510(k) Report

FDA applicant

Sulzer Oscor, Inc.

Palm Harbor, FL2 decisions1997–19990 recalls

FDA records 2 decisions for Sulzer Oscor, Inc. (Palm Harbor, FL) from 1997 to 1999: 2 510(k) clearances. Most are in product codes DTE (Pulse-Generator, Pacemaker, External) and DTB (Permanent Pacemaker Electrode). 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, cardiovascular panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sulzer Oscor, 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.