1,516 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Automated Insulin Dosing Device System, Single Hormonal Control
FDA Pre-Market Approval
FDA Class 3
·MiniMed 670G System, MiniMed 770G System
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·SMARTVIEW
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·SMARTVIEW
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·PARADYM/PARADYM RF CRT-D
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·SAPIEN 3 Ultra transcatheter heart valve
Wearable Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·LIFEVEST (WCD 3000S) WEARABLE DEFIBRILLATOR
Wearable Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·LIFEVEST WEARABLE DEFIBRILLATOR
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·POSTERIOR CHAMBER IOL'S
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·PARADIGM REAL TIME INSULIN PUMP, PARADIGN REAL TIME REVEL INSULIN PUMP
Cancer-Related Germline Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·BRACAnalysis CDx
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICES
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·SOLOX VDD PACING LEAD
Intraocular Pressure Lowering Implant
FDA Pre-Market Approval
FDA Class 3
·Glaukos iStent Trabecular Micro-Bypass Stent System
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·Alinity m HBV
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·VENTAK PRX MINI
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·Axonics Sacral Neuromodulation System
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·VENTAK
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·PROMETRA PROGRAMMABLE IMPLANTABLE PUMP
Bronchial Thermoplasty System
FDA Pre-Market Approval
FDA Class 3
·Alair Bronchial Thermoplasty Catheter
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·DERMAGRAFT-TC(TM)