BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 28, 2024

    OXYGEN/AIR TUBING

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PARALLELING GUIDES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CODEMASTER XL+

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code LDD·June 25, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 22, 2013

    EON MINI IPG

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·December 9, 2010

    UHN Ø6.7 L280 TAN VIOL

    FDA Adverse Event
    Injury ·SYNTHES SALZBURG·Product code JDS·June 23, 2016

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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