BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DTX Studio design

    FDA 510(k)
    FDA Class 2 ·Dental

    ENDEARE BREAST PUMP

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TRULIANT TIB IMP PS INSERT SZ 2 10MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·February 26, 2024

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 48MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·June 18, 2014

    GEMSTAR BOLUSCORD (EACH)

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code FRN·October 12, 2010

    IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·December 20, 2012

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020