328 results · 20ms · Sources: EU EUDAMED, US FDA

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·EXCOR® Pediatric Ventricular Assist Device

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·POLARx and POLARxFIT Cryoablation Catheters

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·LIFEPAK Automated External Defibrillators (AEDs)

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval
FDA Class 3 ·Exablate Model 4000 Type 1.0 & Type 1.1 System (“Exablate Neuro”)

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval
FDA Class 3 ·INFORM HER-2/NEU

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION CYROABLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION CYROABLATION THERAPY SYSTEM

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY HER 2 (CLONE CB11)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·INSITE HER-2/NEU KIT

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER-2/NEU

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM