FDA applicant

Kensey Nash Corporation Dba Dsm Biomedical

Exton, PA7 decisions2013–20180 recalls

FDA records 7 decisions for Kensey Nash Corporation Dba Dsm Biomedical (Exton, PA) from 2013 to 2018: 7 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and NPM (Bone Grafting Material, Animal Source). Since 2016 its 510(k)s took a median of 135 days from receipt to decision, against 154 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 0 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, orthopedic panel, where it files most

How often FDA has decided Kensey Nash Corporation Dba Dsm Biomedical’s devices, and how often a recall has named them.

FDA decisions per year

2in 2018

2013high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Kensey Nash Corporation Dba Dsm Biomedical by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Kensey”

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

Kensey Nash Corp. 25 Kensey Nash Cororation 1

Kensey Nash Corporation Dba Dsm Biomedical

Which product codes does it file in?

How long do its 510(k) reviews take?

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 “Kensey”