CLARIFIED APPLICA. FOR LACEY CONDYLAR TOTAL KNEE

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFIED LABELING TO MODEL 9608 ARTERIAL HEMO BLD.

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TRI-LEVEL LIGAND CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4

FDA 510(k)

FDA Class 2 ·Radiology

PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANA-5 AUTOANTIBODY PROFILE KIT

FDA 510(k)

FDA Class 2 ·Immunology

ULTRASONIC IMAGING SYSTEM (MODIFIED)

FDA 510(k)

FDA Class 2 ·Radiology

DATASCOPE INTERLOCK GUIDE WIRE EXTENSION

FDA 510(k)

FDA Class 2 ·Cardiovascular

CURAPULS 403 DIATHERMY UNIT

FDA 510(k)

FDA Class 2 ·Physical Medicine

MODIFIED CAPTIA(R) TOXO-M

FDA 510(k)

FDA Class 2 ·Microbiology

VZV MICROASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

NPG NONPRECIOUS CROWN AND BRIDGE ALLOY

FDA 510(k)

FDA Class 2 ·Dental

RNP EIA DIAGNOSTIC KIT

FDA 510(k)

FDA Class 2 ·Immunology

PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG.

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MD STRIPS BG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FRANZ(TM) STEERABLE COMBINATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PLAYTEX TAMPONS, NON-DEODORANT/DEODORANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EZ-SCREEN:OPIATES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PROXIMAL FEMORAL REPLACEMENT PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic