K.D. CHIN IMPLANT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PALACOS R

FDA 510(k)

FDA Class 2 ·Orthopedic

SUDOSCAN

FDA 510(k)

FDA Class 2 ·Neurology

OSTEOPAL

FDA 510(k)

FDA Class 2 ·Orthopedic

FLUID FILLED TEETHER - GEL

FDA 510(k)

FDA Class 2 ·Dental

AUDIOSCREENER OAE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

FLUID FILLED TEETHER

FDA 510(k)

FDA Class 2 ·Dental

AUDIOSCREENER OAE + ABR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

K.D. COLORIMETRIC BLOOD UREA N2 TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

e-SDF

FDA 510(k)

FDA Class 2 ·Dental

Single-use Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Single-Use Surgical Mask Model FE2311B

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ULE-2, MULE-2, HAND ACCESSORY KIT

FDA 510(k)

FDA Class 2 ·Physical Medicine

EMBOTRAP III Revascularization Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

FaceHeart Vitals Software Development Kit (FH vitals SDK)

FDA 510(k)

FDA Class 2 ·Cardiovascular

FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)

FDA 510(k)

FDA Class 2 ·Anesthesiology

EMBOGUARD Balloon Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMBOTRAP III Revascularization Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

Device, Vascular, For Promoting Embolization

FDA Pre-Market Approval

FDA Class 2 ·MINI BALLOON