BEUDAMED
    23 results · 19ms · Sources: EU EUDAMED, US FDA

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    PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489105657·PowerChem Neoprene Exam Gloves, Extra Large

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489125556·PowerChem Neoprene Exam Gloves, Extra Large

    Orthopedic manual surgical instrument

    FDA UDI
    BAUI BIOTECH CO. LTD.·04710577043381·Extending Tube Holder

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450740507·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450727881·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450739518·

    EXEL INJECTION PLUG WITH CAP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ASPIRATION PUMP, MODEL IMD-020

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Recall
    Terminated ·Optovue Inc.·Product code OBO·September 7, 2012

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Enforcement
    Class II ·Terminated·Optovue Inc.·October 31, 2012

    ACCENT DR RF

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 14, 2014

    PASSPORT 2 MONITOR

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC·Product code DSI·April 30, 2013

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·May 5, 2011

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 26, 2011

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 30, 2013

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·April 14, 2015

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·May 7, 2010

    LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT

    FDA Adverse Event
    ROCHE MOLECULAR SYSTEMS·Product code OOI·July 11, 2012

    LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233

    FDA Recall
    Terminated ·Esa Biosciences, Inc.·Product code DOF·May 19, 2005