830 results · 20ms · Sources: EU EUDAMED, US FDA

Oximeter, Fetal Pulse

FDA Pre-Market Approval
FDA Class 3 ·COROMETRICS MODEL 120 SERIES MATERNAL/FETAL MONITOR W/INTEGRATED FETAL PULSE OXIMETRY

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

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

Device, Hemostasis, Vascular

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

Sensor, Glucose, Implanted, Non-Adjunctive Use

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

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·MISAGO RX SELF-EXPANDING PERIPHERAL STENT SYSTEM, R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT SYSTEM

Kit, Dna Detection, Human Papillomavirus

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

Device, Hemostasis, Vascular

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

Device, Hemostasis, Vascular

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

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·ColoSense®

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval
FDA Class 3 ·QUANTIFERON -TB GOLD

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 PERIPHERAL SELF-EXPANDING STENT SYSTEM

Device, Hemostasis, Vascular

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

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 ·DIGENE HYBRID CAPTURE II HIGH-RISK HPV DNA TEST

Kit, Dna Detection, Human Papillomavirus

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

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·VIDAS TOTAL PSA

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THxID-BRAF kit

Sensor, Glucose, Implanted, Non-Adjunctive Use

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

Kit, Dna Detection, Human Papillomavirus

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