RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·KODAK MAMMOGRAPHY CAD ENGINE

LUMACARE LC-122M NON-COHERENT LIGHT SOURCE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Helianthus

FDA 510(k)

FDA Class 2 ·Radiology

LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LUMACARE MODEL LC-122M NON-COHERENT LIGHT SOURCE AND MODEL LUM-P FIBRE OPTIC PROBE

FDA 510(k)

FDA Class 2 ·Physical Medicine

Parsortix PC1 Device

FDA 510(k)

FDA Class 2 ·Immunology

FMT Disposable and Autoclavable Temperature Probes

FDA 510(k)

FDA Class 2 ·General Hospital

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER D

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER (CAD) SYSTEM, M1000

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER (CAD) SYSTEM, M100

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY

PlaniMax Orthodontic Software

FDA 510(k)

FDA Class 2 ·Dental

PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)

FDA 510(k)

FDA Class 2 ·General Hospital

FMT Reusable Temperature Probes

FDA 510(k)

FDA Class 2 ·General Hospital

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDTRONIC(R) FALCON(TM) COR. BALL. DIL. CATH.