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

FDA lists 2,727 510(k) clearances, 104 PMA and 5 De Novo decisions across the 117 applicant names Caduvo groups under Medtronic, first 1976, latest 2026. Median 510(k) review time across these names: 80 days. Since 2017 the median was 93 days, against 123 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 117 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 93 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.

Top product codes

Plus 426 more product codes.

Review panels

• Cardiovascular (830)
• Orthopedic (598)
• General and Plastic Surgery (462)
• Anesthesiology (240)
• Neurology (224)
• Gastroenterology and Urology (120)
• Ear, Nose and Throat (113)
• General Hospital (104)
• Clinical Chemistry (36)
• Radiology (23)
• Dental (22)
• Obstetrics and Gynecology (21)
• Hematology (19)
• Physical Medicine (8)
• Ophthalmic (4)
• Microbiology (1)
• Pathology (1)

Most recent Medtronic 510(k) clearances

2,717 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

2,171 product recalls in 663 recall events under these names; 431 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.

Covidien (formerly Tyco Healthcare: United States Surgical, Valleylab, Nellcor Puritan Bennett) acquired January 2015; ev3, Given Imaging and Oridion came in through Covidien. Also Sofamor Danek (1999), Xomed (1999), MiniMed (2001), AVE (1999), Kyphon (2007), Invatec (2010), Osteotech (2010), Mazor Robotics (2018), Intersect ENT (2022). Includes filings made before each acquisition. Left out: Physio-Control names (divested 2006/2007, now Stryker); Kendall-named Covidien filings (patient-care products sold to Cardinal Health in 2017) — note that the main COVIDIEN and TYCO HEALTHCARE names still include some of those pre-2017 patient-care filings, which applicant-level grouping cannot split; Mallinckrodt names (pharma spun out of Covidien in 2013).

Sources

• https://en.wikipedia.org/wiki/Medtronic
• https://en.wikipedia.org/wiki/Covidien
• https://en.wikipedia.org/wiki/MiniMed
• https://en.wikipedia.org/wiki/Kyphon
• https://en.wikipedia.org/wiki/Mazor_Robotics
• https://en.wikipedia.org/wiki/Given_Imaging

Frequently asked questions

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

FDA lists 2,727 510(k) clearances, 104 PMA and 5 De Novo decisions across the 117 applicant names Caduvo groups under Medtronic, first 1976, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Medtronic file under?

The names with the most 510(k) clearances in this group are Medtronic Vascular (480); Medtronic Sofamor Danek (253); Medtronic, Inc. (247); Covidien (224); United States Surgical, A Division of Tyco Healthc (218). The full list of 117 names is on this page.

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

The median time from FDA receipt to decision across 510(k)s cleared under these names is 80 days. Since 2017 the median was 93 days, against 123 days for all cleared 510(k)s in the same product codes.

Does the Medtronic 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 2,727 Medtronic clearances with predicates and recalls
• Run predicate analysis for product code GEI, Medtronic'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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