BEUDAMED
    17 results · 18ms · 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.

    JACKSON RARE EARTH MAGNETIC ATTACHMENT

    FDA 510(k)
    FDA Class 1 ·Dental

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209132058·

    CC-100 CLOCK/CALANDER MODULE ACCESS. FOR G-2000 EL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SHARPLAN MODEL 1060 CO/2 SURGICAL LASER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    UNIFY ASSURA CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·June 6, 2014

    ENTRUST AT

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code LWS·October 5, 2010

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·December 3, 2012

    Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code IXW·April 1, 2016

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code OTE·June 11, 2025

    Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)

    FDA Recall
    Open, Classified ·Fujifilm Medical Systems U.S.A., Inc.·Product code LLZ·May 22, 2020

    FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. Model/Catalog Number: 566-16130-23 566-16130-33

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code KPR·April 11, 2024

    Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code LLZ·September 15, 2016

    FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code KPR·September 15, 2025

    FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code KPR·January 9, 2026

    SYNCHRON System(s) Chemistry RF Rheumatoid Factor Part Number 475136 RF reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems CAL 5 Plus, is intended for quantitative determination of Rheumatoid Factor concentration in human serum or plasma.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DHR·June 21, 2010

    Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code LLZ·April 30, 2021

    Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code LLZ·February 11, 2025