FDA applicant

Quest Medical Imaging

Middenmeer, NL2 decisions2015–20151 recall

FDA records 2 decisions for Quest Medical Imaging (Middenmeer, NL) in 2015: 2 510(k) clearances. Most are in product codes OWN (Confocal Optical Imaging) and NTN (Led Light Source). Its devices cite 4 predicates, 0 of them its own earlier devices. 1 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, gastroenterology and urology panel, where it files most

How often FDA has decided Quest Medical Imaging’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2015high 2 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2024

2015high 1 (2024) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Quest Medical Imaging by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Quest Medical Imaging’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Quest”

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

Quest Medical, Inc. 39 Quest Intl., Inc. 25 Quest Diagnostics, Inc. 8 Quest International, Inc. 3 Quest Dental USA Corp. 2 Quest Diagnostics Nichols Institute 1 Quest Technologies Corp. 1 Quest Enabling Designs, Ltd. 1

Quest Medical Imaging

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Quest”