317 results · 33ms · Sources: EU EUDAMED, US FDA

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC RF ENHANCR II FAMILY OF ABLATION CATHETERS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·BI-DIRECTIONAL THERAPY COOL PATH DUO IRRIGATED ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·RF CONTACTR ABLATION CATHETER

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·SELOX SR STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEAD MODELS SR45, SR53, SR60 SR 53,SELOX SR 60

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MOMENTUM PACERS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·OVATIO CRT SYSTEM

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·QWIKSTAR NAVIGATION/ABLATION CATHETER

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA classification
FDA Class 3 ·Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval
FDA Class 3 ·FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable,

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationFocus CDxBRCA

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·PHYLAX AV ICD SYSTEM

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·NAVISTAR RMT DS CATHETER

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER