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Med-El Elektromedizinische Geraete GmbH

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories2
Latest Approval2020-10-09
TypeNumberDevice NameCodeDate
510(k) K201983 BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) PFO 2020-10-09 View
510(k) K200504 BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote PFO 2020-07-29 View
510(k) K191457 BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) PFO 2019-09-18 View
510(k) K183373 Bonebridge PFO 2019-03-07 View
510(k) DEN170009 Bonebridge PFO 2018-07-20 View
510(k) K172460 ADHEAR System LXB 2018-04-27 View