Atlas FDA

EZP

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Rod, Colostomy
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4270
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2005: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
COLOPLAST OSTOMY ROD, MODEL 12814 (K052229)Coloplast Corp.2006-10-13
EASY LOOP, MODEL EZL-01 (K040110)Tools For Surgery, LLC2004-03-24

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