BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    AGXO

    FDA UDI
    Oticon A/S·05707131260437·H100, MINIBTE 312 WL 85 TC AGXO

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 24, 2014

    CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000

    FDA 510(k)
    FDA Class 2 ·Neurology

    ROMA (HE4 EIA + ARCHITECT CA 125 II)

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

    WAVEWRITER ALPHA? PRIME 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 12, 2025

    BD ULTRA FINE¿ INSULIN PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·June 1, 2018

    AKREOS ADVANCED OPTICS ASPHERIC LENS

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQL·May 24, 2013

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    FDA Adverse Event
    Death ·THORATEC CORP.·Product code DSQ·June 15, 2011

    PUMP MMT-715NAS PRDGM INS V2.1 SK EN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·August 22, 2008

    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