FEI 3012470925
Xtreem Pulse
690 Washington St, New York, NY, US
MDR events0All time
Recalls0All time
Registered products3
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
3 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3012470925.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Oct 13, 2023
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Oct 13, 2023
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(i)Oct 13, 2023
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(j)Oct 13, 2023
Design history file
- 21 CFR 820.80(b)Oct 13, 2023
Lack of or inadequate receiving acceptance 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.