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

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    N LATEX LP(A)

    FDA 510(k)
    FDA Class 2 ·Immunology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450412510·

    Alleset

    FDA UDI
    GRI Medical & Electronic Technology Co., Ltd.·16931918113753·Mayo Stand cover_31.5inx57in_non-sterilize_160e...

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00024021441710·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00887661650221·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00024021441673·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00024021441697·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00024021441819·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00024021441680·

    COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO RELIEF BRIEF

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    NONE

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code LFR·April 17, 2015

    ASR UNI FEMORAL IMPL SIZE 41

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·March 20, 2013

    ASR ACETABULAR IMPLANT 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011

    GLUCOSE MONITORING SYS/KIT

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·March 14, 2008

    FREESTYLE

    FDA Adverse Event
    Injury ·Product code LFR·March 6, 2014

    AMPHIRION DEEP PTA BALLOON CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC MEXICO·Product code DQY·October 12, 2021

    Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

    FDA Enforcement
    Class II ·Terminated·SynCardia Systems Inc.·January 9, 2013

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014