Carl Zeiss, Inc.: FDA filings under this applicant name
FDA lists 44 510(k) clearances under the applicant name “Carl Zeiss, Inc.” (first 1980, latest 2001), across 20 product codes in 6 review panels. Median 510(k) review time under this name: 80 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under ZEISS Medical Technology, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 17 | 17 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 4 | 4 |
| EPT | Microscope, Surgical | 3 | 3 |
| FSH | Tray, Surgical, Needle | 2 | 2 |
| HLI | Ophthalmoscope, Ac-Powered | 2 | 2 |
| HQF | Laser, Ophthalmic | 2 | 2 |
| FSO | Microscope, Surgical, General & Plastic Surgery | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GCT | Light Source, Endoscope, Xenon Arc | 1 | 1 |
| GDC | Table, Operating-Room, Electrical | 1 | 1 |
Plus 10 more product codes.
Review panels
- General and Plastic Surgery (26)
- Ophthalmic (14)
- Gastroenterology and Urology (1)
- General Hospital (1)
- Neurology (1)
- Obstetrics and Gynecology (1)
Most recent Carl Zeiss, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013402 | VISULAS 532S | GEX | 2001-11-14 | 30 |
| K003885 | VISULAS YAG II | GEX | 2001-02-22 | 69 |
| K993357 | IOLMASTER | HJO | 2000-03-20 | 166 |
| K983868 | OPMI TWINER SURGICAL MICROSCOPE | GEX | 1999-01-29 | 88 |
| K965139 | SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM | HAW | 1997-04-23 | 121 |
| K961380 | CPC PROBE | GEX | 1997-03-17 | 341 |
| K961171 | HUMPHREY OCT SCANNER | HLI | 1996-06-21 | 88 |
| K954167 | HUMPHREY FIELD ANALYZER (HFA II) | HPT | 1995-11-24 | 80 |
| K952894 | VISULINK 900 ARGON | HQF | 1995-08-14 | 52 |
| K950985 | ZEISS ENDOLIVE STERO ENDOSCOPE | GCJ | 1995-03-29 | 26 |
34 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Carl Zeiss, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Carl Zeiss Meditec, AG (46 510(k)s)
- Carl Zeiss Meditec, Inc. (30 510(k)s)
- Carl Parker Associates, Inc. (7 510(k)s)
- Carl Zeiss Meditec Cataract Technology, Inc. (7 510(k)s)
- Carl Zeiss Surgical GmbH (4 510(k)s)
- Carl Zeiss Ophthalmic Systems, Inc. (2 510(k)s)
- Carl Zeiss Suzhou Co., Ltd. (2 510(k)s)
- Carl Schuh (1 510(k)s)
- Carl Zeiss Jena GmbH (1 510(k)s)
- Carl Zeiss Vision GmbH (1 510(k)s)
- Carl Zeiss Meditec Production, LLC (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Carl Zeiss, Inc.?
FDA lists 44 510(k) clearances under the applicant name “Carl Zeiss, Inc.” (first 1980, latest 2001), across 20 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Carl Zeiss, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Carl Zeiss, Inc. is 80 days.
Which FDA product codes appear under Carl Zeiss, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 17); HJO (Biomicroscope, Slit-Lamp, Ac-Powered, 4); EPT (Microscope, Surgical, 3).
Next steps
- See all 44 Carl Zeiss, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Carl Zeiss, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.