# Scandinavian Health Limited

- Location (FDA's records): Deerfield Beach, FL
- FDA decisions: 4 (1996–2014): 4 510(k) clearances
- Names in FDA's records: Scandinavian Health Limited (3); Scandinavian Health , Ltd. (1)
- Product codes: KZH (3), FMI (1)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 3 (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
- Owen Mumford USA, Inc.: 4 (https://510kreport.com/company/owen-mumford-usa)
- Novo Nordisk, Inc.: 1 (https://510kreport.com/company/novo-nordisk)
- Feel Tech: 1 (https://510kreport.com/company/feel-tech)
- Union Medico Aps: 1 (https://510kreport.com/company/union-medico)

## Firms that cite its devices most
- Synthon Hispania S.L.: 1 (https://510kreport.com/company/synthon-hispania)
- Innoject, Inc.: 1 (https://510kreport.com/company/innoject)

## Its most-cited devices
- K124026: Lobster Auto-Injector (2013), cited by 2
- K954729: Pen-Inject 2.25 (1996), cited by 1

## Recent decisions
- K141384: Whisperject Autoinjector (Sep 12, 2014)
- K124026: Lobster Auto-Injector (Sep 13, 2013)
- K120191: Push-on Needle 30GX8MM (May 23, 2012)
- K954729: Pen-Inject 2.25 (Jan 29, 1996)

Source page: https://510kreport.com/company/scandinavian-health