3,082 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·VARIOUS MODELS OF PACEMAKERS ICS 3000/ EPR 1000 PLUS
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·MODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA Pre-Market Approval
FDA Class 3
·Vercise Genus Deep Brain Stimulation System
Catheter, Percutaneous, Long Term, Intraspinal
FDA Pre-Market Approval
FDA Class 3
·PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ACS: CENTAUR AFP IMMUNOASSAY
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERCARDIAL BIOPRSTHESIS MODELS 7300 AND 7300TFX
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC SYNCHROMED INFUSION SYSTEM
Lens, Multifocal Intraocular
FDA Pre-Market Approval
FDA Class 3
·ARRAY MULTIFOCAL POSTERIOR CHAMBER INTRAOCULAR LENS
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA)
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·PERCLOSE AT 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·ENLITE SENSOR
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·SOF SENSOR
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·DRIVER MX2 CORONARY STENT SYSTEM
Implant, Corneal, Refractive
FDA Pre-Market Approval
FDA Class 3
·Raindrop Near Vision Inlay
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Sequentia LT INS (Model 977005), Vanta INS with AdaptiveStim (Model 977006)
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 3
·ORTHOPAK II BONE GROWTH STIMULATOR
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·Percept PC INS with BrainSense (Model B35200)
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·LADAR VISION TREATMENTS
Glenoid Fossa Prosthesis
FDA Pre-Market Approval
FDA Class 3
·TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM