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

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    MEDI PEN NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NMI MICROCATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS

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

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 2, 2026

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 16, 2011

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.·Product code DTB·August 21, 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