FEI 1832562Initial importer
Pulmodyne Inc.
2055 Executive Dr, Indianapolis, IN, US
MDR events3All time
Recalls0All time
Registered products20
Establishment typeManufactureManufacture Medical Device
Registered product codes
20 product codes
Recent MDR events
3 on file
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 1832562.
FDA inspections
2 on file
- Official Action Indicated (OAI)Apr 22, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Apr 22, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(a)Apr 22, 2025
Design control - no procedures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.