THERMOFLASH(TM) INFRARED THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

Humelock II Reversible Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

HLS NOETOS SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)

FDA 510(k)

FDA Class 2 ·General Hospital

SpineGuard DSG Zavation Screw System

FDA 510(k)

FDA Class 2 ·Neurology

External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters

FDA 510(k)

FDA Class 2 ·Neurology

COUCH FOR TOTAL BODY RADIATION

FDA 510(k)

FDA Class 2 ·Radiology

LOKKI DT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Alians Fragment Specific

FDA 510(k)

FDA Class 2 ·Orthopedic

PLANET Onco Dose (3.2)

FDA 510(k)

FDA Class 2 ·Radiology

Maestro System (REF100)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STERISPINEPS PEDICLE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

ART-Plan (v.2.2.0)

FDA 510(k)

FDA Class 2 ·Radiology

Perifit

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

HLS UNI EVOLUTION & U-KNEETEC

FDA 510(k)

FDA Class 2 ·Orthopedic

ROSA Spine

FDA 510(k)

FDA Class 2 ·Neurology

HQS Introducer (Model 2064-HQS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE)

FDA 510(k)

FDA Class 2 ·Orthopedic

Bilicocoon™ Phototherapy System

FDA 510(k)

FDA Class 2 ·General Hospital