Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA files no records under this name; these are its 5 companies' records, each linked to the record.
As of Nov 13, 2026, FDA's public records list Cook Group and its 5 subsidiaries with 53 510(k) clearances and 1 device recall. The most recent is a device recall dated Jul 24, 2023: Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneou….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Cook Group and its 5 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jul 24, 2023 | Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): GClass II · Sterility of device may be compromised due to breach of the chevron seal of the packaging | Device recalls |
| Feb 3, 2023 | Cook® Spectrum® 2 MRC Central Venous CatheterK223648 · FOZ | 510(k) clearances |
| Mar 19, 2002 | MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATORK020526 · FHN | 510(k) clearances |
| May 20, 1997 | LOCKING STYLET 2K970690 · DQX | 510(k) clearances |
| Dec 27, 1996 | NEEDLE'S EYE SNAREK961992 · DXE | 510(k) clearances |
| Sep 29, 1995 | MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORSK953417 · DXY | 510(k) clearances |
| Sep 11, 1992 | MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEADK915188 · DTB | 510(k) clearances |
| Oct 16, 1991 | MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMERK905403 · DXY | 510(k) clearances |
| Oct 8, 1986 | MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)K863582 · DXY | 510(k) clearances |
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
