Health Line International Corporation is one of 16601 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Health Line International Corporation - FDA 510(k) Cleared Devices
Recent clearances: Health Line Tearaway Introducer, Power Acute Triple Lumen Hemodialysis Catheter, Acute Dual Lumen Hemodialysis Catheter
12
Total
10
Cleared
0
Denied
Health Line International Corporation has 10 FDA 510(k) cleared medical devices. Based in Clearfield, US.
Latest FDA clearance: Jun 2026. Active since 2006. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Health Line International Corporation Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Health Line International Corporation
12 devices
Cleared
Jun 22, 2026
Health Line Tearaway Introducer
Cardiovascular
12d
Cleared
Jan 13, 2023
Power Acute Triple Lumen Hemodialysis Catheter
Gastroenterology & Urology
176d
Cleared
Dec 24, 2020
Acute Dual Lumen Hemodialysis Catheter
Gastroenterology & Urology
307d
Cleared
Mar 12, 2020
Health Line CT Midline Catheter
General Hospital
38d
Cleared
Dec 10, 2019
Health Line CT CVC
General Hospital
85d
Cleared
Jul 12, 2016
ARTLINE
Cardiovascular
145d
Cleared
Aug 20, 2014
NEXUS MIDLINE CT CATHETER
General Hospital
198d
Cleared
Jan 09, 2014
CASCADE HEMODIALYSIS/APHERESIS CATHETER
Gastroenterology & Urology
288d
Cleared
Mar 08, 2013
UNI-PICC
General Hospital
60d
Cleared
May 04, 2012
HLIC NEEDLE-LESS VALVE
General Hospital
71d
Cleared
Aug 19, 2010
SYNERGY CT PICC
General Hospital
99d
Cleared
May 31, 2006
HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS
General Hospital
107d