BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER

    FDA 510(k)
    FDA Class 1 ·Dental

    Armada

    FDA UDI
    Nuvasive, Inc.·00887517464705·Armada Ti Spoon Retractor, 35mm

    Edge™ Diamond EC012M-24 End Cutting

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172007375·Diamond dental bur, reusable

    VERSEO AIR PRESSURE MASSAGER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    NuVasive NuvaLine

    FDA 510(k)
    FDA Class 2 ·Radiology

    TAPERLOC POR LAT FMRL 9X137

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·March 7, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·August 8, 2014

    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