American Medical Systems Innovation Center - Silicon Valley

FDA Regulatory Profile

Summary

Total Recalls
32
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2180-2015Class IITool, Stripper W/BLD, 44S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping tMay 28, 2015
Z-2167-2015Class IIFiber Stripper, 365¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protMay 28, 2015
Z-2177-2015Class IITool, Stripper W/BLD, 14S, Autoclavable; The Fiber Stripper is a tool provided for stripping the May 28, 2015
Z-2174-2015Class IITool, Stripper W/BLD, 12S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping tMay 28, 2015
Z-2182-2015Class IITool, Stripper W/BLD, 28S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping tMay 28, 2015
Z-2161-2015Class IISureflex 910 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-baMay 28, 2015
Z-2179-2015Class IITool, Stripper W/BLD, 18S, Autoclavable; The Fiber Stripper is a tool provided for stripping the May 28, 2015
Z-2186-2015Class IIStripper, 0.3mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping tMay 28, 2015
Z-2172-2015Class IITool, StripperW/BLD, 10S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping tMay 28, 2015
Z-2187-2015Class IIStripper, 0.2mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping tMay 28, 2015
Z-2173-2015Class IITool, StripperW/BLD, 10S, Autoclavable; The Fiber Stripper is a tool provided for stripping the May 28, 2015
Z-2162-2015Class II200¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surMay 28, 2015
Z-2169-2015Class IIFiber Stripper, 910¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protMay 28, 2015
Z-2185-2015Class IIStripper, 0.4mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping tMay 28, 2015
Z-2166-2015Class IIFiber Stripper, 273¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protMay 28, 2015
Z-2157-2015Class IISureflex 200 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-baMay 28, 2015
Z-2159-2015Class IISureflex 365 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-baMay 28, 2015
Z-2160-2015Class IISureflex 550 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-baMay 28, 2015
Z-2171-2015Class II1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the ouMay 28, 2015
Z-2165-2015Class IIFiber Stripper, 200¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protMay 28, 2015