10,000 results · 58ms · Sources: EU EUDAMED, US FDA

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ADVIA CENTAUR HBCIGM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ENRHYTHM IPG

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CEEON ULTRAVIOLET LIGHT-ABSORBING POLYMETHYLMETHACRYLATE (PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·PROVISC OPHTHALMIC VISCOSURGICAL DEVICE

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD,CONSULTA CRT-P,LEFT VENTRICULAR PACING LEAD,SYNCRA CRT-P

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VERIFLEX (LIBERTE) CORONARY STENT SYSTEM

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN ABILITY LEAD

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS SD RENAL PREMOUNTED STENT SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RADIESSE INJECTABLE IMPLANT

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS

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

FDA Pre-Market Approval
FDA Class 3 ·Oncomine Dx Target Test

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·Cordis® PRECISE® Nitinol Stent System

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·Coaptite Injectable Implant

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·REBEL Platinum Chromium Coronary Stent System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS Simplicity Delivery System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, SPhera DR MRI IPG, and Sphera SR MRI IPG

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·WOLVERINE Coronary Cutting Balloon

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·GELSYN-3

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·Heparin_Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System

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

FDA Pre-Market Approval
FDA Class 3 ·CapSure Sense Lead