BEUDAMED
    13 results · 31ms · Sources: EU EUDAMED, US FDA

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    ONGUARD 1000, CATALOG #043611-000 & 043611-001

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SINGLE USE BALL ELECTRODE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    RII INFRARED EAR THERMOMETER, MODEL TH01BN

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 13, 2014

    IAB: 8 FR - 40 CC

    FDA Adverse Event
    Injury ·ARROW INTL., INC.·Product code DSP·October 8, 2010

    ENDOCARE, CRYOCARE CRYOPROBE 3.8MM LONG

    FDA Adverse Event
    Malfunction ·HEALTHTRONICS, INC.·Product code GEH·December 12, 2012

    BINAXNOW COVID-19 AG SELF TEST 4CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 28, 2024

    BINAXNOW COVID-19 AG SELF TEST 4CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 5, 2024

    BINAXNOW COVID-19 AG SELF TEST 4CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 21, 2024

    BINAXNOW COVID-19 AG SELF TEST 4CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 28, 2024

    BINAXNOW COVID-19 AG SELF TEST 4CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 21, 2024

    SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024

    Zeiss brand IOLMaster, Version 1-5, 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