819 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·PREPSTAIN SYSTEM/PREPMATE
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS® Total Knee System
Device, Impotence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·TITAN INFLATABLE PENILE PROSTHESIS
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·CARELINK HOME MONITOR MODEL 2491
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ENTRUST / VIRTUOSO / PROTECTA
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ENRHYTHM / ENRHYTHM MRI
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·REVO MRI
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·MOBI-C CERVICAL DISC PROSTHESIS
Prosthesis, Testicular
FDA Pre-Market Approval
FDA Class 3
·SALINE FILLED TESTICULAR PROSTHESIS
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·MOBI-C CERVICAL DISC PROSTHESIS
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·CONCERTO / PROTECTA
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS Total Knee System
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·DIASORIN HBSAG CONFIRMATORY TEST
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·MOBI-C CERVICAL DISC PROSTHESIS
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·MOBI-C CERVICAL DISC PROSTHESIS
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS Total Knee System
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·SynchroMed Infusion System, Ascenda Intrathecal Catheters
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·NovaSure Impedance Controlled Endometrial Ablation System
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·CHARITE ARTIFICIAL DISC
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS Total Knee System