BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    ACUSON

    FDA 510(k)
    FDA Class 2 ·Radiology

    PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EUNITY

    FDA 510(k)
    FDA Class 2 ·Radiology

    HARMONIC ACE SHEARS, ERG HANDLE, CURVED BLADE

    FDA Adverse Event
    Malfunction ·STRYKER SUSTAINABILITY SOLUTIONS·Product code LFL·May 22, 2013

    ATTAIN ABILITY

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

    MEDTRONIC

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code LKK·August 20, 2008

    MOZEC¿ RX PTCA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·September 20, 2022

    MOZEC¿ RX PTCA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·September 20, 2022

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·November 18, 2015

    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