Itamar Medical , Ltd. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Itamar Medical , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: WatchPAT400 (WP400), WatchPAT ONE (WP1), EndoPATx
11
Total
11
Cleared
0
Denied
Itamar Medical , Ltd. has 11 FDA 510(k) cleared anesthesiology devices. Based in Washington, US.
Latest FDA clearance: Sep 2025. Active since 2011.
Browse the complete list of FDA 510(k) cleared anesthesiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Hogan Lovells US LLP as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Itamar Medical , Ltd.
11 devices
Cleared
Sep 05, 2025
WatchPAT400 (WP400)
Anesthesiology
199d
Cleared
Jan 06, 2023
WatchPAT ONE (WP1)
Anesthesiology
30d
Cleared
Dec 29, 2022
EndoPATx
Cardiovascular
589d
Cleared
Sep 14, 2022
WatchPAT300 (WP300)
Anesthesiology
43d
Cleared
CT
Mar 21, 2022
WatchPAT200U (WP200U)
Anesthesiology
446d
Cleared
Jun 05, 2019
WatchPAT ONE
Anesthesiology
167d
Cleared
Aug 17, 2018
Watch-PAT300
Anesthesiology
147d
Cleared
Feb 24, 2017
Watch-PAT200U
Anesthesiology
262d
Cleared
Jul 26, 2016
Watch-PAT200U
Anesthesiology
278d
Cleared
May 30, 2014
WATCH-PAT200U (WP200U)
Anesthesiology
162d
Cleared
Jun 02, 2011
WATCH-PAT 200S-3 (WP200S-3)
Anesthesiology
268d