FDA applicant

Biosense, Ltd.

Tirat Hacarmel, IL4 decisions1995–19990 recalls

FDA records 4 decisions for Biosense, Ltd. (Tirat Hacarmel, IL) from 1995 to 1999: 4 510(k) clearances. Most are in product codes DQK (Computer, Diagnostic, Programmable) and DRF (Catheter, Electrode Recording, Or Probe…). Its devices cite 2 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Biosense, Inc.”.

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 Biosense, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biosense, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Biosense”

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

Biosense Webster, Inc. 84

Biosense, Ltd.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Biosense”