BEUDAMED
    9 results · 25ms · 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.

    SEMINOR

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

    Sterngold Implant System Guided Drill 2.7mm x 8mm

    FDA UDI
    STERNGOLD DENTAL LLC·00841549118685·Used to generate the bore into the bone into wh...

    INAMED CONVERTIBLE DRAIN SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SUNGLASS, NON-PRESCRIPTION

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·January 9, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·November 16, 2010

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2014

    Amvex Integrated Flowmeter; a nonback-pressure compensated Bourdon gauge flowmeter; Amvex Corporation, 25B East Pearce St, Richmond Hill, Ontario L4B 2M9, Canada; Model No. FI. The Integrated Flowmeter has two parts, the Outlet port and the Flowmeter port. The Outlet port is intended to be used as a standard wall Outlet, delivering a high flow of gas to secondary equipment. The Flowmeter port is intended to deliver a fixed flow of gas to patient or equipment.

    FDA Recall
    Terminated ·Amvex Corporation·Product code CCN·May 29, 2009

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015