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Cook Medical

Medical device makerAI in United StatesAI. FDA records under 10 spellings of its name, each linked to the record.

  • Records across the group: 1,248, 15 entitiesAI
  • 510(k) clearances: 800
  • Device recalls: 446
  • Warning letters: 1
  • Drug applications: 1

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Cook Medical and its 14 subsidiaries

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Jul 24, 2026EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm ScopesK261274 · KTI510(k) clearances
Jun 2, 2026Hemospray Endoscopic Hemostat (HEMO-[X])K253302 · QAU510(k) clearances
Nov 9, 2025Lunderquist Extra Stiff Wire GuideK251596 · DQX510(k) clearances
Sep 29, 2025SureTome™ SW Sphincterotome with DomeTipK251104 · KNS510(k) clearances
Jun 11, 2025Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)K251499 · BTR510(k) clearances
Jan 17, 2025Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordK243568 · KNS510(k) clearances
Jul 29, 2024EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)K241209 · FCG510(k) clearances
Jun 14, 2024Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)K233079 · FGE510(k) clearances
Sep 4, 2018Warning letter: Medical DevicesCDRHWarning letters
Nov 28, 2017Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The deviClass II · Non-coring needle provided with the Cook Vital-Port¿ Vascular Assess System (Vital-Port) may cut or dislodge a core or sDevice recalls

Subsidiaries and Divisions

14 firms in the Cook Medical group, most records first

Canada and Imports

Across the Cook Medical group, matched by company name
Active Health Canada device licences
222, as of Nov 10, 2026

Names and Identifiers

Appears as
Cook Inc.Cook, Inc.Cook IncorporatedCook (Canada), Inc.Cook Medical IncorporatedCook Medical LlcCook Medical
FEI numbers in warning letters
1820334

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.