FDA 510(k) Decisions During April, 2014  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K140219 04/14/2014 PICASSO II MIS SPINAL SYSTEM ACCEL SPINE LISA PETERSON
K132433 04/24/2014 ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE ACCLARENT, INC. JAMES PATRICK GARVEY II
K132549 04/23/2014 ACCUTIP COVER ACCUTOME, INC. ADAM PICKHOLTZ
K140517 04/28/2014 SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVE Adhezion Biomedical, LLC RICHARD JONES
K132976 04/17/2014 ADVATX ADVALIGHT APS MAUREEN O'CONNELL
K132077 04/23/2014 PATIENT MONITOR ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K133802 04/17/2014 AIS MODULIFT VBR SYSTEM AESCULAP IMPLANT SYSTEM, INC. LISA M BOYLE
K140839 04/28/2014 CAIMAN SEAL AND CUT TECHNOLOGY AESCULAP, INC. DENISE ADAMS
K132933 04/25/2014 THE MOSES ELITE APPLIANCE ALLEN J. MOSES, DDS, LTD. ALLEN J MOSES, DDS
K140303 04/21/2014 ALAMO T ALLIANCE PARTNERS, LLC. KELLEN HILLS
K132021 04/02/2014 AHP 300, EMERGENCY PORTABLE VENTILATOR ALLIED HEALTHCARE PRODUCTS, INC. STEPHEN MUNDWILLER
K131098 04/09/2014 EMERGENCY PORTABLE VENTILATOR ALLIED HEALTHCARE PRODUCTS, INC. STEPHEN MUNDWILLER
K133783 04/16/2014 AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION AMERIWATER BRIAN R BOWMAN
K140247 04/25/2014 MTA FILLAPEX ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA TARA CONRAD
K133998 04/18/2014 ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING ANGIOSCORE, INC. KIMBERLEY KLINE
K133606 04/01/2014 N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL ARTHROCARE CORPORATION MITCHELL DHORITY
K140617 04/25/2014 PINIT SMALL BONE FUSION SYSTEM ARTHROSURFACE, INC. DAWN J WILSON
K133742 04/23/2014 XQ-1 INCUBATOR AT MEDICAL UAB THOMAS PEDERSEN
K140715 04/17/2014 ZIP MIS INTERSPINOUS FUSION SYSTEM AURORA SPINE, INC. JUSTI N EGGLETON
K133521 04/11/2014 AZE PHOENIX SOFTWARE AZE, LTD. KARL DIEDRICH, AZE
K133743 04/07/2014 BAXANO SURGICAL MIS SPINAL SYSTEM BAXANO SURGICAL, INC. KRISTEN ALLEN
K130531 04/08/2014 ULTRAFUSE BAXTER HEALTHCARE CORP. GRETCHEN MURRAY
K131189 04/17/2014 UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) BECKMAN COULTER, INC. Yvette Lloyd
K131838 04/24/2014 DIODE LASER FOR HIAR REMOVAL BEIJING HONKON TECHNOLOGIES CO., LTD MIKE GU
K133915 04/18/2014 GALAXY CO2 LASER SYSTEM BEIJING TOPLASER TECHNOLOGY CO., LTD. ZHANG XIAOSONG
K133873 04/04/2014 TRIBALL INCENTIVE SPIROMETER BESMED HEALTH BUSINESS CORP. PAUL DRYDEN
K140147 04/22/2014 BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE BIO-MEDICAL CARBON TECHNOLOGY CO., LTD. DIANE SUDDUTH
K140764 04/25/2014 LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK Bio-Rad Laboratories SUZANNE PARSONS
K134013 04/24/2014 LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO Bio-Rad Laboratories SUZANNE PARSONS
K133844 04/07/2014 SPEED TRIAD BIOMEDICAL ENT., INC. JOE SOWARD
K133270 04/17/2014 SPEED ARC BIOMEDICAL ENTERPRISES, INC JOE SOWARD
K133939 04/01/2014 MODIFIED DISTAL RADIUS PLATING SYSTEM BIOMET SUZANA OTANO
K140625 04/18/2014 ORTHOSORB LS BIOMET, INC. VICTORIA SCHEITLIN
K140018 04/04/2014 TSP HIP FRACTURE PLATING SYSTEM BIOMET, INC. GARY BAKER
K132825 04/10/2014 RETROMTA-ORTHOMTA II BIOMTA Priscilla Chung
K133522 04/17/2014 RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM BIONIME COPORATION Feng-Yu Lee
K130959 04/04/2014 AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL BIOPLAX LIMITED PAUL KETTERIDGE
K130065 04/30/2014 BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE BIOSONIC TECHNOLOGIES, LLC SHEPARD G BENTLEY
K131734 04/11/2014 ALL-BOND UNIVERSAL SC (NOT FINALIZED) BISCO, INC. Michelle Schiltz-Taing
K132483 04/02/2014 INNESIS PEEK CERVICAL CAGE BK MEDITECH CO., LTD. ELAINE DUNCAN
K133009 04/23/2014 NASAL MASK, NASAL MASK, FULL FACE MASK BMC MEDICAL CO., LTD MS. JINJING
K132914 04/03/2014 ACUITY PRO LEAD DELIVERY SYSTEM BOSTON SCIENTIFIC HOLLY RAMIREZ
K140503 04/15/2014 FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER BOSTON SCIENTIFIC JEANNE O'TOOLE
K140745 04/17/2014 ENCORE 26 ADVANTAGE KIT BOSTON SCIENTIFIC CORP. LISA MEE
K140673 04/16/2014 INSERTION TOOL BOSTON SCIENTIFIC CORP. LISA MEE
K140495 04/17/2014 LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE BOSTON SCIENTIFIC CORP. MATT BEAUCHANE
K140288 04/16/2014 TRUEPATH CTO DEVICE BOSTON SCIENTIFIC CORP. CAROL TIFFANY
K140733 04/28/2014 CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER Boston Scientific Corporation MICHELLE ROEDING
K133933 04/02/2014 INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER Boston Scientific Corporation ASHLEY SANTOS
K131660 04/17/2014 SMART (SMART-D, SMART-DX) BTS SPA ENRICO BISSON
K140501 04/28/2014 XENMATRIX SURGICAL GRAFT C.R. BARD GINA CASSIDY
K133470 04/04/2014 BARD RITECATH INTERMITTENT CATHETER C.R. BARD, INC. MICHELE DAVIS
K134010 04/14/2014 CABOCHON SYSTEM CABOCHON AESTHETICS, INC. BEN F BRIAN, PH.D.
K133366 04/08/2014 ORTHROS POSTERIOR STABILIZATION SYSTEM CAMBER SPINE DANIEL A PONTECORVO
K140831 04/15/2014 MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR CAREFUSION LARRY WALKER
K140761 04/21/2014 KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA CAREFUSION 2200 INC. JANE WEBER
K140271 04/01/2014 TABLET VIEWER SOFTWARE FOR IMAGE SUITE CARESTREAM HEALTH, INC. Alexandra Chamberlain
K133823 04/17/2014 NUFACE MINI DEVICE Carol Cole Company Rand Daoud
K133879 04/29/2014 FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K140851 04/25/2014 INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION CDR YON YU, PHARM.D.
K140857 04/25/2014 INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION CDR YON YU, PHARM.D.
K133758 04/23/2014 CENTERVUE MACULAR INTEGRITY ASSESSMENT CENTERVUE SPA ROGER GRAY
K140321 04/17/2014 INITARY BETTER BLADDER-PEDIATRIC CIRCULATORY TECHNOLOGY, INC. YEHUDA TAMARI
K132381 04/04/2014 CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT CLEARMRI SOLUTIONS, INC. MARY ANN FERGUSON
K140080 04/24/2014 ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB Codman & Shurtleff, Inc. HANNAH FOLEY
K140307 04/21/2014 ENVOY GUIDING CATHETER Codman & Shurtleff, Inc. HANNAH FOLEY
K133600 04/30/2014 COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR COEUR, INC. DEBRA F MANNING
K132738 04/15/2014 COGENT MED-LIF COGENT SPINE LLC JUDE PAGANELLI
K133870 04/24/2014 FLUID LEVEL MONITOR COLEMAN LABORATORIES LE-JUN YIN
K131541 04/03/2014 FLEXIBLE COOAGEN NERVE CUFF COLLAGEN MATRIX, INC. PEGGY HANSEN
K133597 04/18/2014 CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY COOK, INC. SEAN SPENCE
K132993 04/24/2014 COUNTER OTC TENS DEVICE COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD. GUENTER GINSBERG
K123555 04/09/2014 KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY COVIDIEN JIM WELSH
K140609 04/09/2014 RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS COVIDIEN CLARE SANTULLI
K140339 04/10/2014 VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM COVIDIEN BRIANNA REYNOLDS
K133821 04/28/2014 EMPRINT ABLATION SYSTEM Covidien LLC HEATHER V NIGRO
K132105 04/03/2014 PERCLOT TOPICAL CRYOLIFE, INC. KIMBERLY DICONO
K140092 04/16/2014 CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES) CURRIE MEDICAL SPECIALTIES, INC. OWEN J BRY
K132596 04/11/2014 PROPOSED OPTIMUS CUSTOM SPINE, INC. HANAA SHAHIN
K131525 04/24/2014 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES DEFIBTECH, LLC Ed Horton
K133834 04/03/2014 DEPUY GLOBAL UNITE SHOULDER SYSTEM DEPUY (IRELAND) KELLIE MYERS
K133007 04/24/2014 DX3000-L DEXCOWIN CO., LTD Claude Berthoin
K131202 04/03/2014 MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X DIALYSIS MEDICAL SOLUTIONS, LLC COURTNEY J MILLER
K140031 04/28/2014 SUCTION PUMP DING HWA CO., LTD ROBERT O DEAN
K132284 04/10/2014 VECTRA NEO CLINICAL THERAPY SYSTEM DJO, LLC MARIA PRONINA
K140461 04/03/2014 MACH LED 2MC DR. MACH GMBH & CO. KG GUDRUN BUSCH, PH.D.
K140460 04/03/2014 MACH LED 2SC DR. MACH GMBH & CO. KG GUDRUN BUSCH, PH.D.
K132478 04/11/2014 AIR-FLOW HANDY 3.0 E.M.S. ELECTRO MEDICAL SYSTEMS S.A. CYNTHIA J NOLTE
K140123 04/24/2014 POLARIS SPINAL SYSTEM -TRANSLATION SCREW EBI, LLC MIKE MEDINA
K140702 04/04/2014 8MP COLOR LCD MONITOR, RADIFORCE RX850 EIZO CORPORATION HIROAKI HASHIMOTO
K140131 04/03/2014 SUB-Q SUBCUTANEOUS TISSUE INFUSION SET EMED TECHNOLOGIES CORPORATION PETER KOLLINGS
K132930 04/14/2014 MYHEALTHPOINT TELEHEALTH MANAGER ENTRA HEALTH SYSTEMS RICHARD STROBRIDGE
K133537 04/28/2014 EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. Cynthia Hung
K133389 04/15/2014 EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. Cynthia Hung
K132940 04/14/2014 ERCHONIA ALLAY ERCHONIA MEDICAL, INC. Kevin Walls
K132315 04/18/2014 ERGONOMIC PRODUCTS WORKSTATION ERGONOMIC PRODUCTS, INC. RENEE GOULD
K133905 04/15/2014 6200 / 6250 ULTRASOUND SYSTEM ESAOTE S.P.A. Allison Scott
K140677 04/25/2014 MYLABSSOGNO ESAOTE S.P.A. Allison Scott
K140560 04/22/2014 ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING ETHICON ENDO-SURGERY, LLC ASIFA VONHOF
K140645 04/11/2014 GIBRALT ROD-TO-ROD CROSS CONNECTORS EXACTECH SARASOTA PATRICK HUGHES
K123607 04/25/2014 OCTANE ELEVATE SPINAL IMPLANT SYSTEM EXACTECH, INC. PATRICK HUGHES
K133573 04/30/2014 FIAGON NAVIGATION SYSTEM FIAGON GMBH DIRK MUCHA
K133516 04/30/2014 CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER FLEXICARE CHRISTOPHER WATKINS
K140473 04/10/2014 DUALGUARD FLEXICARE MEDICAL LTD. CHRISTOPHER WATKINS
K130171 04/08/2014 FLIGHT 60 VENTILATOR FLIGHT MEDICAL INNOVATIONS LTD. SHOSHANA FRIEDMAN
K133588 04/25/2014 FORA CARE BLOOD PRESSURE MONITORING SYSTEM FORA CARE INC. Sharon Peng
K133006 04/17/2014 NEOV DIODE LASER FAMILY G.N.S NEOLASER LTD. GIL SHAPIRA
K132679 04/18/2014 AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER GALEMED CORP. TOM SHANKS
K133957 04/14/2014 DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE GALEMED CORP. PAUL DRYDEN
K133182 04/09/2014 HTFX-222 GC AMERICA, INC. MARK HEISS
K133922 04/18/2014 GENTLECARE AR APPLICATOR GC MEDTECH, LLC GREGORY MATHISON
K133882 04/30/2014 CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. ROBERT CASARSA
K133278 04/24/2014 DISCOVERY IGS 740 GE MEDICAL SYSTEMS SCS MICHEL GENUER
K133649 04/22/2014 HEPATIC VCAR GE MEDICAL SYSTEMS SCS HUY DOAN
K133705 04/11/2014 REVOLUTION CT GE MEDICAL SYSTEMS, LLC HELEN PENG
K131612 04/18/2014 ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGES GS MEDICAL CO., LTD. DONALD W GUTHNER
K140089 04/08/2014 CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO) Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
K132423 04/08/2014 THE GYNOCULAR GYNIUS AB MATTHEW VOLSKY
K132184 04/28/2014 ACESSA GUIDANCE HANDPIECE HALT MEDICAL INC CLARISA TATE
K131956 04/24/2014 QUICK RELAX PRO HEALTHCARE INNOVATIONS, LLC SHEPARD G BENTLEY, RAC
K140639 04/16/2014 PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM HITACHI ALOKA MEDICAL, LTD. ANGELA VANARSDALE
K131917 04/29/2014 NEURODYN COMPACT, NEURODYN II IBRAMED EQUIPAMENTOS MEDICOS TARA CONRAD
K132724 04/17/2014 ICONN ANSWER SUTURE ANCHOR ICONN ORTHOPEDICS, LLC WHITT ISRAEL
K140445 04/23/2014 DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC IMAGING SCIENCES INTERNATIONAL, LLC SANJAY AHUJA
K133669 04/04/2014 MEDINAUT KYPHOPLASTY SYSTEM IMEDICOM Priscilla Chung
K132911 04/04/2014 I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW IN2BONES SAS ERIC FOURCAULT
K133045 04/10/2014 ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM INFOPIA CO., LTD SeonMi Shin
K132406 04/18/2014 ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM INFOPIA CO., LTD Priscilla Chung
K133897 04/23/2014 TVC IMAGING SYSTEM, TVC INSIGHT CATHETER Infraredx, Inc. STEVEN J CHARTIER
K133932 04/11/2014 INION FREEDOMPIN INION OY KATI MARTTINEN
K133542 04/28/2014 PURACYN PLUS SKIN AND WOUND INNOVACYN, INC. FRED L MA
K131883 04/11/2014 AUDICOR CPAM WITH SDB (ACCELEROMETER BASED) INOVISE MEDICAL, INC. EARL ANDERSON
K134047 04/11/2014 JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS INTEGRA LIFESCIENCES CORPORATION RUTHANNE VENDY
K130557 04/24/2014 NEURAGEN 3D INTEGRA LIFESCIENCES CORPORATION STEPHEN H BEIER
K131962 04/17/2014 DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES INTUITIVE SURGICAL, INC. MIKE YRAMATEGUI
K132179 04/28/2014 ARASYS ION GENIUS INC XANYA SOFRA-WEISS, PH.D
K130456 04/08/2014 WUNDER PREGNANCY TEST JAMES NGUYEN JAMES NGUYEN, M.D.
K131944 04/10/2014 IEEG JORDAN NEUROSCIENCE, INC. ANNE PERRY
K133614 04/03/2014 ALEUTIAN IBF SYSTEM K2M, INC. NANCY GIEZEN
K140420 04/01/2014 VADO STEERABLE SHEATH KALILA MEDICAL, INC. CARRIE NEUBERGER
K133815 04/16/2014 INTESS CERVICAL CAGE SYSTEM KALITEC DIRECT, LLC J.D. WEBB
K140072 04/03/2014 CRYOTOP(R) SC KITAZATO BIOPHARMA CO., LTD. RICHARD VINCINS
K133716 04/09/2014 TRC-PASTE KM CORPORATION Priscilla Chung
K133155 04/07/2014 HYDROPHILIC COATED GUIDEWIRE LAKE REGION MEDICAL TRACY MEYER
K140482 04/08/2014 MANDREL GUIDEWIRE LAKE REGION MEDICAL MATHEW PEXA
K140042 04/10/2014 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME LEMAITRE VASCULAR, INC. BRYAN COWELL
K130878 04/04/2014 CLOUDEKG MAKROMED, INC. BARRY V ASHAR
K133149 04/30/2014 BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM MAR COR PURIFICATION, INC. KINNARI SHAH
K140257 04/02/2014 SIGNATURE PLANNER, SIGNATURE GUIDES MATERIALISE N.V. OLIVER CLEMENS
K132290 04/10/2014 SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES MATERIALISE N.V. OLIVER CLEMENS
K133534 04/18/2014 MCKESSON CARDIOLOGY ECG MOBILE MCKESSON ISRAEL LTD. PAUL SUMNER
K133914 04/03/2014 VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE MEDCOM GMBH LUCA SALVATORE
K130889 04/28/2014 SPLIT CATH RG MEDCOMP TIMOTHY HOLWICK
K133941 04/18/2014 MITEK ARTHROSCOPES MEDOS INTERNATIONAL SARL SUSAN KAGAN
K140402 04/03/2014 MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET MEDSOURCE INTERNATIONAL, LLC. JENNIFER NESS
K140442 04/22/2014 MEDSOURCE SELECTABLE IV SET MEDSOURCE INTERNATIONAL, LLC. JENNIFER NESS
K133903 04/10/2014 BIO-PROBE TRANSDUCER (ADULT) MEDTRONIC INC. RAHUL SHAH
K133653 04/28/2014 ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. JULIE BASSETT
K140375 04/18/2014 MASTERGRAFT PUTTY, MASTERGRAFT STRIP MEDTRONIC SOFAMOR DANEK USA, INC. KELLY ANGLIN
K132617 04/30/2014 MEDTRONIC INPUT PS INTRODUCER MEDTRONIC, INC. NISARG SHAH
K140069 04/07/2014 LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0 MERETE MEDICAL GMBH EMMANUEL ANAPLIOTIS
K140475 04/16/2014 ROTATING ADAPTERS MERIT MEDICAL SYSTEMS, INC. CORY MARSH
K134015 04/11/2014 M-PM-DISC MERZ DENTAL GMBH RICHARD G HUNTER
K134008 04/09/2014 MD-FLEX HEAVY BODY META BIOMED, INC. BLIX WINSTON
K140043 04/03/2014 DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD MICROPORT ORTHOPEDICS INC. MAX MORTENSEN
K133554 04/08/2014 SURGICAL LIGHT HANDLE COVER MICROTEK MEDICAL, INC. AN ECOLAB COMPANY ANDY ROLLER
K132075 04/18/2014 PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M) MINDRAY NORTH AMERICA RUSSELL OLSEN
K133624 04/18/2014 COMPASS CT, COMPASS CT PORT MIRADOR BIOMEDICAL JUSTIN HULVERSHORN
K130852 04/14/2014 AVANCE« FOAM ABDOMINAL DRESSING KIT MOLNLYCKE HEALTHCARE ANGELA L BUNN
K132547 04/17/2014 ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS) MONARCH MEDICAL TECHNOLOGIES ANN A GRAHAM
K132178 04/30/2014 MOSTDI DENTAL IMPLANT SYSTEM MOSTDI INNOVATIONS SDN BHD SUSAN PARK
K133235 04/07/2014 THREADED PEEK K-WIRE MTP SOLUTIONS LLC ROBERT HOY
K140194 04/14/2014 NAMIC RCS SYRINGE NAVILYST MEDICAL, INC. BRANDON M BRACKETT
K140125 04/29/2014 NEW STETIC DENTAL AMALGAM ALLOY NEW STETIC JOHN O'BRIEN
K133951 04/25/2014 SMARTTOUCH NEXUS6, LTD. GARTH SUTHERLAND
K140191 04/14/2014 ELISIO-H HEMODIALYZER NIPRO MEDICAL CORPORATION CAROLYN GEORGE
K133377 04/04/2014 NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE NOBEL BIOCARE AB PHUONG NGUYEN
K133910 04/04/2014 NORDICBRAINEX NORDICNEUROLAB CHANDANA GURUNG BHANDARI
K140003 04/03/2014 COROENT SMALL INTERBODY SYSTEM NUVASIVE, INC. Cynthia Adams
K131140 04/01/2014 OMNYX IDP FOR HER2 MANUAL APPLICATION OMNYX, LLC GAIL E RADCLIFFE
K132208 04/10/2014 ONTEX AND OTHERS PROPRIETARY NAMES ONTEX BVBA RACHEL PAUL
K132595 04/23/2014 ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS ONTEX BVBA RACHEL PAUL
K134039 04/11/2014 DAYTONA ICG (P200TICG) OPTOS PLC RANDY PREBULA
K131563 04/09/2014 SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM OPUS KSD, INC. ROSINA ROBINSON, RN, MED, RAC
K133387 04/29/2014 ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED ORIGIO A/S TOVE KJAER
K133707 04/16/2014 SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS ORIGIO A/S TOVE KJAER
K132999 04/14/2014 CERVICAL STAND ALONE SYSTEM ORTHOFIX INC. NATALIA VOLOSEN
K140414 04/01/2014 IMBIBE NEEDLE ORTHOVITA, INC. John Urtz
K140406 04/17/2014 DESTINO TWIST, STEERABLE GUIDING SHEATH Oscor Inc. TINA STRICKLAND
K132401 04/09/2014 MEGA ISQ OSSTELL AB CHERITA JAMES
K133271 04/28/2014 OPTEO, VIDEOGRAPH HD OWANDY Claude Berthoin
K133397 04/18/2014 P-POD P-POD LINDA BRADDON
K132620 04/16/2014 INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL PAN MEDICAL LTD JENNIE BUDDING
K140397 04/17/2014 PARALOCK PLATING SYSTEM / TUFFNEK SCREW PARAGON 28 KAREN E WARDEN
K131946 04/25/2014 ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS PENTAX MEDICAL COMPANY KRISHNA GOVINDARAJAN
K131028 04/10/2014 PENTAX VIDEO BRONCHOSCOPES (EB FAMILY) PENTAX MEDICAL COMPANY KRISHNA GOVINDARAJAN
K131855 04/09/2014 PENTAX VIDEO COLONOSCOPES (EC FAMILY) PENTAX MEDICAL COMPANY KRISHNA GOVINDARAJAN
K131902 04/10/2014 PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY) PENTAX MEDICAL COMPANY KRISHNA GOVINDARAJAN
K140771 04/25/2014 PHILIPS ELEVA WORKSPOT PHILIPS MEDICAL SYSTEMS DMC GMBH GEROLD SCHWARZ
K140808 04/17/2014 Q-STATION PHILIPS ULTRASOUND, INC. PENNY GRECO
K132563 04/24/2014 PINOOK STIMULATOR PINOOK USA TEJAS SHAH
K140696 04/10/2014 STREAMLINE TL SPINAL FIXATION SYSTEM PIONEER SURGICAL TECHNOLOGY, INC SARAH MCINTYRE
K133524 04/16/2014 PVMED DDR 2430T PORTAVISION MEDICAL LLC TERRY ANCAR
K140179 04/25/2014 EASY GO VAC PRECISION MEDICAL, INC. JAMES PARKER
K133857 04/28/2014 BRELLA-SPEC(TM) VAGINAL SPECULUM PROA MEDICAL, INC. VICTORIA NADERSHAHI
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