BEUDAMED
    11 results · 35ms · Sources: EU EUDAMED, US FDA

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    DIASTAT ANTI-THYROID PEROXIDASE KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    LGN PS HIGH FLEX XLPE SZ 1-2 13MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017

    GII PS HI FLEX ISRT SZ 7-8 9

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·July 19, 2017

    DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LGN PS HIGH FLEX XLPE SZ 1-2 13MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017

    GII ARTICULAR INSERTER/EXTRACT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBH·February 9, 2018

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·February 9, 2013

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·January 6, 2011

    NEOPUFF INFANT RESUSCITATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·July 22, 2014

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024