BEUDAMED
    9 results · 34ms · 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.

    VENTANA ANTI-MELANOMA PRIMARY ANTIBODY

    FDA 510(k)
    FDA Class 2 ·Immunology

    Dynamic TiBase; TRI Screws

    FDA 510(k)
    FDA Class 2 ·Dental

    SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 18, 2013

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MED SYSTEMS GMBH·Product code JAA·December 22, 2010

    M2A-MAGNUM PF CUP 50ODX44ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 17, 2014

    M2A-MAGNUM MOD HD SZ 48MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWY·November 29, 2017

    CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    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