Convatec, Inc. is one of 16079 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Convatec, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Cure Catheter Closed System, Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus, AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE
7
Total
6
Cleared
0
Denied
Convatec, Inc. has 6 FDA 510(k) cleared medical devices. Based in Skillman, US.
Last cleared in 2023. Active since 2010. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Convatec, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by MRC Global, LLC as regulatory consultant. 2 devices have linked clinical trials registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Convatec, Inc.
7 devices
Cleared
Nov 08, 2023
Cure Catheter Closed System
Gastroenterology & Urology
266d
Cleared
Nov 17, 2022
Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus
Gastroenterology & Urology
168d
Cleared
Jun 06, 2013
AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE
General & Plastic Surgery
205d
Cleared
Jul 25, 2012
AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER
General & Plastic Surgery
89d
Cleared
Apr 26, 2012
FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM
Gastroenterology & Urology
255d
Cleared
CT
Aug 19, 2011
VITALA CONTINENCE CONTROL DEVICE
Gastroenterology & Urology
95d
Cleared
CT
Dec 01, 2010
VITALA CONTINENCE CONTROL DEVICE
Gastroenterology & Urology
89d