Mermaid Medical A/S

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
1
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2213-2024Class IIThe D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6May 1, 2024
Z-2190-2015Class IIMermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RXJune 15, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for SemAugust 2, 2016