Simplivia Healthcare L T D

FDA Filings

This page includes the latest FDA filings for Simplivia Healthcare 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 Number9611423
FEI Number3002807615
NameSIMPLIVIA HEALTHCARE LTD.
Owner & OperatorSIMPLIVIA HEALTHCARE LTD.
Contact AddressNorth Ind. Zone, (Migada plant) North Ind. Zone P.O.Box 888
Kiryat Shmona IL-NOTA 1101801 IL
Official Correspondent
  • Sylvia - Gurevich
  • 972-54-9141465-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressNORTH IND. ZONE P.O.BOX 888
KIRYAT SHMONA Ha Zafon, 1101801 IL
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
SIMPLIVIA HEALTHCARE LTD
OnGuard Luer Lock Adaptor 2022-10-11
SIMPLIVIA HEALTHCARE LTD
OnGuard Spike Port Adaptor 2022-10-11
SIMPLIVIA HEALTHCARE LTD
OnGuard2 Syringe Adaptor Sterile Replacement Cap 2022-09-05
SIMPLIVIA HEALTHCARE LTD
Catheter Adaptor 2022-07-12
SIMPLIVIA HEALTHCARE LTD
OnGuard2 Syringe Adaptor Lock II 2022-02-28
SIMPLIVIA HEALTHCARE LTD
OnGuard2 Chemfort Closed Adaptor SP 2021-10-25
SIMPLIVIA HEALTHCARE LTD
OnGuard2 Chemfort Bag Adaptor CP 2021-10-25
SIMPLIVIA HEALTHCARE LTD
OnGuard2 Chemfort Closed Secondary IV Set 2021-10-25
SIMPLIVIA HEALTHCARE LTD
OnGuard2 Chemfort Closed Y Inline Set 2021-10-25
SIMPLIVIA HEALTHCARE LTD
ONGUARD2 20mm VIAL ADAPTOR SL with 13 mm convertor 2021-10-18
SIMPLIVIA HEALTHCARE LTD
Chemfort Bag Adaptor SPT 2021-10-18
Simplivia Healthcare LTD.
OnGuard2 Chemfort Closed Administration (CADM)2021-09-23
SIMPLIVIA HEALTHCARE LTD
OnGuard 2 CSTD IV Secondary Safety 2021-03-19
SIMPLIVIA HEALTHCARE LTD
OnGuard 2 CSTD Bag Adaptor SP with ULTRASITE 2021-03-19
SIMPLIVIA HEALTHCARE LTD
OnGuard 2 CSTD Bag Adaptor LL with ULTRASITE 2021-03-19
SIMPLIVIA HEALTHCARE LTD
OnGuard 2 CSTD Bag Adaptor LL 2021-03-19
SIMPLIVIA HEALTHCARE LTD
OnGuard 2 CSTD IV Secondary Safety Set with ULTRASITE 2021-03-19
SIMPLIVIA HEALTHCARE LTD
Tevadaptor Syringe Adaptor Lock 2021-02-26
SIMPLIVIA HEALTHCARE LTD
Tevadaptor Catheter Adaptor 2021-02-26
SIMPLIVIA HEALTHCARE LTD
Tevadaptor Secondary IV Administration Set 2021-02-26
Simplivia Healthcare Ltd.
TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL With ULTRASITE, TEVADAPTOR Bag Adaptor SP With ULTRASITE, TEVADAPTOR IV Secondary Safety Set With ULTRASITE, TEVADAPTOR IV Secondary Safety Set2021-02-25
SIMPLIVIA HEALTHCARE LTD
OnGuard®2 CSTD Syringe Adaptor Lock 2020-07-20
SIMPLIVIA HEALTHCARE LTD
OnGuard®2 CSTD Syringe Adaptor 2020-07-20
SIMPLIVIA HEALTHCARE LTD
OnGuard®2 CSTD 28mm Vial Adaptor 2020-07-20
SIMPLIVIA HEALTHCARE LTD
OnGuard®2 CSTD Luer Lock Adaptor 2020-07-20
SIMPLIVIA HEALTHCARE LTD
OnGuard®2 CSTD Bag Adaptor SP 2020-07-20
SIMPLIVIA HEALTHCARE LTD
OnGuard®2 CSTD 20mm Vial Adaptor and 13mm Convertor 2020-07-17
Simplivia Healthcare Ltd.
Chemfort CSTD2020-05-07
SIMPLIVIA HEALTHCARE LTD.
TEVADAPTOR - Catheter Adaptor2018-12-19
SIMPLIVIA HEALTHCARE LTD.
TEVADAPTOR- Syringe Adaptor Lock2017-08-22
SIMPLIVIA HEALTHCARE LTD.
OnGuard Contained Medication System with Tevadaptor? Components2015-11-04
SIMPLIVIA HEALTHCARE LTD.
TEVADAPTOR Spike Port Adaptor Set with ULTRASITE Injection Site for use with OnGuard Contained Medication System2014-06-15
SIMPLIVIA HEALTHCARE LTD.
TEVADAPTOR Connecting Set with ULTRASITE Injection Site for use with OnGuard Contained Medication System2014-06-15
SIMPLIVIA HEALTHCARE LTD.
Tevadaptor IV Administration Set without ULTRASITE Injection Site use with OnGuard Contained Medication System2013-02-26
SIMPLIVIA HEALTHCARE LTD.
Tevadaptor IV Administration Set with ULTRASITE Injection Site use with OnGuard Contained Medication System.2013-02-26
SIMPLIVIA HEALTHCARE LTD.
TEVADAPTOR2007-12-05

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092969915Haifa,Israel -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES35 PKG
2020092969915Haifa,Israel -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES35 PKG
2020091839129Haifa,Israel -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES24 PKG
2020091175020Haifa,Israel -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES24 PKG
202009053192Haifa,Israel -> New York/Newark Area, Newark, New JerseyMEDICAL PARTS5 PKG
2020090546104Haifa,Israel -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES34 PKG
2020090546104Haifa,Israel -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES34 PKG
2020082217712Haifa,Israel -> New York/Newark Area, Newark, New JerseyMEDICAL PARTS5 PKG
2020081966973Haifa,Israel -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES44 PKG
2020081966973Haifa,Israel -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES44 PKG
2020073055811Haifa,Israel -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES27 PKG
2020073055811Haifa,Israel -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES27 PKG

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