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.
Registration Number | 1826555 |
FEI Number | 1826555 |
Name | Esaote North America, Inc |
Owner & Operator | ESAOTE S.P.A. |
Contact Address | via Enrico Melen 77 Genoa IT-GE Genova 16152 IT |
Registration Status | 1 |
Initial Importer | Y |
Registration Expiration | 2020-04-25 |
Registration Address | 11907 Exit Five Parkway Fishers, IN 46037 US |
Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
---|---|---|
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabX8 | 2019-12-19 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabX8 eXP | 2019-12-19 |
Esaote North America, Inc [ESAOTE S.P.A.] | 6450 Model | 2019-12-19 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabX8 | 2019-12-19 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabX8 eXP | 2019-12-19 |
Esaote North America, Inc [ESAOTE S.P.A.] | 6450 Model | 2019-12-19 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabX8 | 2019-12-19 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabX8 eXP | 2019-12-19 |
Esaote North America, Inc [ESAOTE S.P.A.] | 6450 Model | 2019-12-19 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabSigma | 2019-06-11 |
Esaote North America, Inc [ESAOTE S.P.A.] | 7410 model | 2019-06-11 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabSigma | 2019-06-11 |
Esaote North America, Inc [ESAOTE S.P.A.] | 7410 model | 2019-06-11 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabSigma | 2019-06-11 |
Esaote North America, Inc [ESAOTE S.P.A.] | 7410 model | 2019-06-11 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabX7 | 2019-05-13 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabX6 | 2019-05-13 |
Esaote North America, Inc [ESAOTE S.P.A.] | 6400 Model | 2019-05-13 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabX7 | 2019-05-13 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabX6 | 2019-05-13 |
Esaote North America, Inc [ESAOTE S.P.A.] | 6400 Model | 2019-05-13 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabX7 | 2019-05-13 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabX6 | 2019-05-13 |
Esaote North America, Inc [ESAOTE S.P.A.] | 6400 Model | 2019-05-13 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabOmega | 2019-04-03 |
Esaote North America, Inc [ESAOTE S.P.A.] | 7400 model | 2019-04-03 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabOmega | 2019-04-03 |
Esaote North America, Inc [ESAOTE S.P.A.] | 7400 model | 2019-04-03 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabOmega | 2019-04-03 |
Esaote North America, Inc [ESAOTE S.P.A.] | 7400 model | 2019-04-03 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabX5 | 2018-12-13 |
Esaote North America, Inc [ESAOTE S.P.A.] | 6420 | 2018-12-13 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabX5 | 2018-12-13 |
Esaote North America, Inc [ESAOTE S.P.A.] | 6420 | 2018-12-13 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabX5 | 2018-12-13 |
Esaote North America, Inc [ESAOTE S.P.A.] | 6420 | 2018-12-13 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab 9 | 2018-01-15 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab 9 eXP | 2018-01-15 |
Esaote North America, Inc [ESAOTE S.P.A.] | 6440 Ultrasound System | 2018-01-15 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab 9 | 2018-01-15 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab 9 eXP | 2018-01-15 |
Esaote North America, Inc [ESAOTE S.P.A.] | 6440 Ultrasound System | 2018-01-15 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab 9 | 2018-01-15 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab 9 eXP | 2018-01-15 |
Esaote North America, Inc [ESAOTE S.P.A.] | 6440 Ultrasound System | 2018-01-15 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabEight MyLabEight eXP | 2017-03-21 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabClass C 6250 MyLabTwice 6200 | 2017-03-21 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabEight MyLabEight eXP | 2017-03-21 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabClass C 6250 MyLabTwice 6200 | 2017-03-21 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabEight MyLabEight eXP | 2017-03-21 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabClass C 6250 MyLabTwice 6200 | 2017-03-21 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabSix CrystaLine | 2016-11-09 |
Esaote North America, Inc [ESAOTE S.P.A.] | 6425 | 2016-11-09 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabSix CrystaLine | 2016-11-09 |
Esaote North America, Inc [ESAOTE S.P.A.] | 6425 | 2016-11-09 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabSix CrystaLine | 2016-11-09 |
Esaote North America, Inc [ESAOTE S.P.A.] | 6425 | 2016-11-09 |
Esaote North America, Inc [ESAOTE S.P.A.] | Shoulder Coil 20 | 2016-11-09 |
Esaote North America, Inc [ESAOTE S.P.A.] | S-scan | 2016-11-09 |
Esaote North America, Inc [ESAOTE S.P.A.] | Head Coil 16 | 2016-11-09 |
Esaote North America, Inc [ESAOTE S.P.A.] | G-scan Brio | 2016-11-09 |
Esaote North America, Inc [ESAOTE S.P.A.] | MylabGamma 7410 | 2016-11-09 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabSeven 7400 MyLabAlpha 6400 | 2016-11-09 |
Esaote North America, Inc [ESAOTE S.P.A.] | MylabGamma 7410 | 2016-11-09 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabSeven 7400 MyLabAlpha 6400 | 2016-11-09 |
Esaote North America, Inc [ESAOTE S.P.A.] | MylabGamma 7410 | 2016-11-09 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabSeven 7400 MyLabAlpha 6400 | 2016-11-09 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabSix | 2016-11-09 |
Esaote North America, Inc [ESAOTE S.P.A.] | 6420 | 2016-11-09 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabSix | 2016-11-09 |
Esaote North America, Inc [ESAOTE S.P.A.] | 6420 | 2016-11-09 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabSix | 2016-11-09 |
Esaote North America, Inc [ESAOTE S.P.A.] | 6420 | 2016-11-09 |
Esaote North America, Inc [ESAOTE S.P.A.] | MRI Dynamic Analysis Plus | 2016-03-16 |
Esaote North America, Inc [ESAOTE S.P.A.] | Speedup Software Option | 2016-03-16 |
Esaote North America, Inc [ESAOTE S.P.A.] | Artoscan C | 2016-03-16 |
Esaote North America, Inc [ESAOTE S.P.A.] | Modification to E-Scan XQ | 2016-03-16 |
Esaote North America, Inc [ESAOTE S.P.A.] | Artoscan M | 2016-03-16 |
Esaote North America, Inc [ESAOTE S.P.A.] | E-Scan | 2016-03-16 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab25 Gold MyLab30 Gold MyLab30 Gold Cardiovascular | 2015-09-24 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab25 Gold MyLab30 Gold MyLab30 Gold Cardiovascular | 2015-09-24 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab25 Gold MyLab30 Gold MyLab30 Gold Cardiovascular | 2015-09-24 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab70 XVG MyLab90 | 2015-09-24 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab70 XVG MyLab90 | 2015-09-24 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab70 XVG MyLab90 | 2015-09-24 |
Esaote North America, Inc [ESAOTE S.P.A.] | 3Viseon | 2015-07-08 |
Esaote North America, Inc [ESAOTE S.P.A.] | 7348 | 2014-12-03 |
Esaote North America, Inc [ESAOTE S.P.A.] | 7348 | 2014-12-03 |
Esaote North America, Inc [ESAOTE S.P.A.] | 7348 | 2014-12-03 |
Esaote North America, Inc [ESAOTE S.P.A.] | 260 Corvus | 2014-01-21 |
Esaote North America, Inc [ESAOTE S.P.A.] | 260 Corvus | 2014-01-21 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabOne | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabOne | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabOne | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabFive | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab5 | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabFive | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab5 | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLabFive | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab5 | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab40 | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab20Plus | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab40 | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab20Plus | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab40 | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab20Plus | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | IMT.Lab | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Art.Lab | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | IMT.Lab | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Art.Lab | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | ART.Lab | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Ultrasound System | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab15/20 New Indications | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Ultrasound System | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab15/20 New Indications | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Ultrasound System | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab15/20 New Indications | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Tringa | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Picus | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Parus | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Falco | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Corvus | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Aquila | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Tringa | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Picus | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Parus | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Falco | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Corvus | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Aquila | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Tringa | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Picus | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Parus | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Falco | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Corvus | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Aquila | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Tringa Ultrasound Imaging System | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Model 50L | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Tringa Ultrasound Imaging System | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Model 50L | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Imaging System | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | 50S Tringa Ultrasound | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | Imaging System | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | 50S Tringa Ultrasound | 2014-01-06 |
Esaote North America, Inc [ESAOTE S.P.A.] | OrthoCAD | 2013-01-24 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab30 | 2013-01-24 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab30 CV | 2013-01-24 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab25 | 2013-01-24 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab30 | 2013-01-24 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab30 CV | 2013-01-24 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab25 | 2013-01-24 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab30 | 2013-01-24 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab30 CV | 2013-01-24 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab25 | 2013-01-24 |
Esaote North America, Inc [ESAOTE S.P.A.] | Megas | 2012-01-11 |
Esaote North America, Inc [ESAOTE S.P.A.] | Megas | 2012-01-11 |
Esaote North America, Inc [ESAOTE S.P.A.] | Caris, Caris-Plus | 2011-12-11 |
Esaote North America, Inc [ESAOTE S.P.A.] | Caris, Caris-Plus | 2011-12-11 |
Esaote North America, Inc [ESAOTE S.P.A.] | Caris, Caris-Plus | 2011-12-11 |
Esaote North America, Inc [ESAOTE S.P.A.] | Technos MP | 2011-06-03 |
Esaote North America, Inc [ESAOTE S.P.A.] | Technos MP | 2011-06-03 |
Esaote North America, Inc [ESAOTE S.P.A.] | Technos 3D & MSK | 2011-06-03 |
Esaote North America, Inc [ESAOTE S.P.A.] | Technos 3D & MSK | 2011-06-03 |
Esaote North America, Inc [ESAOTE S.P.A.] | Technos 3D & MSK | 2011-06-03 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab70 XVision MyLab70 MyLab60 | 2010-06-17 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab70 XVision MyLab70 MyLab60 | 2010-06-17 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab70 XVision MyLab70 MyLab60 | 2010-06-17 |
Esaote North America, Inc [ESAOTE S.P.A.] | O-scan | 2010-06-11 |
Esaote North America, Inc [ESAOTE S.P.A.] | E-scan | 2007-12-11 |
Esaote North America, Inc [ESAOTE S.P.A.] | C-scan | 2007-12-11 |
Esaote North America, Inc [ESAOTE S.P.A.] | Artoscan C | 2007-12-11 |
Esaote North America, Inc [ESAOTE S.P.A.] | Biopsy Accessory | 2007-12-11 |
Esaote North America, Inc [ESAOTE S.P.A.] | E-scan Opera | 2007-12-11 |
Esaote North America, Inc [ESAOTE S.P.A.] | G-scan | 2007-12-11 |
Esaote North America, Inc [ESAOTE S.P.A.] | Electroencephalograph | 2007-11-19 |
Esaote North America, Inc [ESAOTE S.P.A.] | Ultrasound Systems | 2007-11-19 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab50 MyLab50 XVision Cardiovascular MyLab50 Gold MyLab50 CV MyLab50 Gold Cardiovascular MyLab50 XVision | 2007-11-19 |
Esaote North America, Inc [ESAOTE S.P.A.] | Ultrasound Systems | 2007-11-19 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab50 MyLab50 XVision Cardiovascular MyLab50 Gold MyLab50 CV MyLab50 Gold Cardiovascular MyLab50 XVision | 2007-11-19 |
Esaote North America, Inc [ESAOTE S.P.A.] | Ultrasound Systems | 2007-11-19 |
Esaote North America, Inc [ESAOTE S.P.A.] | MyLab50 MyLab50 XVision Cardiovascular MyLab50 Gold MyLab50 CV MyLab50 Gold Cardiovascular MyLab50 XVision | 2007-11-19 |
Esaote North America, Inc [ESAOTE S.P.A.] | BIOPACS | 2007-11-19 |
NCAGE Code | 3RNP2 | ESAOTE NORTH AMERICA, INC. |
CAGE Code | 3RNP2 | ESAOTE NORTH AMERICA, INC. |
S.A.M. Registration | 3RNP2 [45186970] | ESAOTE NORTH AMERICA, INC. |
S.A.M. Registration | 3RNP2 [45186970] | ESAOTE NORTH AMERICA, INC. |
Import ID | Shipment | Cargo Description | Quantity |
---|---|---|---|
2020092541443 | La Spezia,Italy -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIPMENTS | 11 PKG |
2020081857763 | Genova,Italy -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIPMENTS | 21 PKG |
2020081857763 | Genova,Italy -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIPMENTS | 21 PKG |
2020072034651 | Genova,Italy -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIPMENTS | 11 PKG |
2020070113039 | Genova,Italy -> New York, New York | MEDICAL EQUIPMENTS | 10 PKG |
2020063036428 | Genova,Italy -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIPMENTS | 8 PKG |
2020062040085 | Genova,Italy -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIPMENTS | 10 PKG |
2020061580975 | Genova,Italy -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIPMENTS | 10 PKG |
2020060431692 | Genova,Italy -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIPMENTS | 11 PKG |
2020060431692 | Genova,Italy -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIPMENTS | 11 PKG |