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

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    OEC One

    FDA 510(k)
    FDA Class 2 ·Radiology

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331132285·russian tissue forceps, 6" (15.2 cm)

    SYRINGE 60ML LL BRAZIL

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·July 7, 2020

    VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01

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

    PAM 3000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·March 6, 2019

    BD LUER-LOK SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·November 26, 2020

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DRY·July 5, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 21, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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