David Smarro

FDA Filings

This page includes the latest FDA filings for David Smarro. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

David Smarro holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3003989064
FEI Number3003989064
NameDavid Smarro
Owner & OperatorINFINITT Healthcare Co., Ltd.
Contact Address12F Daerung Post Tower III, 182-4 Guro-Dong, Guro-Gu
SEOUL KR-NOTA 08378 KR
Official Correspondent
  • SIEUN - YANG
  • 82-2-21946970-x
US Agent
Importing Logistics Registration
ImporterINFINITT North America
Address755 Memorial Pkwy Ste 304
Phillipsburg, NJ 08865 UNITED STATES
Importer TypeForeign branch
Importing Logistics Registration
ImporterINFINITT North America Inc.
Address755 Memorial Pkwy Ste 304 Phillipsburg
Alpha, NJ 08865 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address755 Memorial Parkway Suite 304
Phillipsburg, NJ 08865 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
David Smarro [INFINITT Healthcare Co., Ltd.]
INFINITT RT PACS2020-03-17
David Smarro [INFINITT Healthcare Co., Ltd.]
INFINITT PACS 7.02017-12-03
David Smarro [INFINITT Healthcare Co., Ltd.]
INFINITT MAMMO 7.02017-12-03
David Smarro [INFINITT Healthcare Co., Ltd.]
INFINITT G7 PACS2017-12-03
David Smarro [INFINITT Healthcare Co., Ltd.]
ULite2017-04-14
David Smarro [INFINITT Healthcare Co., Ltd.]
INFINITT ULite2017-04-14
David Smarro [INFINITT Healthcare Co., Ltd.]
Xelis Cardiac2013-01-07
David Smarro [INFINITT Healthcare Co., Ltd.]
Xelis Fusion2013-01-07
David Smarro [INFINITT Healthcare Co., Ltd.]
Xelis 3D2013-01-07
David Smarro [INFINITT Healthcare Co., Ltd.]
XELIS DENTAL2011-02-20
David Smarro [INFINITT Healthcare Co., Ltd.]
XELIS2011-02-20
David Smarro [INFINITT Healthcare Co., Ltd.]
XELIS Colon2011-02-20
David Smarro [INFINITT Healthcare Co., Ltd.]
INFINITT Cardiology2011-02-20
David Smarro [INFINITT Healthcare Co., Ltd.]
INFINITT Cardiology PACS2011-02-20
David Smarro [INFINITT Healthcare Co., Ltd.]
INFINITT PACS2011-02-20
David Smarro [INFINITT Healthcare Co., Ltd.]
INFINITT Mammo2011-02-20
David Smarro [INFINITT Healthcare Co., Ltd.]
INFINITT G32011-02-20
David Smarro [INFINITT Healthcare Co., Ltd.]
Reformat Gateway2011-02-20
David Smarro [INFINITT Healthcare Co., Ltd.]
STARPACS Dental2011-02-20
David Smarro [INFINITT Healthcare Co., Ltd.]
RapidiaColon System2011-02-20
David Smarro [INFINITT Healthcare Co., Ltd.]
STARPACS Orthopedics System2011-02-20
David Smarro [INFINITT Healthcare Co., Ltd.]
STARPACS2011-02-20

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