BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    HARDYDISK CLINDAMYCIN, 2MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·March 26, 2026

    RANDOX FERRITIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    CHASE CARDIOVASCULAR PATCH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD SYRINGE LUER-LOK¿ TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 30, 2018

    BD 1ML SYRINGE LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 29, 2020

    NEW LIGASURE 5MM

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code GEI·February 13, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·February 9, 2011

    6800

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

    TUMMY TUCK & BREAST PACK-RFMHI 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·September 9, 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