COLLAGEN SHIELD FOR ACUTE CARE

FDA 510(k)

FDA Class 1 ·Ophthalmic

ULTRATUFF CUT RESISTANT GLOVE LINER

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

HPM-6000

FDA 510(k)

FDA Class 2 ·Physical Medicine

Exilite

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)

FDA 510(k)

FDA Class 2 ·Anesthesiology

NAVIPLAN - CT Planning Software for Total Hip Replacement

FDA 510(k)

FDA Class 2 ·Radiology

MCCOY'S 5A M9270 W/L-GLUTAMINE & W/O PHENOL RED &

FDA 510(k)

FDA Class 1 ·Hematology

MEM D-VAL MODIF. M7395, W/EBSS, L-GLUTAMINE, D-VAL

FDA 510(k)

FDA Class 1 ·Hematology

DuraSheath Introducer Sheath System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES &

FDA 510(k)

FDA Class 1 ·Hematology

SILICONE TISSUE/INFLATABLE TISSUE EXPANDER

FDA 510(k)

FDA Unclassified ·Unknown

QM2/QM300 BUFFER AND DILUENT PACK

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316

FDA 510(k)

FDA Class 2 ·Immunology

Leaf Photocoagulator

FDA 510(k)

FDA Class 2 ·Ophthalmic

NASOPORE EAR, MODELS ND04, ND05

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITEK 2 AST - YEAST FLUCONAZOLE

FDA 510(k)

FDA Class 2 ·Microbiology

Catapult Guide Sheath

FDA 510(k)

FDA Class 2 ·Cardiovascular

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)

FDA Class 2 ·Microbiology

Intelli-C

FDA 510(k)

FDA Class 2 ·Radiology