124 results · 17ms · Sources: EU EUDAMED, US FDA

Agent, Injectable, Embolic

FDA Pre-Market Approval
FDA Class 3 ·ONYX LIQUID EMBOLIC SYSTEM

Agent, Injectable, Embolic

FDA Pre-Market Approval
FDA Class 3 ·Onyx Liquid Embolic System and Apollo Onyx Delivery Micro Catheter

Agent, Injectable, Embolic

FDA Pre-Market Approval
FDA Class 3 ·Apollo Onyx Delivery Microcatheter

Agent, Injectable, Embolic

FDA Pre-Market Approval
FDA Class 3 ·Apollo Onyx Delivery Micro Catheter

Agent, Injectable, Embolic

FDA Pre-Market Approval
FDA Class 3 ·ONYX LIQUID EMBOLIC SYSTEM

Agent, Injectable, Embolic

FDA Pre-Market Approval
FDA Class 3 ·Onyx™ Liquid Embolic System

Agent, Injectable, Embolic

FDA Pre-Market Approval
FDA Class 3 ·Onyx Liquid Embolic System

Agent, Injectable, Embolic

FDA Pre-Market Approval
FDA Class 3 ·ONYX LIQUID EMBOLIC SYSTEM

Agent, Injectable, Embolic

FDA Pre-Market Approval
FDA Class 3 ·ONYX LIQUID EMBOLIC SYSTEM

Agent, Injectable, Embolic

FDA Pre-Market Approval
FDA Class 3 ·Apollo™ Onyx™ Delivery Micro Catheter 1.5 cm, Apollo™ Onyx™ Delivery Micro Catheter 3.0 cm

Agent, Injectable, Embolic

FDA Pre-Market Approval
FDA Class 3 ·ONYX 18LES & ONYX 34 LES

Agent, Injectable, Embolic

FDA Pre-Market Approval
FDA Class 3 ·Apollo™ Onyx™ Delivery Micro Catheter

Agent, Injectable, Embolic

FDA Pre-Market Approval
FDA Class 3 ·Onyx Liquid Embolic System

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMP

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval
FDA Class 3 ·AAV5 DetectCDx®

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval
FDA Class 3 ·AAV5 DetectCDx

Cap, Cooling (Infants)

FDA classification
FDA Class 3 ·Cap, Cooling (Infants)

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

FDA Pre-Market Approval
FDA Class 3 ·Promote/+/RF/Q. Promote Accel, Promote Quadra, Unity, Unity Assura, Unity Quadra, Quadra Assura , Epic+/HF/HF+/ II HF, A