ZEISS Medical Technology: FDA 510(k) clearances across all its applicant names

FDA lists 148 510(k) clearances, 5 PMA and 0 De Novo decisions across the 12 applicant names Caduvo groups under ZEISS Medical Technology, first 1979, latest 2026. Median 510(k) review time across these names: 113 days. Since 2017 the median was 181 days, against 114 days for all cleared 510(k)s in the same product codes. Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

510(k) clearances per year

The 12 FDA applicant names in this group

Review time against the same product codes

Since 2017, 510(k)s cleared under these names took a median 181 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.

Top product codes

Plus 35 more product codes.

Review panels

• Ophthalmic (96)
• General and Plastic Surgery (33)
• Radiology (14)
• Neurology (6)
• Dental (1)
• Gastroenterology and Urology (1)
• General Hospital (1)
• Obstetrics and Gynecology (1)

Most recent ZEISS Medical Technology 510(k) clearances

138 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

30 product recalls in 24 recall events under these names; 4 initiated in the last five years.

Recalling firms are matched to the applicant names above by name only, so recalls filed under other names are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

How this group is built

Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

Carl Zeiss (Meditec) entity names, Humphrey Instruments (1991) and Laser Diagnostic Technologies (2005). Includes filings made before each acquisition.

Sources

• https://en.wikipedia.org/wiki/Carl_Zeiss_Meditec

Frequently asked questions

How many FDA 510(k) clearances are listed across ZEISS Medical Technology's applicant names?

FDA lists 148 510(k) clearances, 5 PMA and 0 De Novo decisions across the 12 applicant names Caduvo groups under ZEISS Medical Technology, first 1979, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does ZEISS Medical Technology file under?

The names with the most 510(k) clearances in this group are Carl Zeiss Meditec, AG (46); Carl Zeiss, Inc. (44); Carl Zeiss Meditec, Inc. (30); Zeiss Humphrey System (9); Carl Zeiss Meditec Cataract Technology, Inc. (7). The full list of 12 names is on this page.

How long does FDA take to clear ZEISS Medical Technology 510(k)s?

The median time from FDA receipt to decision across 510(k)s cleared under these names is 113 days. Since 2017 the median was 181 days, against 114 days for all cleared 510(k)s in the same product codes.

Does the ZEISS Medical Technology count include acquired companies?

Yes. A group includes filings an acquired business made under its own name, including before the acquisition. Businesses that were sold are left out, and names whose ownership is unclear are not included. FDA does not group applicants; the sources for each grouping are listed on this page.

Next steps

• See all 148 ZEISS Medical Technology clearances with predicates and recalls
• Run predicate analysis for product code GEX, ZEISS Medical Technology's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls). Applicant names are matched exactly, with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this grouping or data.

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