3,089 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Stent, Iliac Vein
FDA Pre-Market Approval
FDA Class 3
·Abre Venous Self-expanding Stent System
Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia
FDA Pre-Market Approval
FDA Class 3
·Optilume BPH Catheter System
Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant
FDA Pre-Market Approval
FDA Class 3
·Cartiva SCI reusable instrumentation
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·BreathTek UBT for H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·OSTEONICS ABC SYSTEM AND TRIDENT SYSTEM
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Pearl Vision Monthly (confilcon A) Soft (Hydriohilic) Contact Lenses , Pearle Vision Monthly for Astigmatism (comfilcon
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·PROMOTE ACCEL CRT-D
Bronchial Thermoplasty System
FDA Pre-Market Approval
FDA Class 3
·ALAIR BRONCHIAL THERMOPLASTY SYSTEM
Stent, Renal
FDA Pre-Market Approval
FDA Class 3
·FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·SCULPTRA AESTHETIC
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·Genesys HTA System
Mitral Valve Repair Devices
FDA Pre-Market Approval
FDA Class 3
·PASCAL Precision Transcatheter Valve Repair System
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·RESONATE HF, RESONATE EL, MOMENTUM EL, VIGILIANT EL, PERCIVA HF, PERCIVA
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE
Stent Graft, Bypass, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·DETOUR System
Stent, Iliac
FDA Pre-Market Approval
FDA Class 3
·EXPRESS LD ILIAC OVER-THE-WIRE PREMOUNTED STENT SYSTEM
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·R3 Delta Ceramic Hip System
Mitral Valve Repair Devices
FDA Pre-Market Approval
FDA Class 3
·MITRACLIP CLIP DELIVERY SYSTEM
Wearable Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 3000, 3100, 4000.