GDS ENZYMATIC SALICYLATE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

Flexi-Seal PROTECT Fecal Management System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GentleCath Glide Intermittent Urinary Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GentleCath Glide Intermittent Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IMIX PANORAD AND SOMARAD

FDA 510(k)

FDA Class 2 ·Radiology

PANORAD, PANORAD SL

FDA 510(k)

FDA Class 2 ·Radiology

IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K

FDA 510(k)

FDA Class 2 ·Radiology

IMIX INSIGHT X-RAY SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation

FDA 510(k)

FDA Class 2 ·Orthopedic

DIASUS

FDA 510(k)

FDA Class 2 ·Radiology

ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400

FDA 510(k)

FDA Class 2 ·General Hospital

ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS

FDA 510(k)

FDA Class 2 ·Ophthalmic

GUARDIAN HEMOSTASIS VALVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

SurgiCube

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LIFESIGN MI MYOGLOBIN

FDA 510(k)

FDA Class 2 ·Immunology