BEUDAMED
    9 results · 22ms · Sources: EU EUDAMED, US FDA

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    Atellica IM Total PSA II (tPSAII)

    FDA 510(k)
    FDA Class 2 ·Immunology

    SpheRx

    FDA UDI
    Nuvasive, Inc.·00887517454249·SpheRx II Staple, Large Superior

    SUPER VIEW DISPOSABLE BIOM LENS SET

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    G.o.c.c.l.e.s.

    FDA 510(k)
    FDA Class 2 ·Dental

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 14, 2014

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY PUERTO RICO·Product code GEI·August 30, 2011

    CONTAK RENEWAL

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 29, 2013

    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

    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