454 results
·
27ms
·
Sources: EU EUDAMED, US FDA
SELOX SR 53
FDA Adverse Event
Other
·BIOTRONIK GMBH AND CO.·Product code LWS·June 14, 2006
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·HOME MONITORING SYSTEM
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Edora 8 DR-T; Evity 8 DR-T; Enitra 8 DR-T; Enticos 8 DR-T; Evity 6 DR-T; Enitra 6 DR-T; Edora 8 DR; Enitra 6 DR; Edora 8
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·CYLOS FAMILY OF PULSE GENERATORS
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·EVIA FAMILY OF PACEMAKERS
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·Solia CSP S Leads
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·NEO 2101.U
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·EDP 30 EXTERNAL DUAL CHAMBER PACEMAKER
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Pulse Generator, Permanent, Implantable
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·CYLOS DR-T PULSE GENERATOR
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Edora 8 DR & DR-T, Evity 8 DR-T,Enitra 8 DR-T, Enticos 8 DR-T, Edora 8 SR-T and SR, Evity 8 SR-T, Enitra 8 SR-T,Enticos
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·REOCOR S/D EXTERNAL PACEMAKER
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ACTROS, AXIOS, BA03, CYLOS, DROMOS, KAIROS, PHILOS, PHILOS II, AND PROTOS FAMILIES OF PULSE GENERATORS
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·VARIOUS MODELS OF PHILOS/PHILOS, AXIOS, PROTOS PULSE GENERATOR
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ECURO, EFFECTA, ENTOVIS, ESTELLA, EVIA
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·PK-222 and PK-Electrode Clip (accessory to Renamic)
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Enticos 4 DR, Enticos 4 D, Enticos 4 SR, Enticos 4 S, Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·PHILOS PULSE GENERATOR
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·SELOX ST, SELOX JT, SETROX S, DEXTRUS, TILDA, SOLOX SLX, SAFIO