PLLA PIN

FDA 510(k)

FDA Class 2 ·Orthopedic

ELEKTA OY

FDA 510(k)

FDA Class 2 ·Neurology

INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

CREATININE (ENZYMATIC)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SMART Bun-Yo-Matic X-Ray

FDA 510(k)

FDA Class 2 ·Radiology

UREA/BUN, SCAL, NORTROL, ABTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DATEX AIRWAY MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

PLANNED SOPHIED CLASSIC

FDA 510(k)

FDA Class 2 ·Radiology

SIGMA M

FDA 510(k)

FDA Class 2 ·Dental

INION SPINAL GRAFT CONTAINMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

INION GTR BIODEGRADABLE MEMBRANE SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736

FDA 510(k)

FDA Class 2 ·Orthopedic

Planmed Clarity 2D and Clarity S

FDA 510(k)

FDA Class 2 ·Radiology

Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module

FDA 510(k)

FDA Class 2 ·Ophthalmic

MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214

FDA 510(k)

FDA Class 2 ·Orthopedic

DIXI 2

FDA 510(k)

FDA Class 2 ·Dental

DUET SUTURE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

INION HEXALON BIODEGRADABLE ACL/PCL SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology