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

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    AEQUALIS UNIVERSAL SHOULDER GLENOID

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPMILAS CO2-L

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PREMIER-CRYPTOCOCCAL ANTIGEN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TORNIER AEQUALIS REVERSE SHOLDER PROSTHESIS

    FDA Adverse Event
    Malfunction ·TORNIER INC.·Product code HSD·June 18, 2009

    HAENE CLAMP

    FDA Adverse Event
    Injury ·V. MULLER INSTRUMENTS -CARE FUSION-·Product code HCZ·March 1, 2013

    PARADYM

    FDA Adverse Event
    Malfunction ·SORIN BIOMEDICA CRM S.R.L.·Product code NIK·January 14, 2011

    3I T3® TAPERED IMPLANT 5/4 X 11.5MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·August 8, 2014

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024