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

FDA lists 2,551 510(k) clearances, 16 PMA and 3 De Novo decisions across the 68 applicant names Caduvo groups under Stryker, first 1976, latest 2026. Median 510(k) review time across these names: 86 days. Since 2017 the median was 90 days, against 119 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 68 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 119 days.

Top product codes

Plus 308 more product codes.

Review panels

• Orthopedic (1,620)
• Cardiovascular (283)
• General and Plastic Surgery (181)
• Neurology (154)
• Dental (84)
• General Hospital (79)
• Ear, Nose and Throat (56)
• Gastroenterology and Urology (39)
• Radiology (23)
• Physical Medicine (11)
• Obstetrics and Gynecology (10)
• Anesthesiology (8)
• Microbiology (4)
• Pathology (3)
• Ophthalmic (1)
• Clinical Toxicology (1)

Most recent Stryker 510(k) clearances

2,541 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

1,814 product recalls in 609 recall events under these names; 373 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.

Osteonics, Howmedica (from Pfizer, 1998), Leibinger, Concentric Medical (2011), Boston Scientific's neurovascular business incl. Target Therapeutics (2011), Mako Surgical (2013), Physio-Control (2016; earlier owned by Medtronic, so the Medtronic Physio-Control names are here), Sage Products (2016), Novadaq (2017), Entellus (2018), Wright Medical incl. Tornier (2020), Inari Medical (2025). Includes filings made before each acquisition. Left out: STRYKER SPINE and K2M — the U.S. spinal implants business was sold to VB Spine on April 1, 2025. Wright Medical sold its hip/knee business to MicroPort in 2014; its pre-2014 hip/knee filings remain under the Wright name and cannot be split out. Stryker Biotech (OP-1, sold to Olympus Biotech 2010) left out.

Sources

• https://en.wikipedia.org/wiki/Stryker_Corporation
• https://www.stryker.com/us/en/about/news/2025/stryker-completes-sale-of-us-spinal-implants-business.html
• https://en.wikipedia.org/wiki/Physio-Control
• https://www.stryker.com/ir/en/about/news/2020/stryker-completes-acquisition-of-wright-medical.html

Frequently asked questions

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

FDA lists 2,551 510(k) clearances, 16 PMA and 3 De Novo decisions across the 68 applicant names Caduvo groups under Stryker, first 1976, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Stryker file under?

The names with the most 510(k) clearances in this group are Howmedica Corp. (409); Stryker Corp. (352); Wrightmedicaltechnologyinc (302); Howmedica Osteonics Corp. (301); Osteonics Corp. (178). The full list of 68 names is on this page.

How long does FDA take to clear Stryker 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 90 days, against 119 days for all cleared 510(k)s in the same product codes.

Does the Stryker 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 2,551 Stryker clearances with predicates and recalls
• Run predicate analysis for product code HRS, Stryker'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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