FDA 510(k) Applications Received During May, 2014

FDA 510(k) Number Submission Date Device Name Applicant Contact
K141435 05/30/2014 OPAL CHIRO, 20/20 P-DR 2020 IMAGING DANIEL KAMM, P.E.
DEN140044 05/29/2014 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS) 23andMe Kathy Hibbs
K141160 05/05/2014 A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR A & D CO., LTD. JERRY WANG
K141201 05/09/2014 A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR A & D CO., LTD. JERRY WANG
K141179 05/07/2014 A&D MEDICAL UB-543 DIGITAL BLOOD PRESSURE MONITOR A & D CO., LTD. JERRY WANG
K141427 05/30/2014 ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST ACCUMETRICS, INC. FRANK M LADUCA
K141383 05/27/2014 ACUMED HAND FRACTURE SYSTEM ACUMED, LLC MARIAH KNIGHT
K141215 05/12/2014 SURGISEAL TWIST TOPICAL SKIN ADHESIVE Adhezion Biomedical, LLC RICHARD JONES
DEN140018 05/09/2014 ESOPHAGEAL COOLING DEVICE ADVANCED COOLING THERAPY, LLC ERIK KULSTAD
K141194 05/08/2014 FM-3000 FETAL MONITOR ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K141228 05/12/2014 AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW ADVANCED ORTHOPAEDIC SOLUTIONS, INC. ANNA HWANG
K141142 05/02/2014 MAMMAPRINT FFPE AGENDIA Guido Brink
K141192 05/08/2014 DR 400 AGFA HEALTHCARE N.V. SHAEANN CAVANAGH
K141123 05/01/2014 ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM ALLIANCE PARTNERS, LLC. TIM LOHNES
K141237 05/13/2014 HARMONY LITE ALMA INC. KATHY MAYNOR
K141213 05/12/2014 AMERIWATER OZONE DISINFECTION SYSTEM AMERIWATER BRIAN BOWMAN
K141288 05/16/2014 VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE APPLIED MEDICAL RESOURCES JESSICA CHO
K141159 05/05/2014 KONUS DENTAL IMPLANT SYSTEM ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH LINDA SAYLOR
K141189 05/08/2014 NANOBONE / GRANULATE ARTOSS GMBH WALTER GERIKE
K141339 05/21/2014 ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE ASAHI INTECC CO., LTD. CANDACE CEDERMAN
K141380 05/27/2014 PROVOX FREEHANDS FLEXIVOICE ATOS MEDICAL AB FERENC DAHNER
K141317 05/20/2014 ZIP MIS INTERSPINOUS FUSION SYSTEM AURORA SPINE, INC. JUSTIN EGGLETON
K141342 05/21/2014 WEARABLE THERAPY GARMENTS AXIOBIONICS LLC ROBERT J BARD
K141428 05/30/2014 MDMC-12133 BARCO N.V. LIEVEN DE WANDEL
K141374 05/27/2014 BICARBONATE CALIBRATOR BECKMAN COULTER IRELAND INC DAVID G DAVIS
K141388 05/27/2014 SYSTEM CALIBRATER BECKMAN COULTER IRELAND INC DAVID G DAVIS
K141311 05/20/2014 0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE Becton, Dickinson and Company JUMA HOSHINO
K141128 05/01/2014 FINGERTIP PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. LEI CHEN
K141141 05/02/2014 KIVA VCF TREATMENT SYSTEM BENVENUE MEDICAL, INC. CINDY DOMECUS, R.A.C.
K141355 05/23/2014 VOLUMETRIC INCENTIVE SPIROMETER BESMED HEALTH BUSINESS CORPORATION PAUL DRYDEN
K141132 05/01/2014 ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT BIOFILM, INC. Sherry Castello
K141133 05/01/2014 VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II BIOMERIEUX JOHN ALBRIGHT
K141149 05/05/2014 VITEK 2 AST GP CEFTAROLINE BIOMERIEUX, INC. CHARLENE FERRAND
K141219 05/12/2014 JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS BIOMET MANUFACTURING CORP. JARED COOPER
K141263 05/15/2014 TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS BIOMET MANUFACTURING CORP. JARED COOPER
K141331 05/21/2014 BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS) BIOMET, INC. TRACY BICKEL JOHNSON
K141407 05/28/2014 VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL BIOMET, INC. JULIE GANTENBERG, M.S.
K141292 05/19/2014 Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System BIONIME COPORATION Feng-Yu Lee
K141351 05/22/2014 SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM Biotest Medical Corp. Yuhua Chen
K141326 05/21/2014 NEEDLE VIEW CH SCOPE KITS BIOVISION TECHNOLOGIES, LLC
K141335 05/21/2014 EXPEL APD DRAINAGE CATHETER SYSTEM BOSTON SCIENTIFIC CORP. MATT BEAUCHANE
K141344 05/22/2014 EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM BOSTON SCIENTIFIC CORP. MATT BEAUCHANE
K141150 05/05/2014 PTA BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. Carol Tiffany
K141185 05/07/2014 V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM BOSTON SCIENTIFIC CORP. ROBIN MULVEY
K141378 05/27/2014 IDC INTERLOCKING DETACHABLE COIL Boston Scientific Corporation LIZ JOHNSTON
K141236 05/13/2014 NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) Boston Scientific Corporation ADRIENNE HOTCHKISS
K141199 05/09/2014 QUENTRY DOSE REVIEW BRAINLAB AG ALEXANDER SCHWIERSCH
K141285 05/16/2014 BUSSE EXTENSION SET BUSSE HOSPITAL DISPOSABLES MUHAMAD ANSARI
K141413 05/29/2014 CRC PC WITH SMART CHAMBER CAPINTEC, INC. MARY ANNE YUSKO
K141332 05/21/2014 Captiva Spine SmartLOX Cervical Plate System CAPTIVA SPINE TAMALA J WAMPLER
K141297 05/19/2014 FORUM GLAUCOMA WORKPLACE CARL ZEISS MEDITEC AG MANDY AMBRECHT
K141209 05/09/2014 EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES CELONOVA BIOSCIENCES, INC. NICOLE BARBER
K141400 05/28/2014 DCCERAM SYSTEM CERAMAY GMBH & CO.KG PAMELA PAPINEAU, RAC
K141318 05/20/2014 CIANNA MEDICAL SGS SYSTEM CIANNA MEDICAL, INC. GARY MONCNIK
K141364 05/23/2014 CLIMB MAMMOGRAPHY VIEWER SOFTWARE CLIMB MEDICAL SYSTEMS, INC. KENNETH WADE
K141362 05/23/2014 PULSE OXIMETER CMS50EW CONTEC MEDICAL SYSTEMS CO., LTD. Diana Hong
K141322 05/20/2014 ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER COOK INCORPORATED STEVEN LAWRIE
K141148 05/05/2014 EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET COOK VASCULAR, INC. THOMAS J KARDOS
K141382 05/27/2014 BIOS KING BIOCELLULOSE FILM CORELEADER BIOTECH CO., LTD. YA-WEN KUO
K141153 05/05/2014 LIGASURE; CURVED SMALL JAW SEALER/DIVIDER, 5MM BLUNT TIP SEALER/DIVIDER, MARYLAND JAW ONE STEP STEALER/DIVIDERS, CURVED COVIDIEN
K141357 05/23/2014 BARRX FLEX RFA ENERGY GENERATOR COVIDIEN IIC Tim Thomas
K141371 05/27/2014 SONICISION CORDLESS ULTRASONIC DISSECTOR COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H DAVID HORTON
K141354 05/23/2014 NAVAJO PTA BALLOON DILATATION CATHETER CURATIVE MEDICAL INC. BILL JACQMEIN
K141425 05/30/2014 ELITE + LASER SYSTEM CYNOSURE, INC. KELLI MCMILLAN
K141264 05/15/2014 TENSYN BAND, TENSYN FRACTURE PLATES DALLEN MEDICAL, INC. AL MEMMOLO
K141259 05/15/2014 GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON PEEK ANCHOR WITH PERMACORD, GRYPHON PEEK DEPUY MITEK, A JOHNSON & JOHNSON COMPANY JULIE VAFIDES
K141385 05/27/2014 DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) DEPUY SYNTHES COMPANIES OF JOHNSON & JOHNSON JEFFREY DOW
K141144 05/02/2014 STA LIATEST D-DI DIAGNOSTICA STAGO CARLO D'ALESSANDRO
K141410 05/29/2014 ORAGENE DX OGD-500.001 DNA GENOTEK, INC. DAN FULLERTON
K141168 05/06/2014 ANSISTIM DYANSYS, INC. SRINI NAGESHWAR
K141206 05/09/2014 EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM EDWARDS LIFESCIENCES LLC. Nina Brooke
K141254 05/14/2014 ELCAM STOPCOCKS AND MANIFOLDS ELCAM MEDICAL ACAL NATASHA BRANZBURG
K141265 05/15/2014 ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT ELITECHGROUP DEBRA K HUTSON
K141278 05/16/2014 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM ELLIPSE TECHNOLOGIES, INC. John McIntyre
K141347 05/22/2014 EMERGE MEDICAL IM NAIL SYSTEM EMERGE MEDICAL MICHELLE POTVIN
K141275 05/16/2014 ENDOPHYS PRESSURE SENSING SHEATH KIT ENDOPHYS, INC. RONALD S WARREN
K141330 05/21/2014 ENDO-CORD ENROXTECH, INC. LEWIS WARD
K141137 05/01/2014 STEREOS WORKSTATION EOS IMAGING JOHN J SMITH
K141245 05/14/2014 ETEX MIXING AND DELIVERY SYSTEM ETEX CORPORATION ANDY SOMAN
K141129 05/01/2014 EXACTECH CERVICAL SPACER SYSTEM EXACTECH, INC. MEREDITH MAY MS, RAC
K141401 05/28/2014 EASY OUT FEET FOR LIFE PODIATRY CENTER MICHAEL HORWITZ
K141281 05/16/2014 CRIT-LINE CLIP (CLIC) BLOOD CHAMBER FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC DENISE OPPERMANN
K141145 05/02/2014 LIBERTY PDX CYCLER FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC DENISE M OPPERMANN
K141261 05/15/2014 LOGIQ S7 EXPERT, LOGIQ S7 PRO GE HEALTHCARE BRYAN BEHN
K141437 05/30/2014 XLR8 PLUS (XLR8+) GENADYNE BIOTECHNOLOGIES, INC. CHIEN MING, GOH
K141286 05/16/2014 AER-O-SCOPE COLONOSCOPE SYSTEM GI VIEW LTD. MARK HELLER
K141412 05/29/2014 STERILUCENT SELF-SEAL STERILIZATION POUCH GS MEDICAL PACKAGING, INC. PETER KALKBRENNER
K141349 05/22/2014 Disposable sterile needle retractable safety syringe GUANGDONG HAIOU MEDICAL APPARATUS STOCK CO., LTD SALON CHEN
K141429 05/30/2014 SORRENTO BONE GRAFT SUBSTITUTE HAIDER BIOLOGICS, LLC GUSTAVO R PRADO
K141125 05/01/2014 U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE HANDPIECE HEADQUARTERS TINA STEFFANIE-OAK
K141242 05/14/2014 GLIDE DEVICE HOME SKINOVATIONS LTD. AHAVA STEIN
K141161 05/05/2014 ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL) HORIBA ABX SAS FERRER CAROLINE
K141287 05/16/2014 HUIKANG NITRILE POWDER FREE PATIENT EXAM GLOVES, BLUE COLOR HUIKANG GLOVE CO., LTD. CHU XIAOAN
K141343 05/21/2014 AXXENT CERVICAL APPLICATOR ICAD, INC. John DeLucia
K141406 05/28/2014 IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS Immunalysis Corporation joseph Ginete
K141188 05/08/2014 MICRODENT GENIUS IMPLANT SYSTEM IMPLANT MICRODENT RHONDA ALEXANDER
K141341 05/21/2014 CL DETECT RAPID TEST INBIOS INTERNATIONAL INC. ESTELA RAYCHAUDHURI
K141158 05/05/2014 APEX INCONTROL MEDICAL, LLC JESSICA ANDRESHAK
K141274 05/16/2014 QUANTA FLASH ?2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-?2GPI DOMAIN1; CONTROLS. INOVA DIAGNOSTICS, INC. Roger Albesa
K141328 05/21/2014 QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS INOVA DIAGNOSTICS, INC. GABRIELLA LAKOS
K141210 05/09/2014 QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS INOVA DIAGNOSTICS, INC. GABRIELLA LAKOS
K141338 05/21/2014 LIAT STREP A ASSAY IQUUM INC Lingjun Chen
K141359 05/23/2014 HARD PACK SYRINGE JIANGYIN CAINA TECHNOLOGY CO., LTD Diana Hong
K141284 05/16/2014 CASPIAN SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K141147 05/05/2014 RANGE SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K141250 05/14/2014 FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC. LEIGH SPOTTEN
K141294 05/19/2014 U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS KIMBERLY-CLARK CORP. CHARNELLE THOMAS
K141334 05/21/2014 REUSABLE GUIDE KOELIS LAETITIA GERVAIS
K141138 05/02/2014 SURFLASH SAFETY I.V. CATHETER KOFU FACTORY OF TERUMO CORP. PHILLIP LESTER
K141271 05/15/2014 AERODR SYSTEM 2 KONICA MINOLTA, INC. RUSSELL D MUNVES
K141221 05/12/2014 LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR LARES RESEARCH, INC. JASON ORGAIN
K141181 05/07/2014 NUVE FOR WRINKLES, DPL NUVE FOR WRINKLES LED TECHNOLOGIES, LLC SUSAN ANTHONEY-DEWET
K141136 05/01/2014 LEICA FL800 LEICA BIOSYSTEMS RICHMOND BARBARA-ANN CONWAY-MYERS
K141246 05/14/2014 LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM LIFE SPINE, INC RANDY LEWIS
K141222 05/12/2014 NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM LIFE SPINE, INC RANDY LEWIS
K141395 05/28/2014 DELTA TT ACETABULAR SYSTEM LIMACORPORATE S.P.A. STEPHEN J PEOPLES
K141327 05/21/2014 MINIMA S SYSTEM LIMACORPORATE S.P.A. STEPHEN PEOPLES
K141205 05/09/2014 LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6 Lin-Zhi International, Inc. BERNICE LIN
K141320 05/20/2014 LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls Lin-Zhi International, Inc. BERNIECE LIN
K141432 05/30/2014 NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K141358 05/23/2014 CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES MAUNA KEA TECHNOLOGIES MICHAEL A DANIEL
K141232 05/13/2014 APTUS ULNA SHORTENING 2.5 MEDARTIS AG KEVIN A THOMAS
K141151 05/05/2014 CT MIDLINE MEDCOMP (MEDICAL COMPONENTS, INC.) TIMOTHY HOLWICK
K141321 05/20/2014 GLUCOSTABILIZER INSULIN DOSING CALCULATOR MEDICAL DECISION NETWORK JANE KEATHLEY
K141187 05/08/2014 IMPIX ALIF S/A MEDICREA INTERNATIONAL S.A. DAVID RYAN
K141398 05/28/2014 PASS LP SPINAL SYSTEM MEDICREA INTERNATIONAL S.A. DAVID RYAN
K141127 05/01/2014 MEDLINE ANTI-EMBOLISM STOCKING MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K141420 05/29/2014 FASTFORWARD MEDSHAPE, INC JEREMY BLAIR
K141290 05/19/2014 HELICAL RIDGE PEEK INTERFERENCE SCREW MEDSHAPE, INC JACK GRIFFIS
K141233 05/13/2014 AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE MEDTRONIC, INC. JESSICA SIXBERRY
K141377 05/27/2014 BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD MERETE MEDICAL GMBH EMMANUEL ANAPLIOTIS
K141363 05/23/2014 CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER MERIT MEDICAL SYSTEMS, INC. SUSAN CHRISTENSEN
K141295 05/19/2014 MERIT HYDROPHILIC GUIDEWIRE MERIT MEDICAL SYSTEMS, INC. MICHAEL O'SULLIVAN
K141408 05/28/2014 RESOLVE BILIARY LOCKING DRAINAGE CATHETER MERIT MEDICAL SYSTEMS, INC. Glen Norton
K141235 05/13/2014 PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS MICROPORT ORTHOPEDICS INC. BYRON LEDBETTER
K141272 05/15/2014 FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM ENDOSCOPIC CANNULA, FLOSHIELD 10MM BLUNT OBTURATOR MINIMMALLY INVASIVE DEVICES TRUDIE L SEEGER, PH.D.
K141230 05/13/2014 DOSELAB PRO MOBIUS MEDICAL SYSTEMS, LP STAN ESHELMAN
K141316 05/20/2014 COGNISION EEG/EP SYSTEM NEURONETRIX SOLUTIONS CHERYL FISHER
K141368 05/23/2014 NEUROPACE BURR HOLE COVER NEUROPACE INC ISABELLA R ABATI
K141253 05/14/2014 NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM NEW ERA ORTHOPAEDICS, LLC J.D. WEBB
K141291 05/19/2014 VERTIFORM POSTERIOR FIXATION SYSTEM NEXT ORTHOSURGICAL HUAN TRAN
K141376 05/27/2014 INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS NEXXT SPINE LLC KAREN E WARDEN
K141244 05/14/2014 NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES) NORTH AMERICAN SCIENCE ASSOC., INC. JULIE WHEELER
K141207 05/09/2014 NOVABONE BIOACTIVE STRIP NovaBone Products, LLC Lisa Simpson
K141308 05/19/2014 NUTRA LIGHT RED NUTRA LUXE MD, LLC JILL CREASY
K141352 05/23/2014 ENDOCYN ROOT CANAL IRRIGATION SOLUTION OCULUS INNOVATIVE SCIENCES BRIAN W MARTIN
K141256 05/14/2014 OKAMOTO STUDDED CONDOM OKAMOTO U.S.A., INC. JOSEPH W CORMIER, JD, PHD
K141225 05/12/2014 ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P-CORD OLYMPUS WINTER & IBE GMBH GRAHAM A L BAILLIE
K141140 05/02/2014 COMP A-I-R OMRON HEALTHCARE, INC. PAUL DRYDEN
K141157 05/05/2014 BONDEASE TOPICAL SKIN ADHESIVE OPTMED, INC. STEPHANIE RAIS
K141186 05/07/2014 FIREBIRD SPINAL FIXATION SYSTEM ORTHOFIX, INC. JACKI GEREN
K141301 05/19/2014 MAXLOCK EXTREME ELBOW FRACTURE SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. BRIAN HOCKETT
K141177 05/07/2014 VITALA PORCINE DERIVED COLLAGEN MEMBRANE OSTEOGENICS BIOMEDICAL, INC. (FORMERLY OBI BIOLOGI SHANE SHUTTLESWORTH
K141422 05/30/2014 PROFLUORO FLUORIDE VARNISH PAC-DENT INTERNATIONAL, INC. WENYING ZHU
K141200 05/09/2014 PADI-LOCK PADI-LOCK, LLC MARIA GRIFFIN
K141130 05/01/2014 ENCOMPASS PANORAMIC CORP. DANIEL KAMM, P.E.
K141134 05/01/2014 POD SYSTEM PENUMBRA, INC. CHARLES DENAULT
K141375 05/27/2014 ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 PHADIA US INC. MANUELA CONSTANZE HOG
K141381 05/27/2014 DURADIAGNOST PHILIPS HEALTHCARE (SUZHOU) CO., LTD. GORDON SHU
K141369 05/23/2014 VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM PHILIPS ULTRASOUND, INC. SARASWATHI DEORA
K141282 05/16/2014 PGS 5.5 MM CANNULATED PEDICLE SCREW PINNACLE SPINE GROUP MEREDITH MAY
K141423 05/30/2014 NASOPORE-FD Polyganics BV BETTY IJMKER
K141397 05/28/2014 SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM PRECISION SPINE, INC. MICHAEL C DAWSON
K141211 05/09/2014 INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS PRISMATIK DENTALCRAFT, INC. Armin Zehtabchi
K141208 05/09/2014 DYNAMIC NEUROSCREENING DEVICE PROSENEX WILLIAM G MCLAIN
K141389 05/27/2014 SAPPHIRE INFUSION PUMP Q CORE MEDICAL LTD Rhona Shanker
K141403 05/28/2014 LITHO DK30 QUANTA SYSTEM, S.P.A. Maurizio Bianchi
K141164 05/05/2014 ARTEMIS LIGHT ENGINE QUEST MEDICAL IMAGING MARTIN HEUVELMANS
K141173 05/06/2014 AMPLIVUE GAS ASSAY QUIDEL CORPORATION Ronald H Lollar
K141154 05/05/2014 OARTRAC SYSTEM RADIADYNE STUART R GOLDMAN
K141323 05/20/2014 VTI SUCTION IRRIGATION SYSTEM REGULATORY TECHNOLOGY SERVICES, LLC MARK JOB
K141370 05/27/2014 RENOVIS CEMENTED HIP SYSTEM Renovis Surgical Technologies, Inc. Sharyn Orton
K141175 05/06/2014 RENOVOCATH RC120 RENOVORX, INC. RON S WARREN
K141434 05/30/2014 SATURN 5 LASER RESEARCH INSTRUMENTS LTD. DAVID LANDSDOWNE
K141313 05/20/2014 REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM REVERSE MEDICAL CORPORATION JANE METCALF
K141162 05/05/2014 ALL-CERAMIC ZIRCONIA BLOCK RIZHAO HUGE DENTAL INDUSTRY CO., LTD HELEN NAN
K141421 05/30/2014 PMMA BLOCK RIZHAO HUGE DENTAL INDUSTRY CO., LTD HELEN NAN
K141143 05/02/2014 COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET Roche Diagnostics KHOA TRAN
K141426 05/30/2014 ELECSYS FOLATE III Roche Diagnostics KELLI TURNER
K141384 05/27/2014 WHISPERJECT AUTOINJECTOR SCANDINAVIAN HEALTH LIMITED James Haynes
K141366 05/23/2014 VIDEO BRONCHOSCOPE SYSTEM SCHOLLY FIBEROPTIC GMBH SANDRA BAUMANN
K141280 05/16/2014 ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS SEINOH OPTICAL CO. LTD. JENNIFER TING
DEN140017 05/06/2014 SENSIMED TRIGGERFISH SENSIMED AG Marcy Moore
K141260 05/15/2014 ELECTRONIC PULSE STIMULATOR SHENZHEN JINGKEHUI ELECTRONIC CO., LTD BILL QUANQIN DAI
K141416 05/29/2014 BLOOD PRESSURE MONITOR SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. XIE QIONGYU
K141307 05/19/2014 AOK POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SHIJIAZHUANG AOK PLASTIC CO., LTD. CHU XIAOAN
K141305 05/19/2014 RICHFUL POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SHIJIAZHUANG RICHFUL PLASTIC CO., LTD. CHU XIAOAN
K141224 05/12/2014 JIUYUAN POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUNAG JIUYUAN PLASTIC CO., LTD CHU XIAOAN
K141405 05/28/2014 MOBIS II ST SPINAL IMPLANT SIGNUS MEDIZINTECHNIK GMBH J.D. WEBB
K141255 05/14/2014 SIMEX SUBGLOTTIC ASPIRATION SYSTEM SIMEX MEDIZINTECHNIK GMBH HAMID KHOSROWSHAHI
K141193 05/08/2014 MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0 SMITHS MEDICAL ASD, INC. TOM BLISS
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