Atlas FDA

Restoration Robotics

4 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using G recall (Z-0353-2014)Restoration Robotics2013-11-18
ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP- recall (Z-0354-2014)Restoration Robotics2013-11-18
Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY recall (Z-0355-2014)Restoration Robotics2013-11-18
ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with V recall (Z-0356-2014)Restoration Robotics2013-11-18

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Every clearance here is in the API, with alerts when new ones post.