BEUDAMED
    14 results · 26ms · Sources: EU EUDAMED, US FDA

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    SPIR-E-VAC

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771049453·K-Wires, Single diamond, round end, .035-inch (...

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704293135·

    Key Surgical K-Wires and Steinmann Pins

    FDA UDI
    KEY SURGICAL, INC.·00849771012832·K-Wires, Single diamond, round end, .035-inch (...

    mahe medical GmbH

    FDA UDI
    mahe medical gmbh·04050659484603·K-Wire w. lanzet/round end _x000D_...

    K-Wire w. lanzet/round end 0.89mm/229mm, 6 pcs./unit

    FDA UDI
    mahe medical gmbh·EMAHKM712410·K-Wire w. lanzet/round end 0.89mm...

    Symmetry Aufranc

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482125748·Symmetry® Retractor, Aufranc Cobra, 10 mm Smoot...

    Pulse Oximeter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LMS-LIVER

    FDA 510(k)
    FDA Class 2 ·Radiology

    MAXI MOVE

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH MAGOG INC·Product code FSA·January 14, 2014

    COAGUCHEK S SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JPA·February 15, 2008

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2015

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·August 30, 2022

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021