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Medinol, Ltd.

FDA Regulatory Profile

Medinol, Ltd. has 0 FDA recalls, 4 inspections, 6 510(k) clearances and 1 compliance action on record.

Latest inspection
Aug 24, 2017 · NAI
Latest 510(k)
Jan 25, 2018

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances6Oct 4, 2026Not statedCurrent
Inspections4Oct 27, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 24, 2017Jerusalem, IsraelDevicesNo Action Indicated (NAI)3003182398
Mar 31, 2014Tel Aviv, IsraelDevicesVoluntary Action Indicated (VAI)3003084171
Mar 27, 2014Jerusalem, IsraelDevicesVoluntary Action Indicated (VAI)3003182398
Jun 9, 2011Tel Aviv, IsraelDevicesVoluntary Action Indicated (VAI)3003084171

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K173581Gallant PTCA Dilatation CatheterJan 25, 2018
K162434NC Gallant PTCA CatheterJan 19, 2017
K150487X-Suit NIR Biliary Metallic StentFeb 12, 2016
K081956MEDINOL X-SUIT NIR BILIARY METALLIC STENTJan 9, 2009
K002130NIR BILIARY STENTOct 30, 2000
K973171NIR BILIARY STENTNov 13, 1998

FDA data resources