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

BTE HEARING AID CLUB MODEL ST70

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

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

BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

C.CAM

FDA 510(k)

FDA Class 2 ·Radiology

Frova Intubating Introducer

FDA 510(k)

FDA Class 2 ·Anesthesiology

Ambu® aScope™ Gastro, Ambu® aBox™2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TYPE 9210 S/ECG

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONTACT DETACH

FDA 510(k)

FDA Class 2 ·General Hospital

ELPHA 2000

FDA 510(k)

FDA Class 2 ·Physical Medicine

POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIASTAT ANTI-LA (SS-B)

FDA 510(k)

FDA Class 2 ·Immunology

3Shape Implant Studio

FDA 510(k)

FDA Class 2 ·Radiology

DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED

FDA 510(k)

FDA Class 2 ·Radiology

CARDIOMD-AC

FDA 510(k)

FDA Class 2 ·Radiology