BEUDAMED
    15 results · 25ms · Sources: EU EUDAMED, US FDA

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    RAYSCAN a-Expert3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101094·HELVESTON "BIG BARBIE" RETRACTOR 9MM

    LinkBio Instrument

    FDA UDI
    Link Bio Corp·00810022402856·Guide Rod, Tibial Cone D12/L180

    ULTICARE DISPOSABLE PEN NEEDLES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    THERAFORM STANDARD/SHEET

    FDA 510(k)
    FDA Unclassified ·Unknown

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·July 7, 2020

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·August 19, 2020

    TOWEL OR 17X24IN BLUE STERILE 4/PK

    FDA Adverse Event
    Malfunction ·JIANERKANG MEDICAL DRESSING CO. LTD.·Product code FRL·June 30, 2020

    LIGAMAX-5MM ENDO CLIP APPLIER

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

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 26, 2013

    HARMONIC ACE 45 CM, CURVED SHEARS WITH ERGONOMIC HANDLE, HAND CONTROL AND

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY·Product code LFL·July 29, 2011

    TOWEL OR 17X24IN BLUE STERILE 4/PK

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH SHANGHAI·Product code FRL·August 4, 2020

    POWERHEART G3 AED DEFIBRILLATION PADS

    FDA Adverse Event
    Malfunction ·CARDIAC SCIENCE CORPORATION·Product code MKJ·December 20, 2019

    Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001

    FDA Enforcement
    Class II ·Ongoing·Cook Vandergrift, Inc.·September 13, 2023

    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