Medical Device Manufacturer · US , Planisboro , NJ

Integra LifeSciences Corporation - FDA 510(k) Cleared Devices

65 submissions · 65 cleared · Since 2004
65
Total
65
Cleared
0
Denied
65 devices
26-50 of 65
Cleared Aug 25, 2016
Integra TITAN Reverse Shoulder System
K161189 · PHX
Orthopedic · 120d
Cleared Mar 14, 2016
Bundled Neurological Shunts and Accessories Product Families Labeling...
K153041 · JXG
Neurology · 147d
Cleared Mar 04, 2016
Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel...
K152897 · JXG
Neurology · 155d
Cleared Jan 06, 2015
INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW...
K140722 · JXG
Neurology · 291d
Cleared Nov 24, 2014
MAYFIELD Skull Clamp
K142238 · HBL
Neurology · 103d
Cleared Nov 06, 2014
CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K141668 · LFL
General & Plastic Surgery · 136d
Cleared Nov 06, 2014
CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K141674 · LFL
General & Plastic Surgery · 136d
Cleared Oct 30, 2014
Miltex N-Tralig Intraligamentary Syringe
K142414 · EJI
Dental · 63d
Cleared Apr 24, 2014
NEURAGEN 3D
K130557 · JXI
Neurology · 416d
Cleared Apr 11, 2014
JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND...
K134047 · HCZ
Obstetrics & Gynecology · 101d
Cleared Mar 24, 2014
INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
K132250 · JWJ
Orthopedic · 248d
Cleared Mar 06, 2014
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH...
K133754 · GWM
Neurology · 87d
Cleared Oct 28, 2013
INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES
K131446 · DQR
Cardiovascular · 161d
Cleared Apr 23, 2013
MAYFIELD INFINITY XR2 SKULL CLAMP
K130389 · HBL
Neurology · 67d
Cleared Dec 21, 2012
INTEGRA TOTAL FOOT SYSTEMS
K123000 · HRS
Orthopedic · 85d
Cleared Sep 11, 2012
INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS
K120012 · GCJ
General & Plastic Surgery · 252d
Cleared May 24, 2012
MAYFIELD SKULL CLAMP
K120633 · HBL
Neurology · 84d
Cleared Feb 09, 2012
INTEGRA WOUND MATRIX (THIN)
K113104 · KGN
General & Plastic Surgery · 112d
Cleared Feb 08, 2012
JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS
K103726 · KNF
Obstetrics & Gynecology · 413d
Cleared Jul 07, 2011
HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS
K101381 · JXG
Neurology · 416d
Cleared May 11, 2011
INTEGRA LED SURGICAL HEADLIGHT SYSTEM
K110528 · FSR
Ophthalmic · 76d
Cleared Dec 20, 2010
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT
K102875 · GWM
Neurology · 80d
Cleared Nov 23, 2010
INTEGRA ELECTRODE TUNNELING NEEDLE
K102802 · GYC
Neurology · 57d
Cleared Jan 22, 2010
OSV II LOW FLOW LOW PRO VALVE
K093968 · JXG
Neurology · 30d
Cleared Jan 21, 2010
DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM,...
K092388 · GXQ
Neurology · 169d
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