1,016 results · 29ms · Sources: EU EUDAMED, US FDA

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip NT, NTR, and XTR Clip Delivery System

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MITRACLIP CLIP DELIVERY SYSTEM; MITRACLIP STEERABLE GUIDE CATHETER

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip NT, NTR, XTR, G4 Clip Delivery System

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MITRACLIP CLIP DELIVERY SYSTEM, MITRACLIP STEERABLE GUIDE CATHETER

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval
FDA Class 3 ·VENTANA PATHWAY ANTI-C-KIT PRIMARY ANTIBODY (POLYCLONAL)

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval
FDA Class 3 ·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5)RABBIT MONOCLONAL PRIMARY ANTIBODY

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval
FDA Class 3 ·VENTANA ALK (D5F3) CDX ASSAY

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MITRACLIP CLIP DELIVERY SYSTEM AND MITRACLIP STEERABLE GUIDE CATHETER

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip G4 Clip Delivery System; MitraClip G5 Delivery System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·PK-222 and PK-Electrode Clip (accessory to Renamic)

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip NTR/XTR Clip Delivery System and Steerable Guide Catheter

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, TORQUE CLIP DEVICE

Stimulator, Functional Neuromuscular, Scoliosis

FDA Pre-Market Approval
FDA Class 3 ·SCOLITRON(TM) STIMULATOR

Stimulator, Functional Neuromuscular, Scoliosis

FDA Pre-Market Approval
FDA Class 3 ·SCOLITRON(TM) STIMULATOR

Stimulator, Functional Neuromuscular, Scoliosis

FDA Pre-Market Approval
FDA Class 3 ·SCOLITRON(TM) STIMULATOR

Stimulator, Functional Neuromuscular, Scoliosis

FDA Pre-Market Approval
FDA Class 3 ·SCOLITRON(TM) STIMULATOR

Stimulator, Functional Neuromuscular, Scoliosis

FDA Pre-Market Approval
FDA Class 3 ·SCOLITRON(TM) STIMULATOR

Stimulator, Functional Neuromuscular, Scoliosis

FDA Pre-Market Approval
FDA Class 3 ·SCOLITRON(TM) STIMULATOR

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip NTR/XTR Clip Delivery System, MitraClip G4 System, MitraClip G5 Delivery System