SUSTAINED PHONATION

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

VERSION 3 OPERATING SYSTEM SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

3D TOF ANGIOGRAPHY MEASURING FUNCTION

FDA 510(k)

FDA Class 2 ·Radiology

SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

ITO ACUPUNCTURE NEEDLES

FDA 510(k)

FDA Class 2 ·General Hospital

GUGLIELMI DETACHABLE (GDC)

FDA 510(k)

FDA Class 2 ·Neurology

MARCO SURGISCOPE OPERATION MICROSCOPES

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

BODY FAT ANALYZER, MODEL HBF-306

FDA 510(k)

FDA Class 2 ·Cardiovascular

MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR

FDA 510(k)

FDA Class 1 ·Ophthalmic

EMBA Hourglass Peripheral Embolization Device (PED)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES

FDA 510(k)

FDA Class 2 ·Orthopedic

ERBE ESU MODEL VIO 100 C WITH ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PIEDMONT 70 (CH-35)

FDA 510(k)

FDA Class 2 ·Dental

VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER

FDA 510(k)

FDA Class 2 ·Ophthalmic

NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER

FDA 510(k)

FDA Class 2 ·General Hospital

ORTHOFIX TIBIAL NAILING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

IRIS BILATERAL TMJ

FDA 510(k)

FDA Class 2 ·Radiology

CARESIDE CALCIUM, ORIGINAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry