2,762 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) WITH INHIBIZONE TREATMENT
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·Atellica IM CPSA Assay
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne CDx
System, Hemodynamic, Implantable
FDA Pre-Market Approval
FDA Class 3
·CardioMEMS HF System
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone, AMS Ambicor Inflatable Pe
Transurethral Occlusion Insert, Urinary Incontinence-Control, Female
FDA Pre-Market Approval
FDA Class 3
·RELIANCE URINARY CONTROL INSERT & SIZING DEVICE
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·CERVISTA HPV 16/18
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
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·ON-X PROSTHETIC HEART VALVE
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·HYDRELLE
System, Laser, Transmyocardial Revascularization
FDA Pre-Market Approval
FDA Class 3
·TMR2000 HOLMIUM LASER SYSTEM
Intravascular Radiation Delivery System
FDA Pre-Market Approval
FDA Class 3
·NOVOSTE BETA-CATH 3.5F SYSTEM
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