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

Complement C3b Activator Immunoassay Reagents

FDA classification

FDA Class 2 ·Complement C3b Activator Immunoassay Reagents

Complement C3b Activator, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Complement C3b Activator, Antigen, Antiserum, Control

Chamber, Hyperbaric

FDA classification

FDA Class 2 ·Chamber, Hyperbaric

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

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

Isocapnic Ventilation Device

FDA classification

FDA Class 2 ·Isocapnic Ventilation Device

Retrograde Intubation Set

FDA classification

FDA Class 2 ·Retrograde Intubation Set

Respirator, Surgical

FDA classification

FDA Class 2 ·Respirator, Surgical

Negative Pressure Wound Therapy Device For Reduction Of Wound Complications

FDA classification

FDA Class 2 ·Negative Pressure Wound Therapy Device For Reduction Of Wound Complications

Catheter, Peritoneal, Long-Term Indwelling, Exempt

FDA classification

FDA Class 2 ·Catheter, Peritoneal, Long-Term Indwelling, Exempt

Assisted Reproduction Laminar Flow Workstation

FDA classification

FDA Class 2 ·Assisted Reproduction Laminar Flow Workstation

Tester, Auditory Impedance, Exempt

FDA classification

FDA Class 2 ·Tester, Auditory Impedance, Exempt

Colposcope (And Colpomicroscope), Exempt

FDA classification

FDA Class 2 ·Colposcope (And Colpomicroscope), Exempt