510(k) Report

FDA applicant

Emergo Europe Consulting BV

Den Haag, NL2 decisions2012–20150 recalls

FDA records 2 decisions for Emergo Europe Consulting BV (Den Haag, NL) from 2012 to 2015: 2 510(k) clearances. Most are in product codes DRG (Transmitters And Receivers, Physiological…) and EIH (Powder, Porcelain). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Emergo Europe Consulting”.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Emergo Europe Consulting BV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2012: 12015: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Emergo Europe Consulting BV by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Emergo”

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