2,258 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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System, Laser, Photodynamic Therapy
FDA Pre-Market Approval
FDA Class 3
·BLU-U BLUE LIGHT PHOTODYNAMIC THERAPHY ILLUMINATOR
Biologic Material, Dental
FDA Pre-Market Approval
FDA Class 3
·Straumann Emdogain
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·AED 3 Defibrillator with Uni-Padz
Laparoscopic Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·Falope-Ring® Band and Applicator Systems
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS Ambicor Inflatable Penile Prosthesis
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
FDA Pre-Market Approval
FDA Class 3
·CORMET HIP RESURFACING SYSTEM
Stent, Urethral, Prostatic, Semi-Permanent
FDA Pre-Market Approval
FDA Class 3
·THE SPANNER TEMPORARY PROSTATIC STENT AND ACCESSORIES
Ventilator, High Frequency
FDA Pre-Market Approval
FDA Class 3
·MODEL 3100/3100A HIGH FREQUENCY OCILLATORY VENT.
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·MODEL 3000 CONSTANT FLOW IMPLANTABLE INFUSION PUMP WITH BOLUS SAFETY VALVE
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB/ENDOAVITENE
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF
Stent, Urethral, Bulbous, Permanent Or Semi-Permanent
FDA Pre-Market Approval
FDA Class 3
·UROLUME(R) ENDOPROSTHESIS
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF(R) (GRAFTSKIN)
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·ELEVESS
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne Liquid CDx (F1 Liquid CDx)
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·IMPELLA 2.5 SYSTEM