Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDTRONIC(R) MILLENIA (TM) FAMILY OF CORONARY BALLOON DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·VERSAFLEX; BUCHBINDER, OMNIFLEX PTCA CATHETER SYSTEMS MEDTRONIC 18K, 14K, EVERGREEN, FALCON, PANTHER, AND SPIRIT PTCAR

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDTRONIC BUSHBINDER(R) OMNIFLEX(TM) PTCA CATHETER

COIL DIALYSIS, MODELS DM-360 AND DM-360-

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KINGLY STAR POWERED MUSCLE STIMULATOR, MODEL KS-138

FDA 510(k)

FDA Class 2 ·Physical Medicine

ORTHODONTIC CERAMIC BRACKET

FDA 510(k)

FDA Class 2 ·Dental

ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ALKO CAL PACKS FOR CORNING 654 ANALYZERS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL.

FDA 510(k)

FDA Class 2 ·Radiology

DC-UIBC-CO2-CAL, MODEL SE-153

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE

FDA 510(k)

FDA Class 2 ·Hematology

MICRO-COIL 100 COIL DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIALYZER, DISP., COIL, LUNDIA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MICROCOIL 80 DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIALYZER, CD-800 COIL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COIL DIALYZER MODEL ALT 140

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MICROCOIL 150 DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ERI-FLO 900 DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIALYZER, COIL, CD, LSA, 5M1765

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO KIDNEY DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology