2,988 results · 46ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADAPTA, RELIA, SENSIA, & VERSA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CARELINK MONITOR MODELS 2490C AND 2491 DDMA, CARDIOSIGHT READER MODEL 2020A, CARELINK EXPRESS MONITOR 2020B, MYCARELINK

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Enhancements to Software Model 9986 version 2.11.1 and Model SW028 to version 8.2.1

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·C & T SERIES IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CapSure VDD-2 Lead, Service Kit-Pacemaker Repair Kit, and Vitatron Brilliant S+ VDD Lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S DR/SR MRI IPG and Azure XT DR/SR MRI IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Adaptor Assembly Cable, Analzer Cable, CareLink Encore Programmer, CareLink SmartSync Device Manager Patient Connector,

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ENRHYTHM P1501 DR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CapSure VDD-2 Lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·PHILOS, CYLOS, EVIA, ESTELLA, EFFECTA FAMILY IMPLANTABLE PULSE GENERATORS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·KAPPA 400 DR IPG/KAPPA 400 SR IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADVISA MRI (A2DR01)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·KAPPA 700, KAPPA 900, ENPULSE, ADAPTA/VERSA/ SENSIA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Adapta, Versa, Sensia, Advisa DR, Advisa DR MRI, Advisa SR MRI, Relia IPG