PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)

FDA 510(k)

FDA Class 2 ·Dental

X-RAY UNIT, PORTABLE GX-101 AEC

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BACKSTOP AND BACKSTOP INJECTOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

APTOS Threads – Polypropylene Surgical Sutures

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM

FDA 510(k)

FDA Class 2 ·Immunology

PT-MULTI-CALIBRATOR, MODEL OPAT07

FDA 510(k)

FDA Class 2 ·Hematology

SERIES 6600 DIGITAL MOBILE C-ARM

FDA 510(k)

FDA Class 2 ·Radiology

INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)

FDA 510(k)

FDA Class 2 ·Radiology

COMPACT 7600

FDA 510(k)

FDA Class 2 ·Radiology

SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

UROVIEW MODEL 2600

FDA 510(k)

FDA Class 2 ·Radiology

UROVIEW 2800

FDA 510(k)

FDA Class 2 ·Radiology

SCOOTA BUG (MOTORIZED VEHICLE)

FDA 510(k)

FDA Class 2 ·Physical Medicine