ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Alzair Allergy Blocker

FDA 510(k)

FDA Class 2 ·General Hospital

AllerBlock Junior

FDA 510(k)

FDA Class 2 ·General Hospital

Tek RMD (Tek Robotic Mobilization Device)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AMD SYSTEM WORKING CHANNEL SCOPE AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Orthopedic

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY

KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT

FDA 510(k)

FDA Class 2 ·Immunology

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator

FDA 510(k)

FDA Class 2 ·General Hospital

Surgical Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator

FDA 510(k)

FDA Class 2 ·General Hospital

AcQMap 3D Imaging and Mapping Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ablacath™ Mapping Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

FIRMap Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENSITE 3000 SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Sphere-9Dx Diagnostic Catheter (AFR-00009)

FDA 510(k)

FDA Class 2 ·Cardiovascular