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

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    OC-Auto SENSOR io iFOB Test

    FDA 510(k)
    FDA Class 2 ·Hematology

    MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM

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

    POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    FUJIFILM DUODENOSCOPE MODEL ED-580T

    FDA Adverse Event
    Injury ·FUJIFILM CORPORATION·Product code FDT·September 5, 2023

    FUJIFILM ENDOSCOPE

    FDA Adverse Event
    Malfunction ·FUJIFILM CORPORATION·Product code FDS·March 18, 2022

    FUJIFILM DUODENOSCOPE ED-580T

    FDA Adverse Event
    Injury ·FUJIFILM CORPORATION·Product code FDT·March 5, 2025

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·July 17, 2019

    ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE, 11MM DIAMETER - 100 MM LEN

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GCJ·October 9, 2008

    ACRYSOF RESTOR

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·July 29, 2011

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 14, 2013

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·August 1, 2022

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 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