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

FDA lists 566 510(k) clearances, 2 PMA and 2 De Novo decisions across the 29 applicant names Caduvo groups under Teleflex, first 1976, latest 2026. Median 510(k) review time across these names: 89 days. Since 2017 the median was 105 days, against 132 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 29 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 105 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.

Top product codes

Plus 115 more product codes.

Review panels

• Cardiovascular (169)
• Anesthesiology (138)
• General and Plastic Surgery (98)
• General Hospital (85)
• Gastroenterology and Urology (72)
• Orthopedic (4)
• Ear, Nose and Throat (2)
• Neurology (1)
• Clinical Toxicology (1)

Most recent Teleflex 510(k) clearances

556 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

1,203 product recalls in 295 recall events under these names; 244 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.

Weck surgical products (the PILLING WECK and WECK CLOSURE SYSTEMS names are left out because their acquisition history is not confirmed), Rüsch (1989), Hudson RCI (2004), Arrow International (2007), LMA (2012), Vidacare (2013), Vascular Solutions (2017), NeoTract (2017), Z-Medica (2020). Includes filings made before each acquisition.

Sources

• https://en.wikipedia.org/wiki/Teleflex
• https://en.wikipedia.org/wiki/Arrow_International

Frequently asked questions

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

FDA lists 566 510(k) clearances, 2 PMA and 2 De Novo decisions across the 29 applicant names Caduvo groups under Teleflex, first 1976, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Teleflex file under?

The names with the most 510(k) clearances in this group are Vascular Solutions, Inc. (115); Arrow Intl., Inc. (110); Teleflexmedical, Inc. (64); Rusch Intl. (43); Teleflex Medical (41). The full list of 29 names is on this page.

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

The median time from FDA receipt to decision across 510(k)s cleared under these names is 89 days. Since 2017 the median was 105 days, against 132 days for all cleared 510(k)s in the same product codes.

Does the Teleflex 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 566 Teleflex clearances with predicates and recalls
• Run predicate analysis for product code DQY, Teleflex'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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