International Life Sciences
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 3
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1554-2026 | Class II | Artelon FlexBand Dynamic Matrix Ref: 31057 | February 6, 2026 |
| Z-1555-2026 | Class II | Artelon FlexBand Plus Ref: 41054 & 41057 | February 6, 2026 |
| Z-1556-2026 | Class II | Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Q | February 6, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K230316 | FlexBand; FlexPatch; FlexBand Plus | May 26, 2023 |
| K200503 | ATL Anchors | September 2, 2020 |
| K192112 | FlexBand Plus | September 27, 2019 |