211 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·MiniMed 630G System with SmartGuard
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim Therapy System, Verify Evaluation System
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim Therapy System, Verify Evaluation System
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·IntellaNav Ol
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·PyloPlus UBT System
System, Identification, Contact Lens
FDA Pre-Market Approval
FDA Class 3
·SOFTMARK
Cross-Sectional Mammographic Xray System
FDA Pre-Market Approval
FDA Class 3
·KONING BREAST CT (MODEL CBCT1000)
Cross-Sectional Mammographic Xray System
FDA Pre-Market Approval
FDA Class 3
·Koning Breast CT, KBCT (Model CBCT1000)
Cross-Sectional Mammographic Xray System
FDA Pre-Market Approval
FDA Class 3
·Koning Breast CT, KBCT
System, Identification, Contact Lens
FDA Pre-Market Approval
FDA Class 3
·SOFTMARK
Cross-Sectional Mammographic Xray System
FDA Pre-Market Approval
FDA Class 3
·KONING BREAST CT (MODEL CBCT 1000)
System, Identification, Contact Lens
FDA Pre-Market Approval
FDA Class 3
·SOFTMARK
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·Sculptra, Sculptra Aesthetic
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 3
·OL 1000, OL 1000 SC, AND SPINALOGIC BONE GROWTH STIMULATORS
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·PyloPlus® UBT System
Transcervical Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·CONCEPTUS ESSURE SYSTEM
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
FDA Pre-Market Approval
FDA Class 3
·PROLIEVE THERMODILITATION SYSTEM
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
FDA Pre-Market Approval
FDA Class 3
·PROLIEVE THERMODILITATION SYSTEM