EnSite™ X EP System

FDA 510(k)

FDA Class 2 ·Cardiovascular

EnSite X EP System

FDA 510(k)

FDA Class 2 ·Cardiovascular

COMPRESSION ANASTOMOSIS RING (CAR)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER

VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020

FDA 510(k)

FDA Class 2 ·Immunology

OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION

FDA 510(k)

FDA Class 2 ·General Hospital

MODEL 1888 ALPHA COS/RESPIRATION CAR

FDA 510(k)

FDA Class 2 ·General Hospital

ACON ONE STEP PREGNANCY TEST STRIP (URINE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System

FDA 510(k)

FDA Class 2 ·Orthopedic

ACON ONE STEP HOME PREGNANCY TEST STRIP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System

FDA 510(k)

FDA Class 2 ·Orthopedic

COMPEX REHAB

FDA 510(k)

FDA Class 2 ·Physical Medicine

TOTAL KNEE CEMENTED, SEMI-CONSTRAINED

FDA 510(k)

FDA Class 2 ·Orthopedic

LAL TEST RELEASE & BONCHEK CAR/JACKET

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL BION 1/TYPE 1084T CAR IONIZER

FDA 510(k)

FDA Class 2 ·General Hospital

SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS)

FDA 510(k)

FDA Class 2 ·Radiology

WILLIAM HARVEY H-4720 NON-FILTERED CAR

FDA 510(k)

FDA Class 2 ·Cardiovascular