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

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    ADDITIVE HINGE CAP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Neo Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOFTLASE PRO, ORTHOLASE AND HYGIENELASE

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

    UNKNOWN KNEE COMPONENT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·April 9, 2025

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 6, 2014

    ASR ACETABULAR IMPLANT 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·October 15, 2012

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 10, 2010

    SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024