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

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    ANESTHESIA OXYGEN ANALYZER MODEL 101

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SURGIPULSE HEART RATE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AIRWAY PRESSURE MONITOR

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

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·May 5, 2014

    CAPSUREFIX NOVUS

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

    QUPID HCG URINE PREGNANCY CASSETTE

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code JHI·August 2, 2010

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    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