ULTRASONIC SCALER

FDA 510(k)

FDA Class 2 ·Dental

Light based hair removal device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SIGMA ELITE

FDA 510(k)

FDA Class 2 ·Anesthesiology

TiLink-P Joint Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

Synxess Neurovascular Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

VISION SYSTEM UPPER G.I. EXDOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MICROAIR PUP

FDA 510(k)

FDA Class 2 ·Physical Medicine

ROSA Bracket

FDA 510(k)

FDA Class 2 ·Dental

gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Orthodontic Fixation Screw [Smart Anchor Miniscrew]

FDA 510(k)

FDA Class 2 ·Dental

FLUIDIZED AIR BED

FDA 510(k)

FDA Class 2 ·Physical Medicine

MICROAIR TURN-Q

FDA 510(k)

FDA Class 2 ·Physical Medicine

VENUS Bracket, ROSE Bracket

FDA 510(k)

FDA Class 2 ·Dental

MICROAIR FLUIDIZED AIR BED

FDA 510(k)

FDA Class 2 ·Physical Medicine

gentleheel® Adult Incision Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ComfortGuard Surgical Isolation Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MICROAIR 3500

FDA 510(k)

FDA Class 2 ·Physical Medicine

Comfort Guard Mask, level 1, Comfort Guard Mask, level 3

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT

FDA 510(k)

FDA Class 2 ·Dental

Polibond

FDA 510(k)

FDA Class 2 ·Dental