2,328 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·INTERSTIM
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Therapy Cool Path Ablation Catheter
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·DEXCOM SEVEN PLUS SYSTEM
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·Gore Viabahn Endoprosthesis and Gore Viabahn Endoprosthesis with Heparin Bioactive Surface
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MAXIMO II DF4 CRT-D, MAXIMO II DF4 ICD, MAXIMO II ICD, PROTECTA DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA XT
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·SYNCHROMED INFUSION SYSTEM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Atellica IM Hepatitis B orfe IgM (aHBcM) Assay
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Amplia MRI CRT-D DTMB1D4; Amplia MRI Quad CRT-D DTMB1QQ; Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·Axonics Sacral Neuromodulation (SNM) System
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·JUVEDERM HYALURONATE GEL IMPLANTS
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·STAAR SURGICAL COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·EXPRESS 2 MONORAIL AND OVER THE WIRE
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·INTERSTIM THERAPY SYSTEM
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·VERIFLEX CORONARY STENT SYSTEM
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·INTERSTIM THERAPY SYSTEM
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·CHILLI II COOLED ABLATION CATHETER AND CABLE
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·CapSure SP Novus Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead