BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INTEGRA LIFESCIENCES CORPORATION

    Reg #: 3004608878 · FEI: 3004608878 · Expires 2026
    View on FDA
    Products
    188
    Proprietary Names
    105
    Establishment Types
    4
    Classifications
    188

    Registration Details

    Registration Name
    INTEGRA LIFESCIENCES CORPORATION
    Registration Number
    3004608878
    FEI Number
    3004608878
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4900 CHARLEMAR DR.,, BUILDING A
    City
    CINCINNATI
    State
    OH
    ZIP
    45227
    Country
    US

    Regulatory Submissions

    510(k) Number
    K112090

    Owner / Operator

    Firm Name
    Integra LifeSciences Corporation
    Operator Number
    9004007
    Address
    1100 Campus Rd
    City
    Princeton
    State
    NJ
    Postal Code
    08540
    Country
    US

    Products

    Device Name Product Code
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Curette HTF
    Catheter, Irrigation GBX
    Holder, Head, Neurosurgical (Skull Clamp) HBL
    Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) KNF
    Depressor, Tongue, Non-Surgical FMA
    Laparoscopic Accessories, Gynecologic NWV
    Knife, Nasal KAS
    Knife, Ear JYO
    Knife, Surgical EMF
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Elevator, Surgical, General & Plastic Surgery GEG
    Catheter And Tip, Suction JOL
    Saw, Nasal KBC
    Instrument, Microsurgical GZX
    Drills, Burrs, Trephines & Accessories (Manual) HBG
    Orthopedic Stereotaxic Instrument OLO
    Tray, Surgical, Instrument FSM
    Scissors, Ophthalmic HNF
    Neurosurgical Ultrasonic Instruments LBK
    Instrument, Ultrasonic Surgical LFL
    Pick, Microsurgical Ear JYT
    Scissors, General, Surgical LRW
    Punch, Ent KTF
    Handle, Scalpel GDZ
    Needle, Tonsil Suturing KBR
    Irrigator, Sinus KAR
    Mallet HXL
    Dilator, Esophageal, Ent KCF
    Snare, Nasal KBE
    Stripper, Surgical HRT
    Curette, Nasal KAP
    Holder, Ear Speculum JYK
    Headrest, Neurosurgical HBM
    Laryngoscope, Rigid CCW
    Retractor, Self-Retaining, For Neurosurgery GZT
    Gag, Mouth KBN
    Table, Operating-Room, Manual FSE
    Retractor, Ent KAL
    Neurological Stereotaxic Instrument HAW
    System, Planning, Radiation Therapy Treatment MUJ
    Retractor GAD
    Retractor, Self-Retaining FFO
    Cutter, Wire HXZ
    Osteotome, Manual GFI
    Graft, Vascular, Stainless Steel Tunneler MZY
    Rasp, Nasal KBA
    Cutter, Surgical FZT
    Punch, Surgical LRY
    Trocar, Ent KTE
    Laparoscope, Gynecologic (And Accessories) HET
    Clamp, Vascular DXC
    Probe, Ent KAK
    Tube, Ear Suction JZF
    Holder, Needle, Gastroenterologic FHQ
    Nipper, Malleus JYR
    Block, Cutting, Ent, Non-Sterile NNR
    Gouge, Nasal, Ent KAQ
    Spatula, Surgical, General & Plastic Surgery GAF
    Elevator, Ent KAD
    Needle, Aspiration And Injection, Disposable GAA
    Knife, Ent KTG
    Instrument, Cast Application/Removal, Manual LGG
    Mirror, General & Plastic Surgery FTX
    Instrument, Cutting, Orthopedic HTZ
    Orthopedic Manual Surgical Instrument LXH
    Speculum, Ent EPY
    Accelerator, Linear, Medical IYE
    Knife, Laryngeal JZY
    Rasp, Ear JYY
    Curette, Adenoid KBJ
    Rongeur HTX
    Laparoscope, General & Plastic Surgery GCJ
    Forceps, Tooth Extractor, Surgical EMG
    Forceps HTD
    Needle, Aspiration And Injection, Reusable GDM
    Forceps, Wire Holding HYA
    Packer, Uterine HDM
    Forceps, Rongeur, Surgical EMH
    Depressor, Metal Tongue, Surgical KBL
    Forceps, Surgical, Gynecological HCZ
    Dissector, Surgical, General & Plastic Surgery GDI
    Bur, Ear, Nose And Throat EQJ
    Retractor, Non-Self-Retaining FGN
    Endoscope, Neurological GWG
    Light, Surgical, Fiberoptic FST
    Gouge, Surgical, General & Plastic Surgery GDH
    Pliers, Surgical HTC
    Passer, Wire, Orthopedic HXI
    Stylet For Catheter, Gastro-Urology EZB
    Punch, Nasal KAY
    Knife, Tonsil KBQ
    Scalpel, One-Piece GDX
    Retractor, Ophthalmic HNI
    Speculum, Vaginal, Metal HDF
    Dilator, Vessel, Surgical DWP
    Rongeur, Manual HAE
    Ligator, Hemorrhoidal FHN
    Syringe, Ent KCP
    Punch, Antrum KAW
    Clamp, Ossicle Holding JYF
    Probe And Director, Gastro-Urology FGM
    Instrument, Ligature Passing And Knot Tying HCF
    Loop, Wire JYQ
    Rasp, Surgical, General & Plastic Surgery GAC
    Hemostat HRQ
    Driver, Prosthesis HWR
    Screwdriver HXX
    Mobilizer, Ent KAJ
    Adenotome KBH
    Expander, Surgical, Skin Graft FZW
    Indicator, Physical/Chemical Sterilization Process JOJ
    Mirror, Ent KAI
    Rod, Measuring Ear JYZ
    Forceps, General & Plastic Surgery GEN
    Dermatome GFD
    Unit, Cryosurgical, Accessories GEH
    Gauge, Measuring JYJ
    Tourniquet, Gastro-Urology EYR
    Curette, Surgical, General Use FZS
    Instrument, Ent Manual Surgical LRC
    Die, Wire Bending, Ent, Non-Sterile NNP
    Dilator, Tracheal KCG
    Forceps, Ent KAE
    Knife, Myringotomy JYP
    Rongeur, Nasal KBB
    Press, Vein JYW
    Specula Accessories FXG
    Cannula, Sinus KAM
    Instrument, Surgical, Non-Powered HAO
    Caliper KTZ
    Passer HWQ
    Bone Mill LYS
    Sound, Urethral, Metal Or Plastic FBX
    Table And Attachments, Operating-Room BWN
    Hammer, Surgical FZY
    Snare, Tonsil KBZ
    Plier, Orthodontic JEX
    Needle, Catheter GCB
    Hook, Tracheal KCH
    Forceps, Ophthalmic HNR
    Inserter, Myringotomy Tube JYM
    Chisel, Surgical, Manual FZO
    Clamp, Surgical, General & Plastic Surgery GDJ
    Rongeur, Mastoid JZA
    Dilator, Cervical, Fixed Size HDQ
    Hook, Surgical, General & Plastic Surgery GDG
    Tray, Surgical, Ent MMO
    Curette, Uterine HCY
    Stripper, Vein, Reusable GAI
    Applicator, Ent KCJ
    Cannula, Ear JYC
    Cannula, Injection FGY
    Punch, Adenoid KBS
    Hook, Microsurgical Ear JYL
    Clamp HXD
    Stylet, Surgical, General & Plastic Surgery GAH
    Speculum, Rectal FFQ
    Osteotome HWM
    Source, Carrier, Fiberoptic Light EQH
    Endoscope, Rigid GCM
    Tape, Measuring, Rulers And Calipers FTY
    Forceps, Biopsy, Gynecological HFB
    Instrument, Manual, Surgical, General Use MDM
    Tray, Surgical LRP
    Tenaculum, Uterine HDC
    Instruments, Surgical, Cardiovascular DWS
    Camera, Television, Surgical, With Audio FWC
    Operating Room Accessories Table Tray FWZ
    Tube, Tonsil Suction KCB
    Chisel, Middle-Ear JYE
    Scissors, Ear JZB
    Hook, Ophthalmic HNQ
    Twister, Wire HXS
    Clamp, Non-Electrical FFN
    Blade, Scalpel GES
    Curette, Ear JYG
    Chisel, Nasal KAN
    Trocar, Sinus KBG
    Mallet, Surgical, General & Plastic Surgery GFJ
    Rasp, Frontal-Sinus KAZ
    Knife, Orthopedic HTS
    Excavator, Ear JYH
    Specula, Ophthalmic HNC
    Tube, Laryngectomy KAC
    Scissors, Nasal KBD
    Fork, Tuning GWX
    Probe, Lachrymal HNL

    Proprietary Names

    Integra Padgett Jarit MicroFrance MAYFIELD Skull Clamp MAYFIELD 2 Skull Clamp Jarit Supercut Roto-Lok Roto-Cam Miltex Integra Jarit Ruggles-Redmond LumbarTrak Mayfield MR/CT Skull Clamp Codman Instrument Tray Integra Allograft Wedge Instrument Tray Assembly Carb-N-Sert CARB-EDGE CUSA Clarity Ultrasonic Surgical Aspirator System; C7602; C7602EA 5-700;5-702;5801;5803;5804 Acclarent Relieva Vortex 2 Mayfield Adult Disposable Skull Pin Integra Miltex Mayfield BUDDE Halo Retractor System Nashold Biopsy Needle - Single Use Nashold Biopsy Needle - Disposable RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE CRW Biopsy Plus XKnife 5 Galea Elevator Arkis Galea Elevator Mayfield 2000 Radiolucent Skull Cla Mayfield Infinity XR2 Skull Clamp 33-34-SH;33-35;33-35-SH;33-36;33-36-SH;33-37;33-38 33-31;33-31A;33-31AA;33-31AA-P/25;33-31A-P/25;33-31B;33-31-P/25;33-32;33-32-P/25;33-33;33-33-SH;33-34;33-34-P/25 CARDIO-GRIP Mayfield A-2000 Skull Clamp Ceram-A-Grip Petit-Point CARB-BITE 5-800 MAYFIELD Integra Anti-Rotation Peg Holder Integra Allograft Wedge Sizer Instrument Integra Allograft Wedge Instrument Set Gill-Thomas Cosman GTC Dental Tray Grip Deep Xcision GENERAL INSTRUMENT Cardio-Grip Redmond Integra Luxtec UltraLitePro UltraLite Plus Mayfield Child Disposable Skull Pin 33-100;4-410;4-411;4-412;4-415;4-420;4-421;4-422;4-423;4-510;4-511;4-512;4-515;4-515C;4-522 Probe 8" Mayfield Titanium Skull Pins Reusab Mayfield Titanium Skull Pins Dispos Blade P4596 CRW-1 System CRW Precision Arc Steriotactic System CRW Diamond Integra Padgett Miltex Cryosolutions 33-52;33-53;33-54;33-55;33-57 Cosgrove Depth Electrode Kit Thompson Relieva Sidekick LP Relieva Flex Guide Catheter Codman Ventricular Needles Subcutaneous Guidewire Arkis Subcutaneous Guideware Mayfield Infinity Skull Clamp Mayfield Base Unit Mayfield MR/X-Ray Skull Clamp CODMAN Bipolar Cords CRW Precision Arc Sterotactic System Mayfield Infinity XR2 MR Skull Clamp Mayfield Radiolucent Disposable Skull Pins METIS Integra Luxtec DLX UltraLite Pro Luxtec Fiber Optic Cables Light Guide Cable Adapters Relieva Luma Light Guide Cable 2 NeuroSight Arc Software Wound Measuring Kit Wing-Grip CODMAN Disposable Tunneler for Subcutaneous Placement of Catheters Arkis Subcutaneous Guidewire Loop Canulator / Canulator Ruggles-Red Jarit Star Petit-Pt Jarit Super Integra Luxtec DLX UltraLite Pro Camera System Mayfield Base Unit Adaptors Integra Omni-Tract Surgical Retractor Systems Mayfield Composite Series Skull Clamp CUSA Excel+ Ultrasonic Surgical Aspirator System; C2623; C5623; CUSAEXCEL2; C2600; C5601; C5602 4-322;4-323;4-325;4610;4611;4615 4-110;4-111;4-112;4-112B;4-115;4-115C;4-120;4-121;4-122;4-123;4-125;4-310;4-311;4-312;4-312B;4-315;4-315C;4-320;4-321 CUSA Clarity Ultrasonic Surgical Aspirator System; C7023; C7123; C7623; C7601; C7601EA

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility