SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010

FDA 510(k)

FDA Class 2 ·Cardiovascular

DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CODMAN NEUROLASE LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SABRE ULTIMATE SHIELDED TROCAR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OMNIPOD INSULIN MANAGMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

NOVA 12 NA/K/C1/TOTAL CARBON DIOXIDE/GLUCOSE/UREA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SWISS LITHOCLAST LITHOTRIPTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOVASCULAR LASER VEIN SYSTEM KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW

FDA 510(k)

FDA Class 2 ·Radiology

SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CARDIO-VIEW

FDA 510(k)

FDA Class 2 ·Cardiovascular

Straumann® Anatomic Healing Abutments XC (AHA)

FDA 510(k)

FDA Class 2 ·Dental

ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

J&S HDL CHOLESTEROL PRECIPITATING REAGENT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ULTRA-THIN SDS BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TempSure System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

leva Pelvic Floor Trainer

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PULPDENT RESILUTE

FDA 510(k)

FDA Class 2 ·Dental