Ote North America, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Ote North America, LLC - FDA 510(k) Cleared Devices
Recent clearances: OTE MPS 045 Multi-purpose Lens Care Solution
1
Total
1
Cleared
0
Denied
Ote North America, LLC has 1 FDA 510(k) cleared medical devices. Based in Inwood, US.
Last cleared in 2021. Active since 2021. Primary specialty: Ophthalmic.
Browse the FDA 510(k) cleared devices submitted by Ote North America, LLC Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Foresight Regulatory Strategies, Inc. as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Ote North America, LLC
1 devices