Medical Device Manufacturer · US , Fort Lauderdale , FL

Orbus Medical Technologies - FDA 510(k) Cleared Devices

8 submissions · 0 cleared · Since 2001

Recent clearances: LIFESTENT LP SDS BILIARY ENDOPROSTHESIS, R STENT BILIARY ENDOPROSTHESIS

8

Total

0

Cleared

0

Denied

FDA 510(k) Regulatory Record - Orbus Medical Technologies Gastroenterology & Urology ✕

8 devices

1-8 of 8

Cleared Jun 24, 2004

LIFESTENT LP SDS BILIARY ENDOPROSTHESIS

Gastroenterology & Urology · 31d

Cleared May 10, 2004

MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS

Gastroenterology & Urology · 19d

Cleared Mar 16, 2004

LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS

Gastroenterology & Urology · 14d

Cleared Oct 30, 2003

LIFESTENT SDS BILIARY ENDOPROSTHESIS

Gastroenterology & Urology · 27d

Cleared Apr 14, 2003

LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS

Gastroenterology & Urology · 193d

Cleared Mar 10, 2003

LIFESTENT BILIARY ENDOPROSTHESIS

Gastroenterology & Urology · 172d

Cleared Feb 11, 2003

LIFESTENT LP SDS BILIARY ENDOPROSTHESIS

Gastroenterology & Urology · 134d

Cleared Jul 31, 2001

R STENT BILIARY ENDOPROSTHESIS

Gastroenterology & Urology · 200d