ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA.

FDA 510(k)

FDA Class 2 ·Microbiology

ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE

FDA 510(k)

FDA Class 2 ·Cardiovascular

DPX BONE DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology

HYGEIA URINE PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VENTICIS II

FDA 510(k)

FDA Class 2 ·Radiology

SUTTER FINGER JOINT PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

SPINETRAK

FDA 510(k)

FDA Class 2 ·Physical Medicine

TAMPAX TAMPON

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MUREX (TM), SUDS (TM), HCG ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STERILIZATION INDICATOR FOR FLASH STERILIZATION

FDA 510(k)

FDA Class 2 ·General Hospital

DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALL

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMMUNOCCULT-LXI

FDA 510(k)

FDA Class 2 ·Hematology

BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS

FDA 510(k)

FDA Class 2 ·Anesthesiology

IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

DOUBLE LUMEN CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 10200 PREMATURE INFANT INCUBATOR

FDA 510(k)

FDA Class 2 ·General Hospital

SIM 4000I

FDA 510(k)

FDA Class 2 ·Radiology

WHITESIDE ORTHOLOC II REV POST STAB TOTAL KNEE SY

FDA 510(k)

FDA Class 2 ·Orthopedic

COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM

FDA 510(k)

FDA Class 2 ·Dental