BEUDAMED
    18 results · 20ms · 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 Regulation: Us FDA ×

    MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033520291·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033520284·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033520260·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033520277·

    POWDER FREE ELASTIC VINYL EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TOTAL BILIRUBIN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HEALONID GV

    FDA Adverse Event
    Injury ·PHARMACIA & UPJOHN, FYRISLUND·Product code LZP·December 27, 2001

    ASR UNI FEMORAL IMPL SIZE 45

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

    NIAGARA SLIM-CATH 20 CM STRAIGHT KIT

    FDA Adverse Event
    Malfunction ·C. R. BARD, INC. (BASD)·Product code MPB·February 4, 2011

    SYNERGY

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·March 14, 2008

    AXIOM ARISTOS VX PLUS

    FDA Adverse Event
    Injury ·SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD·Product code MQB·April 7, 2021

    HEALONID GV

    FDA Adverse Event
    PHARMACIA & UPJOHN, FYRISLUND·Product code LZP·December 27, 2001

    HEALONID GV

    FDA Adverse Event
    Injury ·PHARMACIA & UPJOHN, FYRISLUND·Product code LZP·December 27, 2001

    HEALONID GV

    FDA Adverse Event
    Injury ·PHARMACIA & UPJOHN, FYRISLUND·Product code LZP·December 28, 2001

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024