Cook Biotech, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Cook Biotech, Inc. - FDA 510(k) Cleared Devices
Recent clearances: SIS HERNIA GRAFT, DIAPHRAGMATIC HERNIA GRAFT, BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
31
Total
31
Cleared
0
Denied
Cook Biotech, Inc. has 31 FDA 510(k) cleared general & plastic surgery devices. Based in West Lafayette, US.
Historical record: 31 cleared submissions from 1998 to 2014.
Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.
1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Cook Biotech, Inc.
31 devices
Cleared
Jul 23, 2014
SIS HERNIA GRAFT
General & Plastic Surgery
268d
Cleared
CT
Jun 20, 2014
DIAPHRAGMATIC HERNIA GRAFT
General & Plastic Surgery
268d
Cleared
Oct 08, 2013
BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
Neurology
180d
Cleared
Apr 02, 2012
HYBRID GRAFT
General & Plastic Surgery
291d
Cleared
Jun 20, 2011
BIODESIGN NIPPLE RECONSTRUCTION CYLINDER
General & Plastic Surgery
129d
Cleared
Jul 10, 2009
COOK UROLOGICAL GRAFT
Gastroenterology & Urology
116d
Cleared
Feb 27, 2009
SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG
General & Plastic Surgery
165d
Cleared
Oct 02, 2008
DYNAMATRIX
Dental
73d
Cleared
Mar 21, 2008
SURGISIS BIODESIGN TISSUE GRAFT
General & Plastic Surgery
109d
Cleared
Oct 17, 2007
MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT
General & Plastic Surgery
247d
Cleared
Apr 05, 2007
SIS FACIAL CYLINDER, SIS FACIAL IMPLANT
General & Plastic Surgery
20d
Cleared
Oct 13, 2006
SURGISIS, SURGISIS ES
General & Plastic Surgery
32d