Medical Device Manufacturer · TW , Taipei Hsien

Fortune Medical Instrument Corp. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1998

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fortune Medical Instrument Corp. Gastroenterology & Urology ✕

5 devices

1-5 of 5

Cleared Apr 03, 2003

FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020

Gastroenterology & Urology · 279d

Cleared Oct 01, 2002

ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865

Gastroenterology & Urology · 175d

Cleared Mar 04, 2002

ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890

Gastroenterology & Urology · 90d

Cleared May 27, 1998

ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV...

Gastroenterology & Urology · 77d

Cleared Mar 31, 1998

ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER

Gastroenterology & Urology · 20d