BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    TEMPO2-I DISPOSABLE THERMOMETERS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BARRIER IMPERVIOUS S-OCKINETTE

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

    Exactech Alteon Modular Dual Mobility (MDM) System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 5, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012

    OCTRODE LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Malfunction ·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·August 6, 2010

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025