Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Elecsys Anti-HCV Immunoassay

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Elecsys Anti-HCV II

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Elecsys Anti-HCV Immunoassay

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Elecsys Anti-HCV Immunoassay

Procedure face mask (Model: KKF-2A)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)

FDA 510(k)

FDA Class 2 ·Radiology

Medical mask (Model: KKF-1A)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)

FDA 510(k)

FDA Class 2 ·Radiology

Infrared Thermometer, Breeze model

FDA 510(k)

FDA Class 2 ·General Hospital

eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S)

FDA 510(k)

FDA Class 2 ·Radiology

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER

FULL CARE Disposable PVC Nelaton Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Absorbable Cranial Flap Fixation System

FDA 510(k)

FDA Class 2 ·Neurology

Longterm NPWT Foam Dressing Kit

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Medical Disposable Sterile Needle Electrode

FDA 510(k)

FDA Class 2 ·Neurology

Fingertip Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CPR Face Shield

FDA 510(k)

FDA Class 2 ·Anesthesiology

Surgical Gown, Model: surgical gown-hp-3

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery