Medical device makerLabelled 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 13, 2026, FDA's public records list Cardio Systems with 9 510(k) clearances. The most recent is a 510(k) clearance dated Jun 24, 2013: STEALTH 360 ORBITAL PAD SYSTEM.
| Jun 24, 2013 | STEALTH 360 ORBITAL PAD SYSTEMK131092 · MCW | 510(k) clearances |
| Aug 14, 2008 | MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEMK081944 · MCW | 510(k) clearances |
| Jan 22, 1998 | ZAK-2000K972022 · FNM | 510(k) clearances |
| Feb 2, 1994 | LOW AIR LOSS MATTRESS, MODIFICATIONK934689 · INX | 510(k) clearances |
| Sep 15, 1992 | CENTRI-SAFE(TM) VALVEK921500 · MJJ | 510(k) clearances |
| Dec 1, 1988 | ADD-ON TO CRITICAL PATIENT CARE BEDK882177 · IOQ | 510(k) clearances |
| Sep 18, 1985 | BAYLOR RAPID AUTOTRANSFUSION SYSTEMK852736 · CAC | 510(k) clearances |
| Nov 13, 1979 | CARDIOPLEGIA SOLUTION ADMIN. SETK792152 · DWF | 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
