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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS

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

    ACTIV.A.C.¿ THERAPY SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·February 12, 2018

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·June 8, 2021

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·July 14, 2021

    INTEL HEALTH GUIDE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VPAP III ST-A

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 29, 2013

    LTV 1150

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC.·Product code CBK·May 11, 2011

    DIMENSION EXL 200

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·June 3, 2016

    DIMENSION EXL WITH LM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·June 13, 2013

    FUJIFILM

    FDA Adverse Event
    Death ·FUJIFILM TECHNO PRODUCTS CO., LTD. MITO SITE·Product code FDF·July 22, 2016

    FUJIFILM

    FDA Adverse Event
    Death ·FUJIFILM TECHNO PRODUCTS CO., LTD.·Product code FCX·July 22, 2016

    FUJIFILM

    FDA Adverse Event
    Death ·FUJIFILM TECHNO PRODUCTS CO., LTD. MITO SITE·Product code FDS·July 22, 2016

    SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils may be included in kits with Mode Numbers: 989603050641, 989603050642.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    Alcon Custom Ophthalmic Surgical Procedure Packs

    FDA Enforcement
    Class II ·Terminated·Alcon Research, LLC·April 7, 2021