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

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    FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138234·Trial, 38 X 30, 17mm Height 28° Hyperlordotic

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138258·Trial, 38 X 30, 21mm Height 28° Hyperlordotic

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138241·Trial, 38 X 30, 19mm Height 28° Hyperlordotic

    ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PURITAN BENNETT 980 SERIES VENTILATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC/COVIDIEN·Product code CBK·September 17, 2025

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MPRI·Product code LWP·October 10, 2014

    LIFECARE

    FDA Adverse Event
    Malfunction ·HOSPIRA·Product code MEA·July 8, 2011

    PFC SIGMA STAB+ INS 15MM SZ2

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 11, 2013

    LUCAS 3 CHEST COMPRESSION SYSTEM

    FDA Adverse Event
    Death ·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024

    LUCAS 3 CHEST COMPRESSION SYSTEM

    FDA Adverse Event
    Death ·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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