Atlas FDA

U&I America

5 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Optima Spinal System and Spinal Hook System, set screw component. recall (Z-1438-04)U&I America2004-09-08
2.5mm Hex Driver recall (Z-0558-04)U&I America2004-02-27
4mm Hex Driver recall (Z-0559-04)U&I America2004-02-27
Optima Poly Screw Driver. recall (Z-1182-03)U&I America2003-08-27
Optima Large Poly Screw Driver recall (Z-1183-03)U&I America2003-08-27

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