BEUDAMED
    16 results · 22ms · 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 ×

    IBS Implant System II

    FDA 510(k)
    FDA Class 2 ·Dental

    DEROYAL SURGICAL, UMBILICUP

    FDA 510(k)
    FDA Class 2 ·Hematology

    CORDIS 13F CATHETER SHEATH INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KARDIAMOBILE

    FDA Adverse Event
    Malfunction ·ALIVECOR·Product code DPS·January 24, 2022

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 24, 2014

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·July 27, 2011

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FPA·July 1, 2013

    PATIENT INTERFACE NIM4CPB1 NIM 4.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·October 28, 2025

    STIMULATOR, ELECTRICAL, EVOKED RESPONSE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·July 31, 2023

    NIM 4.0 CONSOLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·September 5, 2025

    NIM 4.0 CONSOLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·August 2, 2024

    NIM 4.0 CONSOLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·May 20, 2025

    TINA SINGLE PUMP NIBP LCD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKP·October 29, 2008

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021