Atlas FDA

Convatec Limited

10 FDA 510(k) clearances · Manufacturer

Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women (K252943)Convatec Limited2026-04-01
Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C (K250891)Convatec Limited2025-06-06
GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter (K213283)Convatec Limited2022-06-22
Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) (K190114)Convatec Limited2019-04-30
AVELLE Negative Pressure Wound Therapy System (K180205)Convatec Limited2018-10-19
GentleCath Glide Intermittent Urinary Catheter (K181206)Convatec Limited2018-08-16
AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber (K173675)Convatec Limited2018-07-20
GentleCath Intermittent Urinary Catheter (K172924)Convatec Limited2017-11-21
GentleCath Glide Intermittent Catheter (K161344)Convatec Limited2016-09-20
AQUACEL Ag Surgical SP Dressing (K152926)Convatec Limited2016-01-21

Track Convatec Limited automatically

Every clearance here is in the API, with alerts when new ones post.