HEMO-SANITAS SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

KERR XR IONOMER

FDA 510(k)

FDA Class 2 ·Dental

KERR POL-E-LASTIC DENTAL IMPRESSION MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

Microthin Natural Rubber Latex Condom

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

XR PRIMER

FDA 510(k)

FDA Class 2 ·Dental

MODIFIED CASTLE POWERCLAVE

FDA 510(k)

FDA Class 2 ·General Hospital

ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES

FDA 510(k)

FDA Class 2 ·Radiology

ROCC Console

FDA 510(k)

FDA Class 2 ·Radiology

ClearPath Aligner

FDA 510(k)

FDA Class 2 ·Dental

UTERINE TENACLUM HOOK

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Clear Moves Aligner

FDA 510(k)

FDA Class 2 ·Dental

Ensmile

FDA 510(k)

FDA Class 2 ·Dental

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

OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS

FDA 510(k)

FDA Class 2 ·Ophthalmic

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