VITROS Immunodiagnostic Products Intact PTH II Reagent Pack

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Optilite IgA CSF Kit

FDA 510(k)

FDA Class 2 ·Immunology

Xtreme-Loop

FDA 510(k)

FDA Class 2 ·Orthopedic

ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Reusable Interface Cable 1.5 m (PRD-IFC-002)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

UVATAN INDUS. UVATAN 900C, 900B/800 & 600C

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MOORLDLS LASER DOPPLER LINE SCANNER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SmoothSkin Pure

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Simplicit90Y

FDA 510(k)

FDA Class 2 ·Radiology

NETILMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

HUMAN IGM CSF KIT

FDA 510(k)

FDA Class 2 ·Immunology

OSTEOTEC SILICONE FINGER IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIAN II CR45A

FDA 510(k)

FDA Class 2 ·Cardiovascular

PATHFINDER

FDA 510(k)

FDA Class 2 ·Neurology

OXYGEN MEDICELS, CITICELS

FDA 510(k)

FDA Class 2 ·Anesthesiology

MONICA AN24

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology