# Medinol, Ltd.

- Location (FDA's records): Tel Aviv, IL
- FDA decisions: 9 (1998–2018): 6 510(k) clearances and 3 original PMA approvals
- Product codes: FGE (4), LOX (2), MAF (2), NIQ (1)
- 510(k) review time since 2016: median 141 days, against 80 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 11 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 3 (https://510kreport.com/company/boston-scientific)
- Boston Scientific Scimed, Inc.: 2 (https://510kreport.com/company/boston-scientific-scimed)
- Abbott Vascular-Cardiac Therapies: 1 (https://510kreport.com/company/abbott-vascular-cardiac-therapies)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Wilson-Cook Medical, Inc.: 1 (https://510kreport.com/company/wilson-cook-medical)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- Schneider Intl., Ltd.: 1 (https://510kreport.com/company/schneider-intl)

## Its most-cited devices
- K162434: NC Gallant PTCA Catheter (2017), cited by 1

## Recent decisions
- K173581: Gallant PTCA Dilatation Catheter (Jan 25, 2018)
- P170008: EluNIR™ Ridaforolimus Eluting Coronary Stent System (Nov 28, 2017)
- K162434: NC Gallant PTCA Catheter (Jan 19, 2017)
- K150487: X-Suit NIR Biliary Metallic Stent (Feb 12, 2016)
- P110004: Presillion Plus Cocr Coronary Stent RX System (Apr 12, 2012)
- K081956: Medinol X-Suit Nir Biliary Metallic Stent (Jan 9, 2009)
- P020040: Nirflex Premounted Stent (Oct 24, 2003)
- K002130: Nir Biliary Stent (Oct 30, 2000)

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