10,000 results · 227ms · Sources: EU EUDAMED, US FDA

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND MODEL 3307 V.4.5A SOFTWARE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·ATLAS+ DR/BR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND MODEL 3307 V.4.5A SOFTWARE

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval
FDA Class 2 ·NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·IMAGE CHECKER M1000 SYSTEM

Wheelchair, Stair Climbing

FDA Pre-Market Approval
FDA Class 2 ·INDEPENDENCE IBOT 3000/4000 MOBILITY SYSTEM

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND MODEL 3307 V.4.5A SOFTWARE

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

FDA Pre-Market Approval
FDA Class 3 ·QDOT MICRO™ System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·PROFILE(TM) MD (MODELS V-186F AND V-186HV3), PHOTON(TM) DR (MODEL V-230HV) AND PHOTON(TM) U VR/DR IMPLANTABLE CARDIOVER)

Bone Sonometer

FDA Pre-Market Approval
FDA Class 2 ·OMNISENSE 7000S ULTRASOUND BONE SONOMETER

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·SOLOX VDD PACING LEAD

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM CGM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VITALITY 2 AICD SYSTEM (MODELS T165, T167, T175, T177), MODEL 2857 APPLICATION SOFTWARE (VERSION 2.2) AND QUICK PROFILE

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Saluda Medical Evoke SCS System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·THERMOCOOL SMARTTOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER; THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL NAVIGATION CATHETE

Cardiac Ablation Percutaneous Catheter

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

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·BD FOCALPOINT GS IMAGING SYSTEM

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval
FDA Class 3 ·Exablate 2100/2100 VI System