Company
Zeiss, Carl Inc
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)
8recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
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) |
|---|---|---|---|
| Jun 24, 2022 | Zeiss, Carl Inc ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000 Terminated |
MTX | None listed |
| Oct 2, 2019 | Zeiss, Carl Inc Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900) Terminated |
RIB | None listed |
| Jun 9, 2018 | Zeiss, Carl Inc Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple
Laser Scanning Microscopes.
Laser scanning microscopes are used in cell biology research. Terminated |
REM | None listed |
| May 29, 2018 | Zeiss, Carl Inc Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope Terminated |
RGW | None listed |
| Jan 21, 2014 | Zeiss, Carl Inc Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio Imager, Axio Scope. A1, Axio Lab. A1).
Component used to determine composition Terminated |
IBJ | None listed |
| Jul 17, 2013 | Zeiss, Carl Inc Polarizer D Fixed w/Rotating Red 1 lambda plate.
Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation. Terminated |
IBJ | None listed |
| Feb 29, 2012 | Zeiss, Carl Inc DirectFRAP (Direct Flourescence Recovery After Photobleaching) Imaging System is an extension unit for Axio Observer that is used for microscopic analyses of dynamic processes within living cells. Th Terminated |
REK | None listed |
| Feb 29, 2012 | Zeiss, Carl Inc Carl Zeiss Microimaging Laser-TIRF (Total Internal Reflection Fluorescence) Imaging System is a component used in conjunction with Laser Scanning Microscopes, Non-Medical Devices for Research Use. Terminated |
REK | None listed |