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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    MODIFICATION TO EZ HUBER SAFETY INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496071846·STRIPE GAME IDRA, SIZE XL, RUBINO, GRADUATED CO...

    BIOTECH POWERED WHEELCHAIR, C650PW

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ELECSYS INSULIN CALCHECK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AVISTA MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 31, 2022

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·April 22, 2013

    ZENITH

    FDA Adverse Event
    Injury ·Product code MIH·April 21, 2011

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008

    Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·July 18, 2018

    BD INTIMA-II Y 24GAX0.75IN PRN

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·November 3, 2023

    WAVEWRITER ALPHA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 24, 2025

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021