Medical Device Manufacturer · US , Mchenry , IL

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

8 submissions · 6 cleared · Since 1981

Recent clearances: TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION)

8

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gerard Medical Enterprises, Inc. General Hospital ✕

7 devices

1-7 of 7

Cleared May 24, 1996

TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION)

General Hospital · 262d

Cleared Mar 07, 1995

General Hospital · 130d

Cleared Aug 23, 1994

General Hospital · 88d

Cleared Dec 04, 1992

DUAL PLASTIC VASCULAR ACCESS SYSTEM

General Hospital · 211d

Cleared Jan 02, 1992

TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT

General Hospital · 178d

Cleared Oct 08, 1991

MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE

General Hospital · 148d

Cleared Oct 31, 1990

GERARD MEDICAL, INC. TRIM-PORT

General Hospital · 97d