IntellaMap Orion High Resolution Mapping Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIPOLAR ENDOSTASIS PROBE, BEST (TM)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CARESIDE CK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

POLYPECTOMY SNARE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

USW NEEDLEKNIFE PAPILLOTOME

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MICROVASIVE GOLD PROBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Disposable Sphincterotome

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX, 5BEXXX AND 5FEXXX, AND 4UEXXX, 4BEXXX AND 4FEX

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110

FDA 510(k)

FDA Class 2 ·Cardiovascular

PLASMAKINETIC ENDOUROLOGY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CREATINE PHOSPHOKINASE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable

FDA 510(k)

FDA Class 2 ·Cardiovascular

VIKING DIAGNOSTIC ELECTRODE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S

FDA 510(k)

FDA Class 2 ·Cardiovascular

Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

PAPILLOTOME

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

QUICK CEPT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ET/RT PAPILLOTOME

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology