68 results
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62ms
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Sources: EU EUDAMED, US FDA
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Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ Dermal Regeneration Template, (Integra template) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound. Integra template is indicated for the postexcisional treatment of life-threatening full-thickness or deep partial-thickness thermal injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient. Integra template is also indicated for the repair of scar contractures when other therapies have failed or when donor sites for repair are not sufficient or desirable due to the physiological condition of the patient Manufactured by: Integra LifeSciences Corporation 311 Enterprise Drive, Plainsboro, NJ 08536 877-444-1122 USA n 609-936-5400 outside USA 866-800-7742 fax
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·September 21, 2016
Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local or spinal anesthetics. The BD LOR syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp. d.b.a. Integra Pain Management·December 25, 2013
Newdeal (Newdeal Compression Plate) Model #UNI-CP 339900 Sets, Lot Numbers: E71H, E7V1, E86R, EELE, EGTC The Newdeal Compression Plates are intended for fixation of bone fractures or for bone reconstruction.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HRS·November 18, 2010
Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code GWM·August 18, 2014
Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 10-2334, Sterile/EO, Integra LifeSciences Corporation, West Valley City, Utah 84119.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code FMF·May 19, 2011
Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 3403203, Sterile/EO, Integra LifeSciences Corporation, West Valley City, Utah 84119.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code FMF·May 19, 2011
DuraGen XS Dural Regeneration Matrix: 3 inches x 3 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of dura matter.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code GXQ·September 29, 2010
DuraGen XS Dural Regeneration Matrix: 1 inch x 3 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of dura matter.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code GXQ·September 29, 2010
DuraGen XS Dural Regeneration Matrix: 4 inches x 5 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of dura matter.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code GXQ·September 29, 2010
DuraGen XS Dural Regeneration Matrix: 2 inches x 2 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of dura matter
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code GXQ·September 29, 2010
DuraGen XS Dural Regeneration Matrix: 5 inches x 7 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of dura matter.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code GXQ·September 29, 2010
MAYFIELD Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Drive, Building A, Cincinnati, OH 45227 The MAYFIELD Base Units are intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code FWZ·December 21, 2012
Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile; Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 USA
FDA Recall
Terminated
·Integra LifeSciences Corp·Product code MDD·July 2, 2008
Integra LifeSciences Corporation Disposable Convenience Kit, PICC Insertion Tray, CUS791
FDA Recall
Terminated
·Integra Pain Management·Product code FMF·March 18, 2008
Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System CUSANXT2: Latex Free, Rx only. Integra LifeSciences (Ireland) Limited County Offaly, Ireland Distributed by Integra Lifesciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·July 29, 2010
Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System CUSANXT1:Latex Free, Rx only: Integra LifeSciences (Ireland) Limited, County Offaly, Ireland; Distributed by Integra Life Sciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·July 29, 2010
Block Tray, Disposable, Convenience Kit, Reorder Number CUS835, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures.
FDA Recall
Terminated
·Integra Life Sciences Corporation·Product code CAZ·July 13, 2009
Universal Painpak, Disposable, Convenience Kit, Reorder Number SS3278, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures.
FDA Recall
Terminated
·Integra Life Sciences Corporation·Product code CAZ·July 13, 2009
Nerve Block Tray, Disposable, Convenience Kit, Reorder Number DYNJTS0382B, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures.
FDA Recall
Terminated
·Integra Life Sciences Corporation·Product code CAZ·July 13, 2009
Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS1619, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures.
FDA Recall
Terminated
·Integra Life Sciences Corporation·Product code CAZ·July 13, 2009