BEUDAMED
    25 results · 23ms · 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 ×

    FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Complete Cervical

    FDA UDI
    Seaspine Orthopedics Corporation·10889981040529·Implant - 18x15x9mm - 6 deg

    Ascendant

    FDA UDI
    Choice Spine, LP·10885862260666·

    VIVATRAK

    FDA 510(k)
    FDA Class 1 ·General Hospital

    EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Immunology

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 2, 2019

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 23, 2023

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·May 3, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 10, 2011

    SAFETY FLEX CUFFED

    FDA Adverse Event
    Injury ·COVIDIEN/FORMERLY TYCO·Product code BTR·August 6, 2008

    THROMBUSTER II

    FDA Adverse Event
    Malfunction ·KANEKA CORPORATION·Product code MMY·March 17, 2014

    THROMBUSTER II

    FDA Adverse Event
    Malfunction ·KANEKA CORPORATION·Product code DXE·October 23, 2012

    THROMBUSTER II

    FDA Adverse Event
    Malfunction ·KANEKA CORP.·Product code DXE·December 21, 2012

    THROMBUSTER II

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code DXE·January 16, 2019

    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011

    HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·June 12, 2024

    cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025