CA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

I.V. PRIMING SET

FDA 510(k)

FDA Class 2 ·General Hospital

FX-4 NMS (4CHANNEL TABLE MODEL)

FDA 510(k)

FDA Class 2 ·Physical Medicine

REFSTAR RMT EXTERNAL REFERENCE PATCH

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEARTRAIL III GUIDING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

VACUUM ASSISTED CORE BIOPSY DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HOLTER PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

GYRUS PLASMA SKIN RESURFACING SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Hem-Avert Perianal Stabilizer

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ORS-111

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT SET, MODELS: FG0018, FG0026

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CLEARBLUE EASY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870

FDA 510(k)

FDA Class 2 ·General Hospital

RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Tyber Medical Anatomical Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

DURASIS DURAL SUBSTITUTE

FDA 510(k)

FDA Class 2 ·Neurology

G-CEM ONE

FDA 510(k)

FDA Class 2 ·Dental