BEUDAMED
    3,003 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Lens, Contact, Orthokeratology, Overnight

    FDA Pre-Market Approval
    FDA Class 3 ·Paragon Z CRT (tisilfocon A) Rigid Gas Permeable Contact Lenses in Blue Tint

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·Protégé RX Self-expanding Stent System, Protégé GPS Self-Expanding Peripheral Stent System

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·Protégé™ GPS™ Self-Expanding Peripheral Stent System, and Protégé™ RX Carotid Stent System

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 3100A HIGH FREQUENCY OSCILLATORY VENTILATOR

    Drug-Eluting Sinus Stent

    FDA Pre-Market Approval
    FDA Class 3 ·PROPEL SINUS IMPLANT AND PROPEL MINI SINUS IMPLANT

    Gastric Emptying Breath Test

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

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Prospera SCS System, Resilience Surgical Lead

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·PROMUS Everolimus-Eluting Coronary Stent System

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Ranger Paclitaxel-Coated PTA Balloon Catheter

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·NexGen® LPS-Flex / LPS-Mobile Bearing Knee

    Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

    FDA Pre-Market Approval
    FDA Class 3 ·Et Control

    Lens, Contact, Orthokeratology, Overnight

    FDA Pre-Market Approval
    FDA Class 3 ·PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM

    Catheter, Percutaneous, Long Term, Intraspinal

    FDA Pre-Market Approval
    FDA Class 3 ·PORT-A-CATH(R) INTRASPINAL IMPLANTABLE ACCESS SYST

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·iSert® Pre-loaded System; IPURE Pre-loaded System; PreVue Pre-loaded System

    Lens, Contact, Orthokeratology, Overnight

    FDA Pre-Market Approval
    FDA Class 3 ·Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints

    Lens, Contact, Orthokeratology, Overnight

    FDA Pre-Market Approval
    FDA Class 3 ·Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·STAARVISC II & SHELLGEL SODIUM HYAURONATE