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

DuraSheath Introducer Sheath System

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

QM300 CALIBRATOR F PACK

FDA 510(k)

FDA Class 2 ·Immunology

EDGE ORTHOPAEDICS BITE COMPRESSION SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

PROTECTAIDE PERSONAL PROTECTION PACK NO. 24592

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NUCOR COMPOSITE RESTORATIVE MATERIAL PASTE/LIQUID

FDA 510(k)

FDA Class 2 ·Dental

QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK

FDA 510(k)

FDA Class 2 ·Immunology

PROTECTAIDE CPR PROTECTION PACK NO. 22100

FDA 510(k)

FDA Class 2 ·Anesthesiology

QM300 C3 ANTIBODY PACK

FDA 510(k)

FDA Class 2 ·Immunology

MODIFIED QM300 RHEUMATOID FACTOR TEST

FDA 510(k)

FDA Class 2 ·Immunology

KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST

FDA 510(k)

FDA Class 2 ·Immunology

BTL-4000

FDA 510(k)

FDA Class 2 ·Physical Medicine