# Dignitana AB

- Location (FDA's records): Lund, SE
- FDA decisions: 3 (2015–2019): 2 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Dignitana AB (2); Dignitana, Inc. (1)
- Product codes: PMC (3)
- Predicates its devices cite: 2 (2 its own); citations of its devices by later devices: 4 (2 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Stemtech Medical Devices Private Limited: 1 (https://510kreport.com/company/stemtech-medical-devices-private)
- Paxman Coolers Limited: 1 (https://510kreport.com/company/paxman-coolers)

## Its most-cited devices
- DEN150010: Dignitana AB DigniCap System (2015), cited by 2
- K191166: DigniCap Delta (2019), cited by 1
- K170871: DigniCap Scalp Cooling System (2017), cited by 1

## Recent decisions
- K191166: DigniCap Delta (Jun 26, 2019)
- K170871: DigniCap Scalp Cooling System (Jul 3, 2017)
- DEN150010: Dignitana AB DigniCap System (Dec 8, 2015)

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