MRJ EXTENDED

FDA 510(k)

FDA Class 2 ·Radiology

CLUED UP MULTIPURPOSE SOLUTION- NO RUB

FDA 510(k)

FDA Class 2 ·Ophthalmic

ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO AURORA MRI SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

AURORA MR-GUIDED INTERVENTIONAL SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

V.A.D. ACCESS KIT

FDA 510(k)

FDA Class 2 ·General Hospital

HAYFEVER HELMET

FDA 510(k)

FDA Class 2 ·General Hospital

MR INSPIRE WITH EXTENDED KIT

FDA 510(k)

FDA Class 2 ·Radiology

HEMAPROMPT

FDA 510(k)

FDA Class 2 ·Hematology

LUBREASE FEMALE LUBRICANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Philips Avent Single/Double electric breast pump Advanced

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FUJINON COLONOSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Fujifilm Diathermic Slitter (FlushKnife)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006

FDA 510(k)

FDA Class 2 ·Cardiovascular

SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7

FDA 510(k)

FDA Class 2 ·Physical Medicine