18 results
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21ms
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Sources: EU EUDAMED, US FDA
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Country: Israel
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Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor
FDA 510(k)
FDA Class 2
·General Hospital
Aerotel Medical Systems (1998) Ltd.
Manufacturer
🇮🇱 Israel·5 Basic UDI-DIs·5 Devices·SGS FIMKO OY
ECG HOLTER RECORDERS
Device
EU MDD
·
Eu Md Class 2a
·Aerotel Medical Systems (1998) Ltd.·On the market·32 countries
ECG HOLTER RECORDERS
Device
EU MDD
·
Eu Md Class 2a
·Aerotel Medical Systems (1998) Ltd.·On the market·32 countries
ECG HOLTER RECORDERS
Device
EU MDD
·
Eu Md Class 2a
·Aerotel Medical Systems (1998) Ltd.·On the market·32 countries
ECG HOLTER RECORDERS
Device
EU MDD
·
Eu Md Class 2a
·Aerotel Medical Systems (1998) Ltd.·On the market·32 countries
ECG DATA MANAGEMENT SYSTEMS
Device
EU MDD
·
Eu Md Class 2a
·Aerotel Medical Systems (1998) Ltd.·On the market·32 countries
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
HRS
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Aerotel Medical Systems (1998) Ltd.·1 device
HeartView
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Aerotel Medical Systems (1998) Ltd.·1 device
HeartView
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Aerotel Medical Systems (1998) Ltd.·1 device
HeartView
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Aerotel Medical Systems (1998) Ltd.·1 device
HeartView
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Aerotel Medical Systems (1998) Ltd.·1 device
17/07002
Certificate
MDD Annex V·Aerotel Medical Systems (1998) Ltd.·SGS FIMKO OY·5 Basic UDI-DIs