ORGENTEC ANTI-SCL 70 ELISA

FDA 510(k)

FDA Class 2 ·Immunology

Pristine Scope

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA

FDA 510(k)

FDA Class 2 ·General Hospital

Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask

FDA 510(k)

FDA Class 2 ·Anesthesiology

ULTRAMAX WOVEN VELOUR VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

PORTABLE AIR PLETHYSMOGRAPH

FDA 510(k)

FDA Class 2 ·Cardiovascular

DEKA ACE Pump System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VIAL VENT FILTER

FDA 510(k)

FDA Class 2 ·General Hospital

GSI 70 AUDIOPATH SCREENER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NUMALINK

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SYMPACATH HYDROGEL COATED FOLEY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AEx Generator; PlasmaBlade T

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ENDOSCOPIC STAPLE REMOVAL INSTRUMENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE

FDA 510(k)

FDA Class 2 ·General Hospital

SALUTE, MODEL 3022

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CUSTOM WOUND MANAGEMENT KITS AND TRAYS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VASCUMED EZ Y-CONNECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTRAVASCULAR ADMINISTRATION SET

FDA 510(k)

FDA Class 2 ·General Hospital

XOFT AXXENT CERVICAL APPLICATORS

FDA 510(k)

FDA Class 2 ·Radiology