Edwards Lifesciences: FDA 510(k) clearances across all its applicant names

FDA lists 282 510(k) clearances, 18 PMA and 2 De Novo decisions across the 8 applicant names Caduvo groups under Edwards Lifesciences, first 1976, latest 2026. Median 510(k) review time across these names: 86 days. Since 2017 the median was 142 days, against 118 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 8 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 142 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.

Top product codes

Plus 73 more product codes.

Review panels

• Cardiovascular (239)
• Gastroenterology and Urology (26)
• General Hospital (13)
• General and Plastic Surgery (9)
• Orthopedic (7)
• Anesthesiology (2)
• Neurology (1)
• Ophthalmic (1)
• Pathology (1)
• Radiology (1)

Most recent Edwards Lifesciences 510(k) clearances

272 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

186 product recalls in 72 recall events under these names; 21 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 Baxter in 2000; American Edwards Laboratories and Baxter Edwards are its predecessors inside Baxter. Includes filings made before the spin-off. Edwards sold its Critical Care product group to BD on September 3, 2024; Critical Care filings made under the Edwards Lifesciences name before then cannot be split out. Left out: Edwards orthopaedics and pacemaker names (other businesses).

Sources

• https://en.wikipedia.org/wiki/Edwards_Lifesciences
• https://investors.bd.com/news-events/press-releases/detail/849/bd-completes-acquisition-of-critical-care-from-edwards-lifesciences

Frequently asked questions

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

FDA lists 282 510(k) clearances, 18 PMA and 2 De Novo decisions across the 8 applicant names Caduvo groups under Edwards Lifesciences, first 1976, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Edwards Lifesciences file under?

The names with the most 510(k) clearances in this group are Edwards Lifesciences, LLC (156); American Edwards Laboratories (89); Edwards Laboratories (12); Baxter Edwards (11); Edwards Lifesciences Research Medical (6). The full list of 8 names is on this page.

How long does FDA take to clear Edwards Lifesciences 510(k)s?

The median time from FDA receipt to decision across 510(k)s cleared under these names is 86 days. Since 2017 the median was 142 days, against 118 days for all cleared 510(k)s in the same product codes.

Does the Edwards Lifesciences 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 282 Edwards Lifesciences clearances with predicates and recalls
• Run predicate analysis for product code DWF, Edwards Lifesciences'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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