10,000 results · 52ms · Sources: EU EUDAMED, US FDA

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

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

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne CDx (F1CDx)

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·Sprint Quattro Secure MRI SureScan Model 6947M lead, Sprint Quattro Secure S MRI SureScan Model 6935M lead

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC KAPPA 700/600 SERIES

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·BELOTERO BALANCE

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·RAPID SCREEN RS-2000, RS-2000D AND RS-DIGITAL

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval
FDA Class 2 ·INTER FIX THREADED FUSION DEVICE

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER PFO OCCLUDER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·CHILLI II COOLED ABLATION SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·PUREVISION (BALAFILCON A) CONTACT LENS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Prosthesis, Testicular

FDA Pre-Market Approval
FDA Class 3 ·COLOPLAST SALINE-FILLED TESTICULAR IMPLANT

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·Attain StarFix Model 4195 Lead

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·CERAMAX CERAMIC HIP SYSTEM

Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

FDA Pre-Market Approval
FDA Class 3 ·FEMSOFT URETHRAL INSERT

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 ·RESOLUTE INTEGRITY ZOTAROLIMUS_ELUTING CORONARY STENT SYSTEM

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·ESSURE SYSTEM