549 results · 19ms · Sources: EU EUDAMED, US FDA

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval
FDA Class 3 ·QuantiFERON- TB Gold Test and QuantiFERON- TB Gold Plus Test

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·MISAGO® RX Self-expanding Peripheral Stent

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·Angio Seal Vascular Closure Device

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·Misago RX Self-expanding Peripheral Stent

Placental Alpha Microglobulin-1 Immunoassay

FDA Pre-Market Approval
FDA Class 3 ·PartoSure test

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·BD Onclarity™ HPV Assay

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·Onclarity HPV Assay

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·ANGIO-SEAL VASCULAR CLOSURE DEVICE

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·PROLIEVE THERMODILATATION SYSTEM

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense Continuous Glucose Monitoring System

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & HIGH RISK HPV DNA TEST

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·Misago RX Self-expanding Peripheral Stent

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·MISAGO® RX Self-expanding Peripheral Stent

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor , Eversense Insertion Tools, Evers

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·ANGIO-SEAL VASCULAR CLOSURE DEVICE

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense® E3 Continuous Glucose Monitoring (CGM) System

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·8F ANGIO-SEAL VASCULAR CLOSURE DEVICE

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·Misago RX Self-expanding Peripheral Stent