BEUDAMED
    8 results · 29ms · Sources: EU EUDAMED, US FDA

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    STERI-SHURE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    InSitu Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127029233·Bipolar Head Trial, Size 47mm

    MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ACE STAPLER AND CARTRIDGE

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

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·May 20, 2014

    QUATTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 2, 2012

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.·Product code LFL·October 30, 2007

    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