FDA applicant

Loma Vista Medical

Sunnyvale, CA1 decision2012–20121 recall

FDA records 1 decision for Loma Vista Medical (Sunnyvale, CA) in 2012: 1 510(k) clearance. All are in product code OZT (Balloon Aortic Valvuloplasty). 1 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, cardiovascular panel, where it files most

How often FDA has decided Loma Vista Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2013

2012high 1 (2013) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Loma Vista Medical by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Loma Vista Medical’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 “Loma”

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

Loma Linda University Medical Center 1

Loma Vista Medical

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?

What has been recalled?

Other applicant names beginning “Loma”