BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM

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

    COMPLE-SAFE VINYL EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    GALL STONE FORCEPS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    TENDRIL STS

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010

    MONARC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·December 28, 2012

    TOTALCARE BARIATRIC PLUS BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·May 20, 2014

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014