BEUDAMED
    9 results · 23ms · Sources: EU EUDAMED, US FDA

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    Edwards Suture Fastening System

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Oticon

    FDA UDI
    Oticon A/S·05707131283047·RIA2 PRO, MINIBTE 312 WL 85 TC

    Biodur Soft

    FDA UDI
    DFS - DIAMON GmbH·04057176101082·BIODURSOFT, Co-Cr-alloy, pu: 2 x 500 g

    IMC INSULIN SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NEWDEAL ANKLE NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VITALITY

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 8, 2014

    AUGMENTED INSERT

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 29, 2011

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code BTI·June 6, 2013

    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