Irvine Biomedical, Inc.
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 AbbottLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
- 510(k) clearances: 14
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Dec 7, 2022 | ViewFlex Xtra ICE CatheterK223077 · OBJ | 510(k) clearances |
| May 19, 2014 | VIEWFLEX XTRA ICE CATHETERK133853 · OBJ | 510(k) clearances |
| Aug 19, 2008 | INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETERK082061 · DRF | 510(k) clearances |
| Mar 20, 2007 | IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETERK070011 · DQO | 510(k) clearances |
| Apr 19, 2006 | INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETERK060757 · DRF | 510(k) clearances |
| Mar 21, 2006 | INQUIRY AFOCUS II DIAGNOSTIC CATHETERK053582 · DRF | 510(k) clearances |
| Nov 4, 2004 | INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETERK042775 · DRF | 510(k) clearances |
| Jun 6, 2001 | AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569K010471 · DRF | 510(k) clearances |
Canada and Imports
Matched by company name- Active Health Canada device licences
- 6, as of Nov 10, 2026
Names and Identifiers
- Appears as
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