LBK 1244 DELFIA HCG KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BK-A; BK-B; BK-IS SEALING CAP

FDA 510(k)

FDA Class 2 ·Cardiovascular

Easi-Vue® embolic microspheres System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Easi-Vue embolic microspheres System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONSULTANT BODY COMPOSITION ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DELFIA DIGOXIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-AB-HAVK PLUS ASSAY

DTX-200 BONE DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology

MAX-IF1000

FDA 510(k)

FDA Class 2 ·Neurology

FLUORCANASITE DENTAL CERAMIC

FDA 510(k)

FDA Class 2 ·Dental

REUSABLE STIMULATING ELECTRODES

FDA 510(k)

FDA Class 2 ·Neurology

GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PUTMAN STABILIZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AIRPERFECT 1000 (SINGLE-USER SYSTEM), AIRPERFECT 2000 (MULTI-USER SYSTEM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DTX-100 BONE DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology

Changer, Tube, Endotracheal

FDA Pre-Market Approval

FDA Class 2 ·ENDOTRACHEAL TUBE CHANGERS

DURATECH HOSPITAL TOWEL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DTX-200 BONE DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology

Exablate Prostate System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology