12 results · 48ms · Sources: EU EUDAMED, US FDA

Decontamination Kit

FDA classification
FDA Class 1 ·Decontamination Kit

Catheter, Intracardiac Mapping, High-Density Array

FDA classification
FDA Class 2 ·Catheter, Intracardiac Mapping, High-Density Array

Catheter, Intracardiac Mapping, High-Density, Reprocessed

FDA classification
FDA Class 2 ·Catheter, Intracardiac Mapping, High-Density, Reprocessed

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA classification
FDA Class 3 ·Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

Complement C3b Activator, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Complement C3b Activator, Antigen, Antiserum, Control

Apparatus, Autotransfusion

FDA classification
FDA Class 2 ·Apparatus, Autotransfusion

Stent, Coronary

FDA classification
FDA Class 3 ·Stent, Coronary

Mr-Guided Focused Ultrasound System

FDA classification
FDA Class 3 ·Mr-Guided Focused Ultrasound System

Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

FDA classification
FDA Class 2 ·Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

Syringe, Balloon Inflation, Exempt

FDA classification
FDA Class 2 ·Syringe, Balloon Inflation, Exempt

Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

FDA classification
FDA Class 2 ·Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

FDA classification
FDA Not Classified ·Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule