Atlas FDA

Integra LifeSciences Corp.

180 FDA 510(k) clearances · Recalling firm

Sort:Newest firstOldest first

◉ Watch Integra LifeSciences Corp.

RecordFirmDate
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Onl recall (Z-0059-2014)Integra LifeSciences Corp.2013-10-23
Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx O recall (Z-0060-2014)Integra LifeSciences Corp.2013-10-23
Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2.S_.EU R recall (Z-0061-2014)Integra LifeSciences Corp.2013-10-23
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.S_.EU Rx recall (Z-0062-2014)Integra LifeSciences Corp.2013-10-23
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.ST_.EU R recall (Z-0063-2014)Integra LifeSciences Corp.2013-10-23
Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screw recall (Z-1685-2013)Integra LifeSciences Corp.2013-07-11
CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of t recall (Z-1568-2013)Integra LifeSciences Corp.2013-06-21
Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Ver recall (Z-1103-2013)Integra LifeSciences Corp.2013-04-12
Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for u recall (Z-0920-2013)Integra LifeSciences Corp.2013-03-08
Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery recall (Z-0886-2013)Integra LifeSciences Corp.2013-02-26
MAYFIELD Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience recall (Z-0869-2013)Integra LifeSciences Corp.2013-02-21
Integra Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, N recall (Z-2123-2012)Integra LifeSciences Corp.2012-08-01
Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosc recall (Z-1984-2012)Integra LifeSciences Corp2012-07-10
Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute composed recall (Z-1795-2012)Integra LifeSciences Corp.2012-06-12
Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is a bone graft substit recall (Z-1796-2012)Integra LifeSciences Corp.2012-06-12
Panta Arthrodesis Nail Support device, 510 (k) #K050882. One (1) unit of product is kitted recall (Z-1428-2012)Integra LifeSciences Corp.2012-04-16
Integra Endoscopic Gastrocnemius Release (EGR) System. The device consists of one (1) unit recall (Z-1226-2012)Integra LifeSciences Corp.2012-03-19
Integra CUSA EXcel Sterile Tips Rx Only Single Use Only Product Usage: For usage in surgic recall (Z-1215-2012)Integra LifeSciences Corp2012-03-15
Integra InterFix CT Adapter (CTA) Intended for cranial fixation during CT scanning and tre recall (Z-1187-2012)Integra LifeSciences Corp2012-03-08
Tibiaxys Ankle Arthrodesis Plate Compression Guide, Model #159635, part # 159 635, Batch # recall (Z-1144-2012)Integra LifeSciences Corp.2012-03-02
Titanium SURFIX ALPHA SCREWS, a component of the Newdeal Hallu Lock Plate System. Surfix A recall (Z-1147-2012)Integra LifeSciences Corp.2012-03-02
Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty, combined wi recall (Z-0986-2012)Integra LifeSciences Corp2012-02-08
Integra PAC1 Mod 2 Cables used with the Integra MPM, CAM01 Monitors recall (Z-0944-2012)Integra LifeSciences Corp2012-02-03
Luxtec UltraLite Pro Headlight with 9ft bifurcated cable Model: AX2000BIF Product Usage: T recall (Z-0373-2012)Integra LifeSciences Corp.2012-01-11
Luxtec UltraLite Headlight System with 9ft premium bifurcated cable Model: AX2100BIF Produ recall (Z-0374-2012)Integra LifeSciences Corp.2012-01-11
Luxtec UltraLite Headlight System Headband Model: AXI375BIF Product Usage: The fiber optic recall (Z-0375-2012)Integra LifeSciences Corp.2012-01-11
Luxtec UltraLite Headlight System with short linkage Model: AX 1375BIFSL Product Usage: Th recall (Z-0376-2012)Integra LifeSciences Corp.2012-01-11
Luxtec UltraLite Headlight System sweatband Model: AXI385BIF Product Usage: The fiber opti recall (Z-0377-2012)Integra LifeSciences Corp.2012-01-11
Luxtec UltraLite Headlight System sweatband with short linkage Model: AXI385BIFSL Product recall (Z-0378-2012)Integra LifeSciences Corp.2012-01-11
Mark II Headlight module-black Model: 001380LX Product Usage: The fiber optic headlight sy recall (Z-0379-2012)Integra LifeSciences Corp.2012-01-11
Mark II Headlight module-black with short linkage Model: 001380LXSL Product Usage: The fib recall (Z-0380-2012)Integra LifeSciences Corp.2012-01-11
UltraLite Headlight module-grey Model: 001328 Product Usage: The fiber optic headlight sys recall (Z-0381-2012)Integra LifeSciences Corp.2012-01-11
Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLX Product Usage: The Integra recall (Z-0356-2012)Integra LifeSciences Corp.2011-12-02
Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXAU Product Usage: The Integ recall (Z-0357-2012)Integra LifeSciences Corp.2011-12-02
Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXEU recall (Z-0358-2012)Integra LifeSciences Corp.2011-12-02
Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 34 recall (Z-2575-2011)Integra LifeSciences Corp.2011-06-22
Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 10 recall (Z-2576-2011)Integra LifeSciences Corp.2011-06-22
Universal Power Supply Units, Part Number DP0007 and DP0800 , for use with the Integra Pad recall (Z-2225-2011)Integra LifeSciences Corp.2011-05-20
Theken L"POD" Titanium Vertebral Body Replacement System, Vu c"POD" PEEK-Optima Vertebral recall (Z-2202-2011)Integra LifeSciences Corp.2011-05-19
Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South, W recall (Z-2194-2011)Integra LifeSciences Corp.2011-05-13
Manta Ray" Anterior Cervical Plate (ACP) System, Intended use: The Manta Ray ACP System is recall (Z-2197-2011)Integra LifeSciences Corp.2011-05-13
Ventricular Bolt Monitoring Kit W/Cranial Access, Drain, 1104HMC, Integra LifeSciences, 34 recall (Z-2171-2011)Integra LifeSciences Corp.2011-05-10
Luxtec MLX 300 Watt Xenon Light Source, Model OOMLX; Surgical/Medical Light Source This li recall (Z-2060-2011)Integra LifeSciences Corp.2011-04-25
LICOX CMP Tissue Oxygen Monitor; Catalog numbers REF AC31. Manufacturer GMS Gesellschaft f recall (Z-1518-2011)Integra LifeSciences Corp.2011-03-03
Vu a-POD Intervertebral Body Fusion Device. Packaged as surgical kits containing all impla recall (Z-1475-2011)Integra LifeSciences Corp.2011-03-02
Integra Radionics HRAIM Intubation Head Ring Assembly Ref: HRAIM Head Rings serve as the g recall (Z-1400-2011)Integra LifeSciences Corp.2011-02-23
Integra Peritoneal Introducer Sheaths, 61 cm;Integra NeuroSciences/REF 901-124; Manufactur recall (Z-1231-2011)Integra LifeSciences Corp.2011-02-14
Newdeal (Newdeal Compression Plate) Model #UNI-CP 339900 Sets, Lot Numbers: E71H, E7V1, E8 recall (Z-0955-2011)Integra LifeSciences Corp.2011-01-25
DuraGen XS Dural Regeneration Matrix: 2 inches x 2 inches. Non Pyrogenic; Rx only;Integra recall (Z-0450-2011)Integra LifeSciences Corp.2010-11-24
DuraGen XS Dural Regeneration Matrix: 3 inches x 3 inches. Non Pyrogenic; Rx only;Integra recall (Z-0451-2011)Integra LifeSciences Corp.2010-11-24
DuraGen XS Dural Regeneration Matrix: 4 inches x 5 inches. Non Pyrogenic; Rx only;Integra recall (Z-0452-2011)Integra LifeSciences Corp.2010-11-24
DuraGen XS Dural Regeneration Matrix: 5 inches x 7 inches. Non Pyrogenic; Rx only;Integra recall (Z-0453-2011)Integra LifeSciences Corp.2010-11-24
DuraGen XS Dural Regeneration Matrix: 1 inch x 3 inches. Non Pyrogenic; Rx only;Integra Li recall (Z-0454-2011)Integra LifeSciences Corp.2010-11-24
Licox Brain PMO Probe Kit; Ref IP2.P; Multiparameter Monitoring Oxygen + ICP Channel: Cont recall (Z-0161-2011)Integra LifeSciences Corp.2010-10-28
Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System CUSANXT1:Latex Free, Rx only: recall (Z-2637-2010)Integra LifeSciences Corp.2010-09-30
Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System CUSANXT2: Latex Free, Rx only recall (Z-2638-2010)Integra LifeSciences Corp.2010-09-30
Integra Suction Reservoir Kit for use with Integra NeuroSciences Subdural Drainage Cathete recall (Z-2588-2010)Integra LifeSciences Corp.2010-09-28
Integra NeuroSciences Implants, NeuroBalloon Catheter, Sterile/EO, Rx only, single use, la recall (Z-2425-2010)Integra LifeSciences Corp2010-09-22
Integra, Licox Ref 1P2.P; Brain PMO-Probe Kit Rx only; Contains Products: REF 1P2 Bolt kit recall (Z-1422-2010)Integra LifeSciences Corp.2010-04-20
Suturable DuraGen Dural Regeneration Matrix; Non-Pyrogenic; Sterility guaranteed unless pa recall (Z-1081-2010)Integra LifeSciences Corp2010-03-11
Integra Bilayer Matrix Wound Dressing, 8 in X 10 in (20 cm x 25 cm); Non-pyrogenic, Do not recall (Z-1174-2009)Integra LifeSciences Corp.2009-04-07
Integra Mosaik Putty, 15cc, Catalog # PTY10256 Integra Lifesciences, Plainsboro, NJ recall (Z-1034-2009)Integra LifeSciences Corp2009-03-06
Integra Dermal Regeneration Template-TS Catalog number 32021 Catalog number 82021 recall (Z-1035-2009)Integra LifeSciences Corp2009-03-06
Integra Ruggles Surgical Instrument ACF Distraction Screws Sterile, Rx only Catalog number recall (Z-0854-2009)Integra LifeSciences Corp.2009-01-23
Gravity Compensating Accessory; High Pressure Range, Sterile, Single Use, Rx only. CSF shu recall (Z-0458-2009)Integra LifeSciences Corp.2008-12-12
Uni-CP Compression Forceps (spreader); Non-sterile, R only, Catalog number: 339001ND Newde recall (Z-0307-2009)Integra LifeSciences Corp2008-12-01
Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile; Integra LifeSci recall (Z-2328-2008)Integra LifeSciences Corp2008-09-20
PANTA Nails, 10mm x 150 length, Newdeal, Lyon France; Integra, 311 Enterprise Drive, Plain recall (Z-1877-2008)Integra LifeSciences Corp.2008-09-16
QWIX Screw 4.3mm diam; length 26 mm; The stabilization screw is indicated for fixation of recall (Z-1445-2008)Integra LifeSciences Corp.2008-08-15
QWIX Screw 4.3mm diam, length 28 mm; The stabilization screw is indicated for fixation of recall (Z-1446-2008)Integra LifeSciences Corp.2008-08-15
Endura No-React Dural Substitute 2 cm x 10 cm recall (Z-0827-2007)Integra LifeSciences Corp.2007-05-24
EnDura No-React Dural Substitute 4 cm X 4 cm. recall (Z-0828-2007)Integra LifeSciences Corp.2007-05-24
EnDura No-React Dural Substitute 5 cm x 6 cm recall (Z-0829-2007)Integra LifeSciences Corp.2007-05-24
Endura No-React Dural Substitute 6 cm x 10 cm recall (Z-0830-2007)Integra LifeSciences Corp.2007-05-24
EnDura No React Dural Substitute 10 cm x 12 cm recall (Z-0831-2007)Integra LifeSciences Corp.2007-05-24
EnDura No-React Dural Substitute 12 cm Diameter recall (Z-0832-2007)Integra LifeSciences Corp.2007-05-24
BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment. recall (Z-0466-2007)Integra LifeSciences Corp.2007-01-09
Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Ster recall (Z-0431-06)Integra LifeSciences Corp.2006-01-24
Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz recall (Z-0141-06)Integra LifeSciences Corp.2005-11-16
External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implant recall (Z-0606-03)Integra LifeSciences Corp2003-03-05
← Previous

Track Integra LifeSciences Corp. automatically

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