DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)

FDA Class 2 ·Microbiology

INTRABLOCK BIOBALL HIP SYSTEM (IBS)

FDA 510(k)

FDA Class 2 ·Orthopedic

MECRON Cannulated Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

TEMPORARY PACEMAKER ELECTRODE

FDA 510(k)

FDA Class 2 ·Cardiovascular

TB SERIES BIPOLAR PACING LEADS

FDA 510(k)

FDA Class 2 ·Cardiovascular

HATCHER STONE EXTRACTOR - DISPOSABLE CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TOMEY PE-300 PORTABLE ERG

FDA 510(k)

FDA Class 2 ·Ophthalmic

PANORAMIC LOUPES - VARIOUS

FDA 510(k)

FDA Class 2 ·Ophthalmic

URINE NEGATIVE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING

FDA 510(k)

FDA Class 2 ·Ophthalmic

ORBIOGRAPH

FDA 510(k)

FDA Class 2 ·Ophthalmic

IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400

FDA 510(k)

FDA Class 2 ·Cardiovascular

LASEVAC

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5

FDA 510(k)

FDA Class 2 ·General Hospital

MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

GYRUS ENDOUROLOGY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GYRUS HYSTEROSCOPIC RESECTOSCOPE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery