BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    KF-E SERIES OF HOLLOW FIBER DIALYZERS

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

    ERA® Implant Abutment Micro Ang. Base, 4mm Cuff (AQ)

    FDA UDI
    STERNGOLD DENTAL LLC·00841549103186·ERA abutments provide a resilient attachment wi...

    HNC-127 NEUROVASCULAR ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    GEODESIC EEG MOBILE 100 (GEM 100)

    FDA 510(k)
    FDA Class 2 ·Neurology

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 2, 2014

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code LWS·October 31, 2012

    PRESSUREWIRE CERTUS

    FDA Adverse Event
    Injury ·RADI MEDICAL SYSTEMS AB·Product code DXO·August 16, 2010

    Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5 strips 6 mm X100 mm Sterile EO Product Number: 40-2893: Wound Closure Strips , Sterile (1,000pouches/box) Rx; Pouch Label: Wound Closure Strips 6 mm X100 mm, 1/4" X 4 ", Rx Product Usage: intended for skin closure and closure support for sutures and staples

    FDA Enforcement
    Class II ·Terminated·Aspen Surgical Products, Inc.·August 28, 2013