BEUDAMED
    130 results · 12ms · Sources: EU EUDAMED, US FDA

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

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

    Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·January 22, 2014

    ADJUSTABLE DRILL GUIDE, BLACK MAX

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017

    7.2cm Adjustable Drill Guide Product Usage: Electric system

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017

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

    FDA Enforcement
    Class II ·Terminated·Flower Orthopedics Corporation·October 13, 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

    SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·January 20, 2021

    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

    Sterile Nail Clipper Concave Edge (67710)

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·June 12, 2019

    TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000)

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·October 7, 2020

    Biograph mCT Flow Edge-4R, Model Number 10528955

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA Inc.·August 12, 2015

    SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021