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

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    MICROFLOW IRRIGATION SYSTEM

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

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471122987·K-WIRE - SINGLE TROCAR 1.25mm DIA x 150mm

    ARTHREX TENODESIS SCREW FAMILY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ECHO TIP ULTRA FIDUCIAL NEEDLE

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

    AMPLATZER DUCT OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MAE·February 4, 2013

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Other ·INSULET CORPORATION·Product code LZG·December 21, 2010

    BATT-HANDPIECE MOD F/TRS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code GEY·July 17, 2014

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code FGE·September 14, 2018

    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