947 results · 21ms · Sources: EU EUDAMED, US FDA

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·THE CLOSER 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM AND THE CLOSER S 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·PERCLOSE PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSURE SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Nevro Corp Senza™ Spinal Cord Stimulation (SCS) System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·PROSTAR XL 10F PERCUTANEOUS VASCULAR SURGICAL SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·CLOSER XL SUTURE MEDIATED CLOSURE (SMC) SYSTEM

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH

Valve, Pulmonary

FDA Pre-Market Approval
FDA Class 3 ·Zephyr Endobronchial Valve (EBV) System

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM & PERCLOSE AT 6F SUTURE MEDIATED CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·PROSTAR XL 10F PERCUTANEOUS VASCULAR SURGICAL SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·Perclose ProGlide Suture-Mediated Closure (SMC) System; Perclose ProStyle Suture-Mediated Closure and Repair (SMCR) Syst

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Senza HFX iQ System, Senza HFX iQ IPG, HFX Trial Stimulator, HFX iQ Remote, HFX iQ Patient Application

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·Minerva Endometrial Ablation System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·MINERVA ENDOMETRIAL ABLATION SYSTEM

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·Guardant360 CDx

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·Perclose ProStyle Suture-Mediated Closure and Repair System

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·PERCLOSE AT 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM

Valve, Pulmonary

FDA Pre-Market Approval
FDA Class 3 ·Zephyr 5.5 EBV Circle Flange Valve