Pharmaceutical companyLabelled 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.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Coeur Laboratories with 10 510(k) clearances. The most recent is a 510(k) clearance dated Oct 8, 1997: COEUR 130 ML ANGIOGRAPHIC SYRINGE.
| Oct 8, 1997 | COEUR 130 ML ANGIOGRAPHIC SYRINGEK971712 · DXT | 510(k) clearances |
| Mar 28, 1997 | COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)K965214 · DTX | 510(k) clearances |
| Sep 12, 1996 | FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211K960965 · DXT | 510(k) clearances |
| Jun 22, 1989 | PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGEK890292 · DXT | 510(k) clearances |
| Feb 7, 1989 | CAPILLARY TUBE, BLOOD COLLECTIONK885138 · GIO | 510(k) clearances |
| Jan 31, 1989 | 16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FRK885202 · KOD | 510(k) clearances |
| Jun 16, 1988 | UROLOGICAL CATHETERK881646 · KOD | 510(k) clearances |
| Jan 19, 1988 | COEUR CONTROL SYRINGEK874579 · FMF | 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