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

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    ONCOLOGY SALVAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RHK SEGMENTAL SHORT YOKE

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·December 7, 2016

    DURA-CUF

    FDA UDI
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.·00840682109932·DURA-CUF, LARGE ADULT LONG, 2 TB MATED SUBMIN, ...

    RANGER II M6, MODEL IN-888WNL

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BROOKER TIBIA NAILS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 6, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·October 24, 2024

    BD SYRINGE AND NEEDLE COMBINATION LUER-LOK¿¿ TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 27, 2018

    LUMAX 340 DR-T

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code MRM·February 13, 2013

    ASR UNI FEMORAL IMPL SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 17, 2011

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·February 26, 2008

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015

    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