Atlas FDA

NBG

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Marker, Colon
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
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RecordFirmDate
ENDOMARK STERILE INDIA INK (K042901)Pmt Corp.2005-03-16
SPOT ENDOSCOPIC MARKER (K993951)Chek-Med Systems2000-02-18

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