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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    MMSphere

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

    DEFINITIVE, FLEXLENS - SILICONE HYDROGEL

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PLANET 55, MODEL 100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNCHRO2-14 SUPPORT STRAIGHT 215CM

    FDA Adverse Event
    Malfunction ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·December 14, 2023

    DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER

    FDA Adverse Event
    Malfunction ·Product code GEH·June 21, 2013

    ACCOLADE 5.5 PLUS

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS CORK·Product code MEH·October 2, 2008

    XPRT SLEEP SURFACE

    FDA Adverse Event
    Injury ·STRYKER CORP DBA GAYMAR·Product code INX·July 29, 2011

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 29, 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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024