13 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Israel
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Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)
FDA Enforcement
Class I
·Ongoing·Given Imaging Ltd.·July 16, 2025
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
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