1,395 results · 22ms · Sources: EU EUDAMED, US FDA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Instrument Command Library (ICL), Device Command Library (DCL)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·NanoFLEX One Piece Collamer Intraocular Lens (CIOL)

Lens, Intraocular, Phakic

FDA Pre-Market Approval
FDA Class 3 ·EVO/EVO+VISIAN Implantable Collamer Lens

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Device Command Library (DCL), CareLine Express

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·Medtronic MiniMed Hybrid Closed Loop (HCL) 670G

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval
FDA Class 3 ·T-SCAN 2000

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval
FDA Class 3 ·TS2000

Kit, Test, In Vitro Periodontal

FDA Pre-Market Approval
FDA Class 3 ·PERIOCHECK TM ENZYME ACTIVITY TEST KIT

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval
FDA Class 3 ·TRANSCAN T-SCAN 2000

Kit, Test, In Vitro Periodontal

FDA Pre-Market Approval
FDA Class 3 ·PERIOCHECK TM ENZYME ACTIVITY TEST KIT

Pacemaker/Icd/Crt Non-Implanted Components

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

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

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

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