# Biosense, Ltd.

- Location (FDA's records): Tirat Hacarmel, IL
- FDA decisions: 4 (1995–1999): 4 510(k) clearances
- Names in FDA's records: Biosense, Ltd. (3); Biosense, Inc. (1)
- Product codes: DQK (2), DRF (1), HAW (1)
- Predicates its devices cite: 2 (2 its own); citations of its devices by later devices: 5 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Ep Medsystems: 1 (https://510kreport.com/company/ep-medsystems)
- Prucka Engineering, Inc.: 1 (https://510kreport.com/company/prucka-engineering)
- Biosense Webster, Inc.: 1 (https://510kreport.com/company/biosense-webster)

## Its most-cited devices
- K954395: Carto System (1995), cited by 4
- K960542: NOGA (1996), cited by 1

## Recent decisions
- K990494: Modification of Noga (Sep 3, 1999)
- K961903: Magellan (Aug 24, 1998)
- K960542: NOGA (Apr 15, 1996)
- K954395: Carto System (Dec 21, 1995)

Source page: https://510kreport.com/company/biosense