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

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    SCHNEIDER MONORAIL-PMC PRESSURE MONITORING CATH.

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756712019·BREAST MASS/INGUINAL HERNIA PA

    PATIENT EXAMINATION GLOVES (LATEX)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    RECEPTAL (R) SAF-GARD(TM) SUCTION LINER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·May 19, 2014

    QUICK FLEX LV LEAD

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

    REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRA

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code NKB·December 28, 2012

    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