Highland Metals, Inc.

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-0923-2014Class IISuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages.December 13, 2013
Z-0922-2014Class IISuperElastic Regular force NiTi lower or upper Natural arches. 0.16 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
K933376NITI ARCH WIRE ON A SPOOLNovember 12, 1993
K933379STAINLESS STEEL ARCHESNovember 12, 1993
K933380REVERSE SURVE NITI ARCH WIRENovember 12, 1993
K933378REVERSE CURVE NITI ARCH WIRE REPACKER RELABETERNovember 12, 1993