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

Belun Ring BLR-200 (BLR-200)

FDA 510(k)

FDA Class 2 ·Cardiovascular

GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES)

FDA 510(k)

FDA Class 2 ·Cardiovascular

RABBIT ANTIBODY TO DIGOXIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CBR-DIGOXIN ANTISERUM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Keymill

FDA 510(k)

FDA Class 2 ·Dental

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