BEUDAMED
    7 results · 22ms · Sources: EU EUDAMED, US FDA

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    ImagenUniversal

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS; ANASEPT ANTIMICROBIAL SKIN AND WOUND GEL

    FDA 510(k)
    FDA Unclassified ·Unknown

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 17, 2013

    MODIFICATION TO CONTOUR POLARIS URETERAL STENT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA·Product code FAD·July 23, 2011

    NEXGEN CRUCIAT RETAINING ARTICULAR SURFACE

    FDA Adverse Event
    Malfunction ·ZIMMER INC·Product code JWH·August 7, 2014

    Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·October 31, 2018