OLYMPUS CK-MB REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AMYLASE (ETHYLIDENE PNGPG7) KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298

FDA 510(k)

FDA Class 2 ·Neurology

Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Total Bilirubin2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EVA15 insufflator

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GI Genius

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EntericBio Dx Assay

FDA 510(k)

FDA Class 2 ·Microbiology

NEUROMARK System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GLOBAL ICON Stemless Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120

FDA 510(k)

FDA Class 2 ·Anesthesiology

Allergan Botox Needle Electrode

FDA 510(k)

FDA Class 2 ·Physical Medicine

SLENDERTONE Evolve Abs, Type 735

FDA 510(k)

FDA Class 2 ·Physical Medicine

PROCOLL

FDA 510(k)

FDA Unclassified ·Unknown

SYSTEM-MINI, MODELS: 390, E30

FDA 510(k)

FDA Class 2 ·Physical Medicine

ReVene Thrombectomy Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

AERONEB SOLO; AERONEB SOLO ADAPTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

Mobility+ Enteral Feeding System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PolyDev Soft Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic