Home / Companies / ESAOTE S.P.A.

ESAOTE S.P.A.

FDA Regulatory Profile

ESAOTE S.P.A. has 9 FDA recalls, 1 inspection, 69 510(k) clearances and 0 compliance actions on record.

Latest recall
Z-1490-2026 · Class II · Mar 14, 2025
Latest inspection
Dec 2, 2010 · VAI
Latest 510(k)
Jul 31, 2026

Reviewing ESAOTE S.P.A. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check ESAOTE S.P.A. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls9Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances69Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
Z-1490-2026Class IIEsaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038Mar 14, 2025
Z-3053-2020Class IIAC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, AC/DC…Sep 8, 2020
Z-3052-2020Class IIAC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC…Sep 8, 2020
Z-0206-2019Class IIMyLab Seven, Model 6400Jun 11, 2018
Z-0205-2019Class IIMyLab Gamma, Model 7410Jun 11, 2018
Z-0204-2019Class IIMyLab Alpha, Model 7400Jun 11, 2018
Z-1137-2018Class IIMyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10Jan 3, 2018
Z-1138-2018Class IIMyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123…Jan 3, 2018
Z-2124-2016Class IIMagnetic Resonance System G-scan Brio (Part Number /Model No.101002000)Jun 6, 2016

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 2, 2010Florence, ItalyDevicesVoluntary Action Indicated (VAI)3002806925

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 3002806925Florence, Italy1Dec 2, 2010

Recent 510(k) Clearances

K-NumberDeviceDate
K261331I-Genius (100019400)Jul 31, 2026
K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Apr 6, 2026
K260746S-scan Open (100001800)Mar 27, 2026
K251901Magnifico Open (100009900)Mar 5, 2026
K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Nov 25, 2025
K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Jun 18, 2025
K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)May 16, 2025
K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)Jun 26, 2024
K2301796440 MyLabX90Nov 29, 2023
K212419Magnifico Open, Magnifico MSKFeb 4, 2022
K2120216430 MyLabX75, 6430 MyLab XPro75Sep 16, 2021
K1921576450 Ultrasound systemNov 22, 2019
K1910727410 Ultrasound System (MyLabSigma)Jun 10, 2019
K1909896400 Ultrasound System (MyLabX6, MyLabX7)May 10, 2019
K183685O-ScanJan 22, 2019
K1831916420 Ultrasound SystemDec 4, 2018
K180592G-scan BrioMar 30, 2018
K1732916440 Ultrasound SystemJan 12, 2018
K1630826200 Ultrasound System and 6250 Ultrasound SystemMar 16, 2017
K161973G-scan Brio, S-scanOct 25, 2016

FDA data resources

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