BEUDAMED
    11 results · 25ms · Sources: EU EUDAMED, US FDA

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    INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LumaFlex Plus Double J stent, 2 open tips, Ch/Fr6/L.24cm, without wire

    FDA UDI
    Promepla·03700512967637·

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036027544·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450203880·

    RENEGADE HI-FLO MICROCATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CURRENT PLUS VR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 2, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·September 15, 2014

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 16, 2011

    KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024