Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

68 results for "Esaote, S.P.A."
1–24 of 68
Search insights Median review: 51d Cleared: 100% Top manufacturer: Esaote, S.P.A. Lead specialty: Radiology
Cleared Jul 31, 2026
I-Genius (100019400)
K261331 · LNH
Esaote, S.P.A.
Radiology · 100d
Cleared Apr 06, 2026
6450 Ultrasound System (MyLabE80)
K253288 · IYN
Esaote, S.P.A.
Radiology · 189d
Cleared Mar 27, 2026
S-scan Open (100001800)
K260746 · LNH
Esaote, S.P.A.
Radiology · 21d
Cleared Mar 05, 2026
Magnifico Open (100009900)
K251901 · LNH
Esaote, S.P.A.
Radiology · 258d
Cleared Nov 25, 2025
7600 Ultrasound System (MyLabC25)
K253310 · IYN
Esaote, S.P.A.
Radiology · 57d
Cleared Jun 18, 2025
6600 Ultrasound System (MyLabA50)
K243253 · IYN
Esaote, S.P.A.
Radiology · 246d
Cleared May 16, 2025
6450 Ultrasound System (MyLabE80)
K241671 · IYN
Esaote, S.P.A.
Radiology · 339d
Cleared Jun 26, 2024
Magnifico Open (100009900)
K241133 · LNH
Esaote, S.P.A.
Radiology · 63d
Cleared Nov 29, 2023
6440 MyLabX90
K230179 · IYN
Esaote, S.P.A.
Radiology · 310d
Cleared Feb 04, 2022
Magnifico Open, Magnifico MSK
K212419 · LNH
Esaote, S.P.A.
Radiology · 184d
Cleared Sep 16, 2021
6430 MyLabX75, 6430 MyLab XPro75
K212021 · IYN
Esaote, S.P.A.
Radiology · 80d
Cleared Nov 22, 2019
6450 Ultrasound system
K192157 · IYN
Esaote, S.P.A.
Radiology · 105d
Cleared Jun 10, 2019
7410 Ultrasound System (MyLabSigma)
K191072 · IYN
Esaote, S.P.A.
Radiology · 49d
Cleared May 10, 2019
6400 Ultrasound System (MyLabX6, MyLabX7)
K190989 · IYN
Esaote, S.P.A.
Radiology · 25d
Cleared Jan 22, 2019
O-Scan
K183685 · LNH
Esaote, S.P.A.
Radiology · 25d
Cleared Dec 04, 2018
6420 Ultrasound System
K183191 · IYN
Esaote, S.P.A.
Radiology · 15d
Cleared Mar 30, 2018
G-scan Brio
K180592 · LNH
Esaote, S.P.A.
Radiology · 24d
Cleared Jan 12, 2018
6440 Ultrasound System
K173291 · IYN
Esaote, S.P.A.
Radiology · 88d
Cleared Mar 16, 2017
6200 Ultrasound System and 6250 Ultrasound System
K163082 · IYN
Esaote, S.P.A.
Radiology · 133d
Cleared Oct 25, 2016
G-scan Brio, S-scan
K161973 · LNH
Esaote, S.P.A.
Radiology · 99d
Cleared Oct 14, 2016
MyLabSix CrystaLine
K162290 · IYN
Esaote, S.P.A.
Radiology · 60d
Cleared Jul 19, 2016
6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System
K161359 · IYN
Esaote, S.P.A.
Radiology · 64d
Cleared Jul 08, 2016
S-scan
K161238 · LNH
Esaote, S.P.A.
Radiology · 67d
Cleared May 04, 2016
6200 Ultrasound System and 6250 Ultrasound System
K153277 · IYN
Esaote, S.P.A.
Radiology · 174d