HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

BEI MEDICAL SYSTEMS' SMOKE EVACUATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AEI DR. TERAUCHI ULTRASONIC TIPS

FDA 510(k)

FDA Class 2 ·Dental

PACSMATE MMD-3213M MONITOR

FDA 510(k)

FDA Class 2 ·Radiology

PACSMATE MMD-5201M MONITOR

FDA 510(k)

FDA Class 2 ·Radiology

PACSMATE, MODEL MMD-4300C/MMD-4300CX

FDA 510(k)

FDA Class 2 ·Radiology

MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BEI MEDICAL SYSTEMS MG-1000HS MONOPOLAR GENERATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

BICART

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRISMASATE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Hysteroscope System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay

FDA 510(k)

FDA Class 2 ·Immunology

Vitrea View

FDA 510(k)

FDA Class 2 ·Radiology

Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Clear Aligner

FDA 510(k)

FDA Class 2 ·Dental

KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

FDA 510(k)

FDA Class 2 ·Immunology

DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay

FDA 510(k)

FDA Class 2 ·Immunology

GuideMia Ortho+

FDA 510(k)

FDA Class 2 ·Dental