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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    TK Safety Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    QUANTA FLASH H-TTG IGG

    FDA 510(k)
    FDA Class 2 ·Immunology

    SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code MWI·December 7, 2017

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code MWI·January 8, 2017

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 22, 2025

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code GWQ·July 21, 2017

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 22, 2014

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·June 26, 2013

    SM304 M-SERIES W/ZOOM

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·July 1, 2011

    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

    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

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. 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, Cardiac Rhythm Management Division·January 22, 2020