15 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Israel
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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
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Eu Md Class 2a
·Aerotel Medical Systems (1998) Ltd.·On the market·32 countries
ECG HOLTER RECORDERS
Device
EU MDD
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Eu Md Class 2a
·Aerotel Medical Systems (1998) Ltd.·On the market·32 countries
ECG HOLTER RECORDERS
Device
EU MDD
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Eu Md Class 2a
·Aerotel Medical Systems (1998) Ltd.·On the market·32 countries
ECG HOLTER RECORDERS
Device
EU MDD
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Eu Md Class 2a
·Aerotel Medical Systems (1998) Ltd.·On the market·32 countries
ECG DATA MANAGEMENT SYSTEMS
Device
EU MDD
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Eu Md Class 2a
·Aerotel Medical Systems (1998) Ltd.·On the market·32 countries
MeMed Key®
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·MeMed Diagnostics Ltd.·1 device
Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. It is intended to provide increased mobility for elderly and/or disabled person and it is also an aid to independent living. Products can be identified by their color; the recalled products are either metallic blue or metallic silver. The products have two rear wheels and have either one or two wheels in the front. The scooters have an adjustable swivel seat and a front storage basket; some scooters may be fitted with an optional larger rear basket.
FDA Enforcement
Class II
·Terminated·S.A.E. AFIKIM·November 6, 2013
HRS
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Aerotel Medical Systems (1998) Ltd.·1 device
HeartView
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Aerotel Medical Systems (1998) Ltd.·1 device
HeartView
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Aerotel Medical Systems (1998) Ltd.·1 device
HeartView
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Aerotel Medical Systems (1998) Ltd.·1 device
HeartView
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Aerotel Medical Systems (1998) Ltd.·1 device
Hexagonal/Conical System tools (manual use only): Ratchets, Holding Keys,Driver (for Ratchet), Abutment extractors, Direct handle driver, Driver adaptor. Tools (with measuring functions): Torque Ratchets, Depth indicator, Depth probe, Distance indicator .
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Cortex Dental Implants Industries Ltd.·1 device
17/07002
Certificate
MDD Annex V·Aerotel Medical Systems (1998) Ltd.·SGS FIMKO OY·5 Basic UDI-DIs