BEUDAMED
    9 results · 35ms · Sources: EU EUDAMED, US FDA

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    OVERHEAD TUBE MOUNT CASCADE II

    FDA 510(k)
    FDA Class 1 ·Radiology

    E-POLY TIBIAL BEARINGS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    InstruSafe(R) Sterilization Container

    FDA 510(k)
    FDA Class 2 ·General Hospital

    E-POLY TIBIAL BEARINGS

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·July 12, 2017

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·May 30, 2014

    ALPHA INFUSION PUMP

    FDA Adverse Event
    Other ·ADVANCED INFUSION, INC.·Product code MEB·October 19, 2010

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code MTA·December 19, 2012

    Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM

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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015