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

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    Align Studio

    FDA 510(k)
    FDA Class 2 ·Dental

    DigitalDiagnost C90

    FDA 510(k)
    FDA Class 2 ·Radiology

    DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·September 27, 2023

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 13, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011

    T5 SURGICAL HELMET

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code FXZ·July 18, 2013

    GNS II NON-POR TIB SZ 7 RIGHT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·February 18, 2019

    GEN II RESURF PATELLA 38MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·February 19, 2019

    LEGION CR NP FEM SZ 8 RT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·February 18, 2019

    Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVID266 Sterile This OR towel product is intended for external use only. These towels are intended to be used as absorbent towels for hand drying, cleanup, and to provide increased absorbency of blood and bodily fluids. There are no instruction catalogues or manuals included with the product as these are intended to be used in accordance with hospital protocol.

    FDA Enforcement
    Class II ·Terminated·Medical Action Industries Inc·June 6, 2018