K-ASSAY D-DIMER CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

SAGEMAX Z-BLANK

FDA 510(k)

FDA Class 2 ·Dental

HUMAN C-5 RADIAL IMMUNODIFFUSION KIT

FDA 510(k)

FDA Class 2 ·Immunology

WOLDOFF PRISMATIC BICONCAVE LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

SPACELABS MEDICAL MULTIGAS ANALYZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

LYSUS INFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SLEEPAPP

FDA 510(k)

FDA Class 2 ·Dental

CMV EARLY ANTIGEN TEST

FDA 510(k)

FDA Class 2 ·Microbiology

CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

MODIFIED DUAL LUMEN NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CONNECTING SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRESSURE TRANSDUCER AIRFLOW SENSOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

LUKENS 2-0 BRAIDED SILK SUTURES

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRO-FLOW MULTIPURPOSE CANNULA

FDA 510(k)

FDA Class 2 ·Anesthesiology

EEG CUP ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

DUAL LUMEN NEEDLE (PRODUCT CHANGE)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

K-ASSAY APO B

FDA 510(k)

FDA Class 2 ·Immunology