10,000 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TECNIS 3-Piece Acrylic Monofocal
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA Pre-Market Approval
FDA Class 3
·Vercise Deep Brain Stimulation (DBS) System, Vercise PC Deep Brain Stimulation (DBS) System, and Vercise Gevia Deep Brai
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·SIMPSON CORONARY ATHEROCATH(TM)
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS
Lens, Intraocular, Toric Optics
FDA Pre-Market Approval
FDA Class 3
·TRULIGN TORIC WEB-BASED TORIC CALCULATOR
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Precision Spinal Cord Stimulator {SCS) Systems
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MODEL 283 PULSE GENERATOR MODEL 370 PROGRAMMER
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2800 (PERIMOUNT RSR), 6900P (PERIMOUNT PLUS) AND 3000
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) WAVESCAN WAVEFRONT SYSTEM
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·PARADIGM REAL TIME INSULIN PUMPS, PARADIGM REAL TIME REVEL INSULINPUMPS, GUARDIAN REAL TIME MONITOR.
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·SMARTABLATE SYSTEM
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·DEFLUX
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD)
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·IsoFlex
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·THORATEC VENTRICULAR ASSIST DEVICE
Sealant, Polymerizing
FDA Pre-Market Approval
FDA Class 3
·PROGEL Pleural Air Leak Sealant
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
FDA Pre-Market Approval
FDA Class 3
·Freestyle Libre Flash Glucose Monitoring System
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·SENSAR/TECNIS 1-piece IOL with SmartLOAD Delivery Technology, TECNIS Optiblue 1-Piece IOL with SmartLOAD Delivery Techno
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·iSert Preloaded IOL System, Intraocular Lens - Clarisert