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

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    Pocket Colposcope System

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

    Restore

    FDA UDI
    KEYSTONE DENTAL, INC.·D768L18103401K0·Cover Screw

    NIOX MINO MODEL 09-1000

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DRY·July 1, 2011

    DEPUY ASR XL FEM IMP SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·June 20, 2013

    INTELECT ADVANCED COMBO MONOCHROME

    FDA Adverse Event
    Malfunction ·CHATTANOOGA GROUP·Product code IPF·September 29, 2008

    SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

    FDA Enforcement
    Class II ·Terminated·SenTec AG·August 14, 2019