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

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    RecoveryRx

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306804366·Gorney Suction Elevator, 3mm Tip, 19cm with Stylet

    Pre-Finisher

    FDA UDI
    TP ORTHODONTICS INC·00192029041895·2 Upper Bicuspid Extraction

    SYNCHRON MULTI CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333

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

    DELTAFILL10 6MM X 16CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·October 5, 2021

    JUVEDERM XC

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LMH·October 14, 2014

    6000CMS

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·June 10, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·January 5, 2023

    AEQUALIS STEM FOR FRACTURE D.6.5 HA-COATED

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·January 5, 2026

    EXOGEN Ultrasound Coupling Gel

    FDA Enforcement
    Class II ·Terminated·Bioventus, LLC·January 20, 2021

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·January 10, 2023

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·October 21, 2022

    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