FDA applicant

Sulzer Intratherapeutics, Inc.

Saint Paul, MN8 decisions2001–20022 recalls

FDA records 8 decisions for Sulzer Intratherapeutics, Inc. (Saint Paul, MN) from 2001 to 2002: 8 510(k) clearances. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and JCT (Prosthesis, Tracheal, Expandable). Its devices cite 10 predicates, 3 of them its own earlier devices. 2 recalls are linked to its devices.

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 Sulzer Intratherapeutics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sulzer Intratherapeutics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Sulzer”

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

Sulzer Orthopedics, Inc. 45 Sulzer Calcitek, Inc. 9 Sulzer Dental, Inc. 9 Sulzer Spine-Tech 8 Sulzer Carbomedics, Inc. 8 Sulzer Oscor, Inc. 2

Sulzer Intratherapeutics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Sulzer”