66 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Israel
×
Degania Silicone LTD
Manufacturer
🇮🇱 Israel
Biometrix LTD
Manufacturer
🇮🇱 Israel·1 Importer
CT/GAMMA CAMERA SYSTEMS
Device
EU MDR
·
Eu Md Class 2b
·GE Medical Systems Israel", Functional Imaging·On the market·32 countries
MyoSPECT ES
Device
EU MDR
·
Eu Md Class 2a
·GE Medical Systems Israel", Functional Imaging·On the market·32 countries
MyoSPECT
Device
EU MDR
·
Eu Md Class 2a
·GE Medical Systems Israel", Functional Imaging·On the market·23 countries
Aurora
Device
EU MDR
·
Eu Md Class 2b
·GE Medical Systems Israel", Functional Imaging·On the market·2 countries
Xeleris V Processing & Review System
Device
EU MDR
·
Eu Md Class 2a
·GE Medical Systems Israel", Functional Imaging·On the market·32 countries
StarGuide MDD to MDR Upgrade
Device
EU MDR
·
Eu Md Class 2b
·GE Medical Systems Israel", Functional Imaging·On the market·32 countries
StarGuide
Device
EU MDD
·
Eu Md Class 2b
·GE Medical Systems Israel", Functional Imaging·On the market·32 countries
MyoSPECT
Device
EU MDD
·
Eu Md Class 2a
·GE Medical Systems Israel", Functional Imaging·On the market·32 countries
Aurora
Basic UDI-DI
EU MDR
·
Eu Md Class 2b
·GE Medical Systems Israel", Functional Imaging·1 device
StarGuide
Basic UDI-DI
EU MDR
·
Eu Md Class 2b
·GE Medical Systems Israel", Functional Imaging·2 devices
MyoSPECT
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·GE Medical Systems Israel", Functional Imaging·2 devices
Xeleris V Processing and Review System
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·GE Medical Systems Israel", Functional Imaging·1 device
StarGuide
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·GE Medical Systems Israel", Functional Imaging·1 device
MyoSPECT
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·GE Medical Systems Israel", Functional Imaging·1 device
7927
Certificate
MDD Annex II (excluding section 4)·GE Medical Systems Israel", Functional Imaging·GMED SAS·2 Basic UDI-DIs
The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity. The anchors are pre-loaded inside the device shaft and are ready for use. A thimble is also supplied, as an accessory for the device, to be used as a guide channel for better handling of the EnPlace. Intended Use / Indications for Use: The EnPlace system is intended for attaching sutures to ligaments of the pelvic floor.
FDA Enforcement
Class II
·Ongoing·FEMSelect Ltd·February 9, 2022
Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS, ISRAEL LTD.·October 11, 2023
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 28, 2026