7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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System, Laser, Photodynamic Therapy
FDA Pre-Market Approval
FDA Class 3
·600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·DURASPHERE EXP
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·DURASPHERE EXP
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
FDA Pre-Market Approval
FDA Class 3
·XVIVO Perfusion System (XPS) with STEEN Solution Perfusate
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ENPULSE E1 IPG, ENPULSE E2 IPG,KAPPA D (KAPPA 700) IPG, KAP
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG,AT500 DDDRP PACING SYSTEM IPG, ENPULSE E2 IPG,ENPULSE E2 IPG,KAP
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ENTRUST ICD,INTRINSIC 30 ICD, INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD, KAPPA DR(KAPPA 700/600)IPG, KAP