CARIOLINE(ELECTROCARDIOGRAPH)

FDA 510(k)

FDA Class 2 ·Cardiovascular

COMPUTERIZED ANESTHESIA RECORDING & INFO NETWORK

FDA 510(k)

FDA Class 2 ·Anesthesiology

SIGNA HFO/I MAGNETIC RESONANCE SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODEL 78560A CENTRAL STATION PATIENT INFO SYS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ODIS - OBSTETRICAL DISPLAY INFO SYSTEM, HP M1370A

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IQPACS

FDA 510(k)

FDA Class 2 ·Radiology

MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMT BUTTON REPLACEMENT GASTROSTOMY DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMT DECOMPRESSION TUBES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CAUTERIZATION SMOKE EVACUATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LOW PROFILE FEEDING SET ACCESSORY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius System 100 and GI Genius System 200

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology