K-ASSAY MICROALBUMIN CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL NUMBER A943-794, CALIBRATION SOLUTION, PH 7.4 MO

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Calibrator, Multi-Analyte Mixture

FDA classification

FDA Class 2 ·Calibrator, Multi-Analyte Mixture

GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0

FDA 510(k)

FDA Class 2 ·Radiology

Augment Off-Axis Instrument System

FDA 510(k)

FDA Class 2 ·Orthopedic

Augment Off-Axis Instrument System

FDA 510(k)

FDA Class 2 ·Orthopedic

BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF

FDA 510(k)

FDA Class 2 ·Cardiovascular

HE-30 GOLD

FDA 510(k)

FDA Class 2 ·Cardiovascular

Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)

FDA 510(k)

FDA Class 2 ·Radiology

R-X-FIX EXTERNAL FIXATOR

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO CONTOUR SE MICROSPHERES

FDA 510(k)

FDA Class 2 ·Neurology

A BREAST COIL FOR THE GYREX 2T-DIX

FDA 510(k)

FDA Class 2 ·Radiology

VOLUME NECK COIL FOR THE GYREX V-DIX

FDA 510(k)

FDA Class 2 ·Radiology

Impress SFS System

FDA 510(k)

FDA Class 2 ·Orthopedic

FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4

FDA 510(k)

FDA Class 2 ·Orthopedic

Diode laser hair removal device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5

FDA 510(k)

FDA Class 2 ·Orthopedic