CardiMax Electrocardiograph

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMPLANT BODY RETRIEVER/REMOVER

FDA 510(k)

FDA Class 2 ·Dental

LIFE-SPAN CABLE

FDA 510(k)

FDA Class 2 ·Physical Medicine

ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SIBIS REMOTE ACTUATOR

FDA 510(k)

FDA Class 2 ·Neurology

INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

OCO DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

POLY STAT HCG TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BARD AND BTA TEST

FDA 510(k)

FDA Class 2 ·Immunology

AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VENUS BASIC SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Medtronic Model 5392 External Pulse Generator (EPG)

FDA 510(k)

FDA Class 2 ·Cardiovascular

WESTERN DIALYSIS HEMODIALYSIS CONCENTRATE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IMMEDIATE STABILIZING IMPLANT (ISI)

FDA 510(k)

FDA Class 2 ·Dental

THE ALBERTA LENS SM2, SULFOCON B

FDA 510(k)

FDA Class 2 ·Ophthalmic

BARD BTA TRAK TEST

FDA 510(k)

FDA Class 2 ·Immunology

O BUTMENT

FDA 510(k)

FDA Class 2 ·Dental

POLY STAT SERUM/URINE HCG TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OBUTMENT HB

FDA 510(k)

FDA Class 2 ·Dental

PARRALLEL PIN

FDA 510(k)

FDA Class 2 ·Dental