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 8 companies' records, each linked to the record.
As of Nov 14, 2026, FDA's public records list Integer Holdings and its 8 subsidiaries with 139 510(k) clearances and 55 device recalls. The most recent is a 510(k) clearance dated Sep 18, 2026: 25G Huber Needle.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Integer Holdings and its 8 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 18, 2026 | 25G Huber NeedleK254095 · PTI | 510(k) clearances |
| Jun 10, 2026 | Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. hearClass I · Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, und | Device recalls |
| Jun 10, 2026 | Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump andClass I · Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, und | Device recalls |
| Jun 10, 2026 | Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and acceClass I · Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, und | Device recalls |
| Mar 19, 2026 | Enroute 0.014'' Transcarotid GuidewireK253746 · DQX | 510(k) clearances |
| Dec 6, 2024 | PTFE GuidewireK242824 · DQX | 510(k) clearances |
| Oct 7, 2022 | Pre-Formed BlueK221575 · DQX | 510(k) clearances |
| Dec 22, 2021 | Destino Twist 14F (also branded as Guidestar 14F)Class II · There is potential for separation between the threaded hub and threaded cap at the proximal end of the device. | Device recalls |
| Nov 22, 2021 | Pre-Formed Extra Support GuidewireK211741 · DQX | 510(k) clearances |
| Jun 3, 2021 | Breezeway IIK210627 · DYB | 510(k) clearances |
| Apr 18, 2019 | Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, JK182457 · DQX | 510(k) clearances |
| Oct 18, 2016 | ENROUTE 0.014 GuidewireK160643 · DQX | 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
