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

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    STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT

    FDA 510(k)
    FDA Class 2 ·Dental

    FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ENDO PAT 2000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SIMPLYGO MINI

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CAW·November 17, 2023

    OXIMAX N-560 PULSE OXIMETER

    FDA Adverse Event
    Malfunction ·MEDIANA·Product code DQA·October 1, 2014

    UNKNOWN IMPLANTABLE PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·May 29, 2013

    COULTER® LH 750

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·June 17, 2011

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

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