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 14, 2026, FDA's public records list Caradyne with 5 510(k) clearances. The most recent is a 510(k) clearance dated Jun 30, 2004: GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM.
| Jun 30, 2004 | GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEMK040862 · BZD | 510(k) clearances |
| Mar 28, 2003 | OXICHECKK023565 · CCL | 510(k) clearances |
| Jun 22, 2000 | CRITERION 60 OR PM 60K000959 · CAP | 510(k) clearances |
| Jan 6, 2000 | CRITERION 40 OR PM 40K992101 · CAP | 510(k) clearances |
| Mar 9, 1999 | WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WHK982283 · BYE | 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
