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Teleflex

Medical device makerAI in United StatesAI. FDA records under 4 spellings of its name, each linked to the record.

  • Records across the group: 1,858, 26 entitiesAI
  • Device recalls: 1,007
  • 510(k) clearances: 850
  • Drug applications: 1

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Teleflex and its 25 subsidiaries

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Oct 27, 2026OnControl Powered Bone Access Systems;OnControl Bone Marrow Aspiration System;OnControl Bone Marrow Biopsy System;OnControl Bone Lesion Biopsy System;OnControl Power DriverK262531 · KNW510(k) clearances
Sep 23, 2026Liquick X-treme, Liquick X-treme PlusK261418 · EZD510(k) clearances
Aug 5, 2026Rusch Latex Gold Foley CatheterK262056 · EZL510(k) clearances
Jul 9, 2026Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureK261988 · NEW510(k) clearances
May 15, 2026Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledK252643 · CAH510(k) clearances
May 6, 2026Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™K260775 · GAT510(k) clearances
Feb 23, 2026ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with CoaxialK252795 · KNW510(k) clearances
Feb 5, 2026CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration CanisterK260028 · QEW510(k) clearances
Jun 14, 2019Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.Class I · Device vented gas below the stated pressure.Device recalls

Subsidiaries and Divisions

25 firms in the Teleflex group, most records first

Canada and Imports

Across the Teleflex group, matched by company name
Active Health Canada device licences
279, as of Nov 10, 2026
FDA import refusals since 2024
271 shipment lines, through Oct 23, 2026

Names and Identifiers

Appears as
TELEFLEX LLCTeleflex, Inc.Teleflex Incorporated

Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.