Medical Device Manufacturer · IL , Ra'Ananna 43373

Given Imaging , Ltd. - FDA 510(k) Cleared Devices

30 submissions · 28 cleared · Since 2001

Total

Cleared

Denied

Given Imaging, Ltd. specializes in capsule endoscopy and diagnostic imaging systems for Gastroenterology & Urology applications. The company operates with a manufacturing facility in Ra'anana, Israel.

Given Imaging received 28 FDA 510(k) clearances from 30 total submissions between 2001 and 2018. The company's portfolio focuses entirely on Gastroenterology & Urology devices, including capsule endoscopy platforms and diagnostic software systems. The company is currently inactive, with no clearances recorded in the past five years.

Notable cleared devices include the PillCam family of capsule endoscopy systems across multiple clinical applications, the ManoScan System for esophageal diagnostics, and RAPID software platforms for image review and analysis. These products represent the company's core innovation in wireless, minimally invasive gastrointestinal visualization.

Explore the complete regulatory history, including device names, product codes, and clearance dates in the database.

FDA 510(k) Regulatory Record - Given Imaging , Ltd.

30 devices

1-12 of 30