BEUDAMED
    8 results · 21ms · 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.

    T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Transcend 365 miniCPAP System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ANALYZER, 100, BICHROMATIC, ABBOTT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TRANSCEND 365 MINICPAP SYSTEM

    FDA Adverse Event
    Injury ·SOMNETICS INTERNATIONAL, INC.·Product code BZD·October 6, 2021

    SYMBIQ 3.13 DUAL CHA

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 8, 2014

    TERUMO SOFT FLOW CANNULAE

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWF·October 15, 2010

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 19, 2012

    a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025