BEUDAMED
    11 results · 12ms · Sources: EU EUDAMED, US FDA

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    Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716

    FDA Recall
    Open, Classified ·EBI, LLC·Product code LOF·March 22, 2024

    48" Lead Wires, Replacement Part Number: 1067724-4

    FDA Recall
    Open, Classified ·EBI, LLC·Product code LOF·March 22, 2024

    20" Lead Wires, Replacement Part Number: 1067724-2

    FDA Recall
    Open, Classified ·EBI, LLC·Product code LOF·March 22, 2024

    Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718

    FDA Recall
    Open, Classified ·EBI, LLC·Product code LOF·March 22, 2024

    Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 m (by weight) with narrow upper limit particle distribution. Component: N/A

    FDA Recall
    Open, Classified ·Ultradent Products, Inc.·Product code EBF·August 2, 2024

    Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Product Description: Vit-l-escence composite is a light-cured, microhybrid, Bis-GMA esthetic composite restorative material. It is 75% filled by weight, 52% filled by volume with 0.7 m average particle size. Dentin Shades: fluorescent properties to replicate natural dentin. Available in 18 dentin shades. Enamel Shades: opalescent properties to replicate enamel. Available in 16 enamel shades including pearl, translucent, and opaque shades. Component: N/A

    FDA Recall
    Open, Classified ·Ultradent Products, Inc.·Product code EBF·August 2, 2024

    Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.

    FDA Recall
    Open, Classified ·Orascoptic Surgical Acuity·Product code EBA·July 3, 2025

    Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 m (by weight) with narrow upper limit particle distribution. Component: N/A

    FDA Recall
    Open, Classified ·Ultradent Products, Inc.·Product code EBF·August 2, 2024

    Orascoptic Superior Visualization Custom loupes configured with Phantom Frames

    FDA Recall
    Open, Classified ·Orascoptic Surgical Acuity·Product code EBA·July 3, 2025

    Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)

    FDA Recall
    Open, Classified ·Orascoptic Surgical Acuity·Product code EBA·July 3, 2025

    Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)

    FDA Recall
    Open, Classified ·Orascoptic Surgical Acuity·Product code EBA·July 3, 2025