Company
DKK Dai-Ichi Shomei Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FSY | Light, Surgical, Ceiling Mounted | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2024 | DKK Dai-Ichi Shomei Co., Ltd. Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models).
The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site. Open, Classified |
FSY | K071698 |
| Aug 14, 2024 | DKK Dai-Ichi Shomei Co., Ltd. Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models).
The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site. Open, Classified |
FSY | K071698 |
| Aug 14, 2024 | DKK Dai-Ichi Shomei Co., Ltd. Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site. Open, Classified |
FSY | K071698 |
| Aug 14, 2024 | DKK Dai-Ichi Shomei Co., Ltd. Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models).
The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site. Open, Classified |
FSY | K071698 |
| Oct 6, 2023 | DKK Dai-Ichi Shomei Co., Ltd. LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Scr Open, Classified |
FSY | None listed |
| Oct 6, 2023 | DKK Dai-Ichi Shomei Co., Ltd. LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Arm Syst Open, Classified |
FSY | None listed |