Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·CLEAREAD DETECT

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·TESLACON(TM) NMR IMAGING SYSTEM

Antigen, Iha, Cytomegalovirus

FDA classification

FDA Class 2 ·Antigen, Iha, Cytomegalovirus

System, Test, Human Chorionic Gonadotropin

FDA classification

FDA Class 2 ·System, Test, Human Chorionic Gonadotropin

Antigens, Iha, Toxoplasma Gondii

FDA classification

FDA Class 2 ·Antigens, Iha, Toxoplasma Gondii

21-Hydroxylase Antibody (21-Ohab)

FDA classification

FDA Class 2 ·21-Hydroxylase Antibody (21-Ohab)

Antigen, Ha (Including Ha Control), Rubella

FDA classification

FDA Class 2 ·Antigen, Ha (Including Ha Control), Rubella

Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus

FDA classification

FDA Class 2 ·Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus

Antigens, Ha, Treponema Pallidum

FDA classification

FDA Class 2 ·Antigens, Ha, Treponema Pallidum

VERSION 5 OPERATING SYSTEM SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

ALTAIRE INTERVENTIONAL MR PACKAGE

FDA 510(k)

FDA Class 2 ·Radiology

LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE

FDA 510(k)

FDA Class 2 ·Radiology

CLAMPEASE FA

FDA 510(k)

FDA Class 2 ·Cardiovascular

M & R DISPOSABLE ELECTRODE (14200)

FDA 510(k)

FDA Class 2 ·Neurology

MAYFIELD ADULT DISPOSABLE SKULL PIN

FDA 510(k)

FDA Class 2 ·Neurology

ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000

FDA 510(k)

FDA Class 2 ·Radiology

VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator

FDA 510(k)

FDA Class 2 ·General Hospital

ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS150

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology