Paragonix Technologies, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Paragonix Technologies, Inc. - FDA 510(k) Cleared Devices
Recent clearances: BAROguard Donor Lung Preservation System, SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
7
Total
5
Cleared
0
Denied
Paragonix Technologies, Inc. has 5 FDA 510(k) cleared medical devices. Based in Providence, US.
Latest FDA clearance: Jan 2026. Active since 2013. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Paragonix Technologies, Inc. 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, Inc.
7 devices
Cleared
Jan 30, 2026
BAROguard Donor Lung Preservation System
Gastroenterology & Urology
30d
Cleared
Mar 30, 2018
SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
Gastroenterology & Urology
65d
Cleared
Nov 25, 2014
Sherpa Pak Kidney Transport System
Gastroenterology & Urology
33d
Cleared
Nov 25, 2014
Sherpa Pak Cardiac Transport System
Gastroenterology & Urology
29d
Cleared
May 23, 2014
SHERPA PAK TRANSPORTER
Gastroenterology & Urology
171d
Cleared
Feb 21, 2014
SHERPA PAK CARDIAC TRANSPORT SYSTEM
Gastroenterology & Urology
108d
Cleared
Feb 06, 2013
SHERPA PAK CARDIAC TRANSPORT SYSTEM
Gastroenterology & Urology
103d