587 results · 19ms · Sources: EU EUDAMED, US FDA

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·INTACS (INTRASTROMAL CORNEAL RING SEGMENTS)

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·INTACS CORNEAL IMPLANTS

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·CareLink SmartSync™ Micra VR App, CareLink SmartSync™ Micra AV App

Hybrid Stent Graft, Thoracic Aortic Lesion Treatment

FDA Pre-Market Approval
FDA Class 3 ·Thoraflex Hybrid

Hybrid Stent Graft, Thoracic Aortic Lesion Treatment

FDA Pre-Market Approval
FDA Class 3 ·Thoraflex™ Hybrid

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·LATITUDE NXT PATIENT MANAGEMENT SYSTEM

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·PSW 2202.U and NEO 2202.U

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·LATITUDE CONSULT SYSTEM

Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

FDA Pre-Market Approval
FDA Class 3 ·FEMSOFT URETHRAL INSERT

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·CARELINK HOME MONITOR MODEL 2490C, CARDIOSIGHT READER MODEL 2020A, CAELINK NETWORK DEVICE

Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

FDA Pre-Market Approval
FDA Class 3 ·RELIANCE URINARY CONTROL INSERT & SIZING DEVICE

Hybrid Stent Graft, Thoracic Aortic Lesion Treatment

FDA Pre-Market Approval
FDA Class 3 ·Thoraflex™ Hybrid

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·Renamic Neo Programmer

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC CARELINK MONITOR, MYCARELINK PATIENT MONITOR

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·REVEAL DX, REVEAL XT

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC MODELS 2490C CARELINK REMOTE HOME MONITORS

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·MYCARELINK SMART MONITOR AND THE MYCARELINK HEART APPLICATION

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·LATITUDE PATIENT MANAGEMENT SYSTEM, WAVE COMMUNICATOR MODEL 6290; NXT SYSTEM SEVER SOFTWARE MODEL 6460

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·PSW 2201.U/1 and NEO 2201.U/1

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·LATITUDE CONSULT SYSTEM