Company ยท LI
Bemer Int AG
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2023. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 23, 2023 | K223919 | B.Light Clear Evo and B.Light Restore Evo Bemer Int AG, LI | OHS |
| Jun 9, 2023 | K231368 | Bemer Therapy System Evo Bemer Int AG, LI | NGX |
| Feb 4, 2021 | K210174 | BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set Bemer Int AG, LI | NGX |
| Feb 22, 2017 | K151834 | BEMER Classic Set, BEMER Pro-Set Bemer Int AG, LI | NGX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2021 | BEMER INT. AG Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC), REF. 410100 (BEMER Classic-Set), REF. 420200 (B.BOX Professio Terminated |
NGX | K151834 |