Medical Device Manufacturer · US , Germantown , MD

Medispec, Ltd. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1998

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Medispec, Ltd. Gastroenterology & Urology ✕

3 devices

1-3 of 3

Cleared Mar 09, 2007

ECONOLITH EM1000

Gastroenterology & Urology · 109d

Cleared May 25, 2004

ECONOLITH E3000, MODEL 3000 (SW-6)

Gastroenterology & Urology · 92d

Cleared Mar 12, 1998

LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER

Gastroenterology & Urology · 80d