510(k) Report

FDA applicant

Emed Technologies Corporation

El Dorado Hills, CA11 decisions2012–20250 recalls

FDA records 11 decisions for Emed Technologies Corporation (El Dorado Hills, CA) from 2012 to 2025: 11 510(k) clearances. Most are in product codes PKP (Immunoglobulin G (Igg) Infusion System) and FPA (Set, Administration, Intravascular). Its devices cite 14 predicates, 8 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Emed Technologies Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2012: 12014: 22015: 12016: 12018: 12022: 22023: 12024: 12025: 1
2012high 2 (2014) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Emed Technologies Corporation by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Emed”

FDA records each applicant name separately; these may or may not be the same firm.