FDA applicant

Isotis NV

North Attleboro, MA8 decisions2000–20070 recalls

FDA records 8 decisions for Isotis NV (North Attleboro, MA) from 2000 to 2007: 8 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and NUN (Bone Grafting Material, Human Source). Its devices cite 12 predicates, 1 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, dental panel, where it files most

How often FDA has decided Isotis NV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Isotis NV’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 “Isotis”

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

Isotis Orthobiologics, Inc. 10

Isotis NV

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Isotis”