Boss Instruments, Ltd.
FDA Regulatory Profile
Boss Instruments, Ltd. appears in FDA public data with 1 recall, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2767-2020, Class II) was initiated on June 26, 2020. Its most recent 510(k) clearance was granted on June 18, 1998.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2767-2020 | Class II | BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usa | June 26, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K980002 | KOALA VASCULAR CLAMPS AND INSERTS | June 18, 1998 |