Company · US

Integra Life Sciences Corporation

FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2012. Name variants (Inc, Corp, punctuation) are merged.

3510(k) clearances (0 in 12 months)

31recalls (0 in 12 months)

31recalls that name a 510(k)

Product codes

Code	Device	Records
CAZ	Anesthesia Conduction Kit	29
GXQ	Dura Substitute	1
HBG	Drills, Burrs, Trephines & Accessories (Manual)	1
HCA	Catheter, Ventricular	1
ITH	Equipment, Traction, Powered	1
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Jun 15, 2012	K120600	DURAGEN SECURE DURAL REGNERATION MATRIX Integra Life Sciences	GXQ
Apr 5, 2011	K103248	INTEGRITY SPINAL CARE SYSTEM Integra Life Sciences	ITH
Mar 17, 2011	K103742	ACCELL EVO3 (FORMERLY ACCELL A2I) Integra Life Sciences	MBP

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Sep 21, 2009	Integra Life Sciences Corporation Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS185-01, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation Complete Single Shot Tray, Disposable, Convenience Kit, Reorder Number CUS042, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other pr Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number SS1719, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other pr Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1593-01, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and othe Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS1756, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other produc Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation 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 produc Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation South Texas Pain Tray, Disposable, Convenience Kit, Reorder Number CUS1308-01, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other pr Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation 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 s Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1722-01, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and othe Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation Epidural Catheter Pack with Stylet, Disposable, Convenience Kit, Reorder Number CA20CES, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes an Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation CHIBA Spinal 22G X 3.50, Plastic Hub, Metal Stylet, Disposable, Convenience Kit, Reorder Number PICH2235, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, s Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation Extension Set Pack, Disposable, Convenience Kit, Reorder Number CUS994, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other products Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS651, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other product Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation Nerve Block Tray, Disposable, Convenience Kit, Reorder Number 10-2527, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other products s Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1427, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other p Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number SS1453, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other pr Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation Custom Procedure Tray, Disposable, Convenience Kit, Reorder Number CUS015-01, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other pro Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation Tuohy Needle, 20G X 3.5", Removable Wing, Plastic Hub, Metal Stylet, Calibrations (10BX), Disposable, Convenience Kit, Reorder Number PITRW2035, Integra LifeSciences Corporation, Salt Lake City, Utah Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation Nerve Block Tray, Disposable, Convenience Kit, Reorder Number CUS1044-02, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other product Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation Biopsy Tray (BMTX-1039), Disposable, Convenience Kit, Reorder Number CUS1189, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other pro Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation 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 Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1729-01, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and othe Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS1736-02, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other pro Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS511-08, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation Hand Drill - Sterile, Disposable, Convenience Kit, Reorder Number INS030, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other product Terminated	HBG	K961113
Sep 21, 2009	Integra Life Sciences Corporation Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number 10-2378, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other p Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation Single Shot Epidural Tray, Disposable Convenience Kit, Reorder Number CUS1474-01, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation Nerve Block Tray, Disposable, Convenience Kit, Reorder Number CUS1234, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other products s Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation Universal Block Tray, Disposable, Convenience Tray, Reorder Number CUS1407-06, Integra LifeSciencesCorporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other pro Terminated	CAZ	K945484 K960248
Sep 21, 2009	Integra Life Sciences Corporation 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 produc Terminated	CAZ	K945484 K960248
Jul 20, 2004	Integra Life Sciences Corp. Cranial Access Kit (INS-HITH) included in External CSF Drainage Kit convenience Kit #31176. The kit contains: one Hermetic Large Style Ventricular Catheter Set, one Ventricular Drainage System, one IN Terminated	HCA	K961113

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