BEUDAMED
    12 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 ×

    Route 92 Medical Delivery Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HALO90 ULTRA ABLATION CATHETER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEXIS SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    TMJ BILATERAL IMPLANTS

    FDA Adverse Event
    Injury ·TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS·Product code LZD·August 12, 2022

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·August 28, 2019

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·October 21, 2014

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·June 26, 2013

    1644487-2011-01673

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·July 25, 2011

    MAMBA? FLEX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·September 11, 2025

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·June 26, 2019

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024