GE HealthCare: FDA 510(k) clearances across all its applicant names

FDA lists 1,905 510(k) clearances, 7 PMA and 2 De Novo decisions across the 89 applicant names Caduvo groups under GE HealthCare, first 1976, latest 2026. Median 510(k) review time across these names: 74 days. Since 2017 the median was 107 days, against 134 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 89 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 107 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.

Top product codes

Plus 208 more product codes.

Review panels

• Radiology (1,084)
• Cardiovascular (326)
• Anesthesiology (223)
• General Hospital (83)
• Clinical Chemistry (71)
• Obstetrics and Gynecology (51)
• Neurology (18)
• Immunology (8)
• Gastroenterology and Urology (6)
• Clinical Toxicology (4)
• General and Plastic Surgery (3)
• Hematology (1)
• Microbiology (1)
• Physical Medicine (1)

Most recent GE HealthCare 510(k) clearances

1,895 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

1,338 product recalls in 588 recall events under these names; 366 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.

Spun off from General Electric in January 2023; the GENERAL ELECTRIC applicant names (1976–2011) are GE's medical-systems filings and are included by exact name only (not other names starting with "GENERAL"). Acquisitions: Marquette Medical Systems (1998), OEC Medical Systems (1999), Lunar (2000), Instrumentarium/Datex-Ohmeda (2003), Amersham incl. Medi-Physics (2004), Caption Health (2023), MIM Software (2024). Includes filings made before each acquisition. Left out: Instrumentarium imaging/dental names (divested 2003–2004 as a merger condition), Vital Signs, joint ventures (Wipro GE, Intel-GE Care Innovations), GE Infrastructure Water.

Sources

• https://en.wikipedia.org/wiki/GE_HealthCare
• https://en.wikipedia.org/wiki/Amersham_plc

Frequently asked questions

How many FDA 510(k) clearances are listed across GE HealthCare's applicant names?

FDA lists 1,905 510(k) clearances, 7 PMA and 2 De Novo decisions across the 89 applicant names Caduvo groups under GE HealthCare, first 1976, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does GE HealthCare file under?

The names with the most 510(k) clearances in this group are GE Medical Systems (329); General Electric Co. (254); Ge Medical Systems Information Technologies (171); GE Healthcare (169); Ohmeda Medical (119). The full list of 89 names is on this page.

How long does FDA take to clear GE HealthCare 510(k)s?

The median time from FDA receipt to decision across 510(k)s cleared under these names is 74 days. Since 2017 the median was 107 days, against 134 days for all cleared 510(k)s in the same product codes.

Does the GE HealthCare 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 1,905 GE HealthCare clearances with predicates and recalls
• Run predicate analysis for product code IYN, GE HealthCare'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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