FLO-RESTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

INJECTRITE-C15 AND INJECTRITE-C30

FDA 510(k)

FDA Class 2 ·General Hospital

EMPI MODEL GLS 450, TENS

FDA 510(k)

FDA Class 2 ·Neurology

MODIFIED REFLUX REDUCER

FDA 510(k)

FDA Class 2 ·General Hospital

CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KIT

FDA 510(k)

FDA Class 2 ·General Hospital

3M RelyX Pediatric Resin Modified Glass Ionomer Cement

FDA 510(k)

FDA Class 2 ·Dental

FEMORAL AND ALL POLY TIBIAL TRAY COMPONENTS

FDA 510(k)

FDA Class 2 ·Orthopedic

MEDTRONIC EPIDURAL CATHETER KIT MODEL 8716

FDA 510(k)

FDA Class 2 ·Anesthesiology

EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFIED SERIES 2100 ENDOSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMS PELVIC FLOOR REPAIR SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ATRILAZE MALLEABLE ABLATION PROBE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ORTHOMET WIRE FOR SUTURE, CERCLAGE

FDA 510(k)

FDA Class 2 ·Orthopedic

Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software

FDA 510(k)

FDA Class 2 ·Cardiovascular

5000Z FIREFLY SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345

FDA 510(k)

FDA Class 2 ·Clinical Chemistry