BEUDAMED
    151 results · 57ms · 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 FDA Enforcement ×

    St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery System. Model #'s: 9-ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX007F45/80, 9-ITVFX08F45/60, 9-ITVFX08F45/80, 9-ITVFX09F45/80, 9-ITVFX10F45/80 9-ITVFX12F45/80, 9-ITVFX13F45/80. Cardiac surgical instrument, used to close atrial septal defects between the right and left atriums.

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc·February 20, 2013

    FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft

    FDA Enforcement
    Class II ·Ongoing·Atrium Medical Corporation·June 12, 2024

    ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

    FDA Enforcement
    Class II ·Ongoing·Atrium Medical Corporation·June 12, 2024

    ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft

    FDA Enforcement
    Class II ·Ongoing·Atrium Medical Corporation·June 12, 2024

    FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft

    FDA Enforcement
    Class II ·Ongoing·Atrium Medical Corporation·June 12, 2024

    FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft

    FDA Enforcement
    Class II ·Ongoing·Atrium Medical Corporation·June 12, 2024

    ADVANTA VXT, 7X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

    FDA Enforcement
    Class II ·Ongoing·Atrium Medical Corporation·June 12, 2024

    ADVANTA VXT, 6X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

    FDA Enforcement
    Class II ·Ongoing·Atrium Medical Corporation·June 12, 2024

    iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616

    FDA Enforcement
    Class II ·Ongoing·Atrium Medical Corporation·October 16, 2024

    Atrium Oasis Drain Single W / AC, Part No. 3600-100

    FDA Enforcement
    Class II ·Ongoing·Atrium Medical Corporation·January 3, 2024

    Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY

    FDA Enforcement
    Class II ·Ongoing·Atrium Medical Corporation·December 13, 2023

    Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.

    FDA Enforcement
    Class II ·Ongoing·Atrium Medical Corporation·December 13, 2023

    Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.

    FDA Enforcement
    Class II ·Ongoing·Atrium Medical Corporation·December 13, 2023

    Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 15028

    FDA Enforcement
    Class II ·Ongoing·Atrium Medical Corporation·July 6, 2022

    Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P. To evacuate air and/or fluid from the chest cavity or mediastinum.

    FDA Enforcement
    Class II ·Terminated·Atrium Medical Corporation·January 22, 2014

    The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from entering into the pleural space and a suction control chamber, which incorporates a mechanical regulator to control suction pressures imposed upon the patient's pleural cavity.

    FDA Enforcement
    Class II ·Ongoing·Atrium Medical Corporation·December 1, 2021

    Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300. To evacuate air and/or fluid from the chest cavity or mediastinum.

    FDA Enforcement
    Class II ·Terminated·Atrium Medical Corporation·January 22, 2014

    Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100. To evacuate air and/or fluid from the chest cavity or mediastinum.

    FDA Enforcement
    Class II ·Terminated·Atrium Medical Corporation·January 22, 2014

    Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

    FDA Enforcement
    Class II ·Terminated·Atrium Medical Corporation·October 9, 2013

    EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N

    FDA Enforcement
    Class II ·Terminated·Atrium Medical Corporation·July 8, 2015