# Omnia Spa

- Location (FDA's records): Carmel, IN
- FDA decisions: 3 (2011–2018): 3 510(k) clearances
- Product codes: NBY (2), FYA (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- D.I.R.R.a. S.R.L.: 1 (https://510kreport.com/company/dirra)

## Recent decisions
- K180630: Ptfe Surgical Suture (Apr 6, 2018)
- K132464: Ptfe Surgical Suture (Feb 12, 2014)
- K110724: Surgical Procedure Packs (Jun 23, 2011)

Source page: https://510kreport.com/company/omnia