Medical Device Manufacturer · US , West Lafayette , IN

Cook Biotech, Inc. - FDA 510(k) Cleared Devices

31 submissions · 31 cleared · Since 1998
31
Total
31
Cleared
0
Denied

Cook Biotech, Inc. — FDA 510(k) Products and Clearance History General & Plastic Surgery

23 devices
1-23 of 23
Cleared Jul 23, 2014
SIS HERNIA GRAFT
K133306 · FTM
General & Plastic Surgery · 268d
Cleared Jun 20, 2014
DIAPHRAGMATIC HERNIA GRAFT
K133011 · OWV
General & Plastic Surgery · 268d
Cleared Apr 02, 2012
HYBRID GRAFT
K111695 · FTL
General & Plastic Surgery · 291d
Cleared Jun 20, 2011
BIODESIGN NIPPLE RECONSTRUCTION CYLINDER
K110402 · FTM
General & Plastic Surgery · 129d
Cleared Feb 27, 2009
SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG
K082682 · FTM
General & Plastic Surgery · 165d
Cleared Mar 21, 2008
SURGISIS BIODESIGN TISSUE GRAFT
K073391 · FTM
General & Plastic Surgery · 109d
Cleared Oct 17, 2007
MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT
K070405 · FTM
General & Plastic Surgery · 247d
Cleared Apr 05, 2007
SIS FACIAL CYLINDER, SIS FACIAL IMPLANT
K070738 · FTM
General & Plastic Surgery · 20d
Cleared Oct 13, 2006
SURGISIS, SURGISIS ES
K062696 · FTM
General & Plastic Surgery · 32d
Cleared Oct 13, 2006
SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT
K062697 · FTL
General & Plastic Surgery · 32d
Cleared Oct 10, 2006
SURGISIS RVP RECTO-VAGINAL FISTULA PLUG
K062729 · FTM
General & Plastic Surgery · 27d
Cleared Oct 02, 2006
SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100
K062320 · FTM
General & Plastic Surgery · 54d
Cleared Jul 19, 2006
OASIS WOUND MATRIX
K061711 · KGN
General & Plastic Surgery · 30d
Cleared Sep 23, 2005
SURGISIS STAPLE LINE REINFORCEMENT II
K051048 · FTM
General & Plastic Surgery · 151d
Cleared May 19, 2005
SIS DERMAL AUGMENTATION STRAND
K050246 · FTM
General & Plastic Surgery · 106d
Cleared Mar 09, 2005
SIS FISTULA PLUG
K050337 · FTM
General & Plastic Surgery · 27d
Cleared Feb 18, 2004
SIS PLASTIC SURGERY MATRIX
K034039 · FTM
General & Plastic Surgery · 51d
Cleared Aug 23, 2002
SURGISIS STAPLE LINE REINFORCEMENT
K022044 · OXE
General & Plastic Surgery · 60d
Cleared May 30, 2002
SS MATRIX
K020732 · KGN
General & Plastic Surgery · 85d
Cleared Jan 06, 2000
SIS WOUND DRESSING II
K993948 · KGN
General & Plastic Surgery · 45d
Cleared Sep 23, 1999
SURGISIS SLING
K992159 · PAG
General & Plastic Surgery · 90d
Cleared May 28, 1998
SURGISIS
K980431 · FTM
General & Plastic Surgery · 113d
Cleared Apr 30, 1998
SIS WOUND DRESSING
K973170 · KGN
General & Plastic Surgery · 248d
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