Company ยท DK
GN Hearing A/S
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2026. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (1 in 12 months)
2recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 25, 2026 | K254108 | Jabra Enhance Select Self-fit (Jabra Enhance Select 550) GN Hearing A/S, DK | QUH |
| Jan 19, 2022 | K213424 | Jabra Enhance Plus GN Hearing A/S, DK | QDD |
| Feb 20, 2020 | K193303 | Tinnitus Sound Generator Module GN Hearing A/S, DK | KLW |
| Nov 30, 2018 | K180495 | Tinnitus Sound Generator Module GN Hearing A/S, DK | KLW |
| Jul 13, 2018 | K181586 | Tinnitus Sound Generator Module GN Hearing A/S, DK | KLW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2019 | GN Hearing A/S In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP, FT8CIC-MP, FT8ITC-W-HP, FT8ITC-W-LP, FT8ITC-W-MP, FT8ITE-DW-HP, FT8MIH-W-HP, FT8MIH-W-MP, LT5CIC-MP, LT5CIC-UP, LT5IIC-L Terminated |
ESD | None listed |
| Sep 18, 2019 | GN Hearing A/S Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH, ET598-DW, ET788-DWH, ET798-DW, ET988-DWH, ET998-DW, FT861-DRW, FT862-DRW, RE561-DR Terminated |
ESD | None listed |