1,635 results
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19ms
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Sources: EU EUDAMED, US FDA
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Classification: FDA Class 3
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Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·SENSAR SOFT ACRYLIC UV LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·CRYOCOR CRYOABLATION SYSTEM
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RESTYLANE SILK SPHAL
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·Restylane® Kysse
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·Juvéderm Volux XC
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·JUVEDERM VOLLURE XC
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·INTELLANAV STABLEPOINT Ablation Catheter & Force Sensing System on the RHYTHMIA HDX Mapping System
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ROTAPRO Rotational Atherectomy System
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·CraniSeal Dural Sealant
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Implant, Dermal, For Aesthetic Use In The Hands
FDA Pre-Market Approval
FDA Class 3
·Restylane Lyft with Lidocaine
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·JUVEDERM VOLBELLA XC