BEUDAMED
    11 results · 37ms · Sources: EU EUDAMED, US FDA

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    inHEART Models

    FDA 510(k)
    FDA Class 2 ·Radiology

    MYSPINE UNILATERAL LEFT GUIDE S01

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

    HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TOX AMMONIA CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    KINETRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code MHY·February 29, 2012

    INFUSO.R.

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    SERVO 300

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·August 19, 2008

    FLEXCATH STEERABLE SHEATH

    FDA Adverse Event
    Malfunction ·MEDTRONIC CRYOCATH LP·Product code DRA·July 17, 2013

    KINETRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code MHY·March 1, 2012

    KINETRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code MHY·March 1, 2012

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022