BEUDAMED
    9 results · 24ms · Sources: EU EUDAMED, US FDA

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    STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER

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

    Oticon

    FDA UDI
    Oticon A/S·05707131256270·NERA PRO, MINIBTE 312 WL 85 TC

    IMPROVIS IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 3, 2024

    VITALIO

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWP·October 1, 2014

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 29, 2013

    CAPSURE SP NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·June 16, 2011

    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