BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ipsoclip

    FDA UDI
    Cendres+Métaux SA·07640173093732·Ipsoclip Posterior Lock

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450237465·

    BD SHARPS COLL CHEMO 3GAL YELLOW NEW CAP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·November 7, 2022

    PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    GOODNET

    FDA 510(k)
    FDA Class 2 ·Radiology

    STAPLE, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 10, 2013

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·April 12, 2011

    RIATA ST OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008

    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