RANDOX ASSAYED SPECIFIC PROTEIN CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

PneumoLiner

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411

FDA 510(k)

FDA Class 2 ·Neurology

EVA15 insufflator

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NR5000 E.C.G. AND PULSE OXIMETER MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPIRALE DRUG DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O

FDA 510(k)

FDA Class 1 ·General Hospital

RedEx

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Neon EEG

FDA 510(k)

FDA Class 2 ·Neurology

KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411

FDA 510(k)

FDA Class 2 ·Physical Medicine

HI TORQUE CONNECT GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

VELYS™ Robotic-Assisted Solution

FDA 510(k)

FDA Class 2 ·Neurology

EMBOGUARD Balloon Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

DePuy PINNACLE Dual Mobility Liner

FDA 510(k)

FDA Class 2 ·Orthopedic

Albumin BCG2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INHANCETM Hybrid Anatomic Glenoid Implant

FDA 510(k)

FDA Class 2 ·Orthopedic

RANDOX MICROALBUMIN

FDA 510(k)

FDA Class 2 ·Immunology

EMPHASYS Femoral Stems

FDA 510(k)

FDA Class 2 ·Orthopedic

ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT

FDA 510(k)

FDA Class 2 ·Cardiovascular