# Artsana S.P.A

- Location (FDA's records): Bristol, WI
- FDA decisions: 3 (2005–2016): 3 510(k) clearances
- Product codes: FMI (2), FMF (1)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 4 (1 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
- Novo Nordisk, Inc.: 1 (https://510kreport.com/company/novo-nordisk)

## Firms that cite its devices most
- Promisemed Hangzhou Meditech Co., Ltd.: 1 (https://510kreport.com/company/promisemed-hangzhou-meditech)
- M.V.S.R.L.: 1 (https://510kreport.com/company/mvsrl)
- CMT Health PTE., Ltd.: 1 (https://510kreport.com/company/cmt-health)

## Its most-cited devices
- K151311: Safe Block Pen Needle (2016), cited by 2
- K051783: Artsana Pen Needles, Artsana Injection Needles (2005), cited by 2

## Recent decisions
- K151311: Safe Block Pen Needle (Feb 10, 2016)
- K052667: Artsana Piston and Insulin Syringes (Nov 25, 2005)
- K051783: Artsana Pen Needles, Artsana Injection Needles (Oct 4, 2005)

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