14 results
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28ms
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Sources: EU EUDAMED, US FDA
TOMEY CORPORATION
Manufacturer
🇯🇵 Japan·1 Importer
Tomey GmbH
Importer
🇩🇪 Germany·6 Manufacturers
Tomey GmbH
Authorized representative
🇩🇪 Germany·1 Manufacturer
Tomed GmbH
Manufacturer
🇩🇪 Germany
Tomed GmbH
FDA registration
Tomed GmbH·1 product·🇩🇪 Germany
SomnoGuard AP 2
FDA UDI
Tomed GmbH·04260383460297·
SomnoGuard AP Pro
FDA UDI
Tomed GmbH·04260383460341·
SomnoGuard SP Soft
FDA UDI
Tomed GmbH·04260383460013·
SomnoGuard SPX
FDA UDI
Tomed GmbH·04260383460310·
SomnoGuard SP Pro
FDA UDI
Tomed GmbH·04260383460464·
SOMNOGUARD MANDIBULAR ADVANCEMENT DEVICE
FDA Adverse Event
Malfunction
·TOMED, GMBH.·Product code LRK·May 29, 2020
SOMNOGUARD AP2
FDA Adverse Event
Malfunction
·TOMED GMBH·Product code LRK·July 14, 2017
Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management Systems (EMS) are used in hospital facilities to provide ready access to medical gasses, electrical power and audio/visual data services, in addition to managing surgical support equipment such as endoscopic equipment, cautery devices and insufflators.
FDA Enforcement
Class II
·Terminated·Steris Corporation·November 13, 2013
Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management Systems (EMS) are used in hospital facilities to provide ready access to medical gasses, electrical power and audio/visual data services, in addition to managing surgical support equipment such as endoscopic equipment, cautery devices and insufflators.
FDA Recall
Terminated
·Steris Corporation·August 15, 2013