85 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne CDx
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne CDx
DEPUY ASR TAPER SLEEVE ADAPTER
FDA 510(k)
FDA Class 3
·Orthopedic
DEPUY ASR 300 ACETABULAR CUP SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
DEPUY ASR MODULAR ACETABULAR CUP SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·ACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Edora 8 DR & DR-T, Evity 8 DR-T,Enitra 8 DR-T, Enticos 8 DR-T, Edora 8 SR-T and SR, Evity 8 SR-T, Enitra 8 SR-T,Enticos
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Edora, Evity, Enitra, Enticos 8SR/ SR-T/ DR/ DR-T
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ESSENTIO SR, ESSENTIO DR, PROPONENT SR, PROPONENT DR, ACCOLADE SR, ACCOLADE DR, ALTRUA 2 DR, ALTRUA 2 SR
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ESSENTIO SR, ESSENTIO DR, PROPONENT SR, PROPONENT DR, ACCOLADE SR, ACCOLADE DR, ALTRUA 2 SR, ALTRUA 2 DR
Stimulator, Carotid Sinus Nerve
FDA Pre-Market Approval
FDA Class 3
·BAROSTIM NEO® System
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·CareLink SmartSync Micra VR App, CareLink SmartSync Micra AV App
Stimulator, Carotid Sinus Nerve
FDA Pre-Market Approval
FDA Class 3
·Barostim System Heart Failure
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·LATITUDE NXT PATIENT MANAGEMENT SYSTEM
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·PSW 2202.U and NEO 2202.U
Stimulator, Carotid Sinus Nerve
FDA Pre-Market Approval
FDA Class 3
·Barostim System
Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
FDA Pre-Market Approval
FDA Class 3
·remede® System
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·LATITUDE CONSULT SYSTEM