10,000 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·COSMODERM 1 HUMAN-BASED COLLAGEN, COSMODERM 2 HUMAN-BASED COLLAGEN AND COSMOPLAST HUMAN-BASED COLLAGEN
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·Dexcom G5 Mobile Continuous Glucose Monitoring System
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·CELSIUS
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·FreeStyle Libre Pro Flash Glucose Monitoring System
Intracranial Aneurysm Flow Diverter
FDA Pre-Market Approval
FDA Class 3
·Flow Re-Direction Endoluminal Device (FRED®) System, FREDX System
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·ISOFLEX P LEAD FAMILY MODELS 1644T AND 1648T STEROID ELUTING, PASSIVE FIXATION ENDOCARDIAL PACING LEADS
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·PD-L1 IHC 22C3 pharmDx
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·MINIMED 530G INSULIN PUMP
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Fortify, Fortify Assura, Ellipse Family of ICD Devices
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·HANCOCK LOW POROSITY VALVED CONDUIT, MODEL 105
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA Pre-Market Approval
FDA Class 3
·Vercise Deep Brain Stimulation (DBS) Systems
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·SILICON ELASTOMERIC POSTERIOR CHAMBER INTRAOCULAR
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·AUTIMA (TM) MODEL 2251,& 2600
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·META II MODEL 1204 CARDIAC PACING SYSTEM
Stent, Renal
FDA Pre-Market Approval
FDA Class 3
·RX Herculink Elite Renal Stent System
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BIOFINITY XR TORIC
Device. Laser Peripheral Angioplasty
FDA Pre-Market Approval
FDA Class 3
·TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE
Sealant, Polymerizing
FDA Pre-Market Approval
FDA Class 3
·Progel Pleural Air Leak Sealant (Progel PALS)
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HeartMate II Left Ventricular Assist System