Carl Zeiss Meditec, Inc.: FDA filings under this applicant name

FDA lists 30 510(k) clearances under 2 spellings of the applicant name “Carl Zeiss Meditec, Inc.” (first 1993, latest 2025), plus 2 PMA decisions, across 13 product codes in 2 review panels. Median 510(k) review time under this name: 152 days. Since 2017 the median was 155 days, against 140 days for all cleared 510(k)s in the same product codes. 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

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Carl Zeiss Meditec, Inc. took a median 155 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.

Top product codes

Plus 3 more product codes.

Review panels

• Ophthalmic (29)
• Radiology (3)

Most recent Carl Zeiss Meditec, Inc. 510(k) clearances

20 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

17 product recalls in 13 recall events; 1 initiated in the last five years. Most recent: 2022-01-14.

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.

Device clinical trials

An industry sponsor named Carl Zeiss Meditec, Inc. is the lead sponsor of 8 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT06264232: AT ELANA 841P Posterior Chamber Intraocular Lens for Correction of Aphakia Following Cataract Removal (Completed, started 2024-07-12)
• NCT04747834: Assessment of Low Energy Lens Fragmentation Cataract Extraction in Patients Undergoing Cataract Surgery (Completed, started 2021-01-06)
• NCT03518775: Repeatability and Reproducibility of the IOLMaster 700 Vers 1.70 and Agreement With IOLMaster 700 Vers. 1.50 and Pentacam (Completed, started 2018-03-16)
• NCT02430428: Correction of Myopia Wtih or Without Astigmatism Using the VisuMax™ Femtosecond Laser (Completed, started 2015-03)
• NCT01638390: Use of the VisuMax™ Femtosecond Laser (Completed, started 2012-07)

FDA spellings included

FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:

• Carl Zeiss Meditec, Inc. (31)
• Carl Zeiss Meditec (1)

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, Inc. (44 510(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 Meditec, Inc.?

FDA lists 30 510(k) clearances under 2 spellings of the applicant name “Carl Zeiss Meditec, Inc.” (first 1993, latest 2025), plus 2 PMA decisions, across 13 product codes in 2 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 Meditec, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Carl Zeiss Meditec, Inc. is 152 days. Since 2017: 155 days, versus 140 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Carl Zeiss Meditec, Inc.?

The most frequent FDA product codes under this applicant name are OBO (Tomography, Optical Coherence, 8); HLI (Ophthalmoscope, Ac-Powered, 7); QER (Camera, Ophthalmic, Slit-Scanning, 3).

Next steps

• See all 30 Carl Zeiss Meditec, Inc. clearances with predicates and recalls
• Run predicate analysis for product code OBO, Carl Zeiss Meditec, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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