Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NexGen LPS-Flex / LPS-Mobile Bearing Knee

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

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE FIX MODELS 4067,4068, 4568,5068,5568 PACING LEADS

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NexGen LPS-Flex / LPS-Mobile Bearing Knee

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-FLEX MODEL 570C INTRAOCULAR LENS (IOL)

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION RXL MAX TPSA FLEX REAGENT CARTRIDGE

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·Nexgen LPS-Flex/LPS-Mobile Bearing Knee

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Pipeline Flex Embolization Device with Shield Technology

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NexGen LPS-Flex/LPS-Mobile Bearing Knee

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NEXGEN LPS-FLEX/LPS-MOBILE BEARING KNEE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE FIX LEAD & REVO MRI IPG

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Pipeline Flex Embolization Device with Shield Technology

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE FIX LEAD & REVO MRI IPG

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NexGen LPS-Flex/LPS-Mobile Bearing Knee

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-FLEX ASPHERIC INTRAOCULAR LENS MODEL 970C

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NexGen LPS-Flex/LPS-Mobile Bearing Knee

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-FLEX MODEL 570C INTRAOCULAR LENS (IOL)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·FLEX TIP INTRASPINAL KIT, CATALOG AP-07008

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·Dimension Vista TPSA Flex reagent cartridge (K6452)

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NexGen LPS-Flex/ LPS-Mobile Bearing Knee