Spark Biomedical, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Spark Biomedical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Sparrow Ascent, Sparrow Ascent, Sparrow Therapy System
3
Total
3
Cleared
0
Denied
Spark Biomedical, Inc. has 3 FDA 510(k) cleared medical devices. Based in Dallas, US.
Latest FDA clearance: Aug 2025. Active since 2021. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Spark Biomedical, Inc. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by RQM+ and Acknowledge Regulatory Strategies, LLC. 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Spark Biomedical, Inc.
3 devices