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

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    10D (TENS DEVICE)

    FDA 510(k)
    FDA Class 2 ·Neurology

    NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS

    FDA 510(k)
    FDA Class 2 ·Dental

    RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16

    FDA 510(k)
    FDA Class 2 ·Immunology

    TITAN OTR

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code FHW·June 5, 2023

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·May 15, 2014

    SENSIA DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NVZ·October 31, 2012

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·August 18, 2010

    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