BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    CO BREATH ANALYSIS MODULE & MONOXOL II

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Diamondback 360 Peripheral Orbital Atherectomy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 27, 2019

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

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

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·January 4, 2011

    RENASYS EZ PLUS

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW WOUND MANAGEMENT·Product code OMP·July 23, 2014

    ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020