3,777 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Wearable Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·LIFEVEST WEARABLE DEFIBRILLATOR
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·One-Piece IOLs with Daisy-Wheel packaging configuration, TENIC iTEC Preloaded Delivery System, TECNIS SmartLOAD Delivery
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
FDA Pre-Market Approval
FDA Class 3
·PROSTATRON
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·BX VELOCITY STENT ON RAPTORRAIL STENT DELIVERY SYSTEM
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·SIENTRA SILICONE GEL BREAST IMPLANTS
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·Sientra Silicone Gel Breast Implants
Joint, Temporomandibular, Implant
FDA Pre-Market Approval
FDA Class 3
·TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·SWIFT(TM) 1CT SERIES 4040 DEFIBRILLATION LEAD
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MENTOR MEMORYSHAPE BREAST IMPLANTS
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF (GRAFTSKIN)
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·Minitouch 3.8 Era System (Minitouch System)
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·EluNIR Ridaforolimus Eluting Coronary Stent System
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·Aptima HBV Quant Assay
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·Arctic Front Advance and Arctic Front Advance Pro
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·TactiFlex Ablation CatTactiFlex Ablation Catheter, Sensor Enabledheter, Sensor Enabled, TactiSys Quartz Equipment,
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·Arctic Front and Arctic Front Advance Cardiac CryoAlbation Catheters
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·TACTICATH QUARTZ SET
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·TactiCath Contact Force Ablation Catheter, Sensor Enabled
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·Arctic Front Advance Pro Cryoballoon Catheter