331 results · 19ms · Sources: EU EUDAMED, US FDA

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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