10,000 results · 25ms · Sources: EU EUDAMED, US FDA

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Hancock II™ Bioprosthesis

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·polymacon Soft (Hydrophilic) Extended Wear Contact Lenses

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Bioprosthesis

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Evoke SCS System

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·Medtronic Attain Ability Model 4196 Lead

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS LD MONORAIL ILIAC PREMOUNTED STENT SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·JUVEDERM HYALURONATE GEL IMPLANTS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM

Stent, Coronary

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VIRTUOSO

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·KAPPA 400

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·INCEPTA, ENERGEN, PUNCTUA, COGNIS, LIVIAN

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·BARD LIFESTENT VASCULAR STENT SYSTEMS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·COMPLETE SE VASCULAR STENT SYSTEM-SFA AND PPA

Gastric Emptying Breath Test

FDA Pre-Market Approval
FDA Class 3 ·13C-Spirulina Gastric Emptying Breath Test (GEBT)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·Guardian Sensor 3

Agent, Occluding, Vascular, Permanent

FDA Pre-Market Approval
FDA Class 3 ·VenaSeal™ Closure System