BEUDAMED
    19 results · 26ms · Sources: EU EUDAMED, US FDA

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    COLLADENTAL BARRIER

    FDA 510(k)
    FDA Class 2 ·Dental

    Performance Health

    FDA UDI
    Performance Health Supply, LLC·10885914087357·SEIRIN J-TYPE 0.23X30MM ACUPUNCTURE NEEDLE 100/pk

    MOVES

    FDA UDI
    Thornhill Research Inc·10807141000008·Assy, Ventilator Cartridge

    Oticon

    FDA UDI
    Oticon A/S·05707131164025·ACTO, BTE 13 CNB

    Nitanium® Variable Force Spring

    FDA UDI
    Ortho Organizers, Inc.·00190707054700·.020 x .100 Nitanium® Variable Force Spring

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·ACUMED, LLC·Product code HRS·July 14, 2025

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·ACUMED, LLC·Product code HRS·July 14, 2025

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·ACUMED, LLC·Product code HRS·July 14, 2025

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·ACUMED, LLC·Product code HRS·July 14, 2025

    GE DOLPHIN DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASONIC PULSED DOPPLER IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    KOALA CLAMP

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

    FDA Adverse Event
    Malfunction ·COOK INC·Product code OQY·May 13, 2026

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    UNKNOWN·Product code ITJ·May 8, 2013

    QUICKFLASH

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL, INC.·Product code DQY·July 16, 2014

    ON-Q PUMP

    FDA Adverse Event
    Injury ·I-FLOW CORPORATION·Product code MEB·May 18, 2011

    LL100 MULTI TIP W/TC

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code GEH·August 2, 2023

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    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

    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