OptiCross 18, 30 MHz Peripheral Imaging Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

OptiCross X, 40 MHz Coronary Imaging Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADR ULTRASOUND 5.5 MHZ SHORT FOCUS TRANSDUCER

FDA 510(k)

OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·CARELINK IPRO THERAPY MANAGEMENT SOFTWARE (MODEL, MMT-7340)

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·CONTINUOUS GLUCOSE MONITORING SYSTEM, SOF-SENSOR MMT-7002

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL TIME ? MMT-522/722 INSULIN PUMP

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·ENLITE GLUCOSE SENSOR, ENLITE GLUCOSE SENSOR (MMT-7008)

rP19x/5-1 MHz Armored

FDA UDI

FUJIFILM SONOSITE, INC.·00841517100605·Diagnostic Ultrasound Transducer

L38xi/10-5 MHz Armored

FDA UDI

FUJIFILM SONOSITE, INC.·00841517109004·Diagnostic Ultrasound Transducer

rC60xi/5-2 MHz Armored

FDA UDI

FUJIFILM SONOSITE, INC.·00841517104917·

rP19x/5-1 MHz Armored

FDA UDI

FUJIFILM SONOSITE, INC.·00841517105112·Diagnostic Ultrasound Transducer

L38xi/10-5 MHz Armored

FDA UDI

FUJIFILM SONOSITE, INC.·00841517107628·

rP19x/5-1 MHz Armored

FDA UDI

FUJIFILM SONOSITE, INC.·00841517109080·Diagnostic Ultrasound Transducer

rP19x/5-1 MHz Armored

FDA UDI

FUJIFILM SONOSITE, INC.·00841517107161·Diagnostic Ultrasound Transducer

IMZ 3.3 Healing Cap 4mm

FDA UDI

IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307118589·

rC60xi/5-2 MHz Armored

FDA UDI

FUJIFILM SONOSITE, INC.·00841517107147·Diagnostic Ultrasound Transducer

IMZ 4.0 Healing Cap 6mm

FDA UDI

IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307122425·

IMZ 3.3 Healing Cap 2mm

FDA UDI

IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307118572·

UMA Insert-IMZ 3.3-4.0mm

FDA UDI

IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307122364·