SHILEY SPECIALIZED TRACHEOSTOMY TUBE

FDA 510(k)

FDA Class 2 ·Anesthesiology

Sofia Influenza A+B FIA on Sofia 2

FDA 510(k)

FDA Class 2 ·Microbiology

CentriMag Acute Circulatory Support System

FDA 510(k)

FDA Class 2 ·Cardiovascular

SmartStart Air/Water and Suction Valves

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LIGHT, SURGICAL, FLOOR STANDING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HYPERGLIDE OCCLUSION BALLOON SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INSIGNIA

FDA 510(k)

FDA Class 2 ·Dental

WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,

FDA 510(k)

FDA Class 2 ·Cardiovascular

REPLACE CYLINDRICAL IMPLANTS

FDA 510(k)

FDA Class 2 ·Dental

BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HEADWAY 21 MICROCATHETER, MODEL: MC212150S

FDA 510(k)

FDA Class 2 ·Cardiovascular

HARDYDISK AST TELAVANCIN,30UG

FDA 510(k)

FDA Class 2 ·Microbiology

MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)

FDA 510(k)

FDA Class 2 ·Neurology

BARRICADE EMBOLIZATION COIL SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN

FDA 510(k)

FDA Class 2 ·Microbiology

MICRO-AIRE STAPES DRILL SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat