9,662 results · 40ms · Sources: EU EUDAMED, US FDA

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Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·ACS TX2000 VP CORONARY DILITATION CATHETER

Glue, Surgical, Arteries

FDA Pre-Market Approval
FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI Pacemakers

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·ANGIOLINK VASCULAR CLOSURE SYSTEM

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·INVENIA ABUS- AUTOMATED BREAST ULTRASOUND SYSTEM

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·VNS Therapy System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·CoreValve Evolut R System, CoreValve Evolut PRO and Wvolut PRO+ Transcatheter Aortic Valves (TAV)

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Libre 14-day Flash Glucose Monitoring System

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·ACX RX COMET VP CORONARY DILATATION CATHETER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Precision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal Toric (serafilcon A) Soft Conta

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Revanesse Versa 1.0 mL, Revanesse Versa 1.2 mL, Revanesse Versa + with Lidocaine 1.0 mL, Revanesse Versa + with Lidocain

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval
FDA Class 3 ·RAPID FFN FOR THE TLIIQ SYSTEM

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·Oxford Partial Knee System - tibial tray and femoral components

Bone Cement

FDA Pre-Market Approval
FDA Class 2 ·CMW BONE CEMENT, CMW 1, CMW 1 RADIOPAQUE, CMW 2, AND CMW 3 BONE CEMENTS.

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·BLAZER II CARDIAC ABLATION CATHETER AND STEEROCATH-T CARDIAC ABLATION CATHETER

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

FDA Pre-Market Approval
FDA Class 3 ·UROLOGIC TARGIS SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·LIVEWIRE TC AND SAFIRE ABLATION CATHETERS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·IsoMed Infusion System