Tuned , Ltd. is one of 267 FDA 510(k) medical device manufacturers from Israel in the dataset, ranked by real submission volume.
Tuned , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Tuned Self-Fitting Mobile App, Intrisound™ Tuned Lumen® 155 Hearing Aids
2
Total
2
Cleared
0
Denied
Tuned , Ltd. has 2 FDA 510(k) cleared medical devices. Based in Gan Yoshiya, IL.
Latest FDA clearance: Sep 2025. Active since 2023. Primary specialty: Ear, Nose, Throat.
Browse the FDA 510(k) cleared devices submitted by Tuned , Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by ProMedoss, Inc. as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Tuned , Ltd.
2 devices