510(k) Report

FDA applicant

Oscor Medical Corp.

Palm Harbor, FL31 decisions1985–19972 recalls

FDA records 31 decisions for Oscor Medical Corp. (Palm Harbor, FL) from 1985 to 1997: 31 510(k) clearances. Most are in product codes DTB (Permanent Pacemaker Electrode) and LDF (Electrode, Pacemaker, Temporary). 2 recalls are linked to its devices, 1 Class I.

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 Oscor Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Oscor Medical Corp. since 2007.

Recalls per year

1in 2018

2008: 12018: 1, 1 Class I
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Oscor”

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