FDA applicant

Hamilton Thorne Biosciences

Beverly, MA3 decisions2004–20070 recalls

FDA records 3 decisions for Hamilton Thorne Biosciences (Beverly, MA) from 2004 to 2007: 2 510(k) clearances and 1 De Novo grant. All are in product code MRX (System, Assisted Reproduction Laser). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Hamilton Thorne Biosciences’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 — Hamilton Thorne Biosciences by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Hamilton”

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

Hamilton Medical AG 45 Hamilton Co. 16 Hamilton Thorne, Inc. 6 Hamilton Industries, Inc. 5 Hamilton Thorne Research 5 Hamilton Kent 1

Hamilton Thorne Biosciences

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Hamilton”