BEUDAMED
    11 results · 35ms · Sources: EU EUDAMED, US FDA

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    TBD IONTOPHORESIS ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PATIENT EXAMINATION GLOVES (LATEX)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    3.5MM LCP PLATE 12 HOLES 163MM

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HRS·October 31, 2013

    ENSITE CLASSIC SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code DQK·February 9, 2010

    ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GCA·October 15, 2018

    IDRIVE ULTRA POWERED HANDLE 1

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·May 20, 2014

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·November 21, 2012

    IDENTITY ADX DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·November 10, 2010

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    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