HEMODIALYSIS TUBING SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·DERMABOND (A FORMULATION OF 2-OCTYL CYANOACRYLATE)

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR AZTRENAM

GEM HEART ONE/ONE+

FDA 510(k)

FDA Class 2 ·Cardiovascular

4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture,

FDA 510(k)

FDA Class 2 ·Orthopedic

Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICRO THERM MT-500 & MT-600

FDA 510(k)

FDA Class 2 ·General Hospital

MICROTHERM MT-501 & MT-502

FDA 510(k)

FDA Class 2 ·General Hospital

Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Devon 51

FDA 510(k)

FDA Class 2 ·Cardiovascular

Devon 52 Sequential Compression Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

Devon 24

FDA 510(k)

FDA Class 2 ·Cardiovascular

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE NORFLOXACIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR CEFTIZOXIME

External Counterpulsation System, Soulaire

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Alzair Allergy Blocker

FDA 510(k)

FDA Class 2 ·General Hospital

AllerBlock Junior

FDA 510(k)

FDA Class 2 ·General Hospital

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR CHLORAMPHENICOL