Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·GARREN GASTRIC BUBBLE

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

FDA Pre-Market Approval

FDA Class 3 ·PROLIEVE THERMODILITATION SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL VASCULAR CLOSURE DEVICE

Continuous Glucose Monitor, Implanted, 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

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

FDA Pre-Market Approval

FDA Class 3 ·PROLIEVE THERMODILATATION 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 HEMOSTATIC PUNCTURE CLOSURE DEVICE

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 DEVICE - 8F AND 6F

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL VASCULAR CLOSURE DEVICE

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

BIOMETRIC SCREW FIXATION CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

ENCORE CLP OFFSET TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 3 ·Orthopedic

THREADED PINS

FDA 510(k)

FDA Class 3 ·Unknown

KM-3 ACETABULAR COMPONENT

FDA 510(k)

FDA Class 3 ·Orthopedic

ELA MEDICAL UNILITH PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular

SUTURELESS MYOCARDIAL PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

THOMPSON TYPE HIP PROTHESIS

FDA 510(k)

FDA Class 3 ·Orthopedic