10,000 results · 51ms · Sources: EU EUDAMED, US FDA

Linoxsmart

FDA registration
BIOTRONIK, INC.·5 products·🇺🇸 United States

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Pamira S DX 65/15, Pamira S DX 65/17, Plexa ProMRI S DX 65/15, Plexa ProMRI S DX 65/17

Plexa ProMRI

FDA UDI
BIOTRONIK SE & Co. KG·04035479158781·

Pamira

FDA UDI
BIOTRONIK SE & Co. KG·04035479156527·

Plexa ProMRI

FDA UDI
BIOTRONIK SE & Co. KG·04035479158798·

Pamira

FDA UDI
BIOTRONIK SE & Co. KG·04035479156510·

Protego DF-1

FDA UDI
BIOTRONIK SE & Co. KG·04035479151119·

Protego DF-1

FDA UDI
BIOTRONIK SE & Co. KG·04035479151126·

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Permanent Defibrillator Electrodes

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Defibrillator, Implantable, Dual- Chamber, Defibrillator, Automatic Implantable Cardioverter, with Cardiac Resynchroniza

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·SDX PERMANENT PACEMAKERS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·LINOX S DX

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·TENDRIL DX AND TENDRIL SDX ENDOCARDIAL PACING LEADS

Linox

FDA UDI
BIOTRONIK SE & Co. KG·04035479110024·

Linox

FDA UDI
BIOTRONIK SE & Co. KG·04035479110017·

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·TENDRIL SDX MODEL 1488T/TC/K

SDX System

Basic UDI-DI
EU MDD · Eu Md Class 2b ·DYN'R·1 device

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·TENDRIL SDX, TENDRIL ST, TENDRIL STS, OPTISENSE