DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

CHAKOFF ENDOSCOPY (SET LAPAROSCOPY)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CES VASCULAR OCCLUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRU-CABLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2

FDA 510(k)

FDA Class 2 ·Cardiovascular

GYNECOLOGICAL LAPAROSCOPES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PEDIATRIC FEEDING TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CPS AIM UNIVERSAL SLITTABLE INNER CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

DIAZYME POTASSIUM ENZYMATIC ASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

HALOLITE AAD SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABI

FDA 510(k)

FDA Class 2 ·Orthopedic

PACE 10 NON-INVASIVE EXTERNAL PACEMAKER

FDA 510(k)

FDA Class 2 ·Cardiovascular