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

Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)

FDA 510(k)

FDA Class 2 ·General Hospital

INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ECA (SPECIAL) HEME BUFFER

FDA 510(k)

FDA Class 2 ·Hematology

i-STAT TBI Cartridge with the i-STAT Alinity System

FDA 510(k)

FDA Class 2 ·Immunology

KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000

FDA 510(k)

FDA Class 2 ·Ophthalmic

ELUTION SOLUTION

FDA 510(k)

FDA Class 2 ·Hematology

PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

U-200 BAG

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology