Atlas FDA

FFY

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Adaptor, Bulbs, Miscellaneous, For Endoscope
Device class
Class I (low risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
1993: 1 · 1994: 1 · 2006: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CMI E-Z FLO BULB P.N. 701 (K932128)Columbia Medical & Surgical, Inc.1994-04-07
WORKING CHANNEL VALVE (K900781)Applied Urology, Inc.1990-04-25

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