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

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    CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CALYPSO SYSTEM WITH DYNAMIC EDGE GATING

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIFERAY WL CASSETTE, LIFERAY KW CASSETTE

    FDA 510(k)
    FDA Class 2 ·Radiology

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·May 27, 2024

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·May 21, 2025

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 30, 2018

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 30, 2018

    ITREL 4

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 14, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 23, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 26, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·November 12, 2020

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·December 21, 2016

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·November 26, 2025

    CARDIOSAVE HYBRID

    FDA Adverse Event
    Injury ·DATASCOPE CORP. - MAHWAH·Product code DSP·June 11, 2020

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 5, 2021

    CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·January 16, 2013

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021