Atlas FDA

JYT

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Pick, Microsurgical Ear
Device class
Class I (low risk)
Regulation
21 CFR 874.4420
Medical specialty
Ear, Nose, Throat
Adverse events (MAUDE)
1993: 1 · 1996: 1 · 1997: 3 · 1999: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
RIGHT ANGLED PICK (K841355)Treace Medical, Inc.1984-07-03
MICROSURGICAL EAR PICKS (K822176)Kelleher Corp.1982-08-16

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