BEUDAMED
    13 results · 20ms · 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 ×

    Ballast 088 Long Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MASTERGRAFT RESORBABLE CERAMIC GRANULES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DURABLUE STERILIZATION (AMSCO V-PRO) WRAP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PRUITT F3 CAROTID SHUNT

    FDA Adverse Event
    Malfunction ·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021

    MICROMAX

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code ERL·October 17, 2014

    DA VINCI S SURGICAL SYSTEM

    FDA Adverse Event
    Other ·INTUITIVE SURGICAL,INC.·Product code NAY·June 21, 2013

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 28, 2011

    PRUITT F3 CAROTID SHUNT

    FDA Adverse Event
    Injury ·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021

    PRUITT F3 CAROTID SHUNT

    FDA Adverse Event
    Malfunction ·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021

    PRUITT F3 CAROTID SHUNT

    FDA Adverse Event
    Malfunction ·LEMAITRE VASCULAR, INC.·Product code MJN·April 23, 2021

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MAX·September 27, 2018

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020