BEUDAMED
    8 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.

    ABUSCREEN ONTRAK POS. REFERENCE CONTROL FOR THC

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VOLUME VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·AQUATEC OPERATIONS GMBH·Product code FSA·January 2, 2013

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·November 2, 2010

    AXERA 2 ACCESS SYSTEM

    FDA Adverse Event
    Injury ·ARSTASIS, INC.·Product code DYB·June 12, 2014

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

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

    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017