BIOMET ACCESS SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MAXAN ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU

FDA 510(k)

FDA Class 2 ·General Hospital

ICT

FDA 510(k)

FDA Class 2 ·Radiology

VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T

FDA 510(k)

FDA Class 2 ·Radiology

HyPHo Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RINSE MACHINE KR-4 KIDNEY RINSE-4

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Pantheon Proximal Femur Reconstruction (PFR) System

FDA 510(k)

FDA Class 2 ·Orthopedic

IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)

FDA 510(k)

FDA Class 2 ·Neurology

IMRIS ONCOLOGY PACKAGE

FDA 510(k)

FDA Class 2 ·Radiology

Cystatin C

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIODRIVE MICRO SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OsOpia Synthetic Bone Void Filler

FDA 510(k)

FDA Class 2 ·Dental

LASER MECHANISMS LASER SCANNING SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Chartis Precision Catheter

FDA 510(k)

FDA Class 2 ·Anesthesiology

QUANTIMETRIC PLUS C4 REAGENT KIT

FDA 510(k)

FDA Class 2 ·Immunology

DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

SIMS BLUE LINE ENDOBRONCHIAL TUBE

FDA 510(k)

FDA Class 2 ·Anesthesiology

FIAX COMPLEMENT C4 TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

VIVA EB

FDA 510(k)

FDA Class 2 ·Anesthesiology