969 results · 22ms · Sources: EU EUDAMED, US FDA

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