MINIGOLD

FDA 510(k)

FDA Class 2 ·Dental

BLUEPHASE 20I

FDA 510(k)

FDA Class 2 ·Dental

D/C CORE MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

SIGMA 8000 AND SIGMA 8002

FDA 510(k)

FDA Class 2 ·General Hospital

FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS

FDA 510(k)

FDA Class 2 ·General Hospital

HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CreoDent Solidex Custom Abutment

FDA 510(k)

FDA Class 2 ·Dental

NAMIC COURNAND STYLE INTRODUCER NEEDLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader

FDA 510(k)

FDA Class 2 ·Microbiology

CLEARFIL MAJESTY FLOW

FDA 510(k)

FDA Class 2 ·Dental

LED HEADLIGHT

FDA 510(k)

FDA Class 2 ·Ophthalmic

VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE

FDA 510(k)

FDA Class 2 ·Cardiovascular

RCRP Flex reagent cartridge

FDA 510(k)

FDA Class 2 ·Immunology

TRACHEAL TUBE, REINFORCED, CUFFED

FDA 510(k)

FDA Class 2 ·Anesthesiology

CALIBRATION VERIFICATION ASSESSMENT (CVA)

FDA 510(k)

FDA Class 2 ·Hematology

BETTER-BLADDER (BB)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO PANAVIA F

FDA 510(k)

FDA Class 2 ·Dental

PELVICFLEXER EXERCISE DEVICE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology