DIBS (Digital Indirect Bonding System)

FDA 510(k)

FDA Class 2 ·Dental

Agility Symmetric™ Total Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

Wireless Audio System

FDA 510(k)

FDA Class 2 ·Radiology

Hair Laser Headband

FDA 510(k)

FDA Class 2 ·Physical Medicine

FYRELINK

FDA 510(k)

FDA Class 2 ·Radiology

ENTRACARE GASTROSTOMY FEEDING TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SILIMED MALAR IMPLANT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EVEREST SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CoreLink Navigation Instruments

FDA 510(k)

FDA Class 2 ·Neurology

CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001

FDA 510(k)

FDA Class 2 ·Immunology

CloudTMS Edge for OCD

FDA 510(k)

FDA Class 2 ·Neurology

Remedy Acetabular Cup

FDA 510(k)

FDA Class 2 ·Orthopedic

SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

AIRCAST VENAFLOW ELITE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

ProFlex CO2 Laser Fiber

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Aqueduct 100 Cervical Dilator

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LANX ANTERIOR CERVIAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Neurosoft TMS (also CloudTMS)

FDA 510(k)

FDA Class 2 ·Neurology

Temporary Fixation Pins

FDA 510(k)

FDA Class 2 ·Orthopedic

MTS225 and MTS300 Multiple Tray Sterilization Systems

FDA 510(k)

FDA Class 2 ·General Hospital