2,328 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Endotak Reliance IS-1 Lead Family, Endotak Reliance IS4 Lead Family, Reliance 4-Front Lead Family
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·Fineline ll Lead Family
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Acuity Spiral Lead Family, Acuity X4 Lead Family
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·NUCLEUS COCHLEAR IMPLANT SYSTEM
Mitral Valve Repair Devices
FDA Pre-Market Approval
FDA Class 3
·MITRACLIP CLIP DELIVERY SYSTEM, MITRACLIP STEERABLE GUIDE CATHETER
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·SPRINT QUATTRO LEAD
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Ingevity Lead Family
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·REBEL MONORAIL AND OVER-THE-WIRE PLATINUM CHROMIUM CORONARY STENT SYSTEM
Mr-Guided Focused Ultrasound System
FDA Pre-Market Approval
FDA Class 3
·Exablate Model 400 Type 1.0 & Type 1.1, Exablate Transcranial MRgFUS, Exablate Neuro, Exablate TcMRgFUS, Exablate Neurav
Bronchial Thermoplasty System
FDA Pre-Market Approval
FDA Class 3
·ALAIR BRONCHIAL THERMOPLASTY SYSTEM
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HeartMate 3 Left Ventricular Assist System (LVAS)
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HeartMate ll Left Ventricular Assist System (LVAS)
Mr-Guided Focused Ultrasound System
FDA Pre-Market Approval
FDA Class 3
·Exablate Model 4000 System
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES
Implanted Brain Stimulator For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·NEUROPACE RNS SYSTEM
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·EVIA FAMILY OF PACEMAKERS
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·Elecsys free PSA Test System
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·Trident Ceramic System