BODY SIGNAL ECG ELECTRODE

FDA 510(k)

FDA Class 2 ·Cardiovascular

WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Models 2200DR and 1600DR Digital Stationary Radiographic Systems

FDA 510(k)

FDA Class 2 ·Radiology

HEARTWAY POWER MOBILITY SCOOTER, S12

FDA 510(k)

FDA Class 2 ·Physical Medicine

HEARTWAY POWER CHAIR, P23

FDA 510(k)

FDA Class 2 ·Physical Medicine

Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

FDA classification

FDA Class 2 ·Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

Smart Peak Flow Meter

FDA 510(k)

FDA Class 2 ·Anesthesiology

Bag, Hemostatic

FDA classification

FDA Class 2 ·Bag, Hemostatic

Endoscopic Magnetic Retriever

FDA classification

FDA Class 2 ·Endoscopic Magnetic Retriever

Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)

FDA classification

FDA Class 2 ·Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)

Endoscopic Magnetic Retriever, Exempt

FDA classification

FDA Class 2 ·Endoscopic Magnetic Retriever, Exempt

HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology