ACCESS ALERT GAUGE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND

FDA 510(k)

FDA Class 2 ·Radiology

CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100

FDA 510(k)

FDA Class 2 ·General Hospital

NMR-K FUNDUS LASER LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

ACCESS BREAST COIL

FDA 510(k)

FDA Class 2 ·Radiology

S21 OTC Transcutaneous Electrical Nerve Stimulator

FDA 510(k)

FDA Class 2 ·Neurology

K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology

ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Cadwell AmpliScan

FDA 510(k)

FDA Class 2 ·Neurology

ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HOLOPSY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

SonoSite SII Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

INSURE PRO TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

SILICONE CARVING BLOCK

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat