FDA applicant

Monica Healthcare, Ltd.

Nottingham, GB4 decisions2011–20143 recalls

FDA records 4 decisions for Monica Healthcare, Ltd. (Nottingham, GB) from 2011 to 2014: 4 510(k) clearances. All are in product code OSP (Uterine Electromyographic Monitor). Its devices cite 8 predicates, 4 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Monica Healthcare”.

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 Monica Healthcare, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2011high 2 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

3in 2017

2011high 3 (2017) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Monica Healthcare, Ltd. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Monica Healthcare, Ltd.’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 “Monica”

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

Monica Veytia 1

Monica Healthcare, Ltd.

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?

Other applicant names beginning “Monica”