Atlas FDA

MOQ

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Battery, Replacement, Rechargeable
Device class
Class I (low risk)
Regulation
21 CFR 878.4820
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 123 · 2022: 860 · 2023: 125 · 2024: 184 · 2025: 196 · 2026: 84
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
VERTEBRAL ACCESS SYSTEM BY VIDACARE (K081713)Vidacare Corporation2008-11-21
NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116 (K013133)Nordix, Inc.2001-11-13
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822 (K980224)Alexander Mfg. Co.1998-04-02

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