BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    BASSINET STAND WITH DRESSING TRAY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM

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

    SaliPen

    FDA 510(k)
    FDA Class 2 ·Dental

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·June 18, 2014

    INOMAX DS (DELIVERY SYSTEM)

    FDA Adverse Event
    Malfunction ·INO THERAPEUTICS LLC/IKARIA·Product code MRN·October 1, 2010

    LOCKING SCREW

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·December 20, 2012

    Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

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

    CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024

    Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·October 25, 2017