Somnomed Inc.
6513 Windcrest Dr Ste 100, Plano, TX, US
Registered product codes
7 product codes
Recent MDR events
11 on file
- SOMNOMED AVANT ORAL APPLIANCEApr 15, 2026MalfunctionMW5186846
- SOMNOMED AVANT ORAL APPLIANCEApr 15, 2026MalfunctionMW5186847
- SOMNODENT FLEXJul 3, 2024InjuryMW5157034
- SOMNODENT HERBST ADVANCE FLEXNov 29, 2021Injury3005598536-2021-00001
- SOMNOMEDApr 21, 2021InjuryMW5100932
- SUAD SLEEP APNEA ORAL APPLIANCEDec 8, 2020MalfunctionMW5098260
- SOMNODENTAug 19, 2020InjuryMW5096152
- SOMNODENT HERBST SHIMNov 20, 2017InjuryMW5073428
- SOMNODENTAug 16, 20163005598536-2016-00004
- SOMNODENT CLASSICMay 26, 20163005598536-2016-00003
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3005598536.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)May 23, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)May 23, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
5 on file
Top cited requirements
Compare to industry ↗21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.70(i)Software validation for automated processes
121 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
121 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
121 CFR 820.198(a)Lack of or inadequate complaint procedures
1
- 21 CFR 820.50May 23, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(i)May 23, 2025
Software validation for automated processes
- 21 CFR 820.80(a)May 23, 2025
Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.90(b)(2)May 23, 2025
Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.198(a)May 23, 2025
Lack of or inadequate complaint 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.