10,000 results
·
60ms
·
Sources: EU EUDAMED, US FDA
Transcervical Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·Astron Pulsar/Pulsar-18 Stent System
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·Coaxial Umbilical Cable
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Biosense Webster NaviStar Thermocool Catheter
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE
Implanted Brain Stimulator For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·NEUROPACE RNS SYSTEM
Dorsal Root Ganglion Stimulator For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Axium Leads and other accessories
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ANTI-HBC REAGENT PACK AND CALIBRATOR
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·Elecsys free PSA, free PSA Calset, free PSA CalCheck
Valve, Pulmonary
FDA Pre-Market Approval
FDA Class 3
·Spiration Valve System
Joint, Temporomandibular, Implant
FDA Pre-Market Approval
FDA Class 3
·Patient-Fitted TMJ Reconstruction Prosthesis System
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM- OVER THE WIRE; ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM-MONORAIL
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·SOLESTA
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Quadripolar Pacing
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT TOTAL PSA