Integra LifeSciences Corporation
Integra LifeSciences Corporation holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2025, with 29 FDA device recalls on record.
Top product codes for Integra LifeSciences Corporation
FDA recalls by Integra LifeSciences Corporation
10 most recent of 29- Z-2777-2016 — 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
- Z-1084-2015 — The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park-bench and sitting positions. It is intended to be used during diagnostic examinations or surgical procedures where a rigid support between the surgical table and a headrest or skull clamp is necessary and positional freedom is required.
- Z-1697-2014 — Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to anchor various sizes and shapes of bone fixation plates when treating bone fractures or reconstruction of the ankle, foot or hand.
- Z-1736-2013 — Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
- Z-1291-2013 — Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.
- Z-1292-2013 — CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.
- Z-1301-2013 — BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
- Z-1296-2013 — OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.
- Z-1302-2013 — Absorbable Collagen Sponge Provided As Intermediate to Another Company
- Z-1297-2013 — Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Integra LifeSciences Corporation
- K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System
- K250752 — AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
- K240493 — CUSA® Clarity Ultrasonic Surgical Aspirator System
- K230427 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K221835 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K221763 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K210128 — INTEGRA Wound Matrix (Macro-Channels)
- K210016 — Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System
- K193346 — Codman Surgical Patties & Strips
- K201507 — Cadence Total Ankle System
- K200774 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K190588 — Integra TITAN Reverse Shoulder System
- K191684 — MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System
- K190180 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K182809 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K182801 — Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable
- K181639 — Panta 2 Arthrodesis Nail System
- K181999 — Integra TITAN Reverse Shoulder System
- K173717 — Integra TITAN Reverse Shoulder System
- K172595 — CUSA Excel+ Ultrasonic Surgical Aspirator System
- K163456 — DuraGen Secure Dural Regeneration Matrix
- K163457 — NeuraGen 3D Nerve Guide Matrix
- K160811 — CRW STEREOTACTIC SYSTEM
- K161882 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K161992 — Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems
- K161189 — Integra TITAN Reverse Shoulder System
- K153041 — Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling
- K152897 — Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory
- K140722 — INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS
- K142238 — MAYFIELD Skull Clamp
- K141668 — CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM
- K141674 — CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM
- K142414 — Miltex N-Tralig Intraligamentary Syringe
- K130557 — NEURAGEN 3D
- K134047 — JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS
- K132250 — INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
- K133754 — INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER
- K131446 — INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES
- K130389 — MAYFIELD INFINITY XR2 SKULL CLAMP
- K123000 — INTEGRA TOTAL FOOT SYSTEMS
- K120012 — INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS
- K120633 — MAYFIELD SKULL CLAMP
- K113104 — INTEGRA WOUND MATRIX (THIN)
- K103726 — JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS
- K101381 — HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS
- K110528 — INTEGRA LED SURGICAL HEADLIGHT SYSTEM
- K102875 — CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT
- K102802 — INTEGRA ELECTRODE TUNNELING NEEDLE
- K093968 — OSV II LOW FLOW LOW PRO VALVE
- K092388 — DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO
- K093163 — INTEGRA TOTAL WRIST FUSION SYSTEM
- K091302 — INTEGRA MOZAIK AND OS MOLDABLE MORSELS
- K090506 — MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114
- K072929 — LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030
- K072208 — MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
- K071505 — MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM
- K071458 — MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
- K062353 — MOZAIK BONE REGENERATION MATRIX - PUTTY
- K062599 — MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS
- K061640 — INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
- K053655 — TENDON WRAP TENDON PROTECTOR
- K053045 — MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
- K042825 — ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
- K040860 — INTEGRA BONE FIXATION SYSTEM
- K040235 — LICOX PMO BRAIN MONITORING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.