Atlas FDA

FZY

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Hammer, Surgical
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 69 · 2022: 68 · 2023: 79 · 2024: 83 · 2025: 53 · 2026: 36
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SURGICAL HAMMERS (K802524)Midshore Welding Corp.1980-11-12

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