Medical Device Manufacturer · US , Mchenry , IL

Acufex Microsurgical, Inc. - FDA 510(k) Cleared Devices

78 submissions · 75 cleared · Since 1980

78

Total

75

Cleared

0

Denied

FDA 510(k) Regulatory Record - Acufex Microsurgical, Inc. General & Plastic Surgery ✕

16 devices

1-12 of 16

Cleared Jun 21, 1996

PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER

General & Plastic Surgery · 38d

Cleared Feb 08, 1996

ACUFEX ENDOBUTTON TAPE

General & Plastic Surgery · 252d

Cleared Jun 30, 1995

ACUFEX ROTATOR CUFF FIXATION BUTTON

General & Plastic Surgery · 449d

Cleared Sep 28, 1994

GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER

General & Plastic Surgery · 120d

Cleared Apr 12, 1994

ACUFEX VIDEO SYSTEM

General & Plastic Surgery · 83d

Cleared May 05, 1993

ACUFEX SUTURE RETRIEVER

General & Plastic Surgery · 155d

Cleared May 09, 1990

SURGICAL RETENTION BAR

General & Plastic Surgery · 7d

Cleared Nov 20, 1989

ACUFEX FIXATION BUTTON

General & Plastic Surgery · 19d

Cleared Feb 27, 1989

ACUFEX FIXATION BUTTON

General & Plastic Surgery · 118d

Cleared Jun 01, 1988

ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE

General & Plastic Surgery · 71d

Cleared Mar 19, 1984

ACUFEX DREZ COMMUNICATING DRILL GUIDE

General & Plastic Surgery · 97d

Cleared Jun 16, 1983

UNIVERSAL CANNULA

General & Plastic Surgery · 100d