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

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    VPC

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169598997·TRIAL 2190345 O25 IB 27MM 0 DEG 12X45

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517639318·CoRoent Ant TLIF PEEK, 9x10x34mm 15°

    Pre-Finisher

    FDA UDI
    TP ORTHODONTICS INC·00192029041963·2 Upper Bicuspid Extraction w/Seating Springs

    SYSTEMS INTEGRATION MODEL: ENDOALPHA

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

    MENDASIL TWG GEL ANTIMICROBIAL SKIN AND WOUND GEL

    FDA 510(k)
    FDA Unclassified ·Unknown

    GORILLA/BABY GORILLA PLATING SYSTEM

    FDA Adverse Event
    Injury ·PARAGON 28, INC·Product code HRS·September 17, 2020

    NCIRCLE TIPLESS STONE EXTRACTOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FFL·December 19, 2017

    CORAIL2 LAT COXA VARA SIZE 15

    FDA Adverse Event
    Injury ·DEPUY FRANCE S.A.·Product code KWA·October 3, 2008

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    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·June 18, 2013

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·July 27, 2011

    TFNA HELICAL BLADE 95MM STERILE

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HSB·March 12, 2017

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    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