Medical Device Manufacturer · US , Wyckoff , NJ

Promedical , Ltd.

5 submissions · 5 cleared · Since 1994

Total

Cleared

Denied

Promedical , Ltd. — FDA 510(k) Submissions

Promedical , Ltd. has submitted 5 FDA 510(k) premarket notifications since 1994, of which 5 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Biopsy Needle, Guide, Needle, Surgical, Bone Marrow Collection/transfusion Kit . Use the specialty filter in the sidebar to narrow results.

5 devices

1–5 of 5

PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM

K954596 · FCG Biopsy Needle · Gastroenterology & Urology

Oct 1995 4d

JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)

K952350 · LWE Bone Marrow... · General Hospital

Jul 1995 59d

PRO-B BIOPSY NEEDLE

K951598 · FCG Biopsy Needle · Gastroenterology & Urology

Apr 1995 14d

CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE