Integra LifeSciences: FDA 510(k) clearances across all its applicant names

FDA lists 460 510(k) clearances, 7 PMA and 0 De Novo decisions across the 22 applicant names Caduvo groups under Integra LifeSciences, first 1976, latest 2026. Median 510(k) review time across these names: 76 days. Since 2017 the median was 90 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 22 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 90 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 118 more product codes.

Review panels

• Neurology (215)
• General and Plastic Surgery (102)
• Orthopedic (41)
• Radiology (33)
• Dental (22)
• Cardiovascular (18)
• General Hospital (9)
• Ophthalmic (9)
• Gastroenterology and Urology (6)
• Obstetrics and Gynecology (5)
• Physical Medicine (2)
• Microbiology (1)

Most recent Integra LifeSciences 510(k) clearances

450 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

446 product recalls in 157 recall events under these names; 80 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.

Padgett (2004), Radionics (2006, from Tyco), Miltex (2006), Derma Sciences (2017), Codman neurosurgery (from J&J, October 2017 — CODMAN SHURTLEFF filings before 2017 were made under J&J and also cover Codman products J&J kept, which cannot be split out). Includes filings made before each acquisition. Left out: Camino ICP monitoring (divested to Natus Medical in 2017 as a condition of the Codman deal).

Sources

• https://en.wikipedia.org/wiki/Integra_LifeSciences
• https://www.sec.gov/Archives/edgar/data/917520/000091752017000038/pressreleasefiledoctober20.htm

Frequently asked questions

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

FDA lists 460 510(k) clearances, 7 PMA and 0 De Novo decisions across the 22 applicant names Caduvo groups under Integra 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 Integra LifeSciences file under?

The names with the most 510(k) clearances in this group are Codman & Shurtleff, Inc. (152); Integra LifeSciences Corporation (94); Radionics, Inc. (56); Miltex, Inc. (23); Derma Sciences, Inc. (22). The full list of 22 names is on this page.

How long does FDA take to clear Integra LifeSciences 510(k)s?

The median time from FDA receipt to decision across 510(k)s cleared under these names is 76 days. Since 2017 the median was 90 days, against 114 days for all cleared 510(k)s in the same product codes.

Does the Integra 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 460 Integra LifeSciences clearances with predicates and recalls
• Run predicate analysis for product code JXG, Integra 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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