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

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    SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    FUNNEL GUIDE CATHETER MODEL G1020608

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·July 1, 2014

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014

    32MM M2A MOD HEAD +6MM NK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWY·May 14, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·April 28, 2011

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025