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

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    ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Oticon

    FDA UDI
    Oticon A/S·05707131256799·NERA PRO, MINIRITE 312 WL CNB

    ArgenIS

    FDA UDI
    ARGEN CORPORATION, THE·D818131666·TiBase HIO 3.5 1.0G E

    SYNGO. PLAZA VA20A

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RELOAD FOR 60MM ECHELON

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 22, 2021

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 4, 2024

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·May 29, 2013

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014

    ENTRUST AT

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·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