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 LivaNovaLabelled by claude-sonnet-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 14, 2026, FDA's public records list COBE Cardiovascular with 43 510(k) clearances. The most recent is a 510(k) clearance dated Mar 8, 2005: SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG.
| Mar 8, 2005 | SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAGK050111 · DTN | 510(k) clearances |
| Nov 19, 2004 | COBE ANGEL WHOLE BLOOD SEPARATION SYSTEMK042473 · JQC | 510(k) clearances |
| Feb 26, 2004 | DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTERK040184 · DTM | 510(k) clearances |
| Dec 11, 2003 | SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800K033641 · DTN | 510(k) clearances |
| Mar 6, 2003 | COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700K030462 · KFM | 510(k) clearances |
| Jul 2, 2002 | SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEMK021830 · DTR | 510(k) clearances |
| Feb 12, 2002 | COBE REVOLUTIONK011835 · KFM | 510(k) clearances |
| Nov 16, 2001 | COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATORK013480 · DTZ | 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
