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

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    Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772813872·GENUMEDI PRO SILVER SIZE VII

    Vacutron

    FDA UDI
    Allied Medical, LLC·00026072010723·Mini-Vac

    SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEODENT IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    GENTLECATH GLIDE

    FDA Adverse Event
    Malfunction ·UNOMEDICAL S.R.O.·Product code GBM·November 11, 2020

    GENTLECATH GLIDE

    FDA Adverse Event
    Malfunction ·UNOMEDICAL S.R.O.·Product code GBM·November 11, 2020

    GENTLECATH GLIDE

    FDA Adverse Event
    Malfunction ·UNOMEDICAL S.R.O.·Product code GBM·November 11, 2020

    GENTLECATH GLIDE

    FDA Adverse Event
    Malfunction ·UNOMEDICAL S.R.O.·Product code GBM·November 11, 2020

    GENTLECATH GLIDE

    FDA Adverse Event
    Malfunction ·UNOMEDICAL S.R.O.·Product code GBM·November 11, 2020

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·October 9, 2008

    LUMBAR PROBE TIP

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 26, 2013

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·July 29, 2011

    ENDOSKELETON TT INTERBODY SYSTEM

    FDA Adverse Event
    Malfunction ·TITAN SPINE, LLC·Product code HWR·July 12, 2021

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·December 23, 2019

    REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL B

    FDA Adverse Event
    Malfunction ·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·February 10, 2017

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018

    Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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