2,452 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·FPSA FLEX REAGENT CARTRIDGE
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·Dimension Vista FPSA Flex reagent cartridge
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·DIMENSION FPSA FLEX REAGENT
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·DIMENSION FPSA FLEX REAGENT CARTRIDGE
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·Dimension® FPSA Flex® reagent cartridge
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·DIMENSION FPSA FLEX REAGENT CARTRIDGE
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·Oxford Partial Knee System
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·On-X Prosthetic Heart Valve and Ascending Aortic Prothesis
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·DURASEAL EXACT SPINE SEALANT SYSTEM
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·IntellaNav XP and IntellaNav MiFi XP Ablation Catheters
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·INTELLANAV MIFI Open-Irrigated Ablation Catheters
Sealant, Polymerizing
FDA Pre-Market Approval
FDA Class 3
·COSEAL SURGICAL SEALANT
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·PHEMFILCON A
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·FREEZOR, FREEZOR XTRA AND FREEZOR MAX SURGICAL CARDIAC CRYOABLATION DEVICE
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·DURASEAL DURAL SEALANT SYSTEM
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM
Glue, Surgical, Arteries
FDA Pre-Market Approval
FDA Class 3
·BioGlue Surgical Adhesive
Bone Grafting Material, Dental, With Biologic Component
FDA Pre-Market Approval
FDA Class 3
·GEM21S