335 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS Total Knee System
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC MODEL 7223CX MICRO JEWEL II(TM)
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 HPV DNA TEST
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·Access AFP Reagents on the Access Immunoassay Systems
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·cobas HPV
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·Access Hybritech PSA Reagents on the Access Immunoassay Systems
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·cobas HPV Test
P2psa
FDA Pre-Market Approval
FDA Class 3
·Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·SECURE -C CERVICAL ARTIFICIAL DISC
Stimulator, Hypoglossal Nerve, Implanted, Apnea
FDA Pre-Market Approval
FDA Class 3
·SleepSync Programmer
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·VITATRON DA+ C SERIES PULSE GENERATORS
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS (R) Total Knee System
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·SynchroMed® Infusion System, Ascenda® Intrathecal Catheters
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·Master Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec
System, Laser, Transmyocardial Revascularization
FDA Pre-Market Approval
FDA Class 3
·CARDIOGENESIS TMR 2000 HOLMIUM LASER SYSTEM
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·Obalon Balloon System
System, Photopheresis, Extracorporeal
FDA Pre-Market Approval
FDA Class 3
·Therakos CELLEX Procedural Kit
Microspheres Radionuclide
FDA Pre-Market Approval
FDA Class 3
·SIR-SPHERES