 IQ TECHNOLOGIES IQ TECHNOLOGIES INC. ELI JOSEF
K131285 08/19/2014 SONOSENTRY ISONEA LTD KORINA AKHONDZADEH
K141505 08/26/2014 BASAL DIGITAL THERMOMETER K-JUMP HEALTH CO., LTD. JM LIN
K140308 08/15/2014 MASTERSURG / EXPERTSURG KALTENBACH & VOIGT GMBH STEFAN TRAMPLER
K141059 08/01/2014 NATURAL RUBBER LATEX MALE CONDOMS KAREX INDUSTRIES SDN BHD MARY GOH
K131384 08/07/2014 KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE KERICURE INC. JONATHAN WARD
K140305 08/26/2014 CAYA CONTOURED DIAPHRAGM KESSEL MEDINTIM GMBH KESSEL MARKETING
K141294 08/25/2014 U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS KIMBERLY-CLARK CORP. CHARNELLE THOMAS
K141612 08/07/2014 KIMGUARD ONE-STEP STERILIZATION WRAP KIMBERLY-CLARK HEALTH CARE MARCIA JOHNSON
K140516 08/05/2014 Terumo Pen Injector Needle 34 KOFU FACTORY OF TERUMO CORP. PHILLIP LESTER
K141891 08/04/2014 MEDICAL LCD MONITOR KOSTEC CO., LTD Priscilla Chung
DEN140001 08/20/2014 ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. TANIS JIMENEZ
K141136 08/19/2014 LEICA FL800 LEICA BIOSYSTEMS RICHMOND BARBARA-ANN CONWAY-MYERS
K141769 08/18/2014 OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER LIGHTLAB IMAGING, INC. JEFFREY ROBERTS
K141327 08/06/2014 MINIMA S SYSTEM LIMACORPORATE S.P.A. STEPHEN PEOPLES
K140965 08/20/2014 MULTIPIEZO PRO, MULTIPIEZO MECTRON SPA ROGER GRAY
K141988 08/19/2014 M.U.S.T PEDICLE SCREW SYSTEM MEDACTA INTERNATIONAL ADAM GROSS
K141044 08/18/2014 M.U.S.T. EXTENSION MEDACTA INTERNATIONAL ADAM GROSS
K141553 08/25/2014 MEDELA THOPAZ+ MEDELA AG ORLANDO ANTUNES
K140812 08/07/2014 MI-750 PROCEDURAL/MINOR SURGICAL LIGHT MEDICAL ILLUMINATION INTERNATIONAL, INC. ROBERT HESS
K133724 08/27/2014 MINNCARE HD MEDIVATORS, INC. KINNARI SHAH
K141127 08/21/2014 MEDLINE ANTI-EMBOLISM STOCKING MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K141509 08/22/2014 ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS MEDOS SARL KIRSTEN LEHMULLER
K133023 08/27/2014 JETSTREAM SYSTEM MEDRAD, INC. ARMA RACIC
K141951 08/15/2014 DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE MEDTRONIC INC. KEVIN T LAM
K141090 08/15/2014 NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER MEDTRONIC INC. JOHN KILMARTIN
DEN120017 08/22/2014 Medtronic DUET External Drainage and Monitoring System MEDTRONIC NEUROSURGERY DONOVAN MAY
K141494 08/06/2014 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. ERIKKA EDWARDSEN
K141870 08/07/2014 BREAST VOLUME NAVIGATOR METRITRACK LLC MIRELA WOHLFORD
K141083 08/22/2014 MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K140735 08/29/2014 EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS MICROPORT ORTHOPEDICS INC. CAROLINE FRYAR
K140342 08/29/2014 QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT MINDWAYS SOFTWARE, INC. KEENAN BROWN
K130631 08/13/2014 BUZZY MMJ LABS, LLC VALERIE STAFFEY
K141230 08/27/2014 DOSELAB PRO MOBIUS MEDICAL SYSTEMS, LP STAN ESHELMAN
K140862 08/27/2014 MONICA NOVII WIRELESS PATCH SYSTEM MONICA HEALTHCARE LTD. CARL BARRATT
K141983 08/11/2014 NEUROBLATE SYSTEM MONTERIS MEDICAL CORP CRAIG COOMBS
K141684 08/01/2014 JUSHA-C33C LCD MONITOR NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD LI LE
K141679 08/01/2014 JUSHA-C61 LCD MONITOR NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD LI LE
K141690 08/01/2014 JUSHA-M33C LCD MONITOR NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD LI LE
K141446 08/22/2014 ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER, NATUS MEDICAL INCORPORATED JUDY BUCKHAM
K133592 08/22/2014 NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM NEODENT USA, INC. CHRISTOPHER KLACZYK
K141061 08/01/2014 REMOTEYE VIEWER NEOLOGICA S.R.L. MARCO SAMBIN
K141291 08/26/2014 VERTIFORM POSTERIOR FIXATION SYSTEM NEXT ORTHOSURGICAL HUAN TRAN
K133358 08/12/2014 NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT NIDEK CO., LTD ENRICO BISSON
K140100 08/01/2014 TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM NIPRO DIAGNOSTICS, INC. BETH FOSTER
K133506 08/06/2014 NORAS OR HEAD HOLDER FLEXIBILITY NORAS MRI PRODUCTS GMBH ZAHED SEDIGHIANI
K140956 08/07/2014 LCD MONITOR NORDICNEUROLAB CHANDANA G BHANDARI
K140946 08/22/2014 NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE NovaBone Products, LLC Lisa Simpson
K141308 08/20/2014 NUTRA LIGHT RED NUTRA LUXE MD, LLC JILL CREASY
K140563 08/07/2014 LATERAL VBR SYSTEM NUVASIVE, INCORPORATED JEREMY MARKOVICH
K141352 08/18/2014 ENDOCYN ROOT CANAL IRRIGATION SOLUTION OCULUS INNOVATIVE SCIENCES BRIAN W MARTIN
K141012 08/08/2014 HYDROCLEANSE WOUND CARE SOLUTION OCULUS INNOVATIVE SCIENCES BRIAN W MARTIN
K141440 08/29/2014 DICOMPACS DX-R WITH FLAT PANEL OEHM UND REHBEIN GMBH DANIEL KAMM, P.E.
K133562 08/12/2014 CATARHEX 3 OERTLI INSTRUMENTE AG KARIN ROHR
K132633 08/14/2014 OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM OK BIOTECH CO., LTD. JEN KE-MIN
K133538 08/07/2014 VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE OLYMPUS CORPORATION OF THE AMERICAS SHERI L MUSGNUNG
K141225 08/12/2014 ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P-CORD OLYMPUS WINTER & IBE GMBH GRAHAM A L BAILLIE
K141787 08/07/2014 SAGITTILT ORFIT INDUSTRIES NV Lee Leichter
K123690 08/05/2014 CAPNOSTREAM20P WITH HIFI C02 MONITORING ORIDION MEDICAL 1987 LTD. DALIA GIVONY
K141004 08/21/2014 INTRAOSSEOUS FIXATION SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. BRIAN HOCKETT
K142148 08/21/2014 ORTHOHELIX STAPLE SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. BRIAN HOCKETT
K140550 08/25/2014 ORTHOHUB EXTERNAL FIXATOR SOFTWARE ORTHOHUB, INC. PEGGY MCLAUGHLIN
K141930 08/21/2014 OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML OSSEON LLC KEITH BURGER
K140507 08/20/2014 HIOSSEN PROSTHETIC SYSTEM OSSTEM IMPLANT CO., LTD. PATRICK LIM
K140600 08/21/2014 SB ANCHOR OSSTEM IMPLANT CO., LTD. PATRICK LIM
K141497 08/26/2014 PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO) OSSTEM IMPLANT CO.,LTD PATRICK LIM
K140551 08/01/2014 PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR PERKINELMER, INC. DAWN SPOONER
K132631 08/29/2014 EIA SMDP IMMUNOASSAY PHADIA US INC. MARTIN ROBERT MANN
K141979 08/19/2014 ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V. JEANETTE BECKER
K131230 08/04/2014 GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION PHILOSYS, INC. LINDA CHAN
K141423 08/07/2014 NASOPORE-FD Polyganics BV BETTY IJMKER
K133921 08/22/2014 PRECEPTIS TYMPANOSTOMY TUBE INSERTER PRECEPTIS MEDICAL KEITH LELAND
K141788 08/20/2014 OBSIDIAN MILLING BLOCKS PRISMATIK DENTALCRAFT, INC. ARMIN ZEHTABCHI
K132380 08/27/2014 PREVANTICS DEVICE SWAB PROFESSIONAL DISPOSABLES INTERNATIONAL, INC. ELIZABETH ERNST
K141956 08/13/2014 FIBERGRAFT BG MORSELS PROSIDYAN, INC JANICE M HOGAN
K133546 08/06/2014 STARLITE-OM, LIGHT EFFECTS, THIBIANT PS ADVANCED ENGINEERING CD FEAK
K141834 08/05/2014 SAPPHIRE ADMINISTRATION SET Q CORE MEDICAL LTD Rhona Shanker
K142002 08/22/2014 BREAST SPEEDER CX, GRID HOLDER CX QUALITY ELECTRODYNAMICS, LLC. Kathleen Aras
K141101 08/08/2014 LITHO QUANTA SYSTEM, S.P.A. Maurizio Bianchi
K141403 08/07/2014 LITHO DK30 QUANTA SYSTEM, S.P.A. Maurizio Bianchi
K141496 08/04/2014 MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER REFLECTANCE MEDICAL, INC. Nandini Murthy
K133973 08/14/2014 TEMPUS PRO WITH ENHANCED FEATURES REMOTE DIAGNOSTIC TECHNOLOGIES LTD LEIGH CORNOCK
K134014 08/12/2014 TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE) REMOTE DIAGNOSTIC TECHNOLOGIES LTD. LEIGH CORNOCK
K141813 08/05/2014 RHYTHMSTAR SYSTEM RHYTHMEDIX, LLC M.W.(ANDY) ANDERSON
K141162 08/27/2014 ALL-CERAMIC ZIRCONIA BLOCK RIZHAO HUGE DENTAL INDUSTRY CO., LTD HELEN NAN
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