Company · SE

Osstell AB

FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.

5510(k) clearances (1 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
EKX	Handpiece, Direct Drive, Ac-Powered	5

Decided	510(k)	Device and applicant	Code
Sep 8, 2026	K261987	Reusable SmartPeg Osstell AB, SE	EKX
Aug 22, 2019	K181888	Osstell Beacon Osstell AB, SE	EKX
Feb 19, 2015	K142358	Osstell IDx Osstell AB, SE	EKX
Apr 9, 2014	K132401	MEGA ISQ Osstell AB	EKX
Sep 26, 2008	K082523	OSSTELL ISQ IMPLANT STABILITY METER Osstell AB	EKX

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.