MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)

FDA 510(k)

FDA Class 2 ·General Hospital

BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST

FDA 510(k)

FDA Class 2 ·Microbiology

RUBELISA (RUBESTAT)

FDA 510(k)

FDA Class 2 ·Microbiology

TERUMO CIRCUIT CONNECTORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD Vaginal Panel

FDA 510(k)

FDA Class 2 ·Microbiology

A4-XLR8 FOAM DRESSING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System

FDA 510(k)

FDA Class 2 ·Microbiology

SI ASCOPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device

FDA 510(k)

FDA Class 2 ·Neurology

IBU, INTEGRATED BRACHY THERAPY UNIT

FDA 510(k)

FDA Class 2 ·Radiology

HYBRID CAPTURE SYSTEM CMV DNA ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

FINECROSS MG CORONARY MICRO-GUIDE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

HYBRID CAPTURE II CT/GC TEST

FDA 510(k)

FDA Class 2 ·Microbiology

I.V.I.D. FLUID ADMINISTRATION SET MARKER

FDA 510(k)

FDA Class 2 ·General Hospital

COPALIS RUBELLA IGM

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (STREP) 0.125 - 4UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

VIELLE LUBRICANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TELESHARE 910

FDA 510(k)

FDA Class 2 ·Radiology