7,105 results · 22ms · Sources: EU EUDAMED, US FDA

Valve, Pulmonary

FDA Pre-Market Approval
FDA Class 3 ·The Pulmonx Zephyr Endobronchial Valve System (EBV)

Valve, Pulmonary

FDA Pre-Market Approval
FDA Class 3 ·Spiration Valve System

Valve, Pulmonary

FDA Pre-Market Approval
FDA Class 3 ·Spiration® Valve System (SVS)

Microspheres Radionuclide

FDA Pre-Market Approval
FDA Class 3 ·TheraSphere

Valve, Pulmonary

FDA Pre-Market Approval
FDA Class 3 ·Zephyr Valve Registry (ZEVR)

Microspheres Radionuclide

FDA Pre-Market Approval
FDA Class 3 ·SIR-SPHERES MICROSPHERES

Microspheres Radionuclide

FDA Pre-Market Approval
FDA Class 3 ·TheraSphere

Valve, Pulmonary

FDA Pre-Market Approval
FDA Class 3 ·Zephyr Endobronchial Valve System

Microspheres Radionuclide

FDA Pre-Market Approval
FDA Class 3 ·SIR-SPHERES

Valve, Pulmonary

FDA Pre-Market Approval
FDA Class 3 ·SVS Deployment Catheter and Loader

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER-2/NEW (4B5)RABBIT MONOCLONAL PRIMARY ANTIBODY

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval
FDA Class 3 ·CONSERVE PLUS HIP RESURFACING SYSTEM NEW ENROLLMENT STUDY (NES) PROTOCOL

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·TARGIS TARGETED TRANSURETHRAL THERMOABLATION SYSTEM (TARGIS SYSTEM): NEW POUCH SEALER

VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)

FDA 510(k)
FDA Class 3 ·Cardiovascular

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ONE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES MODEL 121UV NEW LENS CARRIER

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ONE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES MODEL 121UV NEW LENS CARRIER

ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE

FDA 510(k)
FDA Class 3 ·Cardiovascular

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

FDA Pre-Market Approval
FDA Class 3 ·NEW JERSEY LCS(R) TOTAL KNEE SYSTEM-ADDITION OF THREE PEGGED PATTELLA PROSTHESES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION SYSTEM-CABLE 10X ETO REUSE/RESTERILIZATION, NEW EXTENSION CABLE

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

FDA Pre-Market Approval
FDA Class 3 ·NEW JERSEY LCS(R) TOTAL KNEE SYSTEM-ADDITION OF THREE PEGGED PATTELLA PROSTHESES