OPTIMA DELIVERY BED (MODELS 33901, 33903, 33902, 33905)

FDA 510(k)

FDA Class 1 ·General Hospital

PM2002 PROLINE, PM2002 PROLINE EC

FDA 510(k)

FDA Class 1 ·Dental

DELFIA TESTTOSTERONE KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DELFIA SHBG KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

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