MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®

FDA 510(k)

FDA Class 2 ·General Hospital

PRIMUS HEARING INSTRUMENT TEST UNIT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AT235

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Dextramer CMV Kit

FDA 510(k)

FDA Class 2 ·Hematology

ULTRASOUND SCANNER TYPE 2102

FDA 510(k)

FDA Class 2 ·Radiology

Hydrozid

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MAGPRO, MODEL R30

FDA 510(k)

FDA Class 2 ·Neurology

aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ULTRASOUND SCANNER PRO FOCUS 2202

FDA 510(k)

FDA Class 2 ·Radiology

Elos Accurate Customized Abutment

FDA 510(k)

FDA Class 2 ·Dental

Lunderquist Extra Stiff Wire Guide

FDA 510(k)

FDA Class 2 ·Cardiovascular

TCM40 MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS

FDA 510(k)

FDA Class 2 ·General Hospital

Ultrasound Scanner System bk2300

FDA 510(k)

FDA Class 2 ·Radiology

MagVita TMS Therapy System

FDA 510(k)

FDA Class 2 ·Neurology

Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™ 2 Advance

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology