BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    PERCUTANEOUS DRAINING CATHETER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    JOE LUB HELMET CONDOM

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

    OXIMETRY INTERFACE KIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MINI-INFUSER RADIATION STERILIZED EXTENSION SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 7, 2021

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 15, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

    3 MOTOR ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·August 17, 2010

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    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