BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    IN VITRO THEOPHYLLINE RIA TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PACING KIT, TRANSMYOCARDIAL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Black Silicone Filiform Double Pigtail Stent Set

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ENDO GIA

    FDA Adverse Event
    Injury ·US SURGICAL PUERTO RICO·Product code GDW·September 5, 2018

    QUATTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 2, 2012

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 18, 2007

    MO.MA. ULTRA 6F ID

    FDA Adverse Event
    Malfunction ·INVATEC SPA·Product code NTE·April 25, 2014

    FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·June 30, 2022

    FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·June 30, 2022

    BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·January 31, 2023

    FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·January 2, 2020

    18.0MM REAMER HEAD FOR RIA 2 STERILE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTO·January 7, 2021

    SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·November 20, 2013

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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