BEUDAMED
    13 results · 25ms · Sources: EU EUDAMED, US FDA

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    MRI MARKER

    FDA 510(k)
    FDA Class 2 ·Radiology

    EMM EQUIPMENT COVER-POLYTHYLENE

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

    DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    WAVEWRITER ALPHA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 6, 2026

    FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·April 2, 2020

    SPECTRA WAVEWRITER?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 13, 2026

    IROX

    FDA Adverse Event
    Malfunction ·GUIDANT ANGLETON/ST. PAUL·Product code DTB·October 1, 2014

    MBT CEM KEEL TIB TRAY SZ4

    FDA Adverse Event
    Injury ·DEPUY (IRELAND)/REG. #9616671·Product code NJL·May 29, 2013

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011

    VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·December 29, 2021

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015

    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