FDA applicant

Edwards Lifesciences Services GmbH

Stevenage, GB3 decisions2007–20091 recall

FDA records 3 decisions for Edwards Lifesciences Services GmbH (Stevenage, GB) from 2007 to 2009: 3 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and FJK (Set, Tubing, Blood, With And Without…). Its devices cite 9 predicates, 1 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 Edwards Lifesciences Services GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2009

2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Edwards Lifesciences Services GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Edwards Lifesciences Services GmbH’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 “Edwards”

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

Edwards Lifesciences, LLC 177 Edwards Pacemaker Systems 13 Edwards Laboratories 12 Edwards Lifesciences Research Medical 6 Edwards Lifeciences, LLC 3 Edwards Lifesiences, LLC 2 Edwards Orthopaedics Div., Baxter Healthcare Corp. 2 Edwards Lifesciencess, LLC 1 Edwards Lfesciences 1 Edwards Lifescience, LLC 1 Edwards Ventilator Co. 1

Edwards Lifesciences Services GmbH

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Edwards”