8ch Foot Ankle Coil

FDA 510(k)

FDA Class 2 ·Radiology

imani i2

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display

FDA 510(k)

FDA Class 2 ·Radiology

Devon 51

FDA 510(k)

FDA Class 2 ·Cardiovascular

Acclarix AX8 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Paonan Armstrong Posterior Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Geniant Cranial (Navigated Neurosurgical Positioning Robot)

FDA 510(k)

FDA Class 2 ·Neurology

Holter System

FDA 510(k)

FDA Class 2 ·Cardiovascular

EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D)

FDA 510(k)

FDA Class 2 ·Ophthalmic

PC ECG

FDA 510(k)

FDA Class 2 ·Cardiovascular

Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)

FDA 510(k)

FDA Class 2 ·Neurology

MEGAFIX® Pedicle Screw Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

Pelvic Floor Stimulator (Intrelief PFE)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SD5 & SD6 Ultrasonic Tabletop Doppler

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Disposable Temperature Probe

FDA 510(k)

FDA Class 2 ·General Hospital

PC ECG

FDA 510(k)

FDA Class 2 ·Cardiovascular

STOPWET iontophoresis apparatus (SW01)

FDA 510(k)

FDA Class 2 ·Physical Medicine