Icare Finland OY is one of 32 FDA 510(k) medical device manufacturers from Finland in the dataset, ranked by real submission volume.
Icare Finland OY - FDA 510(k) Cleared Devices
Recent clearances: iCare ST500 (TA04), iCare IC200, iCare HOME2
7
Total
7
Cleared
0
Denied
Icare Finland OY has 7 FDA 510(k) cleared medical devices. Based in Vantaa, FI.
Latest FDA clearance: Sep 2024. Active since 2016. Primary specialty: Ophthalmic.
Browse the FDA 510(k) cleared devices submitted by Icare Finland OY Filter by specialty or product code using the sidebar.
1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Icare Finland OY
7 devices
Cleared
CT
Sep 27, 2024
iCare ST500 (TA04)
Ophthalmic
128d
Cleared
Oct 06, 2022
iCare IC200
Ophthalmic
197d
Cleared
Jan 25, 2022
iCare HOME2
Ophthalmic
267d
Cleared
May 07, 2020
Icare HOME Tonometer
Ophthalmic
27d
Cleared
Jan 14, 2020
Icare ic200
Ophthalmic
335d
Cleared
Mar 21, 2017
Icare HOME tonometer
Ophthalmic
112d
Cleared
Apr 19, 2016
Icare ic100
Ophthalmic
118d