Integra LifeSciences Corporation

FDA Device Registration & Listing · Princeton, NJ, US · Registration 3003418325

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003418325
FEI Number
3003418325
Entity Name
Integra LifeSciences Corporation
City/State/Country
Princeton, NJ, US
Establishment Address
1100 Campus Road, Princeton, NJ 08540, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Integra LifeSciences Corporation (Owner Number: 9004007)
Owner / Operator Contact Address
1100 Campus Rd, Princeton, NJ 08540, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K082349
PMA Number
N/A

All Registered Proprietary Names

Integra Integra Jarit Integra Miltex Jarit Miltex Miltex Jarit Integra Jarit Miltex MicroFrance Integra Integra Integra Miltex Integra Jarit Integra Ruggles-Redmond Fischer Fischer Cannula CODMAN Elsberg Ventricular Cannula Integra MicroFrance Right Angle Guide CODMAN Mirror Finish Bipolar Forceps CODMAN Spetzler Mirror Finish Bipolar Forceps CODMAN MALIS Mirror Finish Bipolar Forceps CODMAN RHOTON Mirror Finish Bipolar Forceps CODMAN® YASARGIL Mirror Finish Bipolar Forceps Integra Jarit Integra Miltex Integra Integra Jarit Codman Surgical Pattie and Strip DuraSeal Exact Dural Sealant Tri-R Post Miltex Padgett Integra Padgett Jarit Miltex Integra MicroFrance Integra Padgett Padgett Integra MicroFrance Jarit Miltex Padgett OraMem Absorbable Collagen Membrane BioMend Absorbable Collagen Membrane HeliMend Absorbable Collagen Membrane Integra Padgett Miltex Jarit Padgett by Miltex Miltex Integra LICOX PT02 Monitor Acclarent AERA Eustachian Tube Balloon Dilation System DirectLink ICP Extension Cable Patient Monitor Interface Cables DirectLink ICP Module Hermetic TRAUMA CATHETER, VENTRICULAR CATHETER SET Codman Certas Toll Kit CODMAN CERTAS PLUS PROGRAMMAGLE VALVE SYSTEM DuraGen Dural Graft Matrix CereLink ICP Sensor Integra MicroFrance Jarit Miltex Jarit Integra CODMAN EDS 3 - CSF External Drainage System Jarit MicroFrance Integra Miltex Miltex CODMAN EDS 3 - CSF External Drainage System no Catheter Integra MicroFrance MicroFrance CODMAN® HAKIM® Valve Programmer MicroFrance Miltex Integra Padgett Jarit Miltex Padgett CARB-BITE Jarit CODMAN Peel-Away Catheter Introducer Integra Integra Miltex Miltex Integra Jarit Miltex MicroFrance Jarit Miltex Integra Miltex Jarit Integral Drainage Set Integral Ventricular Drainge Set Integral Lumbar Drainge Set TruDi NAVWIRE TenoGlide Tendon Protector Integra Jarit Integra Jarit Medihoney Integra Miltex MicroFrance Jarit Jarit Supercut Jarit MicroFrance Ruggles-Redmond Padgett Miltex Integra Integra Ruggles-Redmond Integra Jarit Miltex Jarit Integra Miltex Padgett Miltex Jarit 5-800 VENTRICULAR DRAINAGE SYSTEM Jarit Integra Miltex Novus Valve System Miltex Miltex Jarit Integra Jarit Miltex Ruggles-Redmond Codman Leroy Scalp Clip Adult Codman Leroy Scalp Clips Pediatric Codman Raney Scalp Clips Codman Leroy Raney Scalp Clips Codman Raney Scalp Clips Bulk Codman Leroy Raney Scalp Bulk DuraGen Plus Dural Regeneration Matrix Miltex Integra Jarit Jarit CUSA Clarity Custom Cart Jarit Miltex Certas Plus Programmable Valve Integra Horizontal-Vertical Lumbar Valve System Integra Miltex MicroFrance Jarit Miltex DuraSeal Dural Sealant SurgiMend PRS Meshed Collagen Matrix Revize-X Collagen Matrix Miltex Integra Jarit MicroFrance Jarit Miltex Integra Cytal Wound Matrix 2-Layer Cytal Burn Matrix Cytal Wound Matrix 3-Layer Cytal Wound Matrix 1-Layer Cytal Wound Matrix 6-Layer Jarit Padgett Miltex Ruggles-Redmond Ruggles-Redmond Integra Jarit MicroFrance Miltex Integra Relieva Spin Balloon Sinuplasty System Jarit Miltex Jarit Integra Integra Miltex Integra Jarit Straight Ventricular Catheter Ventricular Catheter Accessory Kits Miltex MicroFrance Miltex Jarit Integra Miltex DuraGen Dural Graft Matrix CereLink ICP Monitor. CereLink ICP Extension Cable Extended Tip Applicator Miltex Padgett MicroFrance Jarit Integra Cranial Access Kit Hand Drill Miltex Integra Padgett Jarit Ruggles-Redmond CODMAN Bipolar Cords Miltex Jarit Integra Jarit Miltex Jarit MicroFrance Integra Jarit Padgett Miltex MicroFrance Integra MicroFrance Jarit Integra Miltex Miltex Jarit Relieva Tract Balloon Dilation System Miltex Integra Jarit Integra Jarit Miltex NeuraWrap Nerve Protector Acclarent Relieva Circa Ethmoid Punch Integra Jarit MicroFrance Tactile Tone Miltex Integra Ruggles-Redmond Miltex Jarit Padgett External CSF Drainage Systems Integra Miltex Integra Jarit Miltex Jarit Padgett Miltex Integra Single Parameter Monitor SPM-1 Miltex Miltex Jarit MicroFrance Integra Jarit Padgett Ruggles-Redmond Integra Miltex MicroFrance Codman Microsensor Metal Skull Bolt Kit Codman Microsensor Ventricular Catheter Kit Codman Microsensor Plastic Skull Bolt Kit Codman Microsensor Ventricular Catheter Kit With Tuohyborst Adapter Codman Microsensor Basic Kit MicroFrance Jarit Integra OSVII Integra Flow Regulating Valve Low Flow Integra Flow Regulator Integra Miltex MicroFrance MicroFrance Jarit Integra Miltex MicroFrance PriMatrix AG Equi-Flow Valve and Shunt Systems Miltex Padgett Jarit Miltex Integra Miltex Inject-R-Fill Precise Precision Integra Miltex MISHLER 2 CHAMB FLUSHING VALVE,ANTI-SYP DuraGen XS Dural Regeneration Matrix Miltex MicroFrance Jarit Integra Miltex Integra Padgett MicroFrance Jarit Integra Jarit Miltex MicroFrance Relieva Sidekick LP Acclarent Relieva Flex Guide Catheter Miltex Integra Jarit Integra MicroFrance Padgett Miltex 225520; 225525; P4480; P4835; P710; PM-4480; PM-4835; PM-710 CODMAN® HAKIM® Precision Fixed Pressure Valve CODMAN® HAKIM® Programmable Valve; CODMAN® MEDOS® Ventricular Catheter Jarit Miltex Integra Miltex Miltex Padgett Miltex MicroFrance Jarit Integra Ruggles-Redmond Miltex Jarit Acclarent ENT Navigation System Miltex Padgett Miltex Integra Jarit TEW Cranial /Spinal Retractor Syste PriMatrix ASX9/100 ASX9/130 Aurora Surgiscope System ASX9/70 ICB/ASX15 Padgett Sheen Grid Integra Jarit MicroFrance Integra Jarit Miltex Integra MicroFrance Integra Relieva Ultirra Sinus Balloon Catheter NeuraGen Nerve Guide Padgett MicroFrance Padgett Jarit Miltex Integra 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 Miltex CODMAN Bipolar Cords Integra MicroFrance MicroFrance Codman CRAK Kit Miltex Integra Subdural Drainage Catheter Kits Polypropylene Connectors Integra Jarit Ruggles-Redmond Codman® Electrosurgical lrrigator Codman® Electrosurgical Interconnecting Cable Hermetic Plus External CSF Drainage INTEGRA Dermal Regeneration Template INTEGRA Meshed Dermal Regeneration Template Integra Omnigraft Dermal Regeneration Matrix Integra MicroFrance Padgett Jarit CUSA Clarity Ultrasonic Surgical Aspirator System; C7602; C7602EA CODMAN Integrated Bipolar Cord And Tubing Set Padgett Miltex Jarit CODMAN® HAKIM® Programmable Valve Miltex Integra Jarit MicroFrance DuraGen Plus Dural Regeneration Matrix Integra Integra Miltex Miltex CUSA Clarity 23kHz CEM Nosecone Padgett Integra MicroFrance Miltex Jarit Integra Integra Miltex Miltex Tactile Tone Carb-N-Sert Miltex Integra MicroFrance Jarit Ruggles-Redmond Padgett Diamond Peritoneal Introducer and Sheath Integra Gravity Compensating Accessory Integra DP Valve Systems Integra Licox Pt02 Monitor Accessories Malleable Tunneler Padgett Finger Splint Padgett Hand Splint OSVII and OSV Low Pro Valve Systems CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps MicroFrance Integra Acclarent Relieva Vortex 2 Cardion" for Pericardial Repair Jarit Integra Covidien Air Assisted Sprayer Miltex MicroFrance Jarit Integra MicroFrance Integra Endoscopic Ventricular Catheter Integra Miltex Integra Miltex MicroFrance Integra Jarit Jarit Miltex MicroFrance Jarit Padgett Integra Ruggles-Redmond MicroFrance Integra Mayfield Base Unit Jarit Integra Jarit Miltex Padgett Jarit Integra MicroFrance Miltex Wing-Grip CODMAN Disposable Tunneler for Subcutaneous Placement of Catheters Arkis Subcutaneous Guidewire Loop Canulator / Canulator MicroFrance Integra Gentrix Surgical Matrix Plus Gentrix Surgical Matrix Hiatal Gentrix Surgical Matrix Thin Gentrix Surgical Matrix NPH Low Flow Valve Integra Luxtec MLX 300 Watt Xenon Light Jarit Miltex Miltex Jarit Integra Miltex Integra Miltex Integra Padgett Redmond Jarit Ruggles Miltex Jarit Mayfield MR/CT Skull Clamp Padgett Miltex Relieva Ultirra Sinus Balloon Catheter Miltex Miltex Apex Root Locator MicroMatrix® UBM Particulate NeuroSight Arc Software Codman Disposable Perforators Jarit Padgett Miltex Integra Integra Jarit Integra Miltex Padgett Jarit Padgett MicroFrance Miltex Ruggles-Redmond Integra Jarit Integra Jarit Miltex Integra OraMem Absorbable Collagen Membrane BioMend Absorbable Collagen Membrane HeliMend Absorbable Collagen Membrane Integra Flexible EEG Cable Flexible EEG Cables Jarit Integra Integra® Duo LED Surgical Headlight System CSF Reservoirs Integra Flow Regulating Valve Mayfield 2000 Radiolucent Skull Cla INTEGRA Wound Matrix INTEGRA Matrix Wound Dressing Jarit Padgett Miltex Biopatch CODMAN® HAKIM® Programmable Valve CODMAN® HAKIM® Precision Fixed Pressure Valve Integra Miltex Jarit MicroFrance CODMAN LEROY Scalp Clip Applier Forceps CODMAN RANEY Scalp Clip Forceps Codman Bactiseal Endoscopic Ventricular Catheter Jarit MicroFrance Integra Miltex Padgett Mayfield Infinity XR2 Skull Clamp Licox IMC Complete Neuromonitoring Licox IT2 Complete Brain Tunneling Luxtec Light Sources Ultralite MicroFrance Padgett Integra Miltex TruDi Navigation System Acclarent ENT Navigation System Integra MicroFrance Integra Meshed Bilayer Wound Matrix Jarit Miltex Jarit Integra Luxtec MLX Light Source MicroFrance Miltex Integra Disposable Shunt Passer Accudrain External CSF Drainage Sys CODMAN VPV SYSTEM, MODEL 82-3192 Jarit Supercut Roto-Lok Roto-Cam Jarit Miltex Jarit MicroFrance Padgett Miltex Integra Jarit MicroMatrix Flex MicroFrance CODMAN Cranio-blade CODMAN Wire Pass Drill Jarit Integra Ruggles-Redmond Miltex Padgett MicroFrance Wound Measuring Kit MicroFrance Integra Miltex Hakim Percision Valve System Contour-Flex Valve and Shunt System MicroFrance Integra Relieva SpinPlus Balloon Sinuplasty System Miltex Miltex Jarit Integra MicroFrance Jarit Miltex Integra Jarit Integra Miltex CUSA EXCEL Ultrasonic Surgical Aspirator System MicroFrance Integra Polypropylene Burr Hole Reservoir Mayfield Titanium Skull Pins Reusab Mayfield Titanium Skull Pins Dispos Integra Miltex Jarit MicroFrance Integra MicroFrance Padgett Jarit Ruggles-Redmond Miltex Integra Miltex Spectra A EvenWet Lightning Spectra F CODMAN DISPOSABLE SCALP CLIP APPLIER CODMAN CERTAS Plus Electronic Tool Kit Integra Jarit Miltex MicroFrance MicroFrance Integra Miltex Jarit CODMAN EDS 3 - CSF External Drainage System TruDi® Curette Mayfield Base Unit Adaptors Integra Omni-Tract Surgical Retractor Systems Integra Miltex Integra Jarit Relieva Luma Sentry Sinus Illumination System Codman Accessories Ventricular Kit Codman Accessories Cables Codman Accessories Drill Kit Codman Accessories ICP Transducer Basic Kit Codman Microsensor Intracranial Pressure Transducer and Accessories Codman Microsensor Codman Accessories Interface Control Unit Kit Codman Accessories Cranial Access Kit Codman Accessories Bolt Kit Codman Accessories Neuro Monitor Maurice Worldwide Shunt System Essential Shunt Kits Miltex Medihoney Honeycolloid Dressing Miltex Integra OraMem Sustained Absorbable Collagen Membrane Biomend Extend Absorbable Collagen Membrane HeliMend Advanced Absorbable Collagen Membrane Alleghany CSF External Drainage Sys Pudenz Catheters Integra Reservoirs Braden Reservoir Pudenz Peritoneal Catheter Mishler Valve Systems Hermetic External CSF Drainage Syst Pudenz Valves On-Off Flushing Valves Multi-Purpose Valves External CSF Drainage Systems Pudenz Cardiac Catheters Codman External Drainage System II Integra MicroFrance Jarit Codman HAKIM PROGRAMMABLE VALVE SYSTEM MicroFrance Integra Miltex Thompson Integra Tactile Tone Miltex Jarit Padgett CODMAN Disposable Perforators Integra MicroFrance Jarit Miltex CUSA® Clarity 23 kHz Standard Laparoscopic Tip CUSA® Clarity 23 kHz Extended Laparoscopic Tip Jarit Rigid Endoscopes Arkis Subcutaneous Guidewire Arkis Tunneling Guidewire Arkis Precision Tunneler CODMAN® Disposable Catheter Passer Integra Miltex CereLink ICP Replacement Power Supply 826822 CereLink ICP Replacement Battery 826824 CereLink ICP Extension Cable 826845 CereLink ICP Monitor 826820 ACCLARENT SE Inflation Device MicroFrance Miltex Padgett Jarit Integra Integra LED Surgical Headlight Padgett Miltex MicroFrance Jarit Integra SurgiMend MP Integra Straight Ventricular Catheter HeliTape Absorbable Collagen Wound Dressing CollaPlug Absorbable Collagen Wound Dressing HeliCote Absorbable Collagen Wound Dressing HeliPlug Absorbable Collagen Wound Dressing OraTape Absorbable Collagen Wound Dressing OraPlug Absorbable Collagen Wound Dressing CollaCote Absorbable Collagen Wound Dressing CollaTape Absorbable Collagen Wound Dressing MicroFrance Integra Miltex Tactile Tone Edwards Barbaro Syringo Shunt Syste Suturable DuraGen Dural Regenration Matrix Miltex Jarit Integra MicroFrance Integra MicroFrance Padgett Integra Integra Miltex MicroFrance Integra Miltex Loupes LED Light Unit CODMAN Disposable ICP Kits Jarit MicroFrance Integra Miltex Miltex Auragen Cortical Electrodes Miltex Integra Integra Jarit Integra Miltex Miltex MicroFrance Integra Spetzler Lumbar-Peritoneal System Padgett Integra Miltex MicroFrance Jarit Padgett Integra Ruggles-Redmond Jarit Miltex Integra MicroFrance Jarit Integra MicroFrance Miltex Integra Dermal Regeneration Template Single Layer Integra Dermal Regeneration Template Single Layer Thin Integra Meshed Dermal Regeneration Template (OUS) Jarit Integra CODMAN MICROSENSOR Skull Bolt Kits MoniTorr ICP External CSF Drainage MicroMatrix Integra MicroFrance Jarit Miltex MicroFrance Integra INTEGRA Wound Matrix (Thin) Jarit Padgett Miltex Integra Padgett Jarit Miltex MicroFrance Integra Jarit Miltex MicroFrance Integra Miltex Integra Integra Miltex MicroFrance Integra Cyclops Multi-Angle Endoscope Integra Miltex Miltex Cryosolutions 730410 730413 730612 730412 730614 730611 730613 730610 730511 730512 730411 730414 730510 Integra DP Valve Systems Pudenz In-line Valve Systems Tardie Padgett Miltex Jarit Integra Integra Jarit Ruggles-Redmond Codman Ventricular Needles Subcutaneous Guidewire Arkis Subcutaneous Guideware MicroFrance Miltex Jarit Integra Codman Electrosurgical Generator Codman Electrosurgical Foot Pedal Integra Miltex Jarit Mayfield Adult Disposable Skull Pin Miltex Integra Jarit MicroFrance Integra MicroFrance Jarit Miltex Integral Ventricular Reservoir Ventricular Antichamber Jarit Integra Miltex Jarit MicroFrance Integra Ruggles-Redmond Integra Padgett Integra Miltex Integra Jarit TruDi Navigation System Jarit Miltex Depth Electrodes Strip Electrodes Grid Electrodes Miltex Integra Jarit Padgett Mayfield Adult Disposable Skull Pin Jarit Integra Jarit Miltex Integra Miltex CODMAN® GHAJAR GUIDE® Ventriculostomy Kit Inspira Air Balloon Dilation System MoniTorr ICP External CSF Drainage Padgett Jarit Miltex Miltex Integra NeuraGen Nerve Guide Padgett Ceram-A-Grip Jarit Grip Deep Miltex Xcision Carb-N-Sert Miltex Jarit Jarit Supercut Padgett CARB-EDGE CUSA® Clarity 23 kHz Expanded CEM Nosecone Miltex Padgett Jarit Integra Hermetic Lumbar Catheters Miltex Shur Strip Suture Strip Padgett UltraLite Miltex CODMAN® HAKIM® Precision Fixed Pressure Valve CODMAN® HAKIM® Programmable Valve Gentrix" Surgical Matrix Thick MicroFrance SCHWARTZ VESSEL CL CODMAN® SCHWARTZ Clamp Forceps Integra MicroFrance Jarit Miltex Integra Miltex Integra Cranial Access Kit Miltex Jarit Integra Integra Miltex Integra Jarit Probe 8" Jarit Miltex MicroFrance Integra Jarit Padgett Padgett Miltex Jarit Miltex Jarit Integra Padgett Miltex Integra Codman Disposable Perforators Jarit Miltex Integra TruDi NAV Cable TruDi NAV Suction Jarit Miltex LICOX BRAIN OXYGEN MONITORING SYSTEM CATHETER PROBES AND KIT Acclarent Navwire Sinus Navigation Guidewire Miltex Jarit Integra MicroFrance Padgett Ruggles-Redmond Integra MicroFrance Miltex TruDi Shaver Blade Miltex Integra LPV II Standard and Mini Valves Integra Miltex Jarit Integra Meshed Bilayer Wound Matrix CRW CRW Precision Arc Sterotactic System CRW-1 System Medihoney Gel Dressings Miltex Jarit Miltex Jarit Integra Jarit Integra Miltex CODMAN® ACCU-FLO® Straight Connector CODMAN® HOLTER® DuraGen Secure Dural Regeneration Matrix Integra STERILE STD LPV WITH RIGHT ANGLE Acclarent Relieva Ultirra® Nav Sinus Balloon Catheter Mayfield Composite Series Skull Clamp Miltex Jarit Jarit MicroFrance Miltex Integra 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 Fixott-Everett Grid (for x-ray film) OSVII Lumbar Valve System OSVII Low Flow Lumbar Valve Miltex MicroFrance Integra Jarit Integra MicroFrance Integra MicroFrance Integra Ruggles Redmond Integra Jarit CODMAN BACTISEAL EVD CATHETER SET Integra Drainage Accessory Kit Mayfield Infinity XR2 MR Skull Clamp Padgett INTEGRA Flowable Wound Matrix INTEGRA Bilayer Matrix Wound Dressing INTEGRA Bilayer Wound Matrix Sundt Shunt External Corotid Shunts Miltex Helistat Absorbable Collagen Hemostatic Sponge Helitene Absorbable Collagen Hemostatic Agent OraFOAM Absorbable Collagen Hemostatic Sponge SurgiMend -e Collagen Matrix SurgiMend 3 Collagen Matrix SurgiMend 4 Collagen Matrix SurgiMend 2 Collagen Matrix CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT CereLink ICP Replacement Power Supply 826822 CereLink ICP Extension Cable 826845 CereLink ICP Replacement Battery 826824 CereLink ICP Monitor 826820 Tactile Tone Miltex Mayfield A-2000 Skull Clamp Jarit Padgett MicroFrance Ruggles-Redmond Integra Miltex MicroFrance Integra CODMAN Craniotomy Kit (consisting of Disposable Perforator, Cranio-blade, & Wire Pass Drill) Miltex Jarit MicroFrance Integra Carb-N-Sert Ruggles-Redmond Jarit Supercut Miltex Beauty Pink Padgett Mayfield Radiolucent Disposable Skull Pins Jarit Miltex MicroFrance Integra Cytal® Wound Matrix Cytal® Burn Matrix Integra MicroFrance Codman Double Lumen Skull Bolt Codman Single Lumen Skull Bolt Jarit Integra Miltex Padgett MicroFrance Jarit Padgett MicroFrance Miltex Integra NeuraWrap Nerve Protector Petit-Point Jarit Integra GENERAL INSTRUMENT Padgett CODMAN® SCOTT Ventricular Cannula (Disposable) CABLES; CODMAN® ICP EXPRESS® Integra MicroFrance MicroFrance Integra Integra MicroFrance MicroFrance Integra Miltex Ruggles-Redmond Padgett MicroFrance Integra Jarit Integra MicroFrance Miltex Padgett Jarit Suturable DuraGen Dural Regenration Matrix MicroFrance Integra Mayfield Infinity Skull Clamp Padgett CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II) MoniTorr CSF External Drainage Syst Jarit Integra Miltex Jarit Miltex Jarit Miltex Ruggles-Redmond Integra Integra Miltex RMH Integrator Tactile Tone Silitone Miltex GripLite Jarit Miltex CODMAN® HAKIM® Programmable Valve with SIPHONGUARD® Device CODMAN® HAKIM® Precision Fixed Pressure Valve with SIPHONGUARD® Device Integra MicroFrance CODMAN® HAKIM® Precision Fixed Pressure Valve INTEGRA Dermal Regeneration Template INTEGRA Meshed Dermal Regeneration Template Integra Omnigraft Dermal Regeneration Matrix Gravity Compensating Accessory Jarit Padgett CARDIO-GRIP Miltex Ruggles-Redmond Integra Aurora Surgiscope System MediHoney Alginate MediHoney 100% MediHoney Honeycolloid Miltex Jarit Padgett Petit-Point MicroFrance Integra Jarit Miltex Integra Miltex Padgett Jarit Integra Jarit External Drainage Set Jarit Integra Miltex Ruggles-Red Padgett Jarit Star Integra Petit-Pt Jarit Super CARB-BITE Miltex Jarit CARDIO-GRIP CARB-EDGE Tarbell-Loeffler Cosman Pediatric F OraMem Sustained Absorbable Collagen Membrane Biomend Extend Absorbable Collagen Membrane HeliMend Advanced Absorbable Collagen Membrane Bactiseal EVD Catheter Sets: Bactiseal Clear EVD Catheter Set DuraSorb Monofilament Mesh Miltex Padgett Cyst Puncture Catheter Kits MicroFrance Integra Ruggles-Redmond Integra Jarit Miltex Integra Allograft Wedge Impactor Instrument Padgett Integra Blade P4596 MicroFrance Jarit Miltex Integra MicroFrance Miltex Integra Miltex Tactile Tone Miltex Integra Padgett Miltex Padgett Jarit Integra Cardio-Grip Miltex Jarit DuraGen XS Dural Regeneration Matrix XKnife 5 Jarit Miltex Horizontal-Vertical Lumbar Valve System Spetzler Lumbar Peritoneal Shunt Systems MicroFrance Integra Jarit Miltex Miltex Padgett Integra Disposable Filters 775-200 Integra Retention Plate 775-212-INT Mayfield Child Disposable Skull Pin Miltex Integra MicroFrance Jarit SUCTION RESERVOIR KIT CARB-BITE Jarit Ruggles-Redmond Integra Anti-Rotation Peg Holder Integra Allograft Wedge Sizer Instrument Integra Allograft Wedge Instrument Set Integra Jarit Miltex MicroFrance Jarit Miltex Jarit Miltex Integra MicroFrance Padgett Miltex Integra Jarit MicroFrance 33-52;33-53;33-54;33-55;33-57 MicroFrance Miltex Integra 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 Onyx-Flex Tactile Tone Onyx-H Onyx-R Miltex MicroFrance Jarit Miltex Integra Miltex Integra Integra Helistat Absorbable Collagen Hemostatic Sponge Helitene Absorbable Collagen Hemostatic Agent OraFOAM Absorbable Collagen Hemostatic Sponge Miltex Integra Jarit CUSA Excel+ Ultrasonic Surgical Aspirator System; C2623; C5623; CUSAEXCEL2; C2600; C5601; C5602 MicroFrance Integra Jarit Acclarent Relieva SpinPlus Nav Balloon Sinuplasty System Integra Padgett Jarit Jarit Supercut MicroFrance Miltex Carb-N-Sert CARB-EDGE 5-700;5-702;5801;5803;5804 Jarit Miltex

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DWP Dilator, Vessel, Surgical Cardiovascular Class 2 870.4475 2019-09-09
HDL Retractor, Vaginal Obstetrics/Gynecology Class 1 884.4520 1981-04-24
EKJ Burnisher, Operative Dental Class 1 872.4565 1981-04-24
KBZ Snare, Tonsil Ear, Nose, Throat Class 1 874.4420 1981-04-24
HHF Remover, Intrauterine Device, Contraceptive, Hook-Type Obstetrics/Gynecology Class 1 884.4530 2003-09-04
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2011-06-28
HCD Cannula, Ventricular Neurology Class 1 882.4060 2007-12-12
KBA Rasp, Nasal Ear, Nose, Throat Class 1 874.4420 2014-11-04
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-09-26
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2018-11-30
DQR Cannula, Catheter Cardiovascular Class 2 870.1300 2014-02-06
HBA Neurosurgical Paddie Neurology Class 2 882.4700 2021-01-19
NQR Sealant, Dural Unknown Class 3 N/A 2014-01-30
DZA Drill, Dental, Intraoral Dental Class 1 872.4130 1997-01-14
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 2001-08-06
GFD Dermatome General, Plastic Surgery Class 1 878.4820 2005-01-18
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2003-08-05
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2007-11-30
DYX Lock, Wire, And Ligature, Intraoral Dental Class 2 872.4600 2013-03-06
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2008-02-28
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2013-10-21
PNZ Eustachian Tube Balloon Dilation Device Ear, Nose, Throat Class 2 874.4180 2025-05-09
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-09-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2019-02-01
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2013-10-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
GXQ Dura Substitute Neurology Class 2 882.5910 2007-11-30
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2020-01-28
KAK Probe, Ent Ear, Nose, Throat Class 1 874.4420 2000-10-17
GWZ Percussor Neurology Class 1 882.1700 2013-04-22
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2022-06-21
GAH Stylet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1981-04-24
LXM Manipulator, Plunger-Like Joint Unknown Class U N/A 2008-02-28
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
OGH Laryngoscope Kit Anesthesiology Class 1 868.5540 2018-09-10
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
EMD Hemostat, Surgical Dental Class 1 872.4565 1981-04-24
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 2007-05-29
HWK Trephine Orthopedic Class 1 888.4540 2005-03-23
HXS Twister, Wire Orthopedic Class 1 888.4540 1981-04-24
GYK Instrument, Shunt System Implantation Neurology Class 1 882.4545 2017-09-26
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2013-09-25
HHK Curette, Suction, Endometrial (And Accessories) Obstetrics/Gynecology Class 2 884.1175 2008-02-28
GAB Needle, Suturing, Disposable General, Plastic Surgery Class 1 878.4800 2015-07-07
FNY Basin, Emesis General Hospital Class 1 880.6730 2005-03-02
HNB Spoon, Ophthalmic Ophthalmic Class 1 886.4350 2000-12-14
FHN Ligator, Hemorrhoidal Gastroenterology, Urology Class 2 876.4400 2008-02-25
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-18
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2025-05-09
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2006-06-12
HMZ Trabeculotome Ophthalmic Class 1 886.4350 2016-08-29
FRO Dressing, Wound, Drug Unknown Class U N/A 2017-03-24
JZF Tube, Ear Suction Ear, Nose, Throat Class 1 874.4420 1981-04-24
KBD Scissors, Nasal Ear, Nose, Throat Class 1 874.4420 1999-05-05
HXX Screwdriver Orthopedic Class 1 888.4540 2001-04-26
GWG Endoscope, Neurological Neurology Class 2 882.1480 2018-11-01
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2018-11-01
LGG Instrument, Cast Application/Removal, Manual Orthopedic Class 1 888.5980 2003-09-04
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2013-10-24
FZQ Clip, Removable (Skin) General, Plastic Surgery Class 1 878.4320 1981-04-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-12
KYG Device, Irrigation, Ocular Surgery Ophthalmic Class 1 886.4360 2007-01-18
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 2003-08-05
HAE Rongeur, Manual Neurology Class 2 882.4840 2015-05-07
HBO Clip, Scalp Neurology Class 2 882.4150 2008-02-25
GXQ Dura Substitute Neurology Class 2 882.5910 2007-11-30
NWV Laparoscopic Accessories, Gynecologic Obstetrics/Gynecology Class 1 884.1720 2014-01-13
BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment) Anesthesiology Class 1 868.6175 2020-08-20
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 1981-04-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2019-12-05
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2015-06-15
JYT Pick, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 1999-05-19
EKW Broach, Endodontic Dental Class 1 872.4565 1992-08-26
NQR Sealant, Dural Unknown Class 3 N/A 2014-01-30
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2017-08-03
OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery General, Plastic Surgery Class 2 878.3300 2017-08-03
EJI Syringe, Cartridge Dental Class 2 872.6770 2014-12-01
KAZ Rasp, Frontal-Sinus Ear, Nose, Throat Class 1 874.4420 1981-04-24
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2021-02-26
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2008-02-25
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2001-04-26
KAQ Gouge, Nasal, Ent Ear, Nose, Throat Class 1 874.4420 2007-06-27
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2025-05-09
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2015-07-16
KBX Screw, Tonsil Ear, Nose, Throat Class 1 874.4420 2003-09-04
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-18
KBW Screw, Oral Ear, Nose, Throat Class 1 874.4420 1981-04-24
KAC Tube, Laryngectomy Ear, Nose, Throat Class 1 874.4420 2003-09-04
HBO Clip, Scalp Neurology Class 2 882.4150 2012-07-09
GXQ Dura Substitute Neurology Class 2 882.5910 2007-11-30
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2019-05-23
FMF Syringe, Piston General Hospital Class 2 880.5860 2014-01-30
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2008-03-24
JYM Inserter, Myringotomy Tube Ear, Nose, Throat Class 1 874.4420 2014-11-04
HBG Drills, Burrs, Trephines & Accessories (Manual) Neurology Class 2 882.4300 2008-01-08
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2008-02-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-06-06
HDJ Scissors, Umbilical Obstetrics/Gynecology Class 1 884.4520 1981-04-24
FHI Ring, Laparotomy Gastroenterology, Urology Class 1 876.4730 2015-02-04
JYD Chisel, Mastoid General, Plastic Surgery Class 1 878.4800 2003-08-04
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2003-08-05
KCB Tube, Tonsil Suction Ear, Nose, Throat Class 1 874.4420 2009-11-19
LYA Splint, Intranasal Septal Ear, Nose, Throat Class 1 874.4780 2015-07-16
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 1981-04-24
QGK Balloon, Nasal Airway Ear, Nose, Throat Class 1 874.4420 2025-05-09
EZB Stylet For Catheter, Gastro-Urology Gastroenterology, Urology Class 1 876.5130 2015-02-06
GEC Brush, Scrub, Operating-Room General, Plastic Surgery Class 1 878.4800 2007-01-18
JXI Cuff, Nerve Neurology Class 2 882.5275 2007-11-30
KAX Punch, Ethmoid Ear, Nose, Throat Class 1 874.4420 2014-11-04
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2014-06-04
EMI File, Bone, Surgical Dental Class 1 872.4565 1981-04-24
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2012-09-18
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2012-09-18
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-12
HCY Curette, Uterine Obstetrics/Gynecology Class 1 884.4530 2003-08-05
KTZ Caliper Orthopedic Class 1 888.4150 1999-05-10
EID Syringe, Restorative And Impression Material Dental Class 1 872.4565 2008-04-09
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2008-02-28
HKY Tonometer, Manual Ophthalmic Class 2 886.1930 2012-07-09
HGN Stethoscope, Fetal Obstetrics/Gynecology Class 1 884.2900 1981-04-24
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2015-01-19
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1981-04-24
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-09-26
JYF Clamp, Ossicle Holding Ear, Nose, Throat Class 1 874.4420 2014-11-04
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2015-06-15
CAN Regulator, Pressure, Gas Cylinder Anesthesiology Class 1 868.2700 2014-02-27
JYQ Loop, Wire Ear, Nose, Throat Class 1 874.4420 2003-08-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-06-17
JZB Scissors, Ear Ear, Nose, Throat Class 1 874.4420 1981-04-24
FRO Dressing, Wound, Drug Unknown Class U N/A 2015-08-03
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-18
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2015-12-09
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2001-08-09
EKM Gutta-Percha Dental Class 1 872.3850 1994-02-17
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2013-10-24
GXQ Dura Substitute Neurology Class 2 882.5910 2007-11-30
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2008-03-26
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2000-10-24
KAM Cannula, Sinus General, Plastic Surgery Class 1 878.4800 1981-04-24
EMN Scaler, Periodontic Dental Class 1 872.4565 1981-04-24
HWT Template Orthopedic Class 1 888.4800 2001-04-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
EKG Condenser, Amalgam And Foil, Operative Dental Class 1 872.4565 2006-08-03
EJL Bur, Dental Dental Class 1 872.3240 2001-12-04
HXR Spatula, Orthopedic General, Plastic Surgery Class 1 878.4800 2003-09-04
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2000-12-14
KYW Container, Liquid Medication, Graduated General Hospital Class 1 880.6430 2005-03-02
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2025-05-09
EFN Cotton, Roll Dental Class 1 872.6050 2003-09-04
EKC Excavator, Dental, Operative Dental Class 1 872.4565 1981-04-24
GZT Retractor, Self-Retaining, For Neurosurgery Neurology Class 2 882.4800 2008-01-04
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2023-03-06
GZT Retractor, Self-Retaining, For Neurosurgery Neurology Class 2 882.4800 2023-11-01
GWG Endoscope, Neurological Neurology Class 2 882.1480 2023-11-01
MJI Specimen/Tissue, Identification Orientation Pathology Class 1 864.3010 2009-11-19
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2009-11-19
GCM Endoscope, Rigid Gastroenterology, Urology Class 2 876.1500 2009-11-19
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2015-01-19
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2015-01-19
HTS Knife, Orthopedic Orthopedic Class 1 888.4540 1981-04-24
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 1999-02-12
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2025-05-09
JXI Cuff, Nerve Neurology Class 2 882.5275 2007-11-30
NNU Scissors, Wire Cutting, Ent, Non-Sterile Ear, Nose, Throat Class 1 874.3540 2015-02-04
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2003-08-05
EKL Point, Silver, Endodontic Dental Class 1 872.3840 2001-12-04
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-09-26
OJG Neurological Tray Neurology Class 1 882.4525 2018-09-10
EKP Reamer, Pulp Canal, Endodontic Dental Class 1 872.4565 1992-08-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-18
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-18
GZX Instrument, Microsurgical Neurology Class 1 882.4525 1998-08-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-11-30
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-12
MDD Device, Dermal Replacement Unknown Class 3 N/A 2007-11-30
MGR Dressing, Wound And Burn, Interactive Unknown Class 3 N/A 2007-11-30
HWQ Passer Orthopedic Class 1 888.4540 2007-06-27
LBK Neurosurgical Ultrasonic Instruments Unknown Class U N/A 2016-10-21
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2016-10-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-09-26
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2007-01-18
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
FTX Mirror, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1981-04-24
GXQ Dura Substitute Neurology Class 2 882.5910 2007-11-30
EJG Forceps, Rubber Dam Clamp Dental Class 1 872.6300 2003-09-04
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2019-04-26
LBK Neurosurgical Ultrasonic Instruments Unknown Class U N/A 2019-04-26
KAS Knife, Nasal Ear, Nose, Throat Class 1 874.4420 2004-11-09
ITG Bandage, Cast Physical Medicine Class 1 890.3025 2017-03-24
EIR Scissors, Collar And Crown Dental Class 1 872.4565 1981-04-24
ELA Instrument, Hand, Calculus Removal Dental Class 1 872.4565 2006-08-03
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1981-04-24
GYK Instrument, Shunt System Implantation Neurology Class 1 882.4545 2007-12-18
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2016-05-09
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2012-10-25
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-18
GYK Instrument, Shunt System Implantation Neurology Class 1 882.4545 2007-12-18
NOC Splint, Extremity, Non-Inflatable, External, Non-Sterile General, Plastic Surgery Class 1 878.3910 2009-11-19
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2014-09-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-09-26
KAR Irrigator, Sinus Ear, Nose, Throat Class 1 874.4420 2014-11-05
PSQ Intracardiac Patch Or Pledget, Biologically Derived Cardiovascular Class 2 870.3470 2021-02-26
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2014-06-04
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2014-01-30
KTF Punch, Ent Ear, Nose, Throat Class 1 874.4420 2003-08-05
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 2015-03-28
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-12
LYS Bone Mill Orthopedic Class 1 888.4540 2006-03-20
JYL Hook, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2009-11-19
FBQ Trocar, Gastro-Urology Gastroenterology, Urology Class 2 876.5090 2008-03-26
FXE Speculum, Non-Illuminated General, Plastic Surgery Class 1 878.1800 1992-07-16
BWN Table And Attachments, Operating-Room General, Plastic Surgery Class 1 878.4950 2015-03-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-02-16
EGN Scissors, Surgical Tissue, Dental Dental Class 1 872.4565 1981-04-24
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2000-10-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-11-04
OWV Mesh, Surgical, Collagen, Diaphragmatic Hernia General, Plastic Surgery Class 2 878.3300 2021-02-26
OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery General, Plastic Surgery Class 2 878.3300 2021-02-26
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2021-02-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-18
FCW Light Source, Fiberoptic, Routine Gastroenterology, Urology Class 2 876.1500 2016-02-03
HDQ Dilator, Cervical, Fixed Size Obstetrics/Gynecology Class 1 884.4530 1981-04-24
FFN Clamp, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2013-02-26
EJE Frame, Rubber Dam Dental Class 1 872.6300 2001-12-04
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2007-12-27
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2008-02-28
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2008-01-04
DZC Wire, Orthodontic Dental Class 1 872.5410 1992-07-16
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2025-05-09
LQY Locator, Root Apex Unknown Class U N/A 2008-03-24
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2024-08-20
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2007-12-12
HBF Drills, Burrs, Trephines & Accessories (Compound, Powered) Neurology Class 2 882.4305 2020-02-14
EMJ Elevator, Surgical, Dental Dental Class 1 872.4565 1981-04-24
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2004-06-04
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 1981-04-24
DWP Dilator, Vessel, Surgical Cardiovascular Class 2 870.4475 2012-07-09
ECS Pusher, Band, Orthodontic Dental Class 1 872.4565 1981-04-24
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2007-11-30
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2003-07-15
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2011-05-19
FSR Light, Headband, Surgical Ophthalmic Class 2 886.4335 2018-08-28
LKG Port & Catheter, Implanted, Subcutaneous, Intraventricular Neurology Class 2 882.5550 2007-12-18
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2010-10-21
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2008-01-04
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2007-11-30
HXL Mallet General, Plastic Surgery Class 1 878.4800 2003-08-05
SEL Securement Wound Dressing For Reduction Of Infection Unknown Class U N/A 2006-06-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 1981-04-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 1981-04-24
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2009-12-14
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2007-12-18
FCW Light Source, Fiberoptic, Routine Gastroenterology, Urology Class 2 876.1500 2007-12-04
HJH Loupe, Binocular, Low Power Ophthalmic Class 1 886.5120 1981-04-24
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2025-05-09
JYC Cannula, Ear General, Plastic Surgery Class 1 878.4800 1981-04-24
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2008-12-23
HXD Clamp General, Plastic Surgery Class 1 878.4800 2003-09-09
KIK Hook, Bone General, Plastic Surgery Class 1 878.4800 2004-02-26
FCW Light Source, Fiberoptic, Routine Gastroenterology, Urology Class 2 876.1500 2008-11-26
HNX Depressor, Orbital Ophthalmic Class 1 886.4350 2008-03-26
GYK Instrument, Shunt System Implantation Neurology Class 1 882.4545 2007-12-12
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-12
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2009-11-20
HDK Scissors, Episiotomy Obstetrics/Gynecology Class 1 884.4520 1981-04-24
GDH Gouge, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1981-04-24
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2023-09-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-02-10
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2017-09-27
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 1981-04-24
KAW Punch, Antrum Ear, Nose, Throat Class 1 874.4420 1981-04-24
EMP Marker, Periodontic Dental Class 1 872.4565 1981-04-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-18
KAJ Mobilizer, Ent Ear, Nose, Throat Class 1 874.4420 2014-11-04
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2025-05-09
EKT Curette, Endodontic Dental Class 1 872.4565 2001-12-04
JYO Knife, Ear Ear, Nose, Throat Class 1 874.4420 1981-04-24
HDM Packer, Uterine Obstetrics/Gynecology Class 1 884.4520 1981-04-24
LBK Neurosurgical Ultrasonic Instruments Unknown Class U N/A 2005-10-03
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2005-10-03
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2014-09-03
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-18
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2011-10-25
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2007-12-07
GDN Knife, Amputation General, Plastic Surgery Class 1 878.4800 1981-04-24
KBM Dissector, Tonsil Ear, Nose, Throat Class 1 874.4420 2009-11-19
HTX Rongeur Orthopedic Class 1 888.4540 1981-04-24
EHM Strip, Polishing Agent Dental Class 1 872.6010 2001-12-04
HBO Clip, Scalp Neurology Class 2 882.4150 2017-09-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2019-11-01
KBE Snare, Nasal Ear, Nose, Throat Class 1 874.4420 2003-09-04
KBH Adenotome Ear, Nose, Throat Class 1 874.4420 1981-02-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2025-05-09
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2004-07-20
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2013-02-05
KAM Cannula, Sinus General, Plastic Surgery Class 1 878.4800 2025-05-09
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-09-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-12
EMB Zinc Oxide Eugenol Dental Class 1 872.3275 2001-12-04
FRO Dressing, Wound, Drug Unknown Class U N/A 2017-03-24
EMK Curette, Surgical, Dental Dental Class 1 872.4565 1981-04-24
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2007-11-30
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-12
GDM Needle, Aspiration And Injection, Reusable General, Plastic Surgery Class 1 878.4800 2003-07-07
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
KBR Needle, Tonsil Suturing Ear, Nose, Throat Class 1 874.4420 2000-10-17
EIK Carver, Wax, Dental Dental Class 1 872.4565 1981-04-24
HBF Drills, Burrs, Trephines & Accessories (Compound, Powered) Neurology Class 2 882.4305 2017-09-26
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2000-10-24
LBK Neurosurgical Ultrasonic Instruments Unknown Class U N/A 2022-08-18
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2022-08-18
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2009-11-19
GYK Instrument, Shunt System Implantation Neurology Class 1 882.4545 2008-12-12
HDX Dilator, Vaginal Obstetrics/Gynecology Class 2 884.3900 2010-09-23
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2021-05-05
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2025-05-09
KBC Saw, Nasal Ear, Nose, Throat Class 1 874.4420 1981-04-24
FSR Light, Headband, Surgical Ophthalmic Class 2 886.4335 2011-07-27
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 1981-04-24
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2017-04-21
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-18
LPG Material, Dressing, Surgical, Polylactic Acid Unknown Class 3 N/A 2007-11-30
JZE Spoon, Ear Ear, Nose, Throat Class 1 874.4420 2004-02-26
EKH Carver, Dental Amalgam, Operative Dental Class 1 872.4565 1981-04-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-12
GXQ Dura Substitute Neurology Class 2 882.5910 2007-11-30
FKC Clamp, Cannula Gastroenterology, Urology Class 1 876.5540 1981-04-24
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2014-11-04
NNR Block, Cutting, Ent, Non-Sterile Ear, Nose, Throat Class 1 874.3540 2004-10-05
EMO Knife, Periodontic Dental Class 1 872.4565 1981-04-24
JYP Knife, Myringotomy Ear, Nose, Throat Class 1 874.4420 2009-11-19
KYT Light, Examination, Medical, Battery Powered General Hospital Class 1 880.6350 2010-02-22
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-09-26
KBJ Curette, Adenoid Ear, Nose, Throat Class 1 874.4420 1981-04-24
EHZ Evacuator, Oral Cavity Dental Class 1 872.6640 2010-09-21
GYC Electrode, Cortical Neurology Class 2 882.1310 2010-10-21
FFR Device, Locking, For Intestinal Clamp Gastroenterology, Urology Class 1 876.4730 2009-11-13
HNH Ring, Ophthalmic (Flieringa) Ophthalmic Class 1 886.4350 2008-03-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2011-10-07
KAI Mirror, Ent Ear, Nose, Throat Class 1 874.4420 1981-04-24
GWI Discriminator, Two-Point Neurology Class 1 882.1200 2009-11-19
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2009-11-19
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1981-04-24
KCP Syringe, Ent Ear, Nose, Throat Class 1 874.5220 2004-06-04
MDD Device, Dermal Replacement Unknown Class 3 N/A 2017-04-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-09-27
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-09-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-12
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2021-02-26
JYW Press, Vein Ear, Nose, Throat Class 1 874.4420 2004-06-07
KCC Bistoury, Tracheal Ear, Nose, Throat Class 1 874.4420 1981-04-24
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2012-02-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-07-16
GAL Suture, Absorbable, Natural General, Plastic Surgery Class 2 878.4830 2009-12-16
EKI Carrier, Amalgam, Operative Dental Class 1 872.4565 2008-03-26
KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) Ear, Nose, Throat Class 2 874.3620 2015-01-19
KBG Trocar, Sinus Ear, Nose, Throat Class 1 874.4420 1981-04-24
EIS Remover, Crown Dental Class 1 872.4565 1981-04-24
EKR Plugger, Root Canal, Endodontic Dental Class 1 872.4565 1992-08-26
NNP Die, Wire Bending, Ent, Non-Sterile Ear, Nose, Throat Class 1 874.3540 2015-03-28
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2025-05-09
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2010-05-26
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2024-04-10
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-18
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-12
EGS Handpiece, Contra- And Right-Angle Attachment, Dental Dental Class 1 872.4200 2008-02-27
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2014-06-04
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 1999-04-27
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2000-10-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-04-29
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 1981-04-24
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2008-01-04
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 2003-09-04
FXG Specula Accessories General, Plastic Surgery Class 1 878.1800 2014-11-04
HBR Rack, Clip Neurology Class 1 882.4215 1981-04-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-11-19
KCJ Applicator, Ent Ear, Nose, Throat Class 1 874.5220 1981-04-24
HBD Handpiece (Brace), Drill Neurology Class 1 882.4325 2001-05-31
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2025-05-09
GAI Stripper, Vein, Reusable General, Plastic Surgery Class 1 878.4800 2009-11-19
GYC Electrode, Cortical Neurology Class 2 882.1310 2007-12-18
CCX Support, Patient Position Anesthesiology Class 1 868.6820 2008-08-29
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2008-01-04
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2018-04-18
EIF Accessories, Retractor, Dental Dental Class 1 872.4565 2002-01-18
EHJ Disk, Abrasive Dental Class 1 872.6010 2001-12-04
HBG Drills, Burrs, Trephines & Accessories (Manual) Neurology Class 2 882.4300 2017-09-26
KTI Bronchoscope Accessory Ear, Nose, Throat Class 2 874.4680 2025-05-09
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-12
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2000-12-14
EGZ Holder, Film, X-Ray Dental Class 1 872.1905 2008-01-04
JXI Cuff, Nerve Neurology Class 2 882.5275 2007-11-30
EMG Forceps, Tooth Extractor, Surgical Dental Class 1 872.4565 1981-04-24
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2003-09-09
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2023-07-12
LBK Neurosurgical Ultrasonic Instruments Unknown Class U N/A 2023-07-12
HXG Tamp Orthopedic Class 1 888.4540 2004-06-04
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-12
HGE Amniotome Obstetrics/Gynecology Class 1 884.4530 1981-04-24
FPX Strip, Adhesive, Closure, Skin General Hospital Class 1 880.5240 2017-03-24
EQH Source, Carrier, Fiberoptic Light Ear, Nose, Throat Class 1 874.4350 2008-02-28
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
OXK Mesh, Surgical, Collagen, Large Abdominal Wall Defects General, Plastic Surgery Class 2 878.3300 2021-02-26
OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery General, Plastic Surgery Class 2 878.3300 2021-02-26
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2021-02-26
HBT Applier, Hemostatic Clip General, Plastic Surgery Class 1 878.4800 1981-04-24
HNZ Curette, Ophthalmic Ophthalmic Class 1 886.4350 2003-08-05
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2001-12-04
HBG Drills, Burrs, Trephines & Accessories (Manual) Neurology Class 2 882.4300 2006-02-22
FGM Probe And Director, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2003-09-04
JEX Plier, Orthodontic Dental Class 1 872.4565 1981-04-24
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2007-05-29
DZP Instrument, Diamond, Dental Dental Class 1 872.4535 2001-11-27
GWY Pinwheel Neurology Class 1 882.1750 1981-04-24
GDL Needle, Suturing, Reusable General, Plastic Surgery Class 1 878.4800 2004-04-12
HBF Drills, Burrs, Trephines & Accessories (Compound, Powered) Neurology Class 2 882.4305 2017-09-26
EKB Explorer, Operative Dental Class 1 872.4565 1981-04-24
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2025-05-09
EXX Probe, Rectal, Non-Powered Gastroenterology, Urology Class 1 876.4730 1981-04-24
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2007-02-22
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2025-05-09
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1981-04-24
FGY Cannula, Injection General, Plastic Surgery Class 1 878.4200 2015-03-30
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2016-01-11
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2025-05-09
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2025-05-09
EFK Forceps, Articulation Paper Dental Class 1 872.4565 1981-04-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-12
EIX Probe, Periodontic Dental Class 1 872.4565 2001-12-04
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2012-03-02
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2008-12-23
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2007-12-12
FRO Dressing, Wound, Drug Unknown Class U N/A 2017-03-24
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2013-05-29
FNS Ring Cutter General Hospital Class 1 880.6200 1981-04-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
GXQ Dura Substitute Neurology Class 2 882.5910 2012-11-08
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2013-09-25
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2013-10-24
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2025-05-09
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2012-06-14
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 2001-08-06
FHA Clamp, Penile Gastroenterology, Urology Class 1 876.5160 2009-11-13
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2003-09-04
IWZ Film, Radiographic Radiology Class 1 892.1840 2011-05-13
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2010-01-22
JYR Nipper, Malleus Ear, Nose, Throat Class 1 874.4420 2007-01-18
FDE Laparoscopy Kit Gastroenterology, Urology Class 2 876.1500 2018-09-10
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2014-09-22
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2015-09-15
FSE Table, Operating-Room, Manual General, Plastic Surgery Class 1 878.4950 2007-06-27
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2007-11-30
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2007-11-30
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2007-12-12
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2011-05-24
LMF Agent, Absorbable Hemostatic, Collagen Based General, Plastic Surgery Class 3 878.4490 2007-11-30
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2015-08-03
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-09-26
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2024-02-05
EKF Instrument, Contouring, Matrix, Operative Dental Class 1 872.4565 2006-08-03
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2008-01-04
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 1981-04-24
KCF Dilator, Esophageal, Ent Ear, Nose, Throat Class 1 874.4420 2015-03-28
HBF Drills, Burrs, Trephines & Accessories (Compound, Powered) Neurology Class 2 882.4305 2017-09-26
HXZ Cutter, Wire Orthopedic Class 1 888.4540 1981-04-24
EGD Wax, Dental, Intraoral Dental Class 1 872.6890 2001-12-04
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2008-01-04
JZA Rongeur, Mastoid Ear, Nose, Throat Class 1 874.4420 1981-04-24
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2024-08-20
KAY Punch, Nasal Ear, Nose, Throat Class 1 874.4420 2014-11-04
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-09-26
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 2003-08-05
FMA Depressor, Tongue, Non-Surgical General Hospital Class 1 880.6230 1981-04-24
JXI Cuff, Nerve Neurology Class 2 882.5275 2007-11-30
HTD Forceps General, Plastic Surgery Class 1 878.4800 2003-09-09
HCA Catheter, Ventricular Neurology Class 2 882.4100 2017-09-26
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-09-26
JYY Rasp, Ear Ear, Nose, Throat Class 1 874.4420 2009-11-19
GCB Needle, Catheter General, Plastic Surgery Class 1 878.4200 2015-03-30
JYK Holder, Ear Speculum General, Plastic Surgery Class 1 878.1800 1999-06-01
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2015-03-28
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1981-04-24
JYG Curette, Ear Ear, Nose, Throat Class 1 874.4420 2003-09-04
GXQ Dura Substitute Neurology Class 2 882.5910 2007-11-30
JZY Knife, Laryngeal Ear, Nose, Throat Class 1 874.4420 2014-11-04
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2008-01-04
NOK Material, External Aesthetic Restoration, No Adhesive General, Plastic Surgery Class 1 878.3800 2008-07-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-12
DZN Instruments, Dental Hand Dental Class 1 872.4565 2001-11-27
HHM Sound, Uterine Obstetrics/Gynecology Class 1 884.4530 1981-04-24
HAE Rongeur, Manual Neurology Class 2 882.4840 2010-03-09
HHW Pessary, Vaginal Obstetrics/Gynecology Class 2 884.3575 2008-03-26
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2008-03-26
EHY Tray, Impression, Preformed Dental Class 1 872.6880 1992-08-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
HYA Forceps, Wire Holding General, Plastic Surgery Class 1 878.4800 2009-11-19
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
MDD Device, Dermal Replacement Unknown Class 3 N/A 2007-11-30
MGR Dressing, Wound And Burn, Interactive Unknown Class 3 N/A 2007-11-30
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-18
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2012-07-18
GZT Retractor, Self-Retaining, For Neurosurgery Neurology Class 2 882.4800 2019-12-17
GWG Endoscope, Neurological Neurology Class 2 882.1480 2019-12-17
FRO Dressing, Wound, Drug Unknown Class U N/A 2020-07-31
HRQ Hemostat General, Plastic Surgery Class 1 878.4800 2003-09-09
EYR Tourniquet, Gastro-Urology General, Plastic Surgery Class 1 878.5900 2004-06-04
JEP Retainer, Matrix Dental Class 1 872.4565 2008-03-26
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2014-06-04
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-18
BWB Forceps, Tube Introduction Anesthesiology Class 1 868.5780 2003-08-05
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 1981-04-24
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2007-12-12
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2007-11-30
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2024-03-13
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2023-01-31
EEA Plate, Base, Shellac Dental Class 1 872.6200 2001-12-04
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-18
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 1998-12-31
HWA Impactor Orthopedic Class 1 888.4540 2001-04-26
FZW Expander, Surgical, Skin Graft General, Plastic Surgery Class 1 878.4800 2007-06-27
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 1981-04-24
HNG Rongeur, Lachrymal Sac Ophthalmic Class 1 886.4350 2008-03-26
EMQ Hoe, Periodontic Dental Class 1 872.4565 2006-08-03
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2009-12-16
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2011-12-02
HXB Probe Orthopedic Class 1 888.4540 2003-09-04
HCZ Forceps, Surgical, Gynecological Obstetrics/Gynecology Class 2 884.4530 2014-04-15
GXQ Dura Substitute Neurology Class 2 882.5910 2007-11-30
MUJ System, Planning, Radiation Therapy Treatment Radiology Class 2 892.5050 2011-02-24
HER Pelvimeter, External Obstetrics/Gynecology Class 1 884.4520 1981-04-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2016-09-27
KBB Rongeur, Nasal Ear, Nose, Throat Class 1 874.4420 1981-04-24
EEF Clamp, Rubber Dam Dental Class 1 872.6300 2001-12-04
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2015-02-28
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2008-01-04
EMH Forceps, Rongeur, Surgical Dental Class 1 872.4565 1981-04-24
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 1997-04-17
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2005-03-24
KAP Curette, Nasal Ear, Nose, Throat Class 1 874.4420 2003-08-05
FFQ Speculum, Rectal Gastroenterology, Urology Class 1 876.4730 1981-04-24
FBX Sound, Urethral, Metal Or Plastic Gastroenterology, Urology Class 1 876.5520 1981-04-24
JYZ Rod, Measuring Ear Ear, Nose, Throat Class 1 874.4420 2014-11-04
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2003-08-05
GDX Scalpel, One-Piece General, Plastic Surgery Class 1 878.4800 1981-04-24
EKK Spreader, Pulp Canal Filling Material, Endodontic Dental Class 1 872.4565 1992-08-26
KCG Dilator, Tracheal Ear, Nose, Throat Class 1 874.4420 2008-03-25
EIL Gauge, Depth, Instrument, Dental Dental Class 1 872.4565 1992-08-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2016-06-07
LMF Agent, Absorbable Hemostatic, Collagen Based General, Plastic Surgery Class 3 878.4490 2007-11-30
GBY Catheter, Eustachian, General & Plastic Surgery General, Plastic Surgery Class 1 878.4200 2000-12-14
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2015-02-20
KTE Trocar, Ent Ear, Nose, Throat Class 1 874.4420 2009-11-19
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2008-01-08
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2025-05-09
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2025-05-09
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2003-09-09
HDC Tenaculum, Uterine Obstetrics/Gynecology Class 2 884.4530 2009-01-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Integra LifeSciences Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3015194982 SURGICAL INNOVATION ASSOCIATES, INC. Chicago, IL, US
3013505638 REBOUND THERAPEUTICS, CORPORATION Irvine, CA, US
3006697299 INTEGRA LIFESCIENCES (IRELAND) LIMITED SRAGH TULLAMORE Offaly, IE
2648988 INTEGRA NEUROSCIENCES ANASCO, PR, US
9680837 INTEGRA MICROFRANCE SAS SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K071458 Integra LifeSciences Corporation MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS 2007-06-13
K810894 American Edwards Laboratories FOGARTY FLEXIBLE CALIBRATOR 1981-05-15
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0025-2016 Integra LifeSciences Corp. 2
Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra CRW Precision Arc Stereotactic System.
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0027-2007 N/A 2
3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
Z-0039-2020 AZIYO BIOLOGICS 2
BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Z-0040-2020 AZIYO BIOLOGICS 2
CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003418325. Last updated year: 2026. Please use registration number 3003418325 when referencing this establishment in official correspondence.
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