Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO SEAL VASCULAR CLOSURE DEVICE

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·MEDITEC OPL3 ND:YAG LASER

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·MEDITEC OPL3 ND:YAG LASER

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Misago RX Self-expanding Peripheral Stent

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense E3 Continuous Glucose Monitoring System

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL STS+,ANGIO-SEAL VIP, AND ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICES

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HYBRID CAPTURE2

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGENE HYBRID CAPTURE CAPTURE 2 (HC2) HIGH 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 HEMOSTATIC PUNCTURE CLOSURE DEVICE

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

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

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·digene Hybird Capture 2 (HC2) HPV DNA Test

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Digene HC2 HPV DNA Test / Digene HC2 High Risk HPV DNA Test

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Angio Seal Vascular Closure Devices

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QuantiFeron TB Gold and QuantiFeron TB Gold Plus

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QUANTIFERON-TB KIT