Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ClearPath Aligner

FDA 510(k)

FDA Class 2 ·Dental

INVIGRA

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Leadtek Fingertip Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

G.S.A. COLORED CONDOMS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NUDA (CURRENTLY CALLED ULTRA SENSITIVE)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

RIA LATEX CONDOM, NONOXYNOL-9

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR PICO-ST

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR PERCUTANEOUS ANGIOPLASTY CATHETER (PTCA), MODEL 5S, LEOCOR CORFLO MODEL 7.5PT COATED PTCA, AND CORFLO HEMO PUMP

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR CORFLO(TM) MODEL 7.5PT PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR SABLE(TM) PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR,INC. PICOCATH CATHETER 2,2.5,3,3.5, BALLOON

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR PICO RUNNER CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR CORFLO(TM) MODEL 7.1PT (COATED)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER AND LEOCOR PTCA CATHETER MODEL PICO-ST (COATED)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR PICOCATH(TM) MODEL PICO-ST

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR,INC. MODELS 7.5S

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR PICO RUNNER(TM) PTCA CATHETER