BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    OLYMPUS UREA NITROGEN (BUN) REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BabySat 3

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    K-FIX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·January 18, 2013

    COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L-TE4BE1AB

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, IRVINE·Product code OAD·November 19, 2010

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 9, 2014

    MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 2026

    Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class I ·Terminated·Covidien·February 11, 2015

    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