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.
| Registration Number | 9611423 |
| FEI Number | 3002807615 |
| Name | SIMPLIVIA HEALTHCARE LTD. |
| Owner & Operator | SIMPLIVIA HEALTHCARE LTD. |
| Contact Address | North Ind. Zone, (Migada plant) North Ind. Zone P.O.Box 888 Kiryat Shmona IL-NOTA 1101801 IL |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | NORTH IND. ZONE P.O.BOX 888 KIRYAT SHMONA Ha Zafon, 1101801 IL |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| SIMPLIVIA HEALTHCARE LTD | OnGuard®2 20mm Vial Adaptor II and 13mm convertor | 2024-09-23 |
| SIMPLIVIA HEALTHCARE LTD | OnGuard2 Syringe Adaptor Lock II, 5 Units | 2024-09-16 |
| SIMPLIVIA HEALTHCARE LTD | OnGuard2 Syringe Adaptor, 5 Units | 2024-09-16 |
| SIMPLIVIA HEALTHCARE LTD | OnGuard2 20mm Vial Adaptor, 5 Units | 2024-09-16 |
| SIMPLIVIA HEALTHCARE LTD | OnGuard2 20mm Vial Adaptor, 10 Units | 2024-09-16 |
| SIMPLIVIA HEALTHCARE LTD | OnGuard2 Bag Adaptor SP II | 2024-05-14 |
| 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 Set | 2021-02-25 |
| 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 CSTD | 2020-05-07 |
SIMPLIVIA HEALTHCARE LTD. | TEVADAPTOR - Catheter Adaptor | 2018-12-19 |
SIMPLIVIA HEALTHCARE LTD. | TEVADAPTOR- Syringe Adaptor Lock | 2017-08-22 |
SIMPLIVIA HEALTHCARE LTD. | OnGuard Contained Medication System with Tevadaptor? Components | 2015-11-04 |
SIMPLIVIA HEALTHCARE LTD. | TEVADAPTOR Spike Port Adaptor Set with ULTRASITE Injection Site for use with OnGuard Contained Medication System | 2014-06-15 |
SIMPLIVIA HEALTHCARE LTD. | TEVADAPTOR Connecting Set with ULTRASITE Injection Site for use with OnGuard Contained Medication System | 2014-06-15 |
SIMPLIVIA HEALTHCARE LTD. | Tevadaptor IV Administration Set without ULTRASITE Injection Site use with OnGuard Contained Medication System | 2013-02-26 |
SIMPLIVIA HEALTHCARE LTD. | Tevadaptor IV Administration Set with ULTRASITE Injection Site use with OnGuard Contained Medication System. | 2013-02-26 |
SIMPLIVIA HEALTHCARE LTD. | TEVADAPTOR | 2007-12-05 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020092969915 | Haifa,Israel -> New York/Newark Area, Newark, New Jersey | MEDICAL DEVICES | 35 PKG |
| 2020092969915 | Haifa,Israel -> New York/Newark Area, Newark, New Jersey | MEDICAL DEVICES | 35 PKG |
| 2020091839129 | Haifa,Israel -> New York/Newark Area, Newark, New Jersey | MEDICAL DEVICES | 24 PKG |
| 2020091175020 | Haifa,Israel -> New York/Newark Area, Newark, New Jersey | MEDICAL DEVICES | 24 PKG |
| 202009053192 | Haifa,Israel -> New York/Newark Area, Newark, New Jersey | MEDICAL PARTS | 5 PKG |
| 2020090546104 | Haifa,Israel -> New York/Newark Area, Newark, New Jersey | MEDICAL DEVICES | 34 PKG |
| 2020090546104 | Haifa,Israel -> New York/Newark Area, Newark, New Jersey | MEDICAL DEVICES | 34 PKG |
| 2020082217712 | Haifa,Israel -> New York/Newark Area, Newark, New Jersey | MEDICAL PARTS | 5 PKG |
| 2020081966973 | Haifa,Israel -> New York/Newark Area, Newark, New Jersey | MEDICAL DEVICES | 44 PKG |
| 2020081966973 | Haifa,Israel -> New York/Newark Area, Newark, New Jersey | MEDICAL DEVICES | 44 PKG |
| 2020073055811 | Haifa,Israel -> New York/Newark Area, Newark, New Jersey | MEDICAL DEVICES | 27 PKG |
| 2020073055811 | Haifa,Israel -> New York/Newark Area, Newark, New Jersey | MEDICAL DEVICES | 27 PKG |