BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    Slow Wave DS8 (SWDS802)

    FDA 510(k)
    FDA Unclassified ·Unknown

    Sonic

    FDA UDI
    Sbo Hearing A/S·05714464054930·SONIC RADIANT 40 MNR T R BE/TP

    INTEGRA EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AESKULISA CARDIOLIPIN AGM

    FDA 510(k)
    FDA Class 2 ·Immunology

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    TPRLC 133 TYPE1 BM SO 11.0

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·August 7, 2018

    QUICKFLEX MICRO LV LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·September 9, 2011

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·August 26, 2008

    UV FLASH TRANSFER SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 22, 2013

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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