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

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    EXACTECH CERVICAL SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PERSONAL LUBRICATING GEL

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

    ACCU-CHEK COMPACT

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS CORP.·Product code NBW·December 29, 2005

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 3, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·June 22, 2011

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NKM·October 3, 2014

    ELECSYS PROLACTIN ASSAY

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CFT·February 26, 2021

    INFANT CONTINUOUS FLOW BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 24, 2015

    VENTED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 5, 2016

    EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015