Atlas FDA

NXB

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Dispenser, Solid Medication
Device class
Class I (low risk)
Regulation
21 CFR 890.5050
Medical specialty
Physical Medicine
Flags
GMP exempt
FDA definition
A solid medication dispenser is a device intended for medical purposes that is used to issue solid (pills) medication.
Adverse events (MAUDE)
1995: 2 · 1996: 1 · 1999: 2 · 2010: 4 · 2023: 23
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
THE HEART PROTECTOR (K944481)Garan Scientific, Inc.1995-04-10
TAB PAK (K882731)Dynex Trading Co.1988-12-14
NITROGLYCERINE CONTAINER (K833311)Apothecary Products, Inc.1984-02-04

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