SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MEDRAD STELLANT CT INJECTOR SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Disposable High Pressure Syringe

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAVERNOSOMETRY MODULE FOR MENUET

FDA 510(k)

FDA Class 2 ·Cardiovascular

DyeVert Contrast Modulation System

FDA 510(k)

FDA Class 2 ·Cardiovascular

IL TEST DIGOXIN & IL TEST DIGOXIN CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)

FDA 510(k)

FDA Class 2 ·Cardiovascular

FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211

FDA 510(k)

FDA Class 2 ·Cardiovascular

STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM-

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP

FDA 510(k)

FDA Class 2 ·Cardiovascular

Angiography Syringe

FDA 510(k)

FDA Class 2 ·Cardiovascular

Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Single-use Sterile High-pressure Angiographic Syringes and Accessories

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION OF THE CEDIA DIGOXIN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMIT COLUMN DIGOXIN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DELFIA DIGOXIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RANDOX DIGOXIN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE NXT 2.0 PATIENT MANAGEMENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE NXT PATIENT MANAGEMENT SYSTEM, LATITUDE NXT RELEASE 3.0