Atlas FDA

KAD

5 FDA 510(k) clearances · Product code

21 daysmedian time to decision
107 days90th percentile
5clearances measured

FDA profile

Official device name
Elevator, Ent
Device class
Class I (low risk)
Regulation
21 CFR 874.4420
Medical specialty
Ear, Nose, Throat
Adverse events (MAUDE)
1994: 2 · 2001: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDateBuilder
ELEVATOR (K841356)Treace Medical, Inc.1984-07-18+ Add
VARIOUS TYPES OF ENT ELEVATORS (K822270)Kelleher Corp.1982-08-16+ Add
ENT ELEVATORS (K822190)Kelleher Corp.1982-08-16+ Add
BOIES NASAL FRACTURE ELEVATOR (K772391)Edward Weck, Inc.1978-01-17+ Add
DINGMAN ZYGOMA ELEVATOR (K772399)Edward Weck, Inc.1978-01-17+ Add

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