TANARAMA

FDA 510(k)

FDA Class 2 ·Hematology

BODY FAT ANALYZER MODEL TBF-105

FDA 510(k)

FDA Class 2 ·Cardiovascular

SIMULIX-HP

FDA 510(k)

FDA Class 2 ·Radiology

PENTAX Medical EPK-3000 Video Imaging System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TRINDIUM-DENTAL MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

LDH ISOENZYME REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PENTAX Medical Video Bronchoscope EB-J10 Series

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE

FDA 510(k)

FDA Class 2 ·Cardiovascular

INNOFLUOR DIGOXIN CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CCS100 CRYOSURGICAL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RIA TSH IN HUMAN SERUM OR PLASMA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY

FDA 510(k)

FDA Class 2 ·Hematology

LINEAR ACCELERATOR THERAC 25

FDA 510(k)

FDA Class 2 ·Radiology

INNOFLUOR VANCOMYCIN REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

KANSAS I/A SYSTEM & KANSAS I/A & VITRECTROMY SYST.

FDA 510(k)

FDA Class 2 ·Ophthalmic

C2 CryoBalloon Ablation System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

THERAC 25 LINEAR ACCELERATOR

FDA 510(k)

FDA Class 2 ·Radiology