2,305 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 THERAPY ILLUMINATOR
Ventilator, High Frequency
FDA Pre-Market Approval
FDA Class 3
·3100 HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV)
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·THINPREP(R) 2000 SYSTEM
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·SYNVISC (HYLAN G-F 20
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF (GRAFTSKIN)
Reader, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·THINPREP IMAGING SYSTEM
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·IMPELLA LEFT VENTRICULAR SUPPORT SYSTEM
Biologic Material, Dental
FDA Pre-Market Approval
FDA Class 3
·EMDOGAIN GEL
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Cardinal Health Multifunctional Defibrillation Electrode
Stent, Urethral, Bulbous, Permanent Or Semi-Permanent
FDA Pre-Market Approval
FDA Class 3
·AMS UROLUME ENDOPROSTHESIS
Occluder, Internal Vessel, Temporary
FDA Pre-Market Approval
FDA Class 3
·LEGOO ENDOVASCULAR OCCLUSION GEL
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF (GRAFTSKIN)
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·AMS 800 Artificial Urinary Sphincter
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella CP with SmartAssist System, Impella 5.5 with SmartAssist System
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne CDx
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·ARROW MODEL 3000-16 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE
Ventilator, High Frequency
FDA Pre-Market Approval
FDA Class 3
·Model 3100A/B High Frequency Oscillatory Ventilator
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4