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

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    ENDOCEM ZR

    FDA 510(k)
    FDA Class 2 ·Dental

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867010741·GUIDE SLEEVE PARALLEL

    REVOIS IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ATMOS E 201 THORAX AND ATMOS S 201 THORAX

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

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    FDA Adverse Event
    Injury ·REYNOSA MANUFACTURING·Product code FKX·May 24, 2013

    CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·June 17, 2011

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·August 22, 2008

    CHROMID STREPTO B AGAR

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code PQZ·November 1, 2017

    CHROMID STREPTO B AGAR

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code PQZ·November 1, 2017

    The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·December 27, 2023

    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