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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Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·DISCOVISC Ophthalmic Viscosurgical Device
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·FINLINE LEAD FAMILY
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·FreeStyle Libre Pro Flash Glucose Monitoring System
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS(R) TOTAL KNEE SYSTEM
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·CERAMAX CERAMIC HIP SYSTEM
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·SWEET TIP RX/ FLEXTEND LEAD FAMILY
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·INTEGRA® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ENDOTAK LEAD FAMILY
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·FRESHLOOK SPHERICAL, TORIC AND BIFOCAL (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR UP TO 7 DAYS/
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENS)
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
FDA Pre-Market Approval
FDA Class 3
·Freestyle Libre Flash Glucose Monitoring System
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·FreeStyle Libre Pro Flash Glucose Monitoring System
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS
System, Esophageal Pacing
FDA Pre-Market Approval
FDA Class 3
·EXTERNAL PULSE GENERATOR MODEL 2A, TAPSCOPE 500 SERIES ESOPHAGEAL STETHOSCOPE AND PACING CATHETER, TAPSCOPE 210 ESOPHAGR
Stent Graft, Infrapopliteal, Venous Arterialization
FDA Pre-Market Approval
FDA Class 3
·LimFlow System
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 3
·CervicalStim
Barrier, Adhesion, Cardiovascular
FDA Pre-Market Approval
FDA Class 3
·REPEL-CV BIORESORBABLE ADHESION BARRIER