510(k) Report

FDA applicant

Zynergy Cardiovascular, Inc.

Edison, NJ1 decision2000–20000 recalls

FDA records 1 decision for Zynergy Cardiovascular, Inc. (Edison, NJ) in 2000: 1 510(k) clearance. All are in product code LDF (Electrode, Pacemaker, Temporary). 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 Zynergy Cardiovascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zynergy Cardiovascular, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Zynergy Cardiovascular, 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 “Zynergy”

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