SCUBA SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ILLUMINA 25 CO2 LASER SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

XIVE DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)

FDA 510(k)

FDA Class 2 ·Anesthesiology

TERM GUARD II DEVICE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

KARL STORZ Bipolar Resectoscopes with HF Cable

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MAXIBOND

FDA 510(k)

FDA Class 2 ·Dental

HEART NEBULIZER FLOWMETER ADAPTOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

ClearPoint System

FDA 510(k)

FDA Class 2 ·Neurology

ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX)

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMPERVA BOND

FDA 510(k)

FDA Class 2 ·Dental

HEMODIALYSIS CONCENTRATE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PEAK PULSAR II GENERATOR MODEL PS100-102

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PAIRED HYDROGEL ELECTRODE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

THYROXINE (T4) COATED TUBE RIA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry