SAFECATH

FDA 510(k)

FDA Class 2 ·General Hospital

EDGE

FDA 510(k)

FDA Class 2 ·Radiology

GIP/MEDI-GLOBE GOREIGN BODY GRASPERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CEDIA DAU OPIATE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4, THC/OPI/COC/AMP OR MET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VARELISA PARIETAL CELL ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK

FDA 510(k)

FDA Class 2 ·Anesthesiology

Smith+Nephew INTELLIO Tablet

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DentCare Aligners

FDA 510(k)

FDA Class 2 ·Dental

Certas Plus Programmable Valves

FDA 510(k)

FDA Class 2 ·Neurology

Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VS-200 VIDEO SIGMOIDOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

UNICAP 100

FDA 510(k)

FDA Class 2 ·Immunology

POWERED WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

SUCTION CATHETER TRAY PRODUCT NO. 900277

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KODAK AMERLEX MAB FT3 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAINING SYSTEM FOR PNEUMOCYSTIS CARINII

FDA 510(k)

FDA Class 2 ·Microbiology

BERICHROM HEPARIN

FDA 510(k)

FDA Class 2 ·Hematology

PULSE GUARD ELECTRODE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology