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

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    REAL Immersive System

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 8, 2013

    XCATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 18, 2013

    TOTAL KNEE REPLACEMENT CEMENT KLASSIC TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·TOTAL JOINT ORTHOPEDICS, INC.·Product code JWH·August 18, 2020

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·August 28, 2015

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 1, 2014

    AMPLATZ SUPER STIFF GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·April 17, 2007

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 17, 2014

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·July 28, 2011

    SELF-DRILLING HALF PIN APEX Ø 3MM, 110 X 25MM

    FDA Adverse Event
    Malfunction ·STRYKER GMBH·Product code JDW·October 28, 2015

    Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025