BEUDAMED
    8 results · 17ms · 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.

    CONDOM-MULTIPAL STYLES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Preat

    FDA UDI
    Preat Corporation·00842092137697·Sphero Block Abutment Sterioss Flat-Top 3.25mm ...

    Stryker SternalPlate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    QUANTUM MAVERICK BALLOON CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·May 15, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012

    TRIAGE CARDIAC PANEL TEST

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code NBC·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