Esaote North America Inc

FDA Filings

This page includes the latest FDA filings for Esaote North America Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1826555
FEI Number1826555
NameEsaote North America, Inc
Owner & OperatorESAOTE S.P.A.
Contact Addressvia Enrico Melen 77
Genoa IT-GE Genova 16152 IT
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address11907 Exit Five Parkway
Fishers, IN 46037 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabX82019-12-19
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabX8 eXP2019-12-19
Esaote North America, Inc [ESAOTE S.P.A.]
6450 Model2019-12-19
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabX82019-12-19
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabX8 eXP2019-12-19
Esaote North America, Inc [ESAOTE S.P.A.]
6450 Model2019-12-19
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabX82019-12-19
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabX8 eXP2019-12-19
Esaote North America, Inc [ESAOTE S.P.A.]
6450 Model2019-12-19
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabSigma2019-06-11
Esaote North America, Inc [ESAOTE S.P.A.]
7410 model2019-06-11
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabSigma2019-06-11
Esaote North America, Inc [ESAOTE S.P.A.]
7410 model2019-06-11
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabSigma2019-06-11
Esaote North America, Inc [ESAOTE S.P.A.]
7410 model2019-06-11
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabX72019-05-13
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabX62019-05-13
Esaote North America, Inc [ESAOTE S.P.A.]
6400 Model2019-05-13
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabX72019-05-13
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabX62019-05-13
Esaote North America, Inc [ESAOTE S.P.A.]
6400 Model2019-05-13
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabX72019-05-13
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabX62019-05-13
Esaote North America, Inc [ESAOTE S.P.A.]
6400 Model2019-05-13
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabOmega2019-04-03
Esaote North America, Inc [ESAOTE S.P.A.]
7400 model2019-04-03
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabOmega2019-04-03
Esaote North America, Inc [ESAOTE S.P.A.]
7400 model2019-04-03
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabOmega2019-04-03
Esaote North America, Inc [ESAOTE S.P.A.]
7400 model2019-04-03
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabX52018-12-13
Esaote North America, Inc [ESAOTE S.P.A.]
64202018-12-13
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabX52018-12-13
Esaote North America, Inc [ESAOTE S.P.A.]
64202018-12-13
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabX52018-12-13
Esaote North America, Inc [ESAOTE S.P.A.]
64202018-12-13
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab 92018-01-15
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab 9 eXP2018-01-15
Esaote North America, Inc [ESAOTE S.P.A.]
6440 Ultrasound System2018-01-15
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab 92018-01-15
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab 9 eXP2018-01-15
Esaote North America, Inc [ESAOTE S.P.A.]
6440 Ultrasound System2018-01-15
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab 92018-01-15
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab 9 eXP2018-01-15
Esaote North America, Inc [ESAOTE S.P.A.]
6440 Ultrasound System2018-01-15
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabEight MyLabEight eXP2017-03-21
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabClass C 6250 MyLabTwice 62002017-03-21
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabEight MyLabEight eXP2017-03-21
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabClass C 6250 MyLabTwice 62002017-03-21
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabEight MyLabEight eXP2017-03-21
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabClass C 6250 MyLabTwice 62002017-03-21
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabSix CrystaLine2016-11-09
Esaote North America, Inc [ESAOTE S.P.A.]
64252016-11-09
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabSix CrystaLine2016-11-09
Esaote North America, Inc [ESAOTE S.P.A.]
64252016-11-09
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabSix CrystaLine2016-11-09
Esaote North America, Inc [ESAOTE S.P.A.]
64252016-11-09
Esaote North America, Inc [ESAOTE S.P.A.]
Shoulder Coil 202016-11-09
Esaote North America, Inc [ESAOTE S.P.A.]
S-scan2016-11-09
Esaote North America, Inc [ESAOTE S.P.A.]
Head Coil 162016-11-09
Esaote North America, Inc [ESAOTE S.P.A.]
G-scan Brio2016-11-09
Esaote North America, Inc [ESAOTE S.P.A.]
MylabGamma 74102016-11-09
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabSeven 7400 MyLabAlpha 64002016-11-09
Esaote North America, Inc [ESAOTE S.P.A.]
MylabGamma 74102016-11-09
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabSeven 7400 MyLabAlpha 64002016-11-09
Esaote North America, Inc [ESAOTE S.P.A.]
MylabGamma 74102016-11-09
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabSeven 7400 MyLabAlpha 64002016-11-09
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabSix2016-11-09
Esaote North America, Inc [ESAOTE S.P.A.]
64202016-11-09
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabSix2016-11-09
Esaote North America, Inc [ESAOTE S.P.A.]
64202016-11-09
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabSix2016-11-09
Esaote North America, Inc [ESAOTE S.P.A.]
64202016-11-09
Esaote North America, Inc [ESAOTE S.P.A.]
MRI Dynamic Analysis Plus2016-03-16
Esaote North America, Inc [ESAOTE S.P.A.]
Speedup Software Option2016-03-16
Esaote North America, Inc [ESAOTE S.P.A.]
Artoscan C2016-03-16
Esaote North America, Inc [ESAOTE S.P.A.]
Modification to E-Scan XQ2016-03-16
Esaote North America, Inc [ESAOTE S.P.A.]
Artoscan M2016-03-16
Esaote North America, Inc [ESAOTE S.P.A.]
E-Scan2016-03-16
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab25 Gold MyLab30 Gold MyLab30 Gold Cardiovascular2015-09-24
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab25 Gold MyLab30 Gold MyLab30 Gold Cardiovascular2015-09-24
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab25 Gold MyLab30 Gold MyLab30 Gold Cardiovascular2015-09-24
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab70 XVG MyLab902015-09-24
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab70 XVG MyLab902015-09-24
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab70 XVG MyLab902015-09-24
Esaote North America, Inc [ESAOTE S.P.A.]
3Viseon2015-07-08
Esaote North America, Inc [ESAOTE S.P.A.]
73482014-12-03
Esaote North America, Inc [ESAOTE S.P.A.]
73482014-12-03
Esaote North America, Inc [ESAOTE S.P.A.]
73482014-12-03
Esaote North America, Inc [ESAOTE S.P.A.]
260 Corvus2014-01-21
Esaote North America, Inc [ESAOTE S.P.A.]
260 Corvus2014-01-21
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabOne2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabOne2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabOne2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabFive2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab52014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabFive2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab52014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
MyLabFive2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab52014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab402014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab20Plus2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab402014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab20Plus2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab402014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab20Plus2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
IMT.Lab2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Art.Lab2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
IMT.Lab2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Art.Lab2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
ART.Lab2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Ultrasound System2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab15/20 New Indications2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Ultrasound System2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab15/20 New Indications2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Ultrasound System2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab15/20 New Indications2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Tringa2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Picus2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Parus2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Falco2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Corvus2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Aquila2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Tringa2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Picus2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Parus2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Falco2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Corvus2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Aquila2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Tringa2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Picus2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Parus2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Falco2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Corvus2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Aquila2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Tringa Ultrasound Imaging System2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Model 50L2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Tringa Ultrasound Imaging System2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Model 50L2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Imaging System2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
50S Tringa Ultrasound2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
Imaging System2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
50S Tringa Ultrasound2014-01-06
Esaote North America, Inc [ESAOTE S.P.A.]
OrthoCAD2013-01-24
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab302013-01-24
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab30 CV2013-01-24
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab252013-01-24
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab302013-01-24
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab30 CV2013-01-24
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab252013-01-24
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab302013-01-24
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab30 CV2013-01-24
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab252013-01-24
Esaote North America, Inc [ESAOTE S.P.A.]
Megas2012-01-11
Esaote North America, Inc [ESAOTE S.P.A.]
Megas2012-01-11
Esaote North America, Inc [ESAOTE S.P.A.]
Caris, Caris-Plus2011-12-11
Esaote North America, Inc [ESAOTE S.P.A.]
Caris, Caris-Plus2011-12-11
Esaote North America, Inc [ESAOTE S.P.A.]
Caris, Caris-Plus2011-12-11
Esaote North America, Inc [ESAOTE S.P.A.]
Technos MP2011-06-03
Esaote North America, Inc [ESAOTE S.P.A.]
Technos MP2011-06-03
Esaote North America, Inc [ESAOTE S.P.A.]
Technos 3D & MSK2011-06-03
Esaote North America, Inc [ESAOTE S.P.A.]
Technos 3D & MSK2011-06-03
Esaote North America, Inc [ESAOTE S.P.A.]
Technos 3D & MSK2011-06-03
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab70 XVision MyLab70 MyLab602010-06-17
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab70 XVision MyLab70 MyLab602010-06-17
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab70 XVision MyLab70 MyLab602010-06-17
Esaote North America, Inc [ESAOTE S.P.A.]
O-scan2010-06-11
Esaote North America, Inc [ESAOTE S.P.A.]
E-scan2007-12-11
Esaote North America, Inc [ESAOTE S.P.A.]
C-scan2007-12-11
Esaote North America, Inc [ESAOTE S.P.A.]
Artoscan C2007-12-11
Esaote North America, Inc [ESAOTE S.P.A.]
Biopsy Accessory2007-12-11
Esaote North America, Inc [ESAOTE S.P.A.]
E-scan Opera2007-12-11
Esaote North America, Inc [ESAOTE S.P.A.]
G-scan2007-12-11
Esaote North America, Inc [ESAOTE S.P.A.]
Electroencephalograph2007-11-19
Esaote North America, Inc [ESAOTE S.P.A.]
Ultrasound Systems2007-11-19
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab50 MyLab50 XVision Cardiovascular MyLab50 Gold MyLab50 CV MyLab50 Gold Cardiovascular MyLab50 XVision2007-11-19
Esaote North America, Inc [ESAOTE S.P.A.]
Ultrasound Systems2007-11-19
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab50 MyLab50 XVision Cardiovascular MyLab50 Gold MyLab50 CV MyLab50 Gold Cardiovascular MyLab50 XVision2007-11-19
Esaote North America, Inc [ESAOTE S.P.A.]
Ultrasound Systems2007-11-19
Esaote North America, Inc [ESAOTE S.P.A.]
MyLab50 MyLab50 XVision Cardiovascular MyLab50 Gold MyLab50 CV MyLab50 Gold Cardiovascular MyLab50 XVision2007-11-19
Esaote North America, Inc [ESAOTE S.P.A.]
BIOPACS2007-11-19

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092541443La Spezia,Italy -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENTS11 PKG
2020081857763Genova,Italy -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENTS21 PKG
2020081857763Genova,Italy -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENTS21 PKG
2020072034651Genova,Italy -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENTS11 PKG
2020070113039Genova,Italy -> New York, New YorkMEDICAL EQUIPMENTS10 PKG
2020063036428Genova,Italy -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENTS8 PKG
2020062040085Genova,Italy -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENTS10 PKG
2020061580975Genova,Italy -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENTS10 PKG
2020060431692Genova,Italy -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENTS11 PKG
2020060431692Genova,Italy -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENTS11 PKG

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