# Medcare Flaga

- Location (FDA's records): Reykjavik, IS
- FDA decisions: 4 (2003–2004): 4 510(k) clearances
- Product codes: MNR (4)
- Predicates its devices cite: 9 (2 its own); citations of its devices by later devices: 13 (2 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
- Airsep Corp.: 3 (https://510kreport.com/company/airsep)
- Sector Medical Corp.: 2 (https://510kreport.com/company/sector-medical)
- Pro-Tech, Inc.: 1 (https://510kreport.com/company/pro-tech)
- Compumedics USA, Ltd.: 1 (https://510kreport.com/company/compumedics-usa)

## Firms that cite its devices most
- Embla Systems: 4 (https://510kreport.com/company/embla-systems)
- Nox Medical Ehf: 2 (https://510kreport.com/company/nox-medical)
- Earlysense, Ltd.: 2 (https://510kreport.com/company/earlysense)
- Kai Sensors, Inc.: 1 (https://510kreport.com/company/kai-sensors)
- Hypnocore, Ltd.: 1 (https://510kreport.com/company/hypnocore)
- Resmed Germany, Inc.: 1 (https://510kreport.com/company/resmed-germany)

## Its most-cited devices
- K024322: Embla N7000 (2003), cited by 5
- K041904: Compass F10 System (2004), cited by 4
- K043132: Universal Xacttrace (2004), cited by 2
- K041724: Compass M10 System (2004), cited by 2

## Recent decisions
- K043132: Universal Xacttrace (Dec 21, 2004)
- K041724: Compass M10 System (Sep 28, 2004)
- K041904: Compass F10 System (Sep 7, 2004)
- K024322: Embla N7000 (Oct 27, 2003)

Source page: https://510kreport.com/company/medcare-flaga