ECG Cable/Leadwires

FDA 510(k)

FDA Class 2 ·Cardiovascular

ULTRACELL ABSORBENT STICK

FDA 510(k)

FDA Class 2 ·Ophthalmic

MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Digital Electrocardiograph

FDA 510(k)

FDA Class 2 ·Cardiovascular

Bladder Scanner

FDA 510(k)

FDA Class 2 ·Radiology

Powered wheelchair (mobility robot) (M4, M4U)

FDA 510(k)

FDA Class 2 ·Physical Medicine

GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Infared Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

GIVEN DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CARTO SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Microwave Ablation Antennas

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OMNILUX REVIVE AND OMNILUX PLUS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ULTRACELL SUCTION SPONGE

FDA 510(k)

FDA Class 2 ·Ophthalmic

VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology