BEUDAMED
    15 results · 25ms · Sources: EU EUDAMED, US FDA

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    CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CAPNOSTAT CO2 mod upgrd kit

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904086170·

    RENEW NEUROSTIMULATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    OSMED TISSUE EXPANDER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    RD SET GE - 12

    FDA Adverse Event
    Malfunction ·Product code DQA·August 13, 2021

    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFTS

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code JCT·May 22, 2009

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·April 10, 2013

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 4, 2011

    RIATA ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008

    BD DISCARDIT¿ II SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·November 9, 2018

    BD DISCARDIT¿ II SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·June 7, 2018

    BD DISCARDIT¿ II SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·May 22, 2018

    BD DISCARDIT¿ II SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·June 1, 2018

    Panta Arthrodesis Nail Support device, 510 (k) #K050882. One (1) unit of product is kitted within an instrumentation tray. The product is available in six (6) sizes. All nails are color-coded for easy size identification. Bony fixation is achieved using two (2) tibial screws, two (2) calcaneal screws and one (optional) talar screw. The nail, cross-locking screws and end cap are manufactured from a titanium alloy: TI-6AI-4V ELI ISO 5832-3, ASTM F136. The PANTA Arthrodesis Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. The Panta Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include: " Post-traumatic and degenerative arthritis involving both ankle and subtalar joints. " Rheumatoid arthritis. " Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body. " Revision of failed total ankle arthroplasty with subtalar intrusion. " Talar deficiency conditions (requiring a tibiocalcaneal arthrodesis). " Avascular necrosis of the talus. " Neuroarthropathy or neuropathic ankle deformity. " Severe deformity as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease. " Severe pilon fractures with trauma to the subtalar joint.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HSB·May 19, 2011

    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