BEUDAMED
    24 results · 13ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Recall × Status: Terminated × Clear all

    Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

    FDA Recall
    Terminated ·Flower Orthopedics Corporation·Product code HRS·September 3, 2021

    Theratron Elite 80 Cobalt Radiotherapy

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004

    Theratron Phoenix Cobalt Radiotherapy

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004

    Theratron 780E Cobalt Radiotherapy

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004

    Theratron 780C Cobalt Radiotherapy

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004

    Theratron Elite 100 Cobalt Radiotherapy

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004

    Theratron 1000E Cobalt Radiotherapy

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004

    Theratron 1000 Cobalt Radiotherapy

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004

    ReliaMed Deluxe Portable Adjusting Table. Product is a medical table used on patients for massage and chiropractic treatment.

    FDA Recall
    Terminated ·MDC Acquisition Co.·Product code FPS·April 23, 2010

    DICOM Option for the Norland Illuminatus Software Revs 4.2.0 though 4.3.1. Models Norland XR-600, XR-800, XR-46, EXCELL, XR-36 and Eclipse DXA Bone Densitometers. The XR 46 performs DXA scans of the AP Spine, Hip, Forearm, Lateral Spine, and Whole Body, as well as other user selectable sites. It provides BMD (g/cm2), Area (cm2), and BMC (g) values. It compares these values to gender and ethnic matched reference populations and provides T-Score and % young Reference, Z- Score and % age matched, and long term and short term change values. This includes sBMD (mg/cm2). The XR 46 performs soft tissue assessment and provides lean mass, fat mass, percent fat, and total soft tissue values for all scan sites, including Whole Body. The XR 46 includes a Report writer that allows the operator to customize the appearance of their report stand to automate the tedious part of the report. It also allows the user to enter ranges of patient values and the specific statements they want to be printed on their report for each of these ranges. The bone density measurements from the XR 46 can be used as an aid to physicians in determining fracture risk.

    FDA Recall
    Terminated ·Cooper Surgical, Inc.·Product code KGI·September 23, 2011

    TheraSphere Administration Set (Part Number K125914-034). TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable Hepatocellular carcinoma(HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion.

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion 447 March Road Ottawa Canada Ontario·Product code NAW·February 24, 2009

    Ultra-Thin LightMat Surgical Illuminator, Disposable one time use. Model Number: UA2550, Exp Date: 2012-05. Product is packaged in individual sterile pouch w/5 pouches per box. The LightMat is intended for the illumination of surgical procedures, particularly where deep cavities or adjacent tissues limit outside light in the surgical field.

    FDA Recall
    Terminated ·Lumitex Inc·Product code FDG·July 1, 2009

    Fredrick's Converse Retractor #5 F/O, Model Number: 01-0485. A fiber optic retractor used in plastic surgery procedures to retract tissue.

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code FDG·October 24, 2008

    cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code DDG·August 28, 2019

    Transferrin is an in vitro diagnostic assay for the quantitative determination of transferrin in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of transferrin in the sample.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code DDG·May 16, 2018

    Roche Diagnostics STFR Tina-quant Soluble Transferrin Receptor, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 20763454122. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of soluable transferrin receptor in serum and plasma.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code DDG·June 11, 2008

    cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code DDG·August 28, 2019

    Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code DDG·June 9, 2022

    Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code DDG·June 9, 2022

    Weck, DuraHook (6mm) and (12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units, 10 Sales Units per Shipper, Rx Only, Teleflex Medical, Research Triangle Park, NC 277809. For use as skin retraction devices during general surgery. DuraHooks are also cleared for use in procedures requiring retraction of dura mater.

    FDA Recall
    Terminated ·Teleflex Medical·Product code GDG·December 6, 2011