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

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    MPO Knee Instruments; MPO PROPHECY Knee Instruments

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NA

    FDA UDI
    Medos International Sàrl·10886705003280·FISHMOUTH DRILL GUIDE Durable drill guide device

    Tyber Medical Anatomical Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GLO-SPEC

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    LUPINE DRILL GUIDE

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code HRX·January 15, 2008

    LUPINE DRILL GUIDE

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code HRX·January 15, 2008

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 28, 2008

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 17, 2011

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code NJL·July 3, 2013

    MINMED QUICK SET

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 15, 2025

    1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 21, 2017

    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use. Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 21, 2017

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019