529 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Reader, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·BD FocalPoint GS Imaging System
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·Adherus AutoSpray Dural Sealant
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·Mara Water Vapor Ablation System
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·BD Totalys MultiProcessor
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN BONE HEALING SYSTEM 2000 ,3000
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·SONIC ACCELERATED FRACTURE HEALING SYSTEM
Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·AEGEA VAPOR SYSTEM, AEGEA VAPOR PROBE PROCEDURE KIT, AEGEA VAPOR GENERATOR AND AEGEA VAPOR GENERATOR ACCESSORY KIT
Digital Breast Tomosynthesis
FDA Pre-Market Approval
FDA Class 3
·Aspire Cristalle Digital Breast Tomosynthesis Option
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·PREPSTAIN SYSTEM
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) AND EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·DUROLANE
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 3
·Exogen Ultrasound Bone Healing System
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·Adherus ET AutoSpray Dural Sealant, NUS-109
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·PREPSTAIN SYSTEM
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·AUTOCYTE PREP SYSTEM
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN ULTRASOUND BONE HEALING SYSTEM