FDA 510(k) Decisions During May, 2014  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K141081 05/08/2014 FILTEK BULK FILL POSTERIOR RESTROATIVE 3M ESPE DENTAL PRODUCTS SCOTT ERICKSON
K133776 05/28/2014 A-DEC/W&H ELECTRIC HANDPIECE MOTOR A-DEC, INC. BONNIE DUNDAS
K140607 05/08/2014 AAP LOQTEC(R) OLECRANON PLATE AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K140354 05/09/2014 ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG ABBOTT MOLECULAR, INC. STACY FERGUSON
K140483 05/20/2014 ASAP OTC WOUND DRESSING GEL ABL MEDICAL, LLC Calley Herzog
K140925 05/20/2014 ACUMED SUTURE ANCHOR SYSTEM ACUMED, LLC LINO TSAI
K140190 05/29/2014 NIGHT SHIFT ADVANCED BRAIN MONITORING, INC. ADRIENNE LENZ
K140343 05/13/2014 AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP AESCULAP, INC. KATHY A RACOSKY
K133790 05/22/2014 IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM ANDON HEALTH CO., LTD YI LIU
K131531 05/12/2014 TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT NEEDLE ANHUI TIANKANG MEDICAL PRODUCTS CO., LTD XIUMING CHONG
K141041 05/16/2014 APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE APTUS ENDOSYSTEMS BURT GOODSON
K122817 05/01/2014 SILVERLON ISLAND WOUND DRESSING ARGENTUM MEDICAL, LLC. WALT BRITTLE
K131096 05/16/2014 AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM AROBELLA MEDICAL, LLC MATTHEW BERSCHEID
K140287 05/16/2014 AXERA RX ACCESS SYSTEM ARSTASIS, INC. GRACE LI
K140604 05/14/2014 MULTIFIX S KNOTLESS FIXATION SYSTEM ARTHROCARE CORPORATION MITCHELL DHORITY
K123099 05/23/2014 Best-AV2 Pro-Sport(tm) AVAZZIA, INC. TAMMY LAHUTSKY
K140185 05/01/2014 OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE AVINGER, INC. SHERRY KIM
K140428 05/30/2014 ULTRASOUND SCANNER SYSTEM BK2300 B-K MEDICAL APS RANDI HAUERBERG
K140311 05/07/2014 CARESITE LUER ACCESS DEVICE B. BRAUN MEDICAL, INC. KIMBERLY SMITH
K133801 05/07/2014 BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY BAXTER HEALTHCARE CORPORATION THOMAS SAMPOGNA
K140591 05/14/2014 BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR BECTON DICKINSON & CO. JOHN ROBERTS
K140446 05/20/2014 BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. SHERMA WINSTON
K140448 05/20/2014 BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. SHERMA WINSTON
K140111 05/06/2014 BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT Becton, Dickinson and Company Paul Swift
K140447 05/20/2014 BD VIPER LT SYSTEM Becton, Dickinson and Company SHERMA WINSTON
K140916 05/06/2014 LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK Bio-Rad Laboratories SUZANNE PARSONS
K140407 05/02/2014 FILMARRAY GASTROINTESTINAL (GI) PANEL Biofire Diagnostics BETH LINGENFELTER
K132377 05/20/2014 OSTEOSPAN MORPHEUS BIOGENNIX, LLC ELAINE DUNCAN
K140509 05/28/2014 BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE BIOMET MANUFACTURING LLC TRACY BICKEL JOHNSON, RAC
K140622 05/13/2014 DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE BIOMET, INC. SUZANA OTANO
K130067 05/08/2014 MRNA APPLIANCE BIOMODELING SOLUTIONS, LLS COLETTE COZEAN, PH.D.
K131176 05/12/2014 ROSS RU SKIN DISCONTINUITIES BIOTD, S.A. RICHARD GILLIS
K130775 05/09/2014 DUET SYSTEM BIOVIEW LTD. ORLY MAOR
K132167 05/02/2014 I-CHROMA IFOB WITH I-CHROMA READER Boditech Med Inc. SANG YEOL PARK
K140329 05/15/2014 RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT BOSTON SCIENTIFIC MARK MURPHY
K140630 05/23/2014 WALLFLEX BILIARY RX STENT SYSTEM BOSTON SCIENTIFIC THOMAS HIRTE
K133700 05/14/2014 ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS Boston Scientific Corporation ELENA NIEVES
K140151 05/21/2014 EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT BTG INTERNATIONAL, INC. JOCELYN KERSTEN
K133251 05/09/2014 BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM C.R. BARD, INC. MICHELE DAVIS
K140856 05/02/2014 BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS C.R. BARD, INC. MICHELE DAVIS
K140122 05/09/2014 CANDELA GENTLEMAX FAMILY OF LASER SYSTEM CANDELA CORP. SAM WADE
K133148 05/13/2014 BIOMARC COAXIAL NEEDLE CARBON MEDICAL TECHNOLOGIES, INC. ANDREW J ADAMS
K133519 05/16/2014 CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR CAROLINA LIQUID CHEMISTRIES CORP. Melissa F Thompson
K132711 05/08/2014 CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT CAROLINA LIQUID CHEMISTRIES CORP. PHILIP G SHUGART
K140426 05/22/2014 ANTHRACIS REAL-TIME PCR ASSAY CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) HYE-JOO KIM
K133200 05/08/2014 STALIF C(R) CENTINEL SPINE, INC. JOHN PARRY
K140139 05/28/2014 CLEARVIEWHD CLEARVIEW DIAGNOSTICS INC. CHRISTINE PODILCHUK
K131781 05/28/2014 CLEARVIEW TOTAL CLINICAL INNOVATIONS, LLC BRIAN MCROBERTS
K140163 05/29/2014 KOALA TOCO CLINICAL INNOVATIONS, LLC JOANNE BRONIKOWSKI
K140423 05/27/2014 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA SHAH
K140594 05/30/2014 BODY FAT ANALYZER AND SCALE CONMO ELECTRONIC COMPANY LIMITED CHARLES MACK
K141043 05/19/2014 CS2 MULTI-HOLE ACETABULAR SHELL Consensus Orthopedics, Inc MATTHEW M HULL
K140070 05/07/2014 LUXER SHADED ZIRCONIA CONTINENTAL DENTAL CERAMICS, INC. JERRY DOVIACK
K140169 05/21/2014 VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM COOK INCORPORATED THOMAS J KARDOS
K140548 05/23/2014 CORCAM HEART MONITOR CORCAM TECHNOLOGIA, SA JENNIFER A DAUDELIN
K132004 05/02/2014 NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE CREO QUALITY, LLC. JON SPEER
K133204 05/05/2014 AIRVIEW MINI OWIE DICK TEST PACK CROSSTEX INTERNATIONAL MICHAEL G NOLAN
K140038 05/27/2014 DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM CUREXO TECHNOLOGY CORPORATION GLEN EMELOCK
K140158 05/29/2014 S.E.A.L. FRACTURE FUSION TUBE D.N.E., LLC J.D. WEBB
K140206 05/08/2014 SCINTILLATION GAMMA CAMERA DDD-DIAGNOSTIC A/S NEERGAARDS VEJ 5E
K132378 05/30/2014 X-MIND UNITY DE GOTZEN S.R.L. MAURIZIO DE GOTZEN
K132686 05/12/2014 AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE DEGANIA SILICONE, LTD. ZOYA LEE
K121215 05/09/2014 DEKA ARM SYSTEM DEKA INTEGRATED SOLUTIONS CORPORATION ROGER LEROUX
DEN120016 05/09/2014 DEKA ARM SYSTEM DEKA INTEGRATED SOLUTIONS CORPORATION Roger Leroux
K123940 05/30/2014 DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE DEMETECH CORP. JOHN O'BRIEN
K140822 05/29/2014 DRIVE RAIL SYSTEM DEVISE ORTHO, INC. ALEX GREENE
K132225 05/15/2014 EXTRICARE DEVON MEDICAL INC. RUTH WU
K134055 05/09/2014 ADX4000W DEXCOWIN CO., LTD Claude Berthoin
K133448 05/13/2014 QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY DIAGNOSTIC HYBRIDS, INC. RONALD H LOLLAR
DEN140004 05/13/2014 QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY DIAGNOSTIC HYBRIDS, INC. Ronald H Lollar
K133014 05/19/2014 DMS 300-2W HOLTER ECG RECORDER DIAGNOSTIC MONITORING SOFTWARE WILLIAM PARSONS
K140384 05/23/2014 FMWAND HANDPIECE SE DOMAIN SURGICAL, INC. CURTIS JENSEN
K131892 05/22/2014 EV1000 CLINICAL PLATFORM EDWARDS LIFESCIENCES, LLC. SALLY MAHER
K131588 05/22/2014 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR EDWARDS LIFESCIENCES, LLC. SALLY MAHER
K133565 05/09/2014 LEKSELL GAMMA KNIFE PERFEXION ELEKTA INSTRUMENT AB MATILDA FORSBERG
K133405 05/23/2014 MINNIE ELETTRONICA VALSERIANA SRL SERGIO GHERSINI
K141023 05/20/2014 PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM ELLIPSE TECHNOLOGIES, INC. REBECCA SHELBURNE
K140133 05/15/2014 INFUSET FLOW CONTROL EXTENSION SET EMED TECHNOLOGIES CORPORATION PETER KOLLINGS
K140904 05/06/2014 RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6 ENCORE MEDICAL, L.P. TEFFANY HUTTO
K140094 05/21/2014 SPRINGTMS TOTAL MIGRAINE SYSTEM ENEURA THERAPEUTICS, LLC LARRY GETLIN
K133064 05/02/2014 MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31 ENVITEC-WISMAR GMBH STEPHEN GORSKI
K133316 05/28/2014 SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS) EPIMED INTERNATIONAL, INC. PRESTON H FRASIER
K132899 05/13/2014 EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) EQUASHIELD MEDICAL LTD RAYMOND J KELLY, IV
K133718 05/12/2014 ZERONA ERCHONIA CORPORATION Kevin Walls
K133722 05/08/2014 ASTHMA MONITOR AM3 ERESEARCH TECHNOLOGY RICHARD A MILLER
K133198 05/30/2014 ULTRAPRO COMFORT PLUG ETHICON, INC. REYNALDO LIBROJO
K132379 05/29/2014 EUROIMMUN ANTI-PLA2R IFA EUROIMMUN US MICHAEL LOCKE
DEN140002 05/29/2014 EUROIMMUN ANTI-PLA2R IFA EUROIMMUN US MICHAEL LOCKE
K140568 05/13/2014 CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT FACET TECHNOLOGIES, LLC JENNIFER REGISTER
K134001 05/15/2014 FIREFLY FIRSTKIND LIMITED SHEILA HEMEON-HEYER
K132475 05/07/2014 FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM FLUOPTICS MICHAEL A DANIEL
K140211 05/30/2014 ULTRASONIC MESH NEBULIZER FOSHAN GAUNYING ELECTRONICS CO., LTD. GUENTER GINSBERG
K132529 05/12/2014 GALLIEON-1 MEDICAL LASER FUTURE DEVICE AND TECHNOLOGY, INC SOUNGDON CHUNG
K130190 05/09/2014 PIXEL 3 SYSTEM GAUSS SURGICAL, INC. PEGGY MCLAUGHLIN
DEN130015 05/09/2014 PIXEL 3 SYSTEM GAUSS SURGICAL, INC. PEGGY MCLAUGHLIN
K141067 05/23/2014 VIVID T8/VIVID T8 PRO GE HEALTHCARE BRYAN BEHN
K133664 05/15/2014 ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGN CHRIS PAULIK
K140693 05/16/2014 VSCAN WITH DUAL PROBE GE MEDICAL SYSYEMS ULTRASOUND & PRIMARY CARE DIAGN TRACEY ORTIZ
K132027 05/01/2014 OEC 9800 PLUS GE OEC MEDICAL SYSTEMS, INC JEFF WAGNER
K141093 05/15/2014 6VT-D ULTRASOUND TRANSDUCER GE VINGMED ULTRASOUND AS BRYAN BEHN
K140875 05/30/2014 OPTOSSOL COMPRESSION DEVICE SYSTEM GENOSSIS, LLC BARRY E SANDS
K133482 05/21/2014 SILC FIXATION SYSTEM GLOBE MEDICAL, INC. CHRISTINA KICHULA
K131468 05/06/2014 DENRACLE DENTAL ABUTMENT GREEN DENTECH CO LTD SUE RU
K132476 05/02/2014 SHARPS CONTAINER GRP & ASSOCIATES ROBERT SEIPLE
K131941 05/15/2014 FETAL MONITORS GUANGDONG BIOLIGHT MEDITECH CO., LTD Diana Hong
K140899 05/05/2014 HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM HALO MEDICAL TECHNOLOGIES, LLC JENNIFER L KINNEY
K132744 05/27/2014 ACESSA GUIDANCE SYSTEM HALT MEDICAL INC. CLARISA TATE
K133953 05/28/2014 LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M HARTALEGA SDN BHD NURUL AISYAH KONG BT ABDULLAH
K133956 05/28/2014 NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN HARTALEGA SDN BHD NURUL AISYAH KONG
K132937 05/21/2014 HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) HARVEST DENTAL PRODUCTS, LLC ANDREW ROWE
K132416 05/28/2014 REHASTIM 2, ERIGOPRO (FES) HASOMED GMBH MATTHIAS WEBER
K140269 05/08/2014 HERMES MEDICAL IMAGING SUITE V5.4 HERMES MEDICAL SOLUTIONS, AB JOAKIM ARWIDSON
K131866 05/01/2014 SUSTAIN HOLLENDER SUSTAINABLE BRANDS LLC E.J. Smith
K140074 05/21/2014 HYGEDENT ALGINATE IMPRESSION MATERIAL HYGEDENT INC MIKE GU
K133620 05/14/2014 CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM IMAGING SCIENCES INTERNATIONAL RUTH PUI
K140216 05/01/2014 ORTHOPEDIC FIXATION SYSTEMS IMPACT MEDICAL, LLC EJ DUFFY
K131920 05/01/2014 STABILIZATION SCREW IN2BONES SAS NORMAN F ESTRIN, PH.D.
K133290 05/01/2014 COLLACARE DENTAL INNOCOLL PHARMACEUTICALS AARON WYSE
K140238 05/07/2014 EXCELLA III-D SPINAL DEFORMITY SYSTEM INNOVASIS, INC. MASHALL MCCARTY
K133690 05/07/2014 TRUE SPINAL FUSSION SYSTEM INNOVATIVE SURGICAL DESIGNS ED MORRIS
K131304 05/29/2014 SENTIO MMG INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS") AASHISH SHAH
K140198 05/13/2014 IMDX HSV-1/2 FOR ABBOTT M2000 Intelligent Medical Devices, Inc. FRAN WHITE
K140707 05/28/2014 LIFEBORNE INFANT RESUSCITATOR INTERNATIONAL BIOMEDICAL AMY PIEPER
K133203 05/09/2014 SINGLE-SITE PORT INTUITIVE SURGICAL, INC. EINAV YEMINI
K133853 05/19/2014 VIEWFLEX XTRA ICE CATHETER IRVINE BIOMEDICAL, INC. A ST.JUDE MEDICAL COMPANY JENNIFER CORREA
K133859 05/30/2014 WATCH-PAT200U (WP200U) ITAMAR MEDICAL LTD JONATHAN KAHAN, ESQ
K130915 05/15/2014 XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK JAS Diagnostics, Inc. DAVID H JOHNSTON
K140529 05/22/2014 EVEREST SPINAL SYSTEM K2M, LLC NANCY GIEZEN
K134043 05/21/2014 NO TOUCH+FOREHEAD NTF 3000 THERMOMETER KAZ USA, INC (A SUBSIDIARY OF KAZ INC) RAJ KASBEKAR
K133304 05/15/2014 RXG DISTRACTION SYSTEM KLS-MARTIN L.P. JENNIFER DAMATO
K141138 05/30/2014 SURFLASH SAFETY I.V. CATHETER KOFU FACTORY OF TERUMO CORP. PHILLIP LESTER
K140412 05/22/2014 ANS1 SOFTWARE LD TECHNOLOGY LLC ALBERT MAAREK
K122556 05/19/2014 VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) LEICA BIOSYSTEMS NEWCASTLE LTD BARBARA-ANN CONWAY-MAYERS
K140340 05/21/2014 SKINTACT LEONHARD LANG GMBH ELAINE DUNCAN
K133934 05/02/2014 MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER) LINKS MEDICAL PRODUCTS, INC. James Smith
K133272 05/13/2014 VERSACUT + TISSUE MORCELLATOR LUMENIS LTD. YORAM LEVY
K133598 05/21/2014 CARDIOHELP SYSTEM MAQUET CARDIOPULMONARY AG HELDER A SOUSA
K133042 05/12/2014 ENDOCEM ZR MARUCHI Priscilla Chung
K133054 05/12/2014 ENDOSEAL MARUCHI Priscilla Chung
K140027 05/22/2014 ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER MATERIALISE N.V. OLIVER CLEMENS
K133046 05/14/2014 OMNIPORE CUSTOMIZED SURGICAL IMPLANTS MATRIX SURGICAL HOLDINGS, LLC/MATRIX SURGICAL USA JULIE STEPHENS
K132788 05/23/2014 MYSPINE PEDICLE SCREW PLACEMENT GUIDES MEDACTA INTERNATIONAL ADAM GROSS
K132684 05/23/2014 MEDWS SOFTWARE (VARIANTS MEDVIEW, MEDDIAG, MEDMAMMO) MEDECOM SARL CYNTHIA COTTEREAU
K133763 05/15/2014 SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM MEDI-GLOBE CORPORATION SCOTT KARLER
K130080 05/13/2014 EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL MEDICA CORPORATION Photios Makris
K140755 05/08/2014 ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS MEDICAL COMPRESSION SYSTEMS (DBN) LTD. ADELY LEVY
K133428 05/21/2014 MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO MEDIKRO OY MIKKO ELORANTA
K132730 05/30/2014 BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE MEDTRONIC INC. JESSICA SIXBERRY
K140454 05/22/2014 NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS MEDTRONIC SOFAMOR DANEK USA, INC. REGINA HOLMES
K140192 05/22/2014 CARPENTIER BI-CAVAL FEMORAL CANNULA MEDTRONIC, INC. JACQUELINE A HAUGE
K140165 05/20/2014 MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE MEDTRONIC, INC. JACQUELINE A HAUGE
K132506 05/29/2014 SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY MICHAEL D. WILLIAMS,DDS PA MICHAEL D WILLIAMS
K140676 05/30/2014 PROFEMUR TL CLASSIC LONG NECK HIP STEMS MICROPORT ORTHOPEDICS INC. BYRON LEDBETTER
K133779 05/30/2014 CP RELIEF WAND MID-AMERICA MEDICAL INNOVATIONS, LLC. NORM SCHROEDER
K132038 05/02/2014 ACCUTORR 7 VITAL SIGNS MONITOR MINDRAY NORTH AMERICA RUSSELL OLSEN
K132037 05/16/2014 VITAL SIGNS MONITOR MINDRAY NORTH AMERICA RUSSELL OLSEN
K140970 05/13/2014 ONE-PIECE PEEK FUSION IMPLANT MTP SOLUTIONS LLC ROBERT HOY
K132653 05/14/2014 NEOPLATE SPINE ANTERIOR FIXATION SYSTEM NEOORTHO PRODUCTOS ORTHOPEDICOS S/A TARA CONRAD
K132852 05/29/2014 PEEK CAGE FOR THE VERTEBRAL SPINE NEOORTHO PRODUTOS ORTOPEDICOS S/A TARA CONRAD
K140724 05/14/2014 MSP METATARSAL SHORTENING SYSTEM NEXTREMITY SOLUTIONS, INC. JORGE A MONTOYA
K133351 05/22/2014 NEXUS NIS-6P LUER ACTIVATED DEVICE NEXUS MEDICAL LLC HEATHER TURNER
K133731 05/08/2014 NOBELACTIVE WIDE PLATFORM (WP) NOBELBIOCARE AB PHUONG NGUYEN
K140252 05/08/2014 16 CH MULTIPURPOSE COIL VARIETY NORAS RONTGEN-UND MEDIZINTECHNIK GMBH ZAHED SEDIGHIANI
K132291 05/20/2014 NAMSA CHEMICAL PROCESS NORTH AMERICAN SCIENCE ASSOC., INC. JULIE WHEELER
K133738 05/21/2014 NOVOFINE PLUS 32G 4 MM NOVO NORDISK INC. RICK SPRING
K132838 05/23/2014 NUTRA LIGHT BLUE NUTRA LUXE MD, LLC JILL CREASY
K133530 05/02/2014 NUVASIVE EMG ENDOTRACHEAL TUBE NUVASIVE, INCORPORATED JEREMY MARKOVICH
K132694 05/16/2014 NUVASIVE NVM5 SYSTEM NUVASIVE, INCORPORATED Sheila Bruschi
K140571 05/15/2014 NXSTAGE PUREFLOW SL NXSTAGE MEDICAL, INC. MARY L STROUMBOS
K140526 05/19/2014 NXSTAGE SYSTEM ONE NXSTAGE MEDICAL, INC. MARY LOU STROUMBOS
K123876 05/22/2014 SYNERGY ODONTIT SA BLIX WINSTON
K132703 05/19/2014 THUNDERBEAT OLYMPUS MEDICAL SYSTEMS CORP. GRAHAM BAILLIE
K131790 05/09/2014 A9800 ANESTHESIA WORKSTATION ORICARE, INC. KURTIS MONTEGNA
K133912 05/14/2014 ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO ORIGIO A/S TOVE KJAER
K132870 05/07/2014 Origio Gas Line Filter ORIGIO, INC JOHN CLAY
K140709 05/27/2014 SKYHAWK INTERBODY FUSION SYSTEM ORTHOFIX INC. TROY BROOKS
K133082 05/20/2014 OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE OSTEOSYMBIONICS, LLC NICHOLAS WLKINS
K133514 05/01/2014 XCAGE INTERBODY FUSION SYSTEM OUROBOROS MEDICAL JOHN TO
K132857 05/01/2014 RESPIRATORY GAS HUMIDIFIER PACIFIC MEDICO CO., LTD. YOSHIO TOYAMA
K133694 05/23/2014 SHERPA PAK TRANSPORTER PARAGONIX TECHNOLOGIES, INC. LEO BASTA
K133317 05/13/2014 PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX PENUMBRA, INC. SETH SCHULMAN
K132108 05/19/2014 MAXIO PERFINT HEALTHCARE PVT LTD JANICE HOGAN
K133793 05/19/2014 PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE PERSYST DEVELOPMENT CORPORATION DARI DARABBEIGI
K131069 05/14/2014 QUICKSCREEN AMPHETINE 500 TEST PHAMATECH INC. CARL A MONGIOVI
K141015 05/19/2014 INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN MARKUS STACHA
K140066 05/05/2014 INFILL CERVICAL PINNACLE SPINE GROUP, LLC Rebecca K Pine
K140255 05/14/2014 STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA) POLLOGEN LTD JONATHAN S KAHAN
K140127 05/28/2014 FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP PONTIS ORTHOPAEDICS, LLC LEONARD GORDON
K134017 05/02/2014 GIGALASER POWERMEDIC APS M. JOYCE HEINRICH
K133051 05/02/2014 PULMONE MINIBOX PFT TM PULMONE ADVANCED MEDICAL DEVICES, LTD Rhona Shanker
K140522 05/22/2014 RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG
K140060 05/13/2014 DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A RAYENCE CO., LTD DAVE KIM
K140056 05/13/2014 DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A RAYENCE CO., LTD DAVE KIM
K141091 05/28/2014 RAYSERT PLUS INJECTOR RAYNER INTRAOCULAR LENSES LTD. JULIETTE COOK
K140187 05/15/2014 RAY STATION RAYSEARCH LABORATORIES AB LADAN AMIRI
K140638 05/02/2014 PROPELLER SYSTEM - MODEL 2 RECIPROCAL LABS CORPORATION J. DAVID SICKLE
K133988 05/16/2014 TEMPUS PRO EXTENDED FEATURES REMOTE DIAGNOSTIC TECHNOLOGIES LTD. LEIGH CORNOCK
K133257 05/16/2014 BIOPSY PIPETTES RESEARCH INSTRUMENTS LTD. DAVID LANSDOWNE
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