BEUDAMED
    19 results · 28ms · Sources: EU EUDAMED, US FDA

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    AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AIA-900

    FDA Adverse Event
    Injury ·TOSOH CORPORATION·Product code KHO·February 24, 2016

    TOSOH AIA-900

    FDA Adverse Event
    Injury ·TOSOH CORPORATION·Product code KHO·December 13, 2016

    A1A-600II

    FDA Adverse Event
    Injury ·TOSOH CORPORATION·Product code KHO·October 28, 2016

    TOSOH AIA-1800

    FDA Adverse Event
    Injury ·TOSOH CORPORATION·Product code KHO·November 11, 2016

    AIA-360

    FDA Adverse Event
    Injury ·TOSOH CORPORATION·Product code KHO·March 3, 2016

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771048869·K-Wires, Double trocar, .062-inch (1.6mm) diame...

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704292503·

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·14026704912299·

    K-Wire w. double end trocarpoint 1.60mm/102mm, 6 pcs./unit

    FDA UDI
    mahe medical gmbh·EMAHKM711030·K-Wire w. double end trocarpoint 1.60mm...

    mahe medical GmbH

    FDA UDI
    mahe medical gmbh·04050659484047·K-Wire w. double end trocarpoint _x000D_...

    Lumipulse G TSH-III Immunoreaction Cartridges

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HABIB HEXABLATE

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

    SYMBIQ DUAL CHANNEL

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·February 1, 2013

    ASSURE 4 BLOOD GLUCOSE SYSTEM

    FDA Adverse Event
    Injury ·APEX BIOTECHNOLOGY CORP.·Product code CGA·January 26, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 31, 2014

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·July 23, 2025

    The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of standard stationary x-ray room. The DRX-Revolution system incorporates a flat-panel detector that can be used wirelessly for exams such as in-bed chest projections. The system can also be used to expose CR phosphor screens or films.

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·November 15, 2023

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017