Noah Medical

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
1
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0742-2025Class IIGalaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient aOctober 28, 2024
Z-0693-2025Class IIGalaxy System (GAL-001)October 25, 2024
Z-0679-2025Class IIGalaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the NOctober 25, 2024
Z-1734-2024Class IIGalaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its acceMarch 9, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K223144Galaxy SystemMarch 1, 2023