Freudenberg Medical, Llc
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 3
- Inspections
- 10
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1016-2022 | Class II | Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US) | February 21, 2022 |
| Z-1017-2022 | Class II | Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS) | February 21, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K240763 | FirstFit Surgical Kit | December 18, 2024 |
| K192422 | Steerable Introducer 12F | October 4, 2019 |
| K191190 | Steerable Introducer | August 1, 2019 |