ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COE PAK AUTO MIX, REGULAR OR HARD SET

FDA 510(k)

FDA Class 2 ·Dental

TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100

FDA 510(k)

FDA Class 2 ·Ophthalmic

BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320)

FDA 510(k)

FDA Class 2 ·General Hospital

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