Highland Metals, Inc.
FDA Regulatory Profile
Highland Metals, Inc. appears in FDA public data with 2 recalls, 7 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0922-2014, Class II) was initiated on December 13, 2013. Its most recent 510(k) clearance was granted on May 18, 1994.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 7
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0922-2014 | Class II | SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. | December 13, 2013 |
| Z-0923-2014 | Class II | SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. | December 13, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K935638 | NITINOL, NITI | May 18, 1994 |
| K933374 | NITI COIL SPRINGS | November 19, 1993 |
| K933377 | STAINLESS STEEL ARCHES REPACKER RELABETER | November 16, 1993 |
| K933378 | REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER | November 12, 1993 |
| K933379 | STAINLESS STEEL ARCHES | November 12, 1993 |
| K933376 | NITI ARCH WIRE ON A SPOOL | November 12, 1993 |
| K933380 | REVERSE SURVE NITI ARCH WIRE | November 12, 1993 |