FDA applicant

Sorin Group USA, Inc.

Arvada, CO3 decisions1986–20130 recalls

FDA records 3 decisions for Sorin Group USA, Inc. (Arvada, CO) from 1986 to 2013: 2 510(k) clearances and 1 original PMA approval. Most are in product codes LOI (Laser, Neodymium:Yag, Ophthalmic For Uses…) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 2 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, general and plastic surgery panel, where it files most

How often FDA has decided Sorin Group USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sorin Group USA, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sorin Group USA, Inc.’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 “Sorin”

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

Sorin Group Italia S.R.L. 63 Sorin Biomedica, Fiat, USA, Inc. 20 Sorin Group Deutschland GmbH 20 Sorin Biomedical, Inc. 15 Sorin Biomedica Cardio S.R.L. 1

Sorin Group USA, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Sorin”