Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WILSON-COOK BIPOLAR PROBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MILLAR MIKRO-TIP CATHETER PRESSURE TRAN.

FDA 510(k)

FDA Class 2 ·Cardiovascular

CREATINE PHOSPHOKINASE (CK)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Rezum System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SIGMA PROCEDURE 47-UV

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Rezum System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RHYTHMIA MAPPING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SB Knife Jr2 (MD-47702 and MD-47702L)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TRACFINDER II

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220

FDA 510(k)

FDA Class 2 ·Cardiovascular

CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter

FDA 510(k)

FDA Class 2 ·Neurology

EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CANDIDA IMMUNODIFFUSION KIT #CA1001

FDA 510(k)

FDA Class 2 ·Microbiology

St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ISOENZYME TEST CK-MB

FDA 510(k)

FDA Class 2 ·Clinical Chemistry