PHILIPS DIGITAL IMAGING OPTION RELEASE 1

FDA 510(k)

FDA Class 2 ·Radiology

LANDERS-FOULKS TEMP. KERATOPROSTHESIS

FDA 510(k)

FDA Class 2 ·Ophthalmic

ACUSON S3000, S2000 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

LYSUS INFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

LEVEL 10 HDI

FDA 510(k)

FDA Class 2 ·Radiology

QUINTON Q-CATH, MODEL 000460

FDA 510(k)

FDA Class 2 ·Cardiovascular

VSM MODELS A & B

FDA 510(k)

FDA Class 2 ·Cardiovascular

K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B

FDA 510(k)

FDA Class 2 ·Immunology

AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A

FDA 510(k)

FDA Class 2 ·Radiology

QUINTON SINGLE LUMEN CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT

FDA 510(k)

FDA Class 2 ·Microbiology

ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

System, Applicator, Radionuclide, Remote Controlled

FDA 510(k)

FDA Class 2 ·Radiology

SeptiCyte LAB

FDA 510(k)

FDA Class 2 ·Microbiology

5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER

FDA 510(k)

FDA Class 2 ·Radiology

MODIFIED ENDOGUIDE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRI-MED 610 CAPNOSTAT GAS ANALYZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

DURASIL I AND DURASIL II

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Cadwell Guardian

FDA 510(k)

FDA Class 2 ·Neurology