5,008 results · 52ms · Sources: EU EUDAMED, US FDA

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Evolut R TAV, Evolut PRO TAV, Evolut PRO+ TAV, Evolut FX TAV

N/A

FDA UDI
SCHÖLLY FIBEROPTIC GmbH·04250480109045·NIR FI Light Source

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·CoreValve Evolut PRO Transcatheter Aortic Valve; Evolut PRO+ Transcatheter Aortic Valve; Evolut FX Transcatheter Aortic

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·CoreValve EnVeo PRO Delivery Catheter System; Evolut PRO+ Delivery Catheter System; Evolut FX Transcatheter Aortic Valve

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic Evolut PRO Delivery Catheter System, Medtronic Evolut PRO+ Delivery Catheter System, Medtronic Evolut FX Deliv

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve™ EnVeo™ PRO Loading System, Medtronic Evolut™ PRO+ Loading System, Medtronic Evolut™ FX Loading Syst

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·CoreValve EnVeo Pro Delivery Catheter System, Evolut PRO+ Delivery Catheter System, Evolut FX Delivery Catheter System

Collimated handpiece

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Medency S.r.l.·1 device

Fitting Software

Basic UDI-DI
EU MDR · Eu Md Class 2a ·SBO Hearing A/S·4 devices

Fitting Software

Basic UDI-DI
EU MDR · Eu Md Class 2a ·SBO Hearing A/S·10 devices

Sunoptic Technologies

FDA UDI
SUNOPTIC TECHNOLOGIES LLC·M678TX0·Tx series Xenon Lightsource

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EnVeo PRO Delivery Catheter System, EnVeo R Delivery Catheter System, Evolut PRO+ Delivery Catheter System, Evolut FX De

FX Shoulder Solutions

Authorized representative
🇫🇷 France·1 Manufacturer

System, Phonocatheter, Intracavitary

FDA classification
FDA Class 2 ·System, Phonocatheter, Intracavitary

Calibrator, Volume, Gas

FDA classification
FDA Class 1 ·Calibrator, Volume, Gas

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Proclaim Family of Implantable Pulse Generators; St.Jude Medical External Pulse Generator, Clinical Programmer and Patie

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES

Non-sterile, Non-medicated Synthetic Nitrile Male Condoms

Basic UDI-DI
EU MDR · Eu Md Class 2b ·Innolatex (Thailand) Limited·30 devices

Insulin(CLIA)、Insulin Calibrators

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

Minicen

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Álvarez Redondo, S.A.·1 device