EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET

FDA 510(k)

FDA Class 2 ·Hematology

SEARE BIOMEDICAL MALAR IMPLANTS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

URIC ACID (LIQUID) REAGENT SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SEARE BIOMEDICAL SILICONE BLOCK

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MAX IT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GRASPERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P

FDA 510(k)

FDA Class 2 ·Anesthesiology

OSTEO INTERLOCKING-COMPRESSION NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CONMED VERSA STEM NEUROMUSCULAR STIMULATION/TENS

FDA 510(k)

FDA Class 2 ·Neurology

IBC CARDIAC SUCTION WARD

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS

FDA 510(k)

FDA Class 2 ·Hematology

N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BREATHAID TONGUE SCRAPER

FDA 510(k)

FDA Class 1 ·Dental

GLEESON FLOVAC HANDCONTROLLED SUCTION IRRIGATION INSTRUMENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DISOPOSABLE & RESUABLE MONPOLAR CORD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery