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

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    SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Lung Nodule Assessment and Comparison Option (LNA)

    FDA 510(k)
    FDA Class 2 ·Radiology

    STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - CORK·Product code DTK·May 14, 2013

    ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)

    FDA Enforcement
    Class II ·Ongoing·Sklar Instruments·January 22, 2025

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·February 14, 2013

    SIG MOD TIB TRAY CEM COCR 3

    FDA Adverse Event
    Injury ·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code JWH·January 7, 2011

    OXIMAX NEONATAL/ADULT OXYGEN SENSOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code DQA·July 11, 2014

    ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)

    FDA Recall
    Open, Classified ·Sklar Instruments·Product code KAD·December 3, 2024