Gambro is one of 15082 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Gambro - FDA 510(k) Cleared Devices
Recent clearances: PRISMAFLEX SYSTEM, VERSION 3.20
1
Total
1
Cleared
0
Denied
Gambro, is a medical device manufacturer with a manufacturing facility in Lakewood, US. The company specializes in Gastroenterology & Urology devices and solutions for healthcare delivery.
Gambro has received 1 FDA 510(k) clearance from 1 total submission. The company's regulatory activity is historical, with its most recent clearance dating to 2008. The PRISMAFLEX SYSTEM, VERSION 3.20 represents the company's cleared device in the Gastroenterology & Urology category.
This regulatory record reflects Gambro's historical presence in the medical device market. For detailed information on device names, product codes and clearance dates, consult the FDA 510(k) database.
FDA 510(k) Regulatory Record - Gambro
1 devices