BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

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    SPIRO'AIR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809870800·FOR MEN 20-30 MM HG THIGH MICRO DOT BAND OPEN T...

    CBS STRAW

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code KNS·March 15, 2019

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·April 9, 2013

    UPHOLD VAGINAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 6, 2011

    INSIGNIA PLUS

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008

    CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code KNS·February 4, 2019

    CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code KNS·August 8, 2018

    NCB, DF PLATE, RIGHT, 13 HOLES, 324 MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HRS·June 11, 2018

    CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code KNS·August 8, 2019

    HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018