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

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    SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWP·August 30, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 14, 2015

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·January 14, 2013

    DEPUY ASR XL FEM IMP SIZE 49

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·July 3, 2014

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025