Integra Lifesciences Corp. is one of 13162 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Integra Lifesciences Corp. - FDA 510(k) Cleared Devices
Recent clearances: Codman Disposable Perforators, CereLink ICP Monitor, CereLink ICP Extension Cable, CodMan Certas Plus Programmable Valve
29
Total
29
Cleared
0
Denied
Integra Lifesciences Corp. has 29 FDA 510(k) cleared medical devices. Based in Somerville, US.
Historical record: 29 cleared submissions from 1999 to 2019. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Integra Lifesciences Corp. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Integra LifeSciences Corporation as regulatory consultant.
FDA 510(k) Regulatory Record - Integra Lifesciences Corp.
29 devices
Cleared
Jan 20, 2019
Codman Disposable Perforators
Neurology
30d
Cleared
Jan 11, 2019
CereLink ICP Monitor, CereLink ICP Extension Cable
Neurology
32d
Cleared
Nov 20, 2018
CodMan Certas Plus Programmable Valve
Neurology
91d
Cleared
Oct 25, 2018
Codman Certas Plus Electronic Tool Kit
Neurology
101d
Cleared
Dec 18, 2015
CUSA Excel+
General & Plastic Surgery
276d
Cleared
Apr 16, 2015
Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons...
Neurology
56d
Cleared
Aug 30, 2013
INTEGRA LICOX PTO2 MONITOR
Neurology
127d
Cleared
Feb 17, 2010
JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS
Neurology
209d
Cleared
Nov 19, 2009
OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM
Neurology
106d
Cleared
Dec 04, 2008
INTEGRA MESHED BILAYER WOUND MATRIX
General & Plastic Surgery
176d
Cleared
Oct 08, 2008
MAYFIELD MR/X-RAY SKULL CLAMP
Neurology
142d
Cleared
Oct 10, 2007
INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301
General & Plastic Surgery
70d