BEUDAMED
    18 results · 29ms · Sources: EU EUDAMED, US FDA

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    FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·July 21, 2018

    OPTIFLUX 180NRE DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·August 13, 2018

    OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·July 27, 2018

    DURA-CUF

    FDA UDI
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.·00840682110259·DURA-CUF, CHILD, 1 TB SCREW, 12 - 19 CM, SINGLE

    STATLYTE NA/K/CL/LI ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code PAH·March 13, 2013

    ASR ACETABULAR CUPS 54

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

    CELL-DYN SAPPHIRE ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·February 26, 2008

    SMALL BATTERY DRIVE

    FDA Adverse Event
    Malfunction ·SYNTHES OBERDORF·Product code HWE·March 7, 2014

    DISPOSABLE ALLIGATOR

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code FCL·December 8, 2021

    BD INTROSYTE-N¿ PRECISION INTRODUCER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code DYB·April 2, 2018

    RINGLOC-X E1 H/W 50/32MM 23

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code KWA·June 30, 2021

    HAND PIECE FOR BATTERY POWERED DRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HXX·March 11, 2015

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    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