BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    MEDSURG PERCUTANEOUS ASPIRATION BIOPSY (PAB) TRAY

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

    TSH RADIOIMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·June 12, 2014

    ASR UNI FEMORAL IMPL SIZE 53

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·October 7, 2010

    HEARTMATE II LVAS

    FDA Adverse Event
    THORATEC CORPORATION·Product code DSQ·December 12, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 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