FDA 510(k) Applications Received During April, 2013

FDA 510(k) Number Submission Date Device Name Applicant Contact
K130864 04/22/2013 C-MAX+ (PLUS) AAT ALBER ANTRIEBSTECHNIK GMBH STEFANIE D BANKSTON
DEN130010 04/09/2013 VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) ABBOTT MOLECULAR, INC. NANCY W BENGTSON
K131148 04/23/2013 THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH ACCESS SCIENTIFIC, LLC ALBERT MISAJON
K131146 04/30/2013 ARTASSIST AND VENASSIST ACI MEDICAL, LLC ED ARKANS
K131052 04/18/2013 TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) ACTUATED MEDICAL, INC. DEBORA DEMERS, PH.D.
K130986 04/09/2013 FRAG-LOC SYSTEM ACUMED LLC KARA BUDOR
K130755 04/04/2013 HICUT HIGHSPEED INSTRUMENT ADEOR MEDICAL AG FABIO VON ZEPPELIN
K130954 04/15/2013 ARS SCREW; SLANT SCREW ADVANCED INTERVENTIONAL TECHNOLOGY, LLC EDUARDO MARCH
K131167 04/24/2013 UNIVATION AESCULAP IMPLANT SYSTEMS, LLC JULIE T WING
K130732 04/05/2013 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) AIDE PLASTIC CO., LTD. CHU XIAOAN
K130890 04/17/2013 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) AIR PLASTIC CO., LTD. CHU XIAOAN
K130921 04/03/2013 ALIVECOR HEART MONITOR OTC ALIVECOR, INC. MICHAEL RIGHTER
K131098 04/26/2013 EMERGENCY PORTABLE VENTILATOR ALLIED HEALTHCARE PRODUCTS, INC. STEPHEN MUNDWILLER
K131119 04/22/2013 SOLANAS POSTERIOR STABILIZATION SYSTEM ALPHATEC SPINE, INC. TREVOR DENBO
K130845 04/01/2013 AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW AMBU A/S SANJAY PARIKH
K131222 04/30/2013 AMPCARE ESP THERAPY SYSTEM AMPCARE, LLC DIANE RUTHERFORD
K131203 04/29/2013 IHEALTH CLOUD ANDON HEALTH CO., LTD YI LIU
K131111 04/19/2013 IHEALTH FINGERTIP PULSE OXIMETER ANDON HEALTH CO.,LTD LIU YU
K131066 04/16/2013 AXIOM REG ANTHOGYR SAS THERESE CANDAU
K131043 04/29/2013 APEX UNIVERSAL ADHESIVE APEX DENTAL MATERIALS, INC. CHRIS KULTON
K131049 04/29/2013 ZRP APEX DENTAL MATERIALS, INC. CHRIS KULTON
K131096 04/24/2013 AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM AROBELLA MEDICAL, LLC MATTHEW BERSCHEID
K131182 04/26/2013 MULTIFIX S KNOTLESS FIXATION DEVICE ARTHOCARE CORPORATION MITCHELL DHORITY
K130859 04/01/2013 HAMMERTOE CORRECTION SYSTEM ARTHROSURFACE, INC. DAWN J WILSON
K130692 04/09/2013 M2 WRIST 2 MRI SYSTEM ASPECT IMAGING LTD GEORGE HATTUB
K130957 04/05/2013 WVSM (WIRLESS VITAL SIGNS MONITOR) ATHENA GTX SEAN MAHONEY
K131107 04/19/2013 ATRICLIP GILLINOV-COSGROVE LAA CLIP ATRICURE, INC. REBECCA WALTERS
K130987 04/19/2013 VALUTRODE NEUROSTIMLATION ELECTRODES AXELGAARD MFG. CO., LTD. DAN P JEFFERY
K131040 04/22/2013 EXTAVIPRO STERICAN 30G B. BRAUN MELSUNGEN AG KARIN LUBBERS
K131199 04/26/2013 ULTRAVERSE RX PTA BALLOON DILATATION CATHETER BARD PERIPHERAL VASCULAR, INC. MARIO THOMAS
K131208 04/29/2013 BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, BAUSCH & LOMB, INC. BARBARA KLUBE-FALSO
K130947 04/12/2013 FINGERTIP PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. LEI CHEN
K131047 04/18/2013 FINGERTIP PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. LEI CHEN
K131183 04/29/2013 MED-RX ORAL/ENTERAL SYRINGE BENLAN, INC. CHERYL BROWN
K130733 04/05/2013 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) BENTENG PLASTIC CO., LTD. CHU XIAOAN
K130963 04/08/2013 LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK BIO-RAD LABORATORIES, INC. SUZANNE PARSONS
K130990 04/10/2013 VARIANT(TM) II TURBO HBA1C KIT - 2.0 BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVISION EBONY MCKINNIES
K130944 04/10/2013 ISR'OBOT MONA LISA BIOBOT SURGICAL PTE LTD JOHN BABY
K130914 04/02/2013 FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL BIOFIRE DIAGNOSTICS, INC. BETH LINGENFELTER
K130866 04/19/2013 BIOLIGHT BIODYNAM BIOLIGHT AB PAR OLAUSSON LIDO
K130949 04/05/2013 CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS BIOMET 3I LAURA HOSHUE
K131135 04/25/2013 BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS BIOMET MANUFACTURING CORP. CARMEN ALBANY
K131064 04/16/2013 BIOSPACE BIOSPACE CORPORATION LIMITED DANIEL KAMM
K131176 04/25/2013 ROSS RU SKIN DISCONTINUITIES BIOTD, S.A. RICHARD GILLIS
K131058 04/16/2013 BIPOLAR FORCEPS BOSTON ENDO-SURGICAL TECHNOLOGIES, INC. JAMES ROGERS
K130909 04/01/2013 GATEWAY ADVANAGE Y-ADAPTER BOSTON SCIENTIFIC CORP. CHRISTINE SHOEMAKER
K130968 04/08/2013 VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM C.R. BARD, INC. KETI SINO
K131002 04/10/2013 VIDA PTV DILATATON CATHETER C.R. BARD, INC. AARON CONOVALOFF
K130751 04/12/2013 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) CABIN PLASTIC CO., LTD. CHU XIAOAN
K131101 04/19/2013 ITERO SOFTWARE CADENT, LTD. AN ALIGN TECHNOLOGY COMPANY MANAS M LELE
K131106 04/19/2013 DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS, CANON INC. DIANE RUTHERFORD
K131045 04/15/2013 ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE CARDIAC DESIGNS, LLC RAYMOND J KELLY, IV
K130927 04/03/2013 DURABLUE STERILIZATION WRAP CARDINAL HEALTH 200, LLC LAVENIA FORD
K131092 04/18/2013 STEALTH 360 ORBITAL PAD SYSTEM CARDIO SYSTEMS, INC. MAUREEN MCDONNELL
K130027 04/16/2013 DISPOSABLE NEUTRAL ELECTRODE GP202 CATHAY MANUFACTURING CORP. ZHANG HUI
K130872 04/01/2013 CARDIOCEL CELXCEL PTY LTD CHRISTOPHER SLOAN
K130894 04/01/2013 XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE CEPHEID RAINER ZIERMANN PH.D.
K131159 04/26/2013 SMARTRELIEF CHATTEM, INC. ERIC JOSEPH
K130439 04/15/2013 EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING CHONGQING PSK SCI-TECH DEVELOPMENT CO., LTD FIELD FU
K131005 04/12/2013 EBA2 FEMORAL NAILING SYSTEM CITIEFFE S.R.L. CLAUDE BERTHION
K131161 04/24/2013 EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION, CIVCO MEDICAL INSTRUMENTS CO., INC. AMANDA STAHLE
K131178 04/25/2013 IDYS LIF CAGES CLARIANCE JANICE M HOGAN, ESQ.
K131072 04/17/2013 ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC COLOPLAST A/S BRIAN SCHMIDT
K130644 04/01/2013 PEDIATRIC FOLDING WHEELCHAIR COLUMBIA MEDICAL MFG, LLC GARY WERSCHMIDT
K131019 04/12/2013 ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA SHAH
K131198 04/26/2013 TIPI OTC CONTIPI LTD. JONATHAN KAHAN
K131015 04/11/2013 BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT COOK BIOTECH, INC. MARY A FADERAN
K131204 04/29/2013 ADVANCE CS CORONARY SINUS INFUSION CATHETER COOK, INC. JENNIFER RICHARDSON
K131206 04/29/2013 COOK CERVICAL RIPENING BALLOON COOK, INC. CHIRS KILANDER
K131201 04/29/2013 ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET COOK, INC. ERUM B NASIR
K130981 04/11/2013 FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM CORDIS CORP. KIM FONDA
K131225 04/30/2013 ADROIT GUIDING CATHETER CORDIS CORP., A JOHNSON & JOHNSON CO. MARY E HOLDEN
K130904 04/01/2013 TRELLIS-8 PERIPHERAL INFUSION SYSTEM COVIDIEN JENNIFER SULLIVAN
K131170 04/26/2013 SONICISION STERILIZATION TRAY COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE DAVID HORTON
K131079 04/17/2013 CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC CREGANNA MEDICAL DEVICES CHRISTINE NICHOLS
K130906 04/03/2013 ENDOFLIP CATHETER CROSPON, LTD. PAUL DRYDEN
K131033 04/12/2013 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) DECENT PLASTIC CO., LTD. CHU XIAOAN
K131020 04/16/2013 TEMPERATURE SENSOR CATHETER DEGANIA SILICONE, LTD. ZOYA LEE
K131197 04/26/2013 EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS DENTAL MORELLI TARA CONRAD
K130999 04/10/2013 OSSEOSPEED PROFILE EV DENTSPLY IMPLANTS MANUFACTURING GMBH LINDA K SCHULZ
K131191 04/26/2013 4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS DEPUY MITEK, A JOHNSON & JOHNSON COMPANY SUSAN KAGAN
K130917 04/03/2013 HEALIX ADVANCE KNOTLESS BR ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON COMPANY YAYOI FUJIMAKI
K130912 04/02/2013 OMNICUT RESECTION BLADE DEPUY MITEK, A JOHNSON & JOHNSON COMPANY TATYANA KORSUNSKY
K130779 04/04/2013 LVIVO EF SYSTEM DIACARDIO, LTD GEORGE HATTUB
K131044 04/16/2013 SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION DIACOUSTIC MEDICAL DEVICES (PTY) LTD. YOLANDA SMITH
K130511 04/22/2013 CITRISOL ACID CONCENTRATE DIASOL, INC. MONICA ABELES
K131037 04/16/2013 LIAISON XL HCG DIASORIN, INC. MARI MEYER
K131190 04/30/2013 MYPATCH DMS-SERVICE LLC LYNDA S COLE
K131094 04/18/2013 VIMOVE DORSA VI PTY. LTD SHOSHANA FRIEDMAN
K131095 04/22/2013 DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS EL.EN. ELECTRONIC ENGINEERING SPA PAOLO PERUZZI
K130996 04/12/2013 ERCHONIA EMERGE ERCHONIA MEDICAL, INC. KEVIN WALLS
K130922 04/03/2013 ERCHONIA VERJU LASER SYSTEM WITH MASSAGER ERCHONIA MEDICAL, INC. KEVIN WALLS
K130900 04/15/2013 EVICEL APPLICATION DEVICE ETHICON INC (ON BEHALF OF OMRIX BIOPHARACEUTICALS LTD) SHIKHA GOLA
K131185 04/26/2013 ANA SCREEN ELISA (IGG) EUROIMMUN US MICHAEL LOCKE
K130911 04/02/2013 RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER EV3 INC. LAURA J LIND
K131153 04/26/2013 EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP EVENFLO FEEDING INCORPORATED WADE HALMA
K130975 04/08/2013 SWABCAP AND SWABFLUSH EXCELSIOR MEDICAL CORP. MICHAEL HEYL
K131196 04/26/2013 INFANT PHOTOTHERAPY BILITRON SKY 5006 FANEM LDA TARA CONRAD
K130891 04/17/2013 POWDER FREE VINYL PATIENT EXAMINATION GLOVES FRIEND PLASTIC CO., LTD. CHU XIAOAN
K130788 04/25/2013 CAPELLA FUTURE MOBILITY HEALTHCARE INC. ABDULSAMAD PANCHBHAYA
K131118 04/24/2013 4D VIEW GE HEALTHCARE BRYAN BEHN
K131223 04/30/2013 CARESCAPE MONITOR B650 GE HEALTHCARE FINLAND OY JOEL KENT
K130913 04/08/2013 GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM GENESYS SPINE WILLIAM W SOWERS
K130983 04/11/2013 GENII ARC SMART ARGON PROBE GENII, INC. TRACY EBERLY
K130977 04/09/2013 SIGNIFY BIOACTIVE GLOBUS MEDICAL INC. SARAH MARIE FITZGERALD
K130781 04/03/2013 L.A.M. IPM WOUND GEL, IPM DERM GEL GLYCOBIOSCIENCES, INC OLUFEMI ADEOYE
K130908 04/01/2013 DISPOSABLE SILICONE FOLEY CATHETER GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD DIANA HONG
K130997 04/17/2013 NEOVEIL GUNZE LIMITED NOBUYA ONISHI
K130682 04/17/2013 MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT HAGER & MEISINGER GMBH WIEBKE STOLTEN
K130937 04/04/2013 WAVE 2G, SOUL HANSATON AKUSTIK GMBH NICK BURMESTER
K131121 04/29/2013 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR HEALTH & LIFE CO., LTD. SARAH SU
K131177 04/25/2013 SINUFLUSH LAVAGE SYSTEM HEDGEPATH, LLC FRANK E O'DONNELL, JR MD.
K130736 04/03/2013 BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS HELIX MEDICAL, LLC THOMAS M VASSALLO
K131051 04/17/2013 HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) HITACHI CHEMICAL DIAGNOSTICS, INC. ERIKA AMMIRATI
K131217 04/30/2013 S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN HITACHI CHEMICAL DIAGNOSTICS, INC. CHARLES TSOU
K131173 04/25/2013 FIA Blood Glucose Monitoring System (G2) HMD BIOMEDICAL, INC. AXEL LIN
K130925 04/19/2013 AUTOMATIC BLOOD PRESSURE MONITOR HONSUN (NANTONG) CO., LTD. SELINA QIAN
K130807 04/17/2013 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) HOPE PLASTIC CO., LTD. CHU XIAOAN
K131099 04/19/2013 AG MASS HOSPITECH RESPIRATION LTD. YORAM LEVY
K130895 04/01/2013 REUNION RSA SHOULDER SYSTEM HOWMEDICA OSTEONICS CORP ESTELA CELI
K131168 04/24/2013 IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY IMMUNALYSIS CORPORATION JOSEPH GINETE
K131097 04/18/2013 LEGACY3 6MM LENGTH IMPLANTS IMPLANT DIRECT SYBRON MANUFACTURING LLC INES ARAVENA
K130846 04/01/2013 MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN INDUSTRIAL CLOTHINGS, LTD. S.N. HARI
K130958 04/05/2013 TRUE SPINAL FIXATION SYSTEM INNOVATIVE SURGICAL DESIGNS ED MORRIS
K131184 04/25/2013 INTEGRA LICOX PTO2 MONITOR INTEGRA LIFESCIENCES CORP. ELIZABETH MCMENIMAN
K130821 04/02/2013 INTEL-GE CARE INNOVATIONS CONNECT RCM INTEL-GE CARE INNOVATIONS LLC MAUREEN GLYNN
K131000 04/10/2013 V-PATCH SYSTEM INTELESENS LIMITED PAUL DRYDEN
K130915 04/02/2013 XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK JAS DIAGNOSTICS, INC. DAVID H JOHNSTON
K130809 04/17/2013 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) JEWEL PLASTIC CO., LTD. CHU XIAOAN
K130931 04/04/2013 EASY DAY (METHAFILCON A) 1-DAY SOFT (HYDROPHILIC) CONTACT LENS JIANGSU HORIEN CONTACT LENS CO., LTD. JENNIFER REICH
K130847 04/03/2013 JINTRONIX REHABILITATION SYSTEM (JRS) JINTRONIX INC. NAVNEET SEKHON
K131030 04/12/2013 RANGE SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K130800 04/12/2013 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) KAIXUAN PLASTIC CO., LTD. CHU XIAOAN
K130936 04/15/2013 AERODR SYSTEM WITH P-31 KONICA MINOLTA MEDICAL & GRAPHIC, INC. RUSSEL MUNVES
K131068 04/17/2013 TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID KURARAY NORITAKE DENTAL INC. MICHIO TAKIGAWA
K131117 04/22/2013 ZIRMON SERIES KUWOTECH CO., LTD PRISCILLA CHUNG
K130940 04/04/2013 KYMCO EQ20C SCOOTER KWANG YANG MOTOR CO., LTD. JUNNATA CHANG
K130798 04/01/2013 PRE-FORMED GUIDEWIRES LAKE REGION MEDICAL, INC. MATHEW PEXA
K131156 04/24/2013 LANX SPINAL FIXATION SYSTEM LANX, INC. MICHAEL MEDINA
K131006 04/30/2013 ANESTHESIA CONDUCTION NEEDLES LCCS PRODUCTS LIMITED MIKE GU
K130982 04/17/2013 LERADO, POWER WHEELCHAIR LERADO GLOBAL (MACAO COMMERCIAL OFFSHORE) LIMITED JEN KE-MIN
K131048 04/15/2013 LIDCO CNAP MODULE LIDCO LTD. GREGORY SPELLER
K131077 04/18/2013 LIFE SPINE PLATEAU SPACER SYSTEM LIFE SPINE RANDY LEWIS
K131112 04/22/2013 LIMACORPORATE SMR CTA HUMERAL HEADS LIMACORPORATE S.P.A. CHERYL HASTINGS
K131035 04/12/2013 Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM LINVATEC CORPORATION D/B/A CONMED LINVATEC JOY LOVETT
K130878 04/17/2013 CLOUDEKG MAKROMED, INC. BARRY V ASHAR
K131158 04/24/2013 CORVIEW MARREK, INC JEREMY M FOTHERINGHAM
K130889 04/25/2013 SPLIT CATH RG MEDCOMP TIMOTHY HOLWICK
K130897 04/25/2013 MEDCOMP VASCU-PICC WITH VALVE MEDCOMP (MEDICAL COMPONENTS) JESSICA LEO
K130923 04/25/2013 5F DIGNITY CT TITANIUM PORT MEDICAL COMPONENTS INC SARAH SHAFFER
K131155 04/29/2013 UGFT3; FHT7 MEDISIM LTD. MOSHE YARDEN
K131085 04/22/2013 CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000 MESPERE LIFESCIENCES INC. HELEN TAN
K131162 04/24/2013 MIRADRY SYSTEM MIRAMAR LABS, INC. KATHY O'SHAUGHNESSY
K130628 04/03/2013 PATHFAST CK-MB-II CALIBRATORS MITSUBISHI CHEMICAL MEDIENCE CORPORATION JUDI SMITH
K131016 04/11/2013 ROGS MOLECULAR PRODUCTS LTD. PAUL DRYDEN
K130852 04/02/2013 AVANCE MOLNLYCKE HEALTHCARE ANGELA L BUNN
K131038 04/17/2013 NMI PICC MAXIMAL BARRIER NURSING KITS NAVILYST MEDICAL, INC. MARION W GORDON
K130772 04/03/2013 MD211C2 21.3" DIAGNOSTIC IMAGING LCD MONITOR NEC DISPLAY SOLUTIONS, LTD. ANGUS HSU
K130770 04/03/2013 MD211C3 21.3" DIAGNOSTIC IMAGING LCD MONITOR NEC DISPLAY SOLUTIONS, LTD. ANGUS HSU
K130198 04/30/2013 NEO DENTA ZIRCONIA NEO GROUP LIMITED MIKE ADAMS
K130919 04/03/2013 SENSUS NEUROMETRIX, INC. RAINER MAAS
K131082 04/18/2013 INTERFORM INTERBODY CAGE SYSTEM NEXT ORTHOSURGICAL J.D. WEBB
K131061 04/18/2013 RESTORE BUNION CORRECTION SYSTEM NEXTREMITY SOLUTIONS JANET WEBB
K131145 04/26/2013 PROINSERT NIDACON INTERNATIONAL AB DANIEL KAMM
K130930 04/22/2013 OWL CONTACT LENS CASES, DOG CONTACT LENS CASES NINGBO LISHUNDA ELECTRONICS CO., LTD. CHARLES SHEN
K131021 04/23/2013 PULSE OXIMETER NONIN MEDICAL, INC. BRODIE PEDERSEN
K131013 04/17/2013 FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM NOVA BIOMEDICAL CORPORATION PAUL W MACDONALD, PHD
K131226 04/30/2013 NOVAPROBE LED LIGHT SOURCE NOVAPROBE INCORPORATED MANISH INGLE
K131014 04/11/2013 PANA SPRAY PLUS NSK AMERICA CORP. DIANE RUTHERFORD
K130995 04/16/2013 NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY NUANCE MEDICAL, LLC MARC S LIEBERMAN
K131025 04/12/2013 ARCHON ANTERIOR CERVICAL PLATE SYSTEM NUVASIVE, INC. CYNTHIA ADAMS
K131050 04/17/2013 NXSTAGE 1.6M2 DIALYZER NXSTAGE MEDICAL, INC. NNAMDI NWACHUKWU
K131211 04/29/2013 DICOMPACS DX-R WITH FLAT PANEL OEHM UND REHBEIN GMBH FRANZISKA GUENTHER
K130819 04/01/2013 CLL- V1 LIGHT SOURCE OLYMPUS WINTER & IBE GMBH SHERI L MUSGNUNG
K131181 04/25/2013 OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE OMEGA LABORATORIES, INC. ROBERT J BARD, JD, RAC, CQE
K131128 04/23/2013 OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES OMEGA LABORATORIES, INC. ROBERT J BARD, JD
K131140 04/22/2013 OMNYX IDP FOR HER2 MANUAL APPLICATION OMNYX, LLC GAIL E RADCLIFFE
K131126 04/30/2013 OPTI CCA-TS2 OPTI MEDICAL SYSTEMS INC. LEN OWENS
K130971 04/09/2013 OPTUM TELEHEALTH APPLICATION OPTUMHEALTH CARE SOLUTIONS, INC. ROSHANA AHMED, MA, RAC
K131022 04/12/2013 OVATION 10/12 HIP STEM ORTHO DEVELOPMENT CORP. TOM HAUETER
K130932 04/04/2013 FIREBIRD SPINAL FIXATION SYSTEM ORTHOFIX, INC. JACKI GEREN
K131028 04/17/2013 PENTAX VIDEO BRONCHOSCOPES (EB FAMILY) PENTAX MEDICAL COMPANY KRISHNA GOVINDARAJAN
K130920 04/03/2013 CORRECT PLUS 1 PENTRON CLINICAL WENDY GARMAN
K131032 04/24/2013 PHILIPS SURESIGNS CENTRAL PHILIPS MEDICAL SYSTEMS MARY KRUITWAGEN
K130842 04/22/2013 ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. JOS VAN VROONHOVEN
K130893 04/01/2013 XPERCT REL. 3 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. LISELOTTE KORNMANN
K130992 04/10/2013 PINNACLE3 RADIATION THERAPY PLANNING SYSTEM PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. DIANE SUDDUTH
K131230 04/30/2013 GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION PHILOSYS, INC. LINDA CHAN
K131100 04/19/2013 STREAMLINE TL SPINAL SYSTEM PIONEER SURGICAL TECHNOLOGY, INC SARAH MCINTYRE
K130952 04/05/2013 PRECISION ONE LIFECARE; DETECTO; DETECTO PRECISION ONE LIFECARE, LTD. STEVEN CHERNOFF
K131212 04/29/2013 PREMIER CERAMIC PRIMER PREMIER DENTAL PRODUCTS CO. VINCENT D'ALESSANDRO
K130924 04/03/2013 BRUXZIR SHADED PRISMATIK DENTALCRAFT, INC. ARMIN ZEHTABCHI
K131009 04/11/2013 PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) PROTEUS DIGITAL HEALTH, INC. JAFAR SHENASA
K131060 04/18/2013 CLEARGUARD HD END CAP PURSUIT VASCULAR, INC LAURIE E LYNCH, PH.D.
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