BEUDAMED
    9 results · 19ms · 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.

    VISUALINE II COCAINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder

    FDA 510(k)
    FDA Class 2 ·Dental

    INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000

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

    DASHER -14 STEERABLE GUIDEWIRE

    FDA Adverse Event
    Injury ·NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORP·Product code DQX·January 9, 2007

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·February 8, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·December 14, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code CAW·July 22, 2014

    BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·May 3, 2022

    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