Disposable Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VinDr-Mammo

FDA 510(k)

FDA Class 2 ·Radiology

AOI CRANIAL HELMET

FDA 510(k)

FDA Class 2 ·Neurology

AOI UNIVERSAL ULTRASONIC HANDPIECE

FDA 510(k)

FDA Class 2 ·Ophthalmic

AOI LC-40 PHACOEMULSIFIER

FDA 510(k)

FDA Class 2 ·Ophthalmic

KOI PACHYMETER

FDA 510(k)

FDA Class 2 ·Radiology

KOI BLUE FIELD ENTOPTOSCOPE

FDA 510(k)

FDA Class 2 ·Ophthalmic

COOLBLU CURING LIGHT

FDA 510(k)

FDA Class 2 ·Dental

URISCAN OPTIMA II URINE ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COOLBLU2 DENTAL RESIN CURING DEVICE

FDA 510(k)

FDA Class 2 ·Dental

ASCENDX VCF REDUCTION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Ureteral Stent Systems, Biliary Drainage Catheters

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEOVIEW Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

COMPACT TOUCH Ophthalmic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

In2Bones Kirschner wire

FDA 510(k)

FDA Class 2 ·Orthopedic

QUANTUM® Patient Specific Instrumentation (PSI) System

FDA 510(k)

FDA Class 2 ·Orthopedic

ANDROFLOW - RESPIRATORY RATE MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

I-STETHOS LINK

FDA 510(k)

FDA Class 2 ·Cardiovascular

I.B.S. 2.0 Osteosynthesis screw

FDA 510(k)

FDA Class 2 ·Orthopedic