Mermaid Medical A/S
FDA Regulatory Profile
Mermaid Medical A/S appears in FDA public data with 2 recalls, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2213-2024, Class II) was initiated on May 1, 2024. Its most recent 510(k) clearance was granted on August 2, 2016.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2213-2024 | Class II | The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 | May 1, 2024 |
| Z-2190-2015 | Class II | Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX | June 15, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K161409 | M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem | August 2, 2016 |