Medical Device Manufacturer · US , Basking Ridge , NJ

Penn Medical Devices, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1986

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Penn Medical Devices, Inc. Gastroenterology & Urology ✕

7 devices

1-7 of 7

Cleared Oct 14, 1987

HUFFMAN BIOPSY UNIT

Gastroenterology & Urology · 63d

Cleared Oct 14, 1987

DEVINE (SUPRAPUBIC SOUND AND GUIDE)

Gastroenterology & Urology · 63d

Cleared Sep 30, 1987

URETERAL BULB DILATORS

Gastroenterology & Urology · 49d

Cleared Jun 10, 1987

Gastroenterology & Urology · 43d

Cleared May 11, 1987

GASTROINTESTINAL TUBE

Gastroenterology & Urology · 95d

Cleared Oct 24, 1986

PENN 3-RING HANDLE

Gastroenterology & Urology · 98d

Cleared Sep 11, 1986

PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR

Gastroenterology & Urology · 100d