CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Elecsys AMH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Elecsys TSH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Elecsys Tg II

FDA 510(k)

FDA Class 2 ·Immunology

DETRUSAN 500

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000

FDA 510(k)

FDA Class 2 ·Neurology

ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000

FDA 510(k)

FDA Class 2 ·Neurology

BURR HOLE COVER, MODEL XX

FDA 510(k)

FDA Class 2 ·Neurology

NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX

FDA 510(k)

FDA Class 2 ·Neurology

NAVIGUS PASSIVE PROBE, MODEL NP-1000

FDA 510(k)

FDA Class 2 ·Neurology

ACTIVE ARRAY CATHETER, MODEL CS-2000

FDA 510(k)

FDA Class 2 ·Radiology

NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000

FDA 510(k)

FDA Class 2 ·Neurology

NAVIGUS II MR

FDA 510(k)

FDA Class 2 ·Neurology

NAVIGUS PEEL AWAY INTRODUCER

FDA 510(k)

FDA Class 2 ·Neurology

REMOTE INTRODUCER, MODEL PI-1000

FDA 510(k)

FDA Class 2 ·Neurology

NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX

FDA 510(k)

FDA Class 2 ·Neurology