Highland Metals, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
7
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0922-2014Class IISuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages.December 13, 2013
Z-0923-2014Class IISuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages.December 13, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K935638NITINOL, NITIMay 18, 1994
K933374NITI COIL SPRINGSNovember 19, 1993
K933377STAINLESS STEEL ARCHES REPACKER RELABETERNovember 16, 1993
K933380REVERSE SURVE NITI ARCH WIRENovember 12, 1993
K933378REVERSE CURVE NITI ARCH WIRE REPACKER RELABETERNovember 12, 1993
K933376NITI ARCH WIRE ON A SPOOLNovember 12, 1993
K933379STAINLESS STEEL ARCHESNovember 12, 1993