2,295 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Barrier, Adhesion, Cardiovascular
FDA Pre-Market Approval
FDA Class 3
·REPEL-CV
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·Bulkamid Urethral Bulking System
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MEMORY LENS(R) UV ABSORBING HYDROPHILIC POSTERIOR CHAMBER IOL
Laparoscopic Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·ADIANA PERMANENT CONTRACEPTION SYSTEM
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·HYDRELLE
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·ORTHOVISC
Laparoscopic Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·FALOPE-RING BAND AND APPLICATOR SYSTEMS
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·SYNVISC(HYLAN G-F 20)
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·Bulkamid Urethral Bulking System
Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·ENROUTE Transcarotid Stent System
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·AED 3 defibrillator
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·INFUSAID REFILL KIT
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·INFUSAID MODEL 400 IMPLANTABLE INFUSION PUMP
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·Axonics Sacral Neuromodulation System
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·Organ Care System (OCS) Liver
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP