BEUDAMED
    22 results · 19ms · 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.
    Filters Status: Open, Classified ×

    REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631018

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617630 *Not distributed within the US

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617647 *Not distributed within the US

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within the US

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620111 *Not distributed within the US

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661 *Not distributed within the US

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024

    RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024

    RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024

    VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code LYR·November 9, 2022

    CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code PER·September 8, 2025

    Peptic Ulcer Test (H, pylori)

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code LYR·November 3, 2025

    VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code LYR·November 9, 2022

    H pylori (Peptic ulcer) Test

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code LYR·November 3, 2025

    BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed.

    FDA Recall
    Open, Classified ·Becton, Dickinson and Company, BD Bio Sciences·Product code PER·August 12, 2024

    VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code LYR·November 9, 2022

    Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.

    FDA Recall
    Open, Classified ·Sysmex America, Inc.·Product code PER·January 6, 2025