BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    Retractable Safety Insulin Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694009843·3.0mm x 22mm Cannulated Lag Screw

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K1430220·Rod Cutter, Table Top

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694071161·Cannulated 3.0 x 22mm Lag Screw Sterile Qty 5

    KIM

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

    THE PICC WAND PEELABLE SAFETY INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 13, 2008

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 27, 2013

    POWERCROSS¿ PTA BALLOON

    FDA Adverse Event
    Injury ·EV3 INC.·Product code DQY·August 5, 2011

    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

    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

    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