Global Instrumentation, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Global Instrumentation, LLC - FDA 510(k) Cleared Devices
Recent clearances: M12 Telemetry System, M5 Recorder
5
Total
5
Cleared
0
Denied
Global Instrumentation, LLC has 5 FDA 510(k) cleared medical devices. Based in Manlius, US.
Latest FDA clearance: May 2026. Active since 2005. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Global Instrumentation, LLC Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Accelerated Device Approval Services as regulatory consultant.
FDA 510(k) Regulatory Record - Global Instrumentation, LLC
5 devices
Cleared
May 29, 2026
M12 Telemetry System
Cardiovascular
266d
Cleared
Dec 29, 2020
M5 Recorder
Cardiovascular
124d
Cleared
May 24, 2017
Matrix Data Management System
Cardiovascular
264d
Cleared
Apr 22, 2016
Matrix Mini ECG Monitor
Cardiovascular
214d
Cleared
Sep 26, 2005
MATRIX HOLTER SYSTEM, MODEL M12
Cardiovascular
91d