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

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    KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay

    FDA 510(k)
    FDA Class 2 ·Immunology

    LIGHT CURE RETAINER

    FDA 510(k)
    FDA Class 2 ·Dental

    ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PINNACLE MTL INS NEUT40IDX60OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·October 10, 2014

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 11, 2013

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY AG·Product code MTA·October 20, 2015

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4 LEFT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 23, 2017

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024