BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    MATRX, PYRAMID TRIANGLE BANDAGE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    VIZION DR

    FDA 510(k)
    FDA Class 2 ·Radiology

    LATERA Absorbable Nasal Implant System

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PLUM A+ 3 MEDNET SW

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 14, 2014

    ACCU-CHEK ® INFORM METER

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·January 14, 2013

    LINOX TD 65/16

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code LWS·November 24, 2010

    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·May 16, 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