FDA applicant

Biopsybell S.R.L.

Mirandola, IT7 decisions2001–20232 recalls

FDA records 7 decisions for Biopsybell S.R.L. (Mirandola, IT) from 2001 to 2023: 7 510(k) clearances. Most are in product codes KNW (Instrument, Biopsy) and NDN (Cement, Bone, Vertebroplasty). Its devices cite 8 predicates, 3 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Biopsybell S.A.S.”.

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 Biopsybell S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2021

2007high 2 (2021) · low 0 (2007)2026

Class I Class II/III not classified

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

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Biopsybell S.R.L.

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?

What has been recalled?