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

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    Posterior Cervical Spine System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    K-ETCHANT SYRINGE; NEEDLE TIP (E)

    FDA 510(k)
    FDA Class 2 ·Dental

    CADD SOLIS VIP PUMP

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·June 7, 2022

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 26, 2011

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 18, 2013

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025