Convatec is one of 16081 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Convatec - FDA 510(k) Cleared Devices
Recent clearances: Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16), Cure Twist Female 8 Catheter (T8), Flexi-Seal AIR (with ENFit Connector)
8
Total
8
Cleared
0
Denied
Convatec has 8 FDA 510(k) cleared medical devices. Based in Skillman, US.
Latest FDA clearance: Aug 2026. Active since 2008. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Convatec Filter by specialty or product code using the sidebar.
1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Convatec
8 devices
Cleared
Aug 05, 2026
Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16)
Gastroenterology & Urology
152d
Cleared
Jul 01, 2025
Cure Twist Female 8 Catheter (T8)
Gastroenterology & Urology
116d
Cleared
Mar 28, 2025
Flexi-Seal AIR (with ENFit Connector)
Gastroenterology & Urology
171d
Cleared
Jan 25, 2024
GentleCath Air for Women (CH10)
Gastroenterology & Urology
147d
Cleared
Mar 07, 2017
Flexi-Seal PROTECT Fecal Management System
Gastroenterology & Urology
141d
Cleared
CT
Apr 02, 2010
VITALA CONTINENCE CONTROL DEVICE
Gastroenterology & Urology
469d
Cleared
Dec 16, 2009
AQUACEL AG SURGICAL
General & Plastic Surgery
250d
Cleared
Mar 07, 2008
AMADEUS ADAPTIVE COMPRESSION THERAPY
Cardiovascular
252d