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

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    BACT/ALERT SN CULTURE BOTTLE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BACT/ALERT I NST 100 BTLS - 259785

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX INC.·Product code MDB·March 4, 2024

    ULTRAPOWER

    FDA UDI
    Conmed Corporation·10845854007471·ULTRAPOWER BUR, ROUND(COPPER), 1.5 MM

    Zavation

    FDA UDI
    Zavation LLC·00842166108431·PLIF-R 11x23-15

    Zavation

    FDA UDI
    Zavation LLC·00842166108400·PLIF-R 11x23-12

    Zavation

    FDA UDI
    Zavation LLC·00842166108417·PLIF-R 11x23-13

    Zavation

    FDA UDI
    Zavation LLC·00842166108448·PLIF-R 11x23-16

    Zavation

    FDA UDI
    Zavation LLC·00842166108424·PLIF-R 11x23-14

    KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    NIDOIL

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    UNKNOWN RF ELECTRODE

    FDA Adverse Event
    Injury ·COVIDIEN MFG DC BOULDER·Product code GEI·September 3, 2021

    VERITAS

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code FTM·August 9, 2021

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·March 26, 2013

    VIRTUOSO DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code LWS·March 16, 2011

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·March 27, 2008

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    FDA Adverse Event
    Malfunction ·A.I.D.D LONGFORD·Product code MMI·January 12, 2022

    STEMMED TIBIAL COMPONENT PRECOAT SIZE 4

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code JWH·May 2, 2023

    ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code MIH·December 6, 2021

    UNKNOWN_NEUWAVE

    FDA Adverse Event
    Injury ·NEUWAVE MEDICAL, INC.·Product code NEY·July 7, 2021

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014