SILKPRO laser hair removal system

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Arm Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Non-contact Infrared Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

POLLER CALIBRANTS

FDA 510(k)

FDA Class 2 ·Hematology

Acclarix AX8 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Holter System

FDA 510(k)

FDA Class 2 ·Cardiovascular

PC ECG

FDA 510(k)

FDA Class 2 ·Cardiovascular

SD5 & SD6 Ultrasonic Tabletop Doppler

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PC ECG

FDA 510(k)

FDA Class 2 ·Cardiovascular

Patient Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Antigen, Cf, B. Dermatitidis

FDA classification

FDA Class 2 ·Antigen, Cf, B. Dermatitidis

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

Assay, Nucleic Acid Amplification, Bacillus Anthracis

FDA classification

FDA Class 2 ·Assay, Nucleic Acid Amplification, Bacillus Anthracis

Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control

VivoSight Dx Topical OCT System

FDA 510(k)

FDA Class 2 ·Radiology

Arc Endocuff Glide AEG110 & AEG120

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VITROS Immunodiagnostic Products CEA Reagent Pack

FDA 510(k)

FDA Class 2 ·Immunology

CENTRAFIX EXTERNAL FIXATOR

FDA 510(k)

FDA Class 2 ·Orthopedic