BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    Intracept Intraosseous Nerve Ablation System

    FDA 510(k)
    FDA Class 2 ·Neurology

    BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM)

    FDA 510(k)
    FDA Unclassified ·Unknown

    QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

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

    CLARIUS ULTRASOUND SCANNER

    FDA Adverse Event
    Malfunction ·CLARIUS MOBILE HEALTH CORP.·Product code IYN·October 17, 2024

    RADIAL JAW 3 BIOPSY FORCEPS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FCL·October 22, 2008

    MAESTRO MEDIUM ANGLED ATTCHMNT

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBB·August 4, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 9, 2013

    LAPIPLASTY 4.0MM FULLY THREADED SCREW

    FDA Adverse Event
    Injury ·TREACE MEDICAL CONCEPTS, INC.·Product code HWC·March 14, 2025

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 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