47 results · 30ms · Sources: EU EUDAMED, US FDA

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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

GE Medical Systems Israel", Functional Imaging

Manufacturer
🇮🇱 Israel·6 Basic UDI-DIs·8 Devices·GMED SAS

GE MEDICAL SYSTEMS Israel Ltd.

Manufacturer
🇮🇱 Israel

Spectrum Dynamics Medical ltd

Manufacturer
🇮🇱 Israel·4 Basic UDI-DIs·12 Devices

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

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