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Integra LifeSciences Corporation

33 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
The MAYFIELD Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: recall (Z-1084-2015)Integra LifeSciences Corporation2015-02-10
Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and recall (Z-1697-2014)Integra LifeSciences Corporation2014-06-02
Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis recall (Z-1736-2013)Integra LifeSciences Corporation2013-07-16
Dural Graft Matrix DuraGen Dural Graft Matrix is an absorbable implant for repair of dural recall (Z-1282-2013)Integra LifeSciences Corporation2013-05-10
Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is recall (Z-1283-2013)Integra LifeSciences Corporation2013-05-10
DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbab recall (Z-1284-2013)Integra LifeSciences Corporation2013-05-10
DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable recall (Z-1285-2013)Integra LifeSciences Corporation2013-05-10
NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of per recall (Z-1286-2013)Integra LifeSciences Corporation2013-05-10
NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve disc recall (Z-1287-2013)Integra LifeSciences Corporation2013-05-10
INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in recall (Z-1288-2013)Integra LifeSciences Corporation2013-05-10
Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures recall (Z-1289-2013)Integra LifeSciences Corporation2013-05-10
Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedure recall (Z-1290-2013)Integra LifeSciences Corporation2013-05-10
Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen W recall (Z-1291-2013)Integra LifeSciences Corporation2013-05-10
CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wo recall (Z-1292-2013)Integra LifeSciences Corporation2013-05-10
CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wo recall (Z-1293-2013)Integra LifeSciences Corporation2013-05-10
HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wou recall (Z-1294-2013)Integra LifeSciences Corporation2013-05-10
HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wou recall (Z-1295-2013)Integra LifeSciences Corporation2013-05-10
OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Woun recall (Z-1296-2013)Integra LifeSciences Corporation2013-05-10
Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wou recall (Z-1297-2013)Integra LifeSciences Corporation2013-05-10
OraMem Absorbable Collagen Membrane OraMem Absorbable Collagen Membrane is an absorbable, recall (Z-1298-2013)Integra LifeSciences Corporation2013-05-10
BioMend Extend" Absorbable Collagen Membrane BioMend Extend" Absorbable Collagen Membrane recall (Z-1299-2013)Integra LifeSciences Corporation2013-05-10
Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable i recall (Z-1300-2013)Integra LifeSciences Corporation2013-05-10
BioMend Absorbable Collagen Membrane BioMend Absorbable Collagen Membrane is an absorbable recall (Z-1301-2013)Integra LifeSciences Corporation2013-05-10
Absorbable Collagen Sponge Provided As Intermediate to Another Company recall (Z-1302-2013)Integra LifeSciences Corporation2013-05-10
MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral recall (Z-0558-2013)Integra LifeSciences Corporation2012-12-19
MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull C recall (Z-0559-2013)Integra LifeSciences Corporation2012-12-19
Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly recall (Z-2428-2012)Integra LifeSciences Corporation2012-09-20
Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is use recall (Z-2429-2012)Integra LifeSciences Corporation2012-09-20
Panta Support Device Panta Arthrodesis Nail Instrumentation Tray One unit per package. The recall (Z-0308-2011)Integra LifeSciences Corporation2010-11-02
Mayfield Infinity XR2 Base Unit, model A-2079, manufactured by Integra LifeSciences Corpor recall (Z-2336-2010)Integra LifeSciences Corporation2010-09-09
Qwix 4.3mm Stabilization Screws - 32mm recall (Z-1253-2010)Integra LifeSciences Corporation2010-04-07
Qwix 4.3mm Stabilization Screws - 34mm recall (Z-1254-2010)Integra LifeSciences Corporation2010-04-07
MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020 recall (Z-1221-04)Integra LifeSciences Corporation2004-07-27

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Every clearance here is in the API, with alerts when new ones post.