11 results
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41ms
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Sources: EU EUDAMED, US FDA
OXY-1 System
FDA registration
Breethe, Inc.·4 products·🇺🇸 United States
OXY-1 System
FDA registration
ABIOMED, INC.·4 products·🇺🇸 United States
OXY-1 System
FDA 510(k)
FDA Class 2
·Cardiovascular
Ponto
FDA UDI
Oticon Medical AB·05712149026494·PONTO 5 SUPERPOWER, SIL
SmartGuard Elite
FDA registration
SMARTGUARD RX INC·2 products·🇺🇸 United States
Biofeedback Nerve and Muscle Stimulator (Models: KM530B, KM531B, KM536, KM537)
FDA registration
SHENZHEN KONMED TECHNOLOGY CO., LTD·2 products·🇨🇳 China
Oxygenator, Cardiopulmonary Bypass
FDA classification
FDA Class 2
·Oxygenator, Cardiopulmonary Bypass
SMARTSTEP SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE
FDA 510(k)
FDA Unclassified
·Unknown
Device, Warning, Overload, External Limb, Powered
FDA classification
FDA Class 2
·Device, Warning, Overload, External Limb, Powered
Mouthguard, Prescription
FDA classification
FDA Unclassified
·Mouthguard, Prescription