Vatech Co L T D

FDA Filings

This page includes the latest FDA filings for Vatech Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3004706313
FEI Number3004706313
NameVATECH CO., LTD.
Owner & OperatorVATECH CO., LTD.
Contact Address13, Samsung 1-ro 2-gil
Hwaseong-si KR-41 Gyeonggido 18449 KR
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address13, Samsung 1-ro, 2-gil
Hwaseong-si Gyeonggido, 18449 KR
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Vatech Co., Ltd
Green X 18(Model : PHT-75CHS)2021-02-18
VATECH CO., LTD.
EzRay Air Portable2020-04-16
VATECH CO., LTD.
EzRay Air 2020-03-20
Vatech Co., Ltd
EzRay Air Portable (Model: VEX-P300)2020-02-11
VATECH CO., LTD.
EzRay Air W 2019-04-02
VATECH CO., LTD.
EzRay Air W 2019-04-02
VATECH CO., LTD.
EzRay Air W 2019-04-02
VATECH CO., LTD.
PaX-i3D Smart 2019-03-29
VATECH CO., LTD.
PaX-i3D Smart 2019-03-29
VATECH CO., LTD.
Green16/Green18 (Model: PHT-65LHS)2017-06-25
VATECH CO., LTD.
Green16/Green18 (Model: PHT-65LHS)2017-06-16
VATECH CO., LTD.
PaX-i Plus/PaX-i Insight (Model: PCH-30CS)2017-05-26
VATECH CO., LTD.
EzRay Air Wall (Model: VEX-S300W)2017-05-26
VATECH CO., LTD.
Smart Plus (Model: PHT-35LHS)2017-05-26
VATECH CO., LTD.
EzRay Air Portable (Model: VEX-P300)2017-05-26
VATECH CO., LTD.
Green21 (Model: PCT-90LH)2017-05-26
Vatech Co., Ltd
System, X-Ray, Extra Oral Source, Digital, PaX-i Plus, PaX-i Insight2017-04-04
Vatech Co., Ltd
EzRay Air W2017-01-24
VATECH CO., LTD
PaX-i3D Green Premium (Model: PCT-90LH)2016-10-28
VATECH CO., LTD
Green Smart (Model: PHT-35LHS)2016-10-20
Vatech Co., Ltd
EzRay Air (Model VEX-P300)2016-09-01
VATECH CO., LTD.
PaX-i3D Smart (Model:PHT-30LFO)2015-12-17
VATECH CO., LTD
Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart2015-10-23
VATECH CO., LTD.
TON-95LH, PAX-I3D ORTHO2014-08-07
VATECH CO., LTD.
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM2013-07-15
VATECH CO., LTD.
PHT-6500, PHT-60CFO2013-05-31
VATECH CO., LTD.
VEX-S 100W INTRAORAL X-RAY SYSTEM2012-12-13
VATECH CO., LTD.
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM2012-09-04
VATECH CO., LTD.
PAX-UNI3D, PHT-75002012-08-28
VATECH CO., LTD.
PAX-FLEX3D, PHT-70002012-06-08
VATECH CO., LTD.
PAX-DUO3D PLUS, PCT-50002012-05-24
VATECH CO., LTD.
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM2012-03-27
VATECH CO., LTD.
RADIOLOGICAL IMAGE PROCESSING SYSTEM2011-08-10
VATECH CO., LTD.
COMPUTED TOMOGRAPHY X-RAY SYSTEM2011-03-25
VATECH CO., LTD.
COMPUTED TOMOGRAPHY X-RAY SYSTEM2011-03-11
VATECH CO., LTD.
DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM2011-02-18
VATECH CO., LTD.
DIGITAL FLAT PANEL X-RAY DETECTOR2010-11-29
VATECH CO., LTD.
DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM2010-10-22
VATECH CO., LTD.
DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-10002010-07-21
VATECH CO., LTD.
DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO2010-03-24
VATECH CO., LTD.
DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D2010-01-08
VATECH CO., LTD.
DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)2009-10-09
VATECH CO., LTD.
DENTAL DIGITAL X-RAY IMAGING SYSTEM2008-04-08

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091492285Pusan,South Korea -> Los Angeles, CaliforniaSPARE PARTS FOR DIGITAL DENTAL X-RAY EQUIPMEN T20 PKG
2020091188709Pusan,South Korea -> Los Angeles, CaliforniaDIGITAL X RAY36 PKG
2020091188709Pusan,South Korea -> Los Angeles, CaliforniaDIGITAL X RAY36 PKG
2020091066253Pusan,South Korea -> Los Angeles, CaliforniaDIGITAL X RAY18 PKG
2020082061821Pusan,South Korea -> Los Angeles, CaliforniaDIGITAL X RAY3 PKG
2020081747972Pusan,South Korea -> Long Beach, CaliforniaDIGITAL X RAY20 PKG
2020081592775Pusan,South Korea -> Los Angeles, CaliforniaAUTO PARTS OF BODIES19 PKG
2020080756413Pusan,South Korea -> Long Beach, CaliforniaDIGITAL X RAY4 PKG
2020071461428Pusan,South Korea -> Los Angeles, CaliforniaSPARE PARTS FOR DIGITAL DENTAL X-RAY EQUIPMEN T20 PKG

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