BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    SERO/TEX LE TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    VECTOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ATAC PAK BUN REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PROGRASP FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 20, 2014

    PULSAR GENERATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012

    THERMAL ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE INC.·Product code JJE·August 26, 2010

    VIDAS® ANALYZER

    FDA Adverse Event
    Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

    VIDAS® ANALYZER

    FDA Adverse Event
    Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

    VIDAS® ANALYZER

    FDA Adverse Event
    Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

    VIDAS® ANALYZER

    FDA Adverse Event
    Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

    VIDAS® ANALYZER

    FDA Adverse Event
    Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

    VIDAS® ANALYZER

    FDA Adverse Event
    Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

    VIDAS® ANALYZER

    FDA Adverse Event
    Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

    VIDAS® ANALYZER

    FDA Adverse Event
    Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·June 3, 2021

    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