Company ยท AT
Med-El Elektromedizinische Geraete GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2020. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 9, 2020 | K201983 | BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) Med-El Elektromedizinische Geraete GmbH, AT | PFO |
| Jul 29, 2020 | K200504 | BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote Med-El Elektromedizinische Geraete GmbH, AT | PFO |
| Sep 18, 2019 | K191457 | BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) Med-El Elektromedizinische Geraete GmbH, AT | PFO |
| Mar 7, 2019 | K183373 | Bonebridge Med-El Elektromedizinische Geraete GmbH, AT | PFO |
| Jul 20, 2018 | DEN170009 | Bonebridge Med-El Elektromedizinische Geraete GmbH, AT | PFO |
| Apr 27, 2018 | K172460 | ADHEAR System Med-El Elektromedizinische Geraete GmbH, AT | LXB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||