Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HC2 STSTEM SOFTWARE

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HYBRID CAPTURE 2 HPV DNA TEST

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

FDA Pre-Market Approval

FDA Class 3 ·PROLIEVE THERMODILATATION 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 VASCULAR CLOSURE DEVICE STS PLATFORM AND ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM

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

FDA Pre-Market Approval

FDA Class 3 ·CELSION PROLIEVE THERMODILATATION SYSTEM

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert

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

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

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense Continuous Glucose Monitoring System

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

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