NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

SIGMA'S CALCIUM PROCEDURE NO. 587

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LYME DISEASE ELISA

FDA 510(k)

FDA Class 2 ·Microbiology

FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Burn Resuscitation Decision Support System - Clinical (BRDSS-C)

FDA 510(k)

FDA Class 2 ·Anesthesiology

HYBRID GRAFT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MEDI-DX 7000 CPT WITH AMREX ELECTRODES

FDA 510(k)

FDA Class 2 ·Neurology

ONCO TRAC MODEL 1, 2, 4

FDA 510(k)

FDA Class 2 ·Radiology

SUPER STAPLE(TM) CLASSIC

FDA 510(k)

FDA Class 2 ·Orthopedic

BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

OKAMOTO STUDDED CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Tube, Feeding

FDA classification

FDA Class 2 ·Tube, Feeding

Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep.

FDA classification

FDA Class 2 ·Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep.

Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

FDA classification

FDA Class 2 ·Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

BEI MEDICAL SYSTEMS MG-1000HS MONOPOLAR GENERATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders

FDA classification

FDA Class 2 ·Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders

Device, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders

FDA classification

FDA Class 2 ·Device, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders

Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

FDA classification

FDA Class 2 ·Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay