335 results · 18ms · Sources: EU EUDAMED, US FDA

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