3,397 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Reply SR, Reply DR, Esprit SR, Esprit DR
Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
FDA Pre-Market Approval
FDA Class 3
·TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
Agent, Absorbable Hemostatic, Non-Collagen Based
FDA Pre-Market Approval
FDA Class 3
·Arista AH Absorbable Hemostat
Prosthesis, Breast, Inflatable, Internal, Saline
FDA Pre-Market Approval
FDA Class 3
·SALINE-FILLED BREAST IMPLANTS
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
FDA Pre-Market Approval
FDA Class 3
·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses
Lipoprotein, Low Density, Removal
FDA Pre-Market Approval
FDA Class 3
·LIPOSORBER LA-15 System
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·FLOSEAL HEMOSTATIC MATRIX
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN 2000+ BONE HEALING SYSTEM
Transcervical Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·CONCEPTUS ESSURE SYSTEM
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·Attain StarFix Lead
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·SelectSecure Lead
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·Sprint Quattro Lead Models 6935, 6944, 6947
Agent, Injectable, Embolic
FDA Pre-Market Approval
FDA Class 3
·Onyx Liquid Embolic System
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·ACUITY X4 Lead Models 4671, 4672, 4674, 4675, 4677, 4678
Agent, Absorbable Hemostatic, Non-Collagen Based
FDA Pre-Market Approval
FDA Class 3
·SURGICEL® ORIGINAL Absorbable Hemostat, SURGICEL® NU-KNIT Absorbable Hemostat, SURGICEL® SNOW Absorbable Hemostat
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·INTERSTIM IMPLANTABLE NEUROSTIMULATORS
Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Sapien 3 - Transcatheter Heart Valve and Accessories
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
FDA Pre-Market Approval
FDA Class 3
·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear