BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JuggerKnot Soft Anchors

    FDA UDI
    Biomet Orthopedics, LLC·00880304523401·

    PG&E - 10 Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588120843·PG&E - 10 Poly White

    Madison Total Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SONOREAL 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    JGRKNT 1.0MM MINI 3-0 NDL 10PK

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code DZL·April 30, 2026

    JGRKNT 1.0MM MINI 3-0 NDL 10PK

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code DZL·April 30, 2026

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·January 11, 2013

    UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·December 1, 2010

    UNKNOWN CALCAR REAMER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.1818910·Product code KXA·July 3, 2014

    Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class I ·Terminated·Covidien·February 11, 2015

    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015