BEUDAMED
    7,415 results · 88ms · 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.

    Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.

    FDA Recall
    Terminated ·C.L.R. Medicals International, Inc.·Product code LZP·November 25, 2013

    Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.

    FDA Enforcement
    Class I ·Terminated·C.L.R. Medicals International, Inc.·January 1, 2014

    670G INSULIN PUMP MMT-1780KL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·February 14, 2022

    PUMP MMT-1781K 670G V4.11 MG

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·June 25, 2021

    640G INSULIN PUMP MMT-1710K

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 9, 2021

    PUMP MMT-1712KL 640G V4.10 BK SF MG

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 27, 2023

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code NIP·January 16, 2024

    PULSE GEN MODEL 106

    FDA Adverse Event
    Malfunction ·CYBERONICS - HOUSTON·Product code LYJ·October 23, 2023

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·December 10, 2020

    GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·March 13, 2025

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·November 6, 2018

    GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·February 18, 2025

    LEAD MODEL 304

    FDA Adverse Event
    Malfunction ·HOUSTON·Product code LYJ·December 5, 2025

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DTK·October 29, 2018

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·October 20, 2017

    PUMP MMT-1782KL 670G MM RPL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·January 12, 2023

    PULSE GEN MODEL 102

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·October 22, 2014

    LEAD MODEL 304

    FDA Adverse Event
    Malfunction ·CYBERONICS - HOUSTON·Product code LYJ·March 8, 2024

    LEAD, MODEL UNKNOWN

    FDA Adverse Event
    Malfunction ·LIVANOVA USA, INC.·Product code LYJ·February 29, 2024

    640G INSULIN PUMP MMT-1711K

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 25, 2023