317 results · 31ms · Sources: EU EUDAMED, US FDA

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE SP NOVUS

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·PHILOS PULSE GENERATOR FAMILY AND SWM1000 B-K-00.0U SOFTWARE CARTRIDGE

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

FDA Pre-Market Approval
FDA Class 3 ·TENDRIL STS LEAD MODEL 2088TC

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·TENDRIL ST LEAD MODELS 1788T/TC AND 1782 TC

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati

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

FDA Pre-Market Approval
FDA Class 3 ·PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS

Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

FDA Pre-Market Approval
FDA Class 3 ·NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE

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

FDA Pre-Market Approval
FDA Class 3 ·THERAPY COOL FLEX ABLATION CATHETER

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR (MODELS 4000)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·RIATA STS OPTIM LEAD MODELS 7120, 7121,7122,7130 AND 7131

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·AccelStim

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·ISOFLEX P LEAD FAMILY MODELS 1644T AND 1648T STEROID ELUTING, PASSIVE FIXATION ENDOCARDIAL PACING LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·RIATA SERIES 1500 DEFIBRILLATION LEAD SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·AFFINITY SR MODELS 5130 (LS,RS,L,R)PULSE GENERATORS AFFINITY DR MODELS 5330 (LS, RS,L,R)PULSE GENERATORS

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE Z MODELS 5034/5534/5033 PACING LEADS

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC INTERSTIM CONTINENCE CONTROL SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·ORCHESTRA PROGRAMMER

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

FDA Pre-Market Approval
FDA Class 3 ·TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·ISOFLEX S PERMANENT PACING LEAD MODELS