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
1-16 of 16
Cleared Jun 21, 1996
PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER
K961853 · HRX
General & Plastic Surgery · 38d
Cleared Feb 08, 1996
ACUFEX ENDOBUTTON TAPE
K952535 · GAT
General & Plastic Surgery · 252d
Cleared Jun 30, 1995
ACUFEX ROTATOR CUFF FIXATION BUTTON
K941740 · KGS
General & Plastic Surgery · 449d
Cleared Sep 28, 1994
GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER
K942574 · GCJ
General & Plastic Surgery · 120d
Cleared Apr 12, 1994
ACUFEX VIDEO SYSTEM
K940241 · GCJ
General & Plastic Surgery · 83d
Cleared May 05, 1993
ACUFEX SUTURE RETRIEVER
K926036 · GAE
General & Plastic Surgery · 155d
Cleared May 09, 1990
SURGICAL RETENTION BAR
K902001 · KGS
General & Plastic Surgery · 7d
Cleared Nov 20, 1989
ACUFEX FIXATION BUTTON
K896310 · KGS
General & Plastic Surgery · 19d
Cleared Feb 27, 1989
ACUFEX FIXATION BUTTON
K884565 · KGS
General & Plastic Surgery · 118d
Cleared Jun 01, 1988
ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE
K881224 · GAE
General & Plastic Surgery · 71d
Cleared Mar 19, 1984
ACUFEX DREZ COMMUNICATING DRILL GUIDE
K834350 · FZX
General & Plastic Surgery · 97d
Cleared Jun 16, 1983
UNIVERSAL CANNULA
K830719 · GCJ
General & Plastic Surgery · 100d
Cleared Jun 16, 1983
GRAF MENISCAL SUTURE SET
K830720 · FZX
General & Plastic Surgery · 100d
Cleared May 02, 1983
ACUFEX UNIVERSAL LEG HOLDER
K830707 · FWZ
General & Plastic Surgery · 56d
Cleared Oct 13, 1982
ACUFEX MAGNETIC RETRIEVER
K822439
General & Plastic Surgery · 61d
Cleared Feb 19, 1980
ACUFEX FORCEPS
K800273 · HTD
General & Plastic Surgery · 12d
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