BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    LED CURING LIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180521311·PTP Ball Level

    LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PHOENIX INFANT RADIANT WARMER, MODEL 100NWS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MAXZERO EXTENSION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·August 29, 2018

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 29, 2013

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

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

    PSS SELECT HCG URINE CASSETTE

    FDA Adverse Event
    Malfunction ·INNOVACON, INC.·Product code LCX·August 22, 2008

    Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 340 mm, Item Number: 814313340

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 19, 2018

    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

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024