969 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·Aptima HPV 16 18/45 Genotype Assay
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·ReShape Lap-Band System
Analyzer, Diagnostic, Fiber Optic (Colon)
FDA Pre-Market Approval
FDA Class 3
·OPTICAL BIOPSY(TM) SYSTEM
Stent Graft, Infrapopliteal, Venous Arterialization
FDA Pre-Market Approval
FDA Class 3
·LimFlow System
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·DEXCOM CGM
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·CHILLI COOLED RPM CATHETER
System, Oxygen, Aqueous
FDA Pre-Market Approval
FDA Class 3
·TherOx Downstream System
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Biofinity Toric
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Biofinity Sphere
Stent Graft, Infrapopliteal, Venous Arterialization
FDA Pre-Market Approval
FDA Class 3
·LimFlow System
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)
Contrast Media, Ultrasound
FDA Pre-Market Approval
FDA Class 3
·ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Biofinity (comfilcon A) Soft (Hydrophilic) Extended Wear Contact Lenses
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·DEXCOM SEVEN PLUS SYSTEM
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·CONFILCON A SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM