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

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    FLOW 90 Wand

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

    BYTE DAY ALIGNERS

    FDA Adverse Event
    Malfunction ·STRAIGHT SMILE, LLC·Product code NXC·October 31, 2024

    DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY

    FDA 510(k)
    FDA Class 2 ·Dental

    NEON SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 56

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 15, 2021

    KLEENSPEC 590 SERIES DISP VAGINAL SPECULA

    FDA Adverse Event
    Malfunction ·WELCH ALLYN·Product code HIB·March 13, 2013

    KLEENSPEC 590 SERIES DISP VAGINAL SPECULA

    FDA Adverse Event
    Malfunction ·WELCH ALLYN·Product code HIB·March 13, 2013

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 18, 2014

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code IKZ·June 21, 2013

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·July 28, 2011

    Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·April 24, 2019

    BD MAX¿ CTGCTV2 (US)

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code LSL·December 17, 2025

    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