Paragonix Technologies is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Paragonix Technologies - FDA 510(k) Cleared Devices
Recent clearances: KIDNEYvault Portable Renal Perfusion System, BAROguard, SherpaPak Pediatric Liver Transport System
5
Total
5
Cleared
0
Denied
Paragonix Technologies has 5 FDA 510(k) cleared medical devices. Based in Braintree, US.
Latest FDA clearance: Oct 2024. Active since 2018. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Paragonix Technologies Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Northstar Biomedical Associates as regulatory consultant.
FDA 510(k) Regulatory Record - Paragonix Technologies
5 devices
Cleared
Oct 23, 2024
KIDNEYvault Portable Renal Perfusion System
Gastroenterology & Urology
306d
Cleared
Aug 15, 2023
BAROguard
Gastroenterology & Urology
235d
Cleared
Jul 02, 2020
SherpaPak Pediatric Liver Transport System
Gastroenterology & Urology
72d
Cleared
Dec 20, 2019
Paragonix SherpaPak Pancreas Transport System
Gastroenterology & Urology
204d
Cleared
Oct 19, 2018
Paragonix SherpaPak Cardiac Transport System
Gastroenterology & Urology
21d