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Convatec

8 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18). (K260737)Convatec2026-08-05
Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K) (K250699)Convatec2025-07-01
Flexi-Seal AIR (with ENFit Connector) (K243228)Convatec2025-03-28
GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) (K232665)Convatec2024-01-25
Flexi-Seal PROTECT Fecal Management System (K162906)Convatec2017-03-07
VITALA CONTINENCE CONTROL DEVICE (K083785)Convatec2010-04-02
AQUACEL AG SURGICAL (K091034)Convatec2009-12-16
AMADEUS ADAPTIVE COMPRESSION THERAPY (K071763)Convatec2008-03-07

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