BEUDAMED
    8 results · 23ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GISH ARTERIAL FILTER WITH GBS COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tacrolimus Assay Kit

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008

    UNKNOWN STRATA OR DELTA VALVES

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·August 18, 2011

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·July 10, 2013

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·November 16, 2015

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026