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

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    QUANTA FLASH H-TTG IGA

    FDA 510(k)
    FDA Class 2 ·Immunology

    Wisp

    FDA UDI
    Respironics, Inc.·00606959021266·Wisp Mask, Clear Frame, with Headgear, Internat...

    BENCO

    FDA UDI
    BENCO DENTAL SUPPLY CO.·00366975004758·Orthodontic Pliers Wire Cone Bending #139

    MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MICROAIRE 1000E SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 22, 2025

    ICON PREMO

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·November 20, 2024

    ICON PREMO

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·June 26, 2025

    STANDARD INSERT

    FDA Adverse Event
    Injury ·8010379 DEPUY INTL., LTD.·Product code KWA·May 6, 2013

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 16, 2014

    FLEXIBLE SCOPE

    FDA Adverse Event
    Other ·GYRUS ACMI, INC.·Product code FAJ·April 29, 2011

    Wisp and Wisp Youth Nasal Mask

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·October 12, 2022

    Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the 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. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013

    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