BEUDAMED
    20 results · 23ms · Sources: EU EUDAMED, US FDA

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    Advanced RBC Application

    FDA 510(k)
    FDA Class 2 ·Hematology

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704293388·

    Mini Port

    FDA UDI
    Covidien LP·20884521066301·Introducer

    Oticon

    FDA UDI
    Oticon A/S·05711584070123·OPN PLAY 1, MINIRITE T 312 2.4G C047

    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

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690191735·Tibia Tray Inserter Assembly

    SR PIP

    FDA UDI
    Stryker GmbH·00886385019741·SIZE 1: PIP PROXIMAL TRIAL

    INTEGRAL X-SERIES HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304650442·

    STRYKER CMF MEDPOR CUSTOMIZED IMPLANT

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

    MULTIPURPOSE DRAINAGE CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EXPECT PULMONARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·May 19, 2026

    EXPECT PULMONARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·September 24, 2025

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 2, 2025

    ACQUIRE? PULMONARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·October 10, 2025

    EXPECT PULMONARY

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·November 14, 2024

    EXPECT PULMONARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FCG·April 14, 2026

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 14, 2014

    BD SYR NED UFIN SHRT 0.3ML 31G 5/16

    FDA Adverse Event
    Malfunction ·Product code FMI·July 15, 2011

    PRECLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·September 22, 2008

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021