11 results · 40ms · Sources: EU EUDAMED, US FDA

Monitor, Fetal Doppler Ultrasound

FDA classification
FDA Class 2 ·Monitor, Fetal Doppler Ultrasound

Alpha-D-Glucosidase (Gaa) Newborn Screening Test System

FDA classification
FDA Class 2 ·Alpha-D-Glucosidase (Gaa) Newborn Screening Test System

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

Replacer, Urethral

FDA classification
FDA Class 3 ·Replacer, Urethral

Igg, Peroxidase, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Igg, Peroxidase, Antigen, Antiserum, Control

Stent, Coronary

FDA classification
FDA Class 3 ·Stent, Coronary

Mr-Guided Focused Ultrasound System

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

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