PATHWAY - ATS/CHEPS

FDA 510(k)

FDA Class 2 ·Neurology

MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS)

FDA 510(k)

FDA Class 2 ·Neurology

CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS)

FDA 510(k)

FDA Class 2 ·Neurology

Bladeless Trocar – Artemis Lap Cannula

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Bladeless Trocar – Artemis Lap Cannula

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET

FDA 510(k)

FDA Class 2 ·General Hospital

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NEEDLE ZAP

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·SUNLIGHT OMNISENSE ULTRASOUND BONE SONOMETER

CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)

FDA 510(k)

FDA Class 2 ·General Hospital

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

Clavicle and Scapula System

FDA 510(k)

FDA Class 2 ·Orthopedic

JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK)

FDA 510(k)

FDA Class 2 ·General Hospital

RAPIDIA

FDA 510(k)

FDA Class 2 ·Radiology

CALSCOR SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514

FDA 510(k)

FDA Class 2 ·Anesthesiology

Well-life TM Pen Needles, Well-life TM Safety Pen Needles

FDA 510(k)

FDA Class 2 ·General Hospital

SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14

FDA 510(k)

FDA Class 2 ·Anesthesiology