1,395 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·Instrument Command Library (ICL), Device Command Library (DCL)
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·NanoFLEX One Piece Collamer Intraocular Lens (CIOL)
Lens, Intraocular, Phakic
FDA Pre-Market Approval
FDA Class 3
·EVO/EVO+VISIAN Implantable Collamer Lens
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·Device Command Library (DCL), CareLine Express
Automated Insulin Dosing Device System, Single Hormonal Control
FDA Pre-Market Approval
FDA Class 3
·Medtronic MiniMed Hybrid Closed Loop (HCL) 670G
Imager, Breast, Electrical Impedance
FDA Pre-Market Approval
FDA Class 3
·T-SCAN 2000
Imager, Breast, Electrical Impedance
FDA Pre-Market Approval
FDA Class 3
·TS2000
Kit, Test, In Vitro Periodontal
FDA Pre-Market Approval
FDA Class 3
·PERIOCHECK TM ENZYME ACTIVITY TEST KIT
Imager, Breast, Electrical Impedance
FDA Pre-Market Approval
FDA Class 3
·TRANSCAN T-SCAN 2000
Kit, Test, In Vitro Periodontal
FDA Pre-Market Approval
FDA Class 3
·PERIOCHECK TM ENZYME ACTIVITY TEST KIT
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·CareLink SmartSync Micra VR App, CareLink SmartSync Micra AV App
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
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·LATITUDE CONSULT SYSTEM
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·CARELINK HOME MONITOR MODEL 2490C, CARDIOSIGHT READER MODEL 2020A, CAELINK NETWORK DEVICE
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·Renamic Neo Programmer
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC CARELINK MONITOR, MYCARELINK PATIENT MONITOR
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·REVEAL DX, REVEAL XT
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC MODELS 2490C CARELINK REMOTE HOME MONITORS
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·MYCARELINK SMART MONITOR AND THE MYCARELINK HEART APPLICATION