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

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    DISPOSABLE PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 28, 2025

    MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VOYAGER/VIPER WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MAMMARY IMPLANT

    FDA Adverse Event
    Injury ·DOW CORNING CORP.·Product code FTR·September 23, 1994

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 25, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 6, 2025

    TI VECTRA-T PLATE

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code KWQ·February 28, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 1, 2011

    CLEARSTAR PUMP

    FDA Adverse Event
    Malfunction ·ROSS PRODUCTS DIVISION·Product code LZH·February 21, 2008

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024