VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL

FDA 510(k)

FDA Class 2 ·Radiology

FALLER STYLET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BD MAX Vaginal Panel

FDA 510(k)

FDA Class 2 ·Microbiology

FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)

FDA 510(k)

FDA Class 2 ·Orthopedic

METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000

FDA 510(k)

FDA Class 2 ·Cardiovascular

VersaCross Connect™ Transseptal Dilator

FDA 510(k)

FDA Class 2 ·Cardiovascular

POLYURETHANE SOLUTION 29% W/W

FDA 510(k)

FDA Class 2 ·Dental

SYNERMED CALCIUM REAGENT KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VISULIZE FACTOR IX ANTIGEN KIT

FDA 510(k)

FDA Class 2 ·Hematology

AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)

FDA 510(k)

FDA Class 2 ·Anesthesiology

7D Surgical System

FDA 510(k)

FDA Class 2 ·Neurology

Efficient Care 3D Planning

FDA 510(k)

FDA Class 2 ·Radiology

THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME

FDA 510(k)

FDA Class 2 ·Immunology

AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRIVE POWER WHEELCHAIRS.

FDA 510(k)

FDA Class 2 ·Physical Medicine

ALLEGRO VIEWING WAND

FDA 510(k)

FDA Class 2 ·Radiology

AVANZA

FDA 510(k)

FDA Class 2 ·Radiology

CREATININE-PO REAGENT KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CANWEST-PREGBLUE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SPY IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

iASSIST Knee System

FDA 510(k)

FDA Class 2 ·Neurology