Atlas FDA

FDZ

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Attachment, Eyepiece, For Insertion Of Prescription Lens
Device class
Class I (low risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2001: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
EXEL INDWELLING CATHETER (K895772)Exel Intl.1990-02-16
CENTRAL VEIN CATHETERIZATION TRAY (K852642)Teleflexmedical, Inc.1986-01-16

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