331 results
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19ms
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Sources: EU EUDAMED, US FDA
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Country: Israel
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TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Enforcement
Class III
·Completed·STRATASYS LTD·July 16, 2025
TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Enforcement
Class III
·Completed·STRATASYS LTD·July 16, 2025
TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Enforcement
Class III
·Completed·STRATASYS LTD·July 16, 2025
TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Enforcement
Class III
·Completed·STRATASYS LTD·July 16, 2025
TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Enforcement
Class III
·Completed·STRATASYS LTD·July 16, 2025
TREE OF LIFE PHARMA LTD.
FDA registration
TREE OF LIFE PHARMA LTD.·11 products·🇮🇱 Israel
Biosense Webster (Israel) Ltd.
Manufacturer
🇮🇱 Israel·2 Importers
Oorspray 7ml
Device
EU MDR
·
Eu Md Class 2a
·Tree of Life Pharma Ltd.·On the market·2 countries
POCKET-X GEL
Device
EU MDD
·
Eu Md Class 2a
·Tree of Life Pharma Ltd.·On the market·1 country
OTIKON
Device
EU MDD
·
Eu Md Class 2a
·Tree of Life Pharma Ltd.·On the market·1 country
POCKET-X GEL
Device
EU MDR
·
Eu Md Class 2a
·Tree of Life Pharma Ltd.·Not intended for eu market
OTIKON (15ml for Israel)
Device
EU MDR
·
Eu Md Class 2a
·Tree of Life Pharma Ltd.·Not intended for eu market
POCKET-X GEL
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Tree of Life Pharma Ltd.·1 device
OTIKON Ear Drops
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Tree of Life Pharma Ltd.·1 device
POCKET-X GEL
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Tree of Life Pharma Ltd.·1 device
Olive Oil-Based Ear Drops
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Tree of Life Pharma Ltd.·2 devices
EPT 0477.MDD.20/4036
Certificate
MDD Annex II (excluding section 4)·Tree of Life Pharma Ltd.·Eurofins Product Testing Italy S.r.l.·1 Basic UDI-DI
EPT 0477.MDD.19/3135
Certificate
MDD Annex II (excluding section 4)·Tree of Life Pharma Ltd.·Eurofins Product Testing Italy S.r.l.·1 Basic UDI-DI
CVAID Ltd.
Manufacturer
🇮🇱 Israel
Simplivia Healthcare LTD.
Manufacturer
🇮🇱 Israel·3 Importers