53 results · 19ms · Sources: EU EUDAMED, US FDA

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense E3 CGM System

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval
FDA Class 3 ·VENTANA MMR RxDx Panel, VENTANA ANTI-MLH1 (M1), VENTANA ANTI-MSH6 (SP93), VENTANA ANTI-MSH2 (G219-1129), VENTANA ANTI-PM

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense Continuous Glucose Monitoring System

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval
FDA Class 3 ·VENTANA MMR RxDx Panel

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval
FDA Class 3 ·VENTANA MMR RxDx Panel

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval
FDA Class 3 ·VENTANA MMR RxDx Panel

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense Continuous Glucose Monitoring System

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval
FDA Class 3 ·VENTANA MMR RxDx Panel, VENTANA ANTI-MLH1 (M1), VENTANA ANTI-MSH6 (SP93), VENTANA ANTI-MSH2 (G219-1129), VENTANA ANTI-PM

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·PROMOTE/+/RF/Q, ACCEL/ QUADR;UNIFY ASSURA/ QUADRA, EPIC+/HF/HF+/II HF/II+ HF,ATLAS+HF/II HH/II+ H FAMILY OF CRT-D FAMILY