# Entific Medical Systems, Inc.

- Location (FDA's records): Findley, MN
- FDA decisions: 5 (1999–2004): 5 510(k) clearances
- Product codes: LXB (5)
- Predicates its devices cite: 8 (2 its own); citations of its devices by later devices: 12 (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
- Nobelpharma USA, Inc.: 6 (https://510kreport.com/company/nobelpharma-usa)

## Firms that cite its devices most
- Cochlear Americas: 2 (https://510kreport.com/company/cochlear-americas)
- Cochlear Bone Anchored Systems AB: 2 (https://510kreport.com/company/cochlear-bone-anchored-systems)
- United Hearing Systems, Inc.: 2 (https://510kreport.com/company/united-hearing-systems)
- Oticon Medical AB: 2 (https://510kreport.com/company/oticon-medical)
- Sonitus Medical, Inc.: 1 (https://510kreport.com/company/sonitus-medical)
- Cochlear: 1 (https://510kreport.com/company/cochlear)

## Its most-cited devices
- K042017: Baha Divino (2004), cited by 5
- K021837: Branenmark Bone-Anchored-Hearing Aid (Baha) (2002), cited by 3
- K002913: Headband for Baha (2000), cited by 2
- K992872: Branemark Bone-Anchored Hearing Aid (Baha) Cordelle II (1999), cited by 1
- K011438: Bilateral Fitting of the Branemark Bone-Anchored Hearing Aid (Baha) System. (2001), cited by 1

## Recent decisions
- K042017: Baha Divino (Aug 26, 2004)
- K021837: Branenmark Bone-Anchored-Hearing Aid (Baha) (Aug 30, 2002)
- K011438: Bilateral Fitting of the Branemark Bone-Anchored Hearing Aid (Baha) System. (Jul 23, 2001)
- K002913: Headband for Baha (Oct 17, 2000)
- K992872: Branemark Bone-Anchored Hearing Aid (Baha) Cordelle II (Nov 24, 1999)

Source page: https://510kreport.com/company/entific-medical-systems