10,000 results
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32ms
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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
·CARELINK MONITORS 2490H, AND MODEL 2020A CARDIOSIGHT READER
Applicator, Hyperthermia, Superficial, Rf/Microwave
FDA Pre-Market Approval
FDA Class 3
·HYPERTHERMIA SYSTEM 100 A
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·ACTIVARC AND ACTIVAPC
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RADIESSE INJECTABLE IMPLANT
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Revo MRI, EnRhythm MRI
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime IDH1
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
FDA Pre-Market Approval
FDA Class 3
·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC INSYNC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MODEL 7272
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
FDA Pre-Market Approval
FDA Class 3
·PROLIEVE THERMODILATATION SYSTEM CATHETER AND HEAT EXCHANGER
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM AND THE ORCHESTRA PROGRAMMER
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·PRIZM AND VITALITY FAMILY
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·EDWARDS PRIMA PLUS STENTLESS BIOPROTHESIS, MODEL 2500P
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·CONCERTO II/CONSULTA/MAXIMO II CRT-DS
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·EVIA/ENTOVIS & VARIOUS MODELS OF PHILOS/PHILOS2 & CYLOS PULSE GENERATORS; SELOX JT/ST/SR, DEXTRUS, SELTROX S, SLX
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·SYNCHROMED II PROGRAMMABLE DRUG PUMP
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·SELUTE PICOTIP STEROID ELUTING LEAD
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Platinium, Paradym RF, RF VR, RF DR, Intensia CRT-Ds
Prosthesis, Spinous Process Spacer/Plate
FDA Pre-Market Approval
FDA Class 3
·SUPERION INDIRECT DECOMPRESSION SYSTEM
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS TOTAL KNEE SYSTEM