1,872 results · 35ms · Sources: EU EUDAMED, US FDA

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

FDA Pre-Market Approval
FDA Class 3 ·Evia HF-T, Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T, Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Eni

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Ilivia 7 HF-T, Intica 7/5 HF-T, Acticor 7 HF-T, Rivacor 7/5/3 HF-T, Ilivia 7 HF-T QP, Initca 7 HF-T QP, Acticor 7 HF-T Q

SMEDTEC OÜ

Authorized representative
🇪🇪 Estonia·1 Manufacturer

MI+BW-Mantel "M"

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Rosa Toifl & Co GmbH·2 devices

Radioimmunoassay, Phenobarbital

FDA classification
FDA Class 2 ·Radioimmunoassay, Phenobarbital

Reamer, Pulp Canal, Endodontic

FDA classification
FDA Class 1 ·Reamer, Pulp Canal, Endodontic

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

FDA Pre-Market Approval
FDA Class 3 ·Corox (ProMRI0 OTW,75,85,S75,L75,LB85 BP; Sentus (ProMRI) OTW,75,85,S75,S85,L75,L85,QP S75S85,S95,l75,l85,L95,S75/49,S75

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

FDA Pre-Market Approval
FDA Class 3 ·Corox OTW BP/OTW-S BP; Corox OTW-L BP/ProMRI OTW-L BP; Corox ProMRI OTW BP/ProMRI OTW-SBP; Sentus ProMRI OTW QP S/ProMRI

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Amvia Edge DR-T, Amvia Edge SR-T, Amvia Sky DR-T, Amvia Sky SR-T, Solvia Rise DR-T, Solvia Rise SR-T, Amvia Edge HF-T QP

Drill & Drill Accessories (Guide Drill, Drill Extension, Twist Drill, Pilot Drill, Cortical Drill, Drill Stopper)

FDA registration
SEWON MEDIX, INC.·1 product·🇰🇷 South Korea

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

FDA Pre-Market Approval
FDA Class 3 ·Evia HF, HF-T, Entovis HF, HF-T, Edora 8 HF-T, Enitra HF-T, Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T, Edora 8 HF-T QP,

CF1210A, CF1211A, CF1212A, CF1213A, CF1201B, CF1202B, CF1203B, CF1204B, CF1205B, CF1207B, CF1208B, CF1209B, CF1210B,

FDA registration
SHENZHEN GREATMADE TECH LIMITED·1 product·🇨🇳 China