Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Integer HoldingsLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Oscor with 49 510(k) clearances and 39 device recalls. The most recent is a device recall dated Jun 10, 2026: Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer Sys….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| 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 |
| 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 |
| Jun 3, 2021 | Breezeway IIK210627 · DYB | 510(k) clearances |
| Sep 22, 2015 | Destino ReachK151951 · DYB | 510(k) clearances |
| Mar 19, 2015 | IS4/DF4 Port PlugK143463 · DTD | 510(k) clearances |
| Jul 9, 2014 | INTRODUCER, MODEL ADELANTE MAGNUMK140917 · DYB | 510(k) clearances |
| Apr 17, 2014 | DESTINO TWIST, STEERABLE GUIDING SHEATHK140406 · DYB | 510(k) clearances |
| Feb 13, 2014 | INTRODUCER SETS, MODEL ADELANTE RADIALK130633 · DYB | 510(k) clearances |
| Jan 8, 2014 | SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIREK130843 · DRC | 510(k) clearances |
| Jun 13, 2013 | GUIDEWIRE, PURSUER SERIESK130104 · 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
