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

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    CPR TRAVELER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5828019470·

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209137794·

    T.I.M.S., VERSION 2.00

    FDA 510(k)
    FDA Class 2 ·Radiology

    GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 9, 2014

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 23, 2012

    THERAKOS CELLEX PHOTOPHERESISI SYSTEM

    FDA Adverse Event
    Malfunction ·THERAKOS INC.·Product code LNR·May 28, 2015

    Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.

    FDA Enforcement
    Class II ·Ongoing·Genesee BioMedical, Inc.·June 6, 2018

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    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