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

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    Vital Navigation System

    FDA 510(k)
    FDA Class 2 ·Neurology

    ALYTE Y-MESH GRAFT

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

    COAXIAL APPLICATOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COULTER AC*T DIFF HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·June 26, 2013

    RESTORE PRIME ADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 22, 2011

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·October 22, 2014

    bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018