Atlas FDA

Coloplast

15 FDA 510(k) clearances · Manufacturer

Sort:Newest firstOldest first

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

RecordFirmDate
Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) (K241028)Coloplast2024-07-26
Virtue Male Sling System with Alexis Wound Retractor Convenience Kit (K231891)Coloplast2023-09-25
Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging) (K230165)Coloplast2023-08-25
Self-Cath Closed System (K223821)Coloplast2023-08-02
Self-Cath and Self-Cath Plus (K221401)Coloplast2022-12-02
SpeediCath Flex Set (K222059)Coloplast2022-09-21
SpeedCath Compact Male (K210250)Coloplast2022-04-26
SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) (K203637)Coloplast2022-03-08
SpeediCath Compact Set (K200820)Coloplast2020-11-13
SpeediCath Compact Set (K192904)Coloplast2020-11-02
SpeediCath Soft (K200142)Coloplast2020-07-30
SpeediCath Flex Coude Pro (K190620)Coloplast2019-07-10
SpeediCath Standard (K180258)Coloplast2018-10-25
Meridian Vaginal Positioning System (VPS) (K173501)Coloplast2018-02-09
SpeediCath Flex Coude Pro (K180070)Coloplast2018-02-02

Track Coloplast automatically

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