Data / Medical devices / United States / Teleflex Medical LLC

Teleflex Medical LLC: FDA-registered device maker in Morrisville, NC, United States, 421 510(k) clearances and 5 PMA approvals

Teleflex Medical LLC is registered with the FDA (registration 3011137372) in Morrisville, NC, United States. It lists 547 device types. The FDA files 421 510(k) clearances and 5 PMA approvals under its listings, the newest dated July 9, 2026. 135 recall events name it as the recalling firm (14 Class I). Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number

3011137372

FEI number

3005747797

Address

3015 Carrington Mill Blvd, Morrisville, NC, United States, 27560

Owner or operator

Teleflex (9062981)

Roles

Complaint file establishment, Manufacturer, Specification developer

First device listed

April 29, 1985

Registered through

2027

Brand names listed

(K792088), , GEN, 0.2 Micron Filter, 0.2 Micron Flat Epidural Filter, 12 Fr Heparin Two-Lumen Hemodialysis Catheterization Kit/Set, 12 Fr. Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter, 14 Fr Two-Lumen Hemodialysis Catheterization Kit/Set, ACULUX-PILLING and more

Devices it lists

147 more device types in the FDA listing

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 421.

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI. Newest 100 of 135.

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Updated July 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.