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Itamar Medical , Ltd.

FDA Regulatory Profile

Itamar Medical , Ltd. has 0 FDA recalls, 2 inspections, 17 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 19, 2019 · VAI
Latest 510(k)
Jul 31, 2026

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances17Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 19, 2019Caesarea, IsraelDevicesVoluntary Action Indicated (VAI)3003616071
Jan 13, 2011Caesarea, IsraelDevicesVoluntary Action Indicated (VAI)3003616071

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.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3003616071Caesarea, Israel2Dec 19, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K254042WatchPAT SWJul 31, 2026
K250460WatchPAT400 (WP400)Sep 5, 2025
K223675WatchPAT ONE (WP1)Jan 6, 2023
K211557EndoPATxDec 29, 2022
K222331WatchPAT300 (WP300)Sep 14, 2022
K203839WatchPAT200U (WP200U)Mar 21, 2022
K183559WatchPAT ONEJun 5, 2019
K180775Watch-PAT300Aug 17, 2018
K161579Watch-PAT200UFeb 24, 2017
K153070Watch-PAT200UJul 26, 2016
K133859WATCH-PAT200U (WP200U)May 30, 2014
K102567WATCH-PAT 200S-3 (WP200S-3)Jun 2, 2011
K081982WATCH-PAT 200S-2 (WP200S-2)Aug 14, 2008
K081037WATCH-PAT 200I (WP200I)Jun 9, 2008
K080427WATCH-PAT MODEL 100S-2May 23, 2008
K042916WATCH PAT 100SDec 29, 2004
K032519ENDO PAT 2000Nov 12, 2003

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.