FDA applicant

Sulzer Carbomedics, Inc.

Austin, TX8 decisions1998–20022 recalls

FDA records 8 decisions for Sulzer Carbomedics, Inc. (Austin, TX) from 1998 to 2002: 8 510(k) clearances. Most are in product codes KRH (Ring, Annuloplasty) and DSY (Prosthesis, Vascular Graft, Of 6mm And Greater…). Its devices cite 3 predicates, 0 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, cardiovascular panel, where it files most

How often FDA has decided Sulzer Carbomedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

2in 2021

2007high 2 (2021) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Sulzer Carbomedics, 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 Intratherapeutics, Inc. 8 Sulzer Oscor, Inc. 2

Sulzer Carbomedics, Inc.

Which product codes does it file in?

Whose devices does it build on?

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Which of its devices are cited most?

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Other applicant names beginning “Sulzer”