Company ยท US
Somnomed, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2026. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 12, 2026 | K261366 | Virtus Somnomed, Inc. | LRK |
| Oct 3, 2024 | K233497 | Rest Assure System Somnomed, Inc. | PLC |
| May 8, 2019 | K183443 | SomnoDent Avant Somnomed, Inc. | LRK |
| Sep 20, 2016 | K162306 | SomnoDent ALPHA Somnomed, Inc. | LRK |
| Jun 18, 2015 | K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance Somnomed, Inc. | PLC |
| Jun 20, 2014 | K140278 | SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX Somnomed, Inc. | LRK |
| May 17, 2013 | K130558 | SOMNODENT HERBST; CLASSIC, FLEX Somnomed, Inc. | LRK |
| May 30, 2012 | K121340 | SOMNODENT G2 Somnomed, Inc. | LRK |
| Dec 13, 2011 | K102909 | SOMNOBRUX SPLINTS Somnomed, Inc. | MQC |
| Mar 28, 2011 | K102521 | PANTINO PRO POSITINER Somnomed, Inc. | LRK |
| Jan 30, 2008 | K073004 | SOMNOMED BFLEX Somnomed, Inc. | LRK |
| Jul 12, 2005 | K050592 | SOMNOMED MAS RXA Somnomed, Ltd. | LRK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||