FEI 3001617730Initial importer
A.m. Surgical, Inc.
402 Amherst St Ste 300, Nashua, NH, US
MDR events10All time
Recalls0All time
Registered products13
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
13 product codes
Recent MDR events
10 on file
- STRATOS ENDOSCOPIC RELEASE SYSTEMJan 9, 2026Injury3001617730-2026-00001
- STRATOS ENDOSCOPIC CARPAL AND CUBITAL TUNNEL RELEASE SYSTEMDec 15, 2025InjuryMW5180550
- STRATOS ENDOSCOPIC RELEASE SYSTEMNov 14, 2025Malfunction23554449
- STRATOS ENDOSCOPIC RELEASE SYSTEMOct 28, 2024InjuryMW5161831
- ULTRAAug 24, 2023Malfunction17610354
- STRATOS ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEMJun 22, 2018MalfunctionMW5078016
- STRATOSJun 18, 2018MalfunctionMW5077925
- STRATOS ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEMMay 23, 2018MalfunctionMW5077426
- STRATOSOct 20, 2014Malfunction2437731-2014-00001
- STRATOSOct 20, 2014Malfunction2437731-2014-00002
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3001617730.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Oct 20, 2023
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Oct 20, 2023
Postmarket Assurance: Devices · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.181Oct 20, 2023
DMR - not or inadequately maintained
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.