Company ยท CH
Leica Microsystems (Schweiz) AG
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2019. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 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 |
|---|---|---|---|
| Mar 28, 2019 | DEN180024 | Leica FL400 Leica Microsystems (Schweiz) AG, CH | QFX |
| Sep 7, 2018 | K181537 | GLOW800 Leica Microsystems (Schweiz) AG, CH | IZI |
| Jul 5, 2017 | K170239 | Leica FL560 Leica Microsystems (Schweiz) AG, CH | IZI |
| May 9, 2008 | K080612 | LEICA FL800 Leica Microsystems (Schweiz) AG | IZI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2013 | Leica Microsystems (Schweiz) Ag Surgical microscope
The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medica Terminated |
FSO | None listed |
| Sep 10, 2013 | Leica Microsystems (Schweiz) Ag Surgical microscope
The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medica Terminated |
FSO | None listed |