# Med-El Elektromedizinische Geraete GmbH

- Location (FDA's records): Innsbruck, AT
- FDA decisions: 6 (2018–2020): 5 510(k) clearances and 1 De Novo grant
- Product codes: PFO (5), LXB (1)
- Predicates its devices cite: 6 (4 its own); citations of its devices by later devices: 7 (4 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
- Audifon-USA, Inc.: 1 (https://510kreport.com/company/audifon-usa)
- Cochlear Americas: 1 (https://510kreport.com/company/cochlear-americas)

## Firms that cite its devices most
- Cochlear Americas: 1 (https://510kreport.com/company/cochlear-americas)
- Oticon Medical AB: 1 (https://510kreport.com/company/oticon-medical)
- Zdeer Technology (Henan) Co., Ltd.: 1 (https://510kreport.com/company/zdeer-technology-henan)

## Its most-cited devices
- DEN170009: Bonebridge (2018), cited by 4
- K191457: BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) (2019), cited by 1
- K172460: ADHEAR System (2018), cited by 1
- K183373: Bonebridge (2019), cited by 1

## Recent decisions
- K201983: BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) (Oct 9, 2020)
- K200504: BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote (Jul 29, 2020)
- K191457: BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) (Sep 18, 2019)
- K183373: Bonebridge (Mar 7, 2019)
- DEN170009: Bonebridge (Jul 20, 2018)
- K172460: ADHEAR System (Apr 27, 2018)

Source page: https://510kreport.com/company/med-el-elektromedizinische-geraete