ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024

FDA 510(k)

FDA Class 2 ·Radiology

PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CATHETER INSERTION TRAY

FDA 510(k)

FDA Class 2 ·General Hospital

BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VERTEX THERMOSENS RIGID

FDA 510(k)

FDA Class 2 ·Dental

SURGICAD(TM) VIEW(TM)

FDA 510(k)

FDA Class 2 ·Radiology

ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ORGEN TEC ANTI-DSDNA ELISA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

MINIBORE STOPCOCK SET

FDA 510(k)

FDA Class 2 ·General Hospital

IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RUSCH BRONCHUS BLOCKER KIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound

FDA 510(k)

FDA Class 2 ·Radiology

Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented

FDA 510(k)

FDA Class 2 ·Anesthesiology

UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR

FDA 510(k)

FDA Class 2 ·General Hospital

ORGENTEC ENASCREEN ELISA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ADVANTA SST GRAFT (>_6MM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

REUSABLE TROCAR WITH SLEEVE (COMMON)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OVER THE NEEDLE SPLITABLE CATHETER ASSEMBLY TYPE 1

FDA 510(k)

FDA Class 2 ·Cardiovascular

Palladium High Flow Therapy System

FDA 510(k)

FDA Class 2 ·Anesthesiology