2,258 results · 29ms · Sources: EU EUDAMED, US FDA

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF

Stent, Iliac Vein

FDA Pre-Market Approval
FDA Class 3 ·VICI VENOUS STENT System

Monitor, Intracranial Pressure, Implanted

FDA Pre-Market Approval
FDA Class 3 ·COSMAN ICP TELE-SENSOR(R)

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

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne Liquid CDx (F1LCDx)

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·TMX-2000 BPH THERMOTHERAPY SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·CODMAN 3000 IMPLANTABLE INFUSION PUMP

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 800 ARTIFICAL URINARY SPHINCTER

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS SPHINCTER 800 URINARY PROSTHESIS

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·CODMAN 3000 CONSTANT-FLOW IMPLANTABLE INFUSION PUMP

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·ARTEGRAFT COLLAGEN VASCULAR GRAFT

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·STAARVISC II SODIUM HYALURONATE AND SHELLGEL SODIUM HYALURONATE

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

FDA Pre-Market Approval
FDA Class 3 ·ADVIA CENTAUR HBC TOTAL ASSAY

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·ProCol Vascular Bioprosthesis

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·ADVIA Centaur PSA Readypack Reagents

Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

FDA Pre-Market Approval
FDA Class 3 ·UROLUME URETHRAL STENT

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation System