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

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    REUSABLE/DISPOSABLE AUTOPSY KNIFE SET

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT

    FDA 510(k)
    FDA Class 2 ·Dental

    ClotTriever Thrombectomy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GBO·September 26, 2018

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·CARROLL HEALTHCARE·Product code FNL·December 10, 2012

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·June 10, 2014

    ALLEGRETTO WAVE EYE-Q EXCIMER LASER

    FDA Adverse Event
    Malfunction ·WAVELIGHT GMBH·Product code LZS·June 23, 2015

    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