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

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    SPOTLIGHT ACCESS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    AEROVENT PLUS CHC

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 15, 2022

    OCTRODE

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 25, 2013

    ARCHITECT C4000 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·June 3, 2011

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM WITH DURAFLO TREATMENT

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code KRH·August 11, 2008

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 31, 2019

    MYSPINE UNILATERAL LEFT GUIDE S01

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·August 22, 2024

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 31, 2019

    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