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

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    SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CAPSTONE CONTROL™ Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169055643·SPACER 3990927 CAPSTONE IR 0 DEG 09X27

    Capstone Control PTC Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169679559·SPACER 4990927 CONTROL PTC 0 DEG 9X27

    Oscillometric Blood Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OXYGENERATOR NO. M-049

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LIBERTÉ¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code MAF·March 6, 2013

    SCREW-IN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MPRI·Product code NVY·August 8, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021