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

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    RightLance Blood Lancing System

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

    HEALIX ADVANCE PEEK ANCHOR w/DYNACORD

    FDA UDI
    Medos International Sàrl·10886705029501·HEALIX ADVANCE PEEK ANCHOR w/DYNACORD AND NEEDL...

    75H - Class A MRO 21 - w/Select Logo

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620343·75H - Class A MRO 21 - w/Select Logo

    MRJ 3300

    FDA 510(k)
    FDA Class 2 ·Radiology

    aprevo Intervertebral Body Fusion Device

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 6, 2008

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·August 24, 2011

    CENTRA BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·July 3, 2013

    Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·May 18, 2016

    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