Integra LifeSciences Production Corporation

FDA Device Registration & Listing · Mansfield, MA, US · Registration 3014334038

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
3014334038
FEI Number
3014334038
Entity Name
Integra LifeSciences Production Corporation
City/State/Country
Mansfield, MA, US
Establishment Address
11 Cabot Blvd., Mansfield, MA 02048, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Integra LifeSciences Corporation (Owner Number: 9004007)
Owner / Operator Contact Address
1100 Campus Rd, Princeton, NJ 08540, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K041296
PMA Number
N/A

All Registered Proprietary Names

Jarit Supercut Roto-Lok Roto-Cam Jarit Jarit Miltex Integra Jarit Ruggles-Redmond Padgett Integra Miltex MicroFrance Padgett Jarit Miltex Integra MicroFrance MicroFrance Miltex Integra Jarit Miltex Padgett Jarit Miltex 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 Jarit Integra Miltex MicroFrance Integra Jarit MicroFrance Ruggles-Redmond Padgett Miltex OSVII Integra Flow Regulating Valve Low Flow Miltex Integra Jarit Miltex Integra Miltex MicroFrance Integra Jarit Integra Miltex MicroFrance Integra Jarit Miltex Integra CODMAN® BACTISEAL® Clear EVD Catheter Nasostat Miltex Miltex Jarit Integra MicroFrance Jarit Integra CerebroFlo EVD Catheter Arkis CerebroFlo EVD Catheter Miltex Integra MicroFrance Jarit MicroFrance Integra Jarit Padgett Integra Flow Regulating Valve Integra Miltex Integra Jarit Miltex Jarit Jarit Integra Miltex Integra MicroFrance Jarit Miltex MicroFrance Integra Padgett Miltex Jarit Ruggles-Redmond CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps Miltex Jarit CABLES; CODMAN® ICP EXPRESS® Miltex Beauty Pink Padgett Miltex Carb-N-Sert Miltex Padgett Jarit Integra Integra Jarit Integra Miltex Padgett CODMAN EDS 3 - CSF External Drainage System Codman Double Lumen Skull Bolt Codman Single Lumen Skull Bolt Miltex Jarit MicroFrance Integra Jarit Integra Integra Miltex Miltex Integra CODMAN Disposable ICP Kits Codman Subarachnoid Screw Miltex Jarit Integra Jarit Padgett MicroFrance Miltex Miltex Tactile Tone Miltex Jarit Miltex Ruggles-Redmond Integra CODMAN Disposable Perforators Codman Certas Plus Programmable Valves Integra MicroFrance Jarit Miltex Hi-5 Miltex Mor-Flex Liberator Moyco Flex-R Jarit Padgett Miltex Padgett Miltex MicroFrance Jarit Integra OSVII Lumbar Valve System OSVII Low Flow Lumbar Valve Jarit Codman Electrosurgical Generator Codman Electrosurgical Foot Pedal Integra Jarit Miltex Padgett UltraLite Miltex Codman HAKIM PROGRAMMABLE VALVE SYSTEM Miltex Padgett Miltex Jarit Integra Integra Miltex Integra Jarit Probe 8" Integra MicroFrance MicroFrance Codman CRAK Kit Miltex Miltex Integra Miltex Integra Integra Jarit MicroFrance Miltex Jarit Miltex Jarit Miltex Padgett Jarit Integra CODMAN EDS 3 - CSF External Drainage System MicroFrance Miltex Padgett Jarit Integra Ruggles-Redmond Jarit Miltex MicroFrance Miltex Jarit Integra MicroFrance Jarit Miltex Integra Integra Miltex Jarit Integra Miltex MicroFrance Integra MicroFrance Miltex Integra MicroFrance Padgett MicroFrance Miltex Integra Jarit Miltex Integra Jarit Jarit Miltex Jarit Integra Padgett Jarit Jarit Supercut MicroFrance Miltex Carb-N-Sert CARB-EDGE 5-700;5-702;5801;5803;5804 LICOX BRAIN OXYGEN MONITORING SYSTEM CATHETER PROBES AND KIT Padgett Jarit Miltex Integra MicroFrance Padgett Jarit Miltex T Electron Jarit Ruggles-Redmond Padgett Miltex Integra MicroFrance Galea Elevator Arkis Galea Elevator Jarit Padgett Miltex Integra Integra Jarit Integra Miltex Miltex Tactile Tone Padgett Jarit MicroFrance CARB-BITE Miltex Integra Integra Ruggles-Redmond MicroFrance Padgett Miltex Jarit RMH Integrator Tactile Tone Silitone Miltex GripLite Jarit Miltex Inject-R-Fill Precise Precision Integra Miltex Padgett Jarit MicroFrance Miltex Integra 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 MicroFrance Jarit Integra Jarit Jarit MicroFrance Integra Miltex Codman® Electrosurgical lrrigator Codman® Electrosurgical Interconnecting Cable CODMAN CERTAS PLUS PROGRAMMAGLE VALVE SYSTEM Ruggles-Redmond Integra MicroFrance Jarit MicroFrance Miltex Padgett Integra Integra Miltex Integra Jarit Jarit Miltex Cardio-Grip Miltex Jarit Integra Miltex Padgett Padgett Miltex Integra Padgett Integra MicroFrance Miltex Jarit Padgett Petit-Point MicroFrance Integra 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 Miltex Integra MicroFrance Integra Miltex Jarit Padgett MicroFrance Miltex Ruggles-Redmond Integra Ruggles-Redmond Integra Padgett Integra Miltex Integra Jarit Integra MicroFrance Miltex Padgett Jarit Padgett Jarit Miltex Integra MicroFrance Integra Padgett Miltex Jarit 5-800 Jarit Integra Ruggles-Redmond Miltex Padgett MicroFrance Wound Measuring Kit Jarit Integra MicroFrance Padgett Integra Miltex Integra Jarit CODMAN Integrated Bipolar Cord And Tubing Set Padgett Jarit MicroFrance Miltex Integra MicroFrance Integra Jarit Integra Miltex Jarit MicroFrance CODMAN LEROY Scalp Clip Applier Forceps CODMAN RANEY Scalp Clip Forceps Integra Jarit Miltex MicroFrance MicroFrance Miltex Integra Miltex Tactile Tone Jarit Integra Miltex Jarit Integra Miltex Integra Jarit Miltex Integra MicroFrance Integra Jarit CODMAN® ACCU-FLO® Straight Connector CODMAN® HOLTER® CODMAN® HAKIM® Programmable Valve CODMAN® HAKIM® Precision Fixed Pressure Valve CODMAN Peel-Away Catheter Introducer Petit-Point Jarit Integra GENERAL INSTRUMENT Padgett Miltex MicroFrance Jarit Integra Miltex Integra MicroFrance Jarit Miltex Integra Padgett Integra Ruggles-Redmond MicroFrance Jarit Miltex Integra Jarit Miltex Ruggles-Redmond Miltex Padgett CARB-BITE Jarit Jarit Miltex Integra Jarit Miltex MicroFrance Relieva Sidekick LP Acclarent Relieva Flex Guide Catheter Miltex Codman Disposable Perforators Integra Jarit Miltex MicroFrance MicroFrance Integra Miltex Jarit Miltex Tri-R Post MicroFrance Padgett Miltex Integra Jarit MicroFrance Jarit Miltex Integra Miltex Jarit Miltex MicroFrance Integra Padgett Integra Miltex MicroFrance Jarit CODMAN® MICROSENSOR® Ventricular Catheter Kit With ICP Sensor Integra MicroFrance Jarit Hakim Percision Valve System Integra MicroFrance MicroFrance Jarit Miltex Integra LICOX BRAIN OXYGEN MONITORING SYSTEM CATHETER PROBES AND KIT Miltex Jarit Integra Jarit Integra Miltex Jarit Miltex MicroFrance Tactile Tone Miltex Integra CereLink ICP Replacement Power Supply 826822 CereLink ICP Replacement Battery 826824 CereLink ICP Extension Cable 826845 CereLink ICP Monitor 826820 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 Integra Miltex CODMAN Bipolar Cords Integra Padgett Jarit Ruggles-Redmond CODMAN Bipolar Cords Jarit Miltex MicroFrance Integra CODMAN® BACTISEAL® Clear with Barium Stripe Catheter Kit MicroFrance Padgett Jarit Ruggles-Redmond Miltex Integra Integra Miltex MicroFrance Jarit MicroFrance Miltex Integra Jarit Rigid Endoscopes Integra Jarit Miltex Jarit Integra MicroFrance DirectLink ICP Extension Cable Patient Monitor Interface Cables DirectLink ICP Module Jarit Miltex Codman Instrument Tray Integra Integra Allograft Wedge Instrument Tray Assembly Jarit Miltex Integra MicroFrance Jarit Miltex Integra CODMAN Craniotomy Kit (consisting of Disposable Perforator, Cranio-blade, & Wire Pass Drill) CODMAN® HAKIM® Programmable Valve with SIPHONGUARD® Device CODMAN® HAKIM® Precision Fixed Pressure Valve with SIPHONGUARD® Device Jarit Integra Miltex Integra Jarit Padgett Ruggles-Redmond Integra Jarit Miltex Integra Integra Miltex Integra Jarit Integra MicroFrance MicroFrance Integra Codman IsoCool Bipolar Forceps MicroFrance Integra Jarit Integra Miltex Padgett MicroFrance Integra Jarit Miltex MicroFrance Jarit Miltex Miltex Jarit MicroFrance Integra Integra MicroFrance Padgett Jarit 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 Jarit Miltex MicroFrance Integra External Drainage Set Thompson Integra Tactile Tone Miltex Jarit Padgett Miltex Jarit Integra MicroFrance CODMAN BACTISEAL EVD CATHETER SET CODMAN HAKIM SHUNT SYSTEMS Padgett Ceram-A-Grip Jarit Grip Deep Miltex Xcision Miltex Integra Jarit CODMAN CERTAS Plus Electronic Tool Kit Jarit LumbarTrak Ruggles-Redmond Miltex MicroFrance SCHWARTZ VESSEL CL CODMAN® SCHWARTZ Clamp Forceps Integra Miltex Integra Padgett MicroFrance Jarit CODMAN Cranio-blade CODMAN Wire Pass Drill Miltex Spectra A EvenWet Lightning Spectra F Jarit Miltex Padgett Jarit Integra MicroFrance Padgett Miltex 225520; 225525; P4480; P4835; P710; PM-4480; PM-4835; PM-710 Integra Integra Miltex Miltex Jarit Integra MicroFrance Miltex Padgett Jarit Miltex CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT Integra Jarit Miltex MicroFrance Miltex Jarit Integra Jarit Padgett Miltex MicroFrance Integra Miltex Jarit Integra Integra Miltex Integra Jarit CODMAN® SCOTT Ventricular Cannula (Disposable) Jarit Arkis Subcutaneous Guidewire Arkis Tunneling Guidewire Arkis Precision Tunneler CODMAN® Disposable Catheter Passer Bactiseal EVD Catheter Sets: Bactiseal Clear EVD Catheter Set Jarit Miltex Miltex Jarit Integra MicroFrance Padgett Ruggles-Redmond Codman Surgical Pattie and Strip Padgett Jarit Miltex Miltex Jarit Integra Miltex Ruggles-Redmond Integra Jarit Miltex Integra Allograft Wedge Impactor Instrument Miltex Jarit Integra Integra Miltex Integra Stainless Steel Peritoneal Introducer Tunneling Guidewire Arkis Tunneling Guidewire Luxtec Light Sources Ultralite MicroFrance Padgett Integra CARB-BITE Jarit Ruggles-Redmond Integra Anti-Rotation Peg Holder Integra Allograft Wedge Sizer Instrument Integra Allograft Wedge Instrument Set Miltex Padgett Jarit Integra Miltex Integra Miltex Jarit Integra Integra Miltex Integra Jarit Ruggles-Red Padgett Jarit Star Integra Petit-Pt Jarit Super CARB-BITE Miltex Jarit CARDIO-GRIP CARB-EDGE Integra Miltex Miltex Articodent MicroFrance Integra Jarit Jarit Miltex Integra Ceram-A-Grip Miltex Petit-Point MicroFrance Jarit Padgett CARB-BITE Integra NPH Low Flow Valve Integra MicroFrance CODMAN® HAKIM® Precision Fixed Pressure Valve CODMAN® HAKIM® Programmable Valve Miltex Jarit Padgett MicroFrance Miltex Integra Onyx-Flex Tactile Tone Onyx-H Onyx-R Miltex Integra MicroFrance Luxtec MLX Light Source MicroFrance Integra Miltex MicroFrance Jarit Integra Miltex Ruggles-Redmond Padgett MicroFrance Integra Jarit Integra Jarit Ruggles-Redmond Jarit Supercut Jarit MicroFrance Ruggles-Redmond Padgett Miltex Integra Integra MicroFrance Miltex Jarit Carb-N-Sert Miltex Jarit Jarit Supercut Padgett CARB-EDGE Padgett Integra CODMAN® BACTISEAL® Ventricular Catheter and Distal Catheter Kit Miltex Tactile Tone Miltex Jarit MicroFrance Integra Integra Miltex MicroFrance Jarit Integra MicroFrance Jarit Miltex Integra Miltex Padgett Jarit Jarit Miltex Codman Jarit Miltex Integra MicroFrance Jarit Miltex Integra Integra Jarit Ruggles-Redmond Codman Ventricular Needles Subcutaneous Guidewire Arkis Subcutaneous Guideware Integra MicroFrance Codman Disposable Perforators Tactile Tone Miltex Miltex Integra Jarit Miltex Jarit MicroFrance Integra MicroFrance Integra Jarit Miltex Jarit Miltex Jarit Padgett MicroFrance Ruggles-Redmond Integra Miltex CODMAN MICROSENSOR Skull Bolt Kits Integra MicroFrance HAKIM PROGRAMMABLE VALVE SYSTEM HAKIM MICRO PROGRAMMABLE VALVE SYSTEM SiphonGuard TM CSF Control Device HAKIM PRECISION VALVE SYSTEM

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2009-11-20
ECS Pusher, Band, Orthodontic Dental Class 1 872.4565 1981-04-24
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 1981-04-24
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 2001-08-06
KBT Punch, Tonsil Ear, Nose, Throat Class 1 874.4420 2003-09-04
HDL Retractor, Vaginal Obstetrics/Gynecology Class 1 884.4520 1981-04-24
HTR Rasp General, Plastic Surgery Class 1 878.4800 2004-11-09
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-09-26
JZB Scissors, Ear Ear, Nose, Throat Class 1 874.4420 1981-04-24
GEG Elevator, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1981-04-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2015-06-15
EKP Reamer, Pulp Canal, Endodontic Dental Class 1 872.4565 1992-08-26
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 1981-04-24
KCH Hook, Tracheal Ear, Nose, Throat Class 1 874.4420 1981-04-24
JYR Nipper, Malleus Ear, Nose, Throat Class 1 874.4420 2007-01-18
HTT Burr, Orthopedic Orthopedic Class 1 888.4540 1981-04-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
EMX Balloon, Epistaxis Ear, Nose, Throat Class 1 874.4100 2004-04-12
EKJ Burnisher, Operative Dental Class 1 872.4565 1981-04-24
JYH Excavator, Ear Ear, Nose, Throat Class 1 874.4420 2009-11-19
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2019-08-29
EMH Forceps, Rongeur, Surgical Dental Class 1 872.4565 1981-04-24
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2007-05-29
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2010-10-21
HCY Curette, Uterine Obstetrics/Gynecology Class 1 884.4530 2003-08-05
HTP File Orthopedic Class 1 888.4540 2003-09-04
BWB Forceps, Tube Introduction Anesthesiology Class 1 868.5780 2003-08-05
GWX Fork, Tuning Neurology Class 1 882.1525 2003-09-04
KAD Elevator, Ent Ear, Nose, Throat Class 1 874.4420 1981-04-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-09-26
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 2001-08-06
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-09-26
EGD Wax, Dental, Intraoral Dental Class 1 872.6890 2001-12-04
EKL Point, Silver, Endodontic Dental Class 1 872.3840 2001-12-04
EFL Forceps, Dressing, Dental Dental Class 1 872.4565 2001-12-04
FSE Table, Operating-Room, Manual General, Plastic Surgery Class 1 878.4950 2007-06-27
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2022-06-21
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-09-26
HNY Cystotome Ophthalmic Class 1 886.4350 2003-09-04
EIS Remover, Crown Dental Class 1 872.4565 1981-04-24
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-09-26
HBG Drills, Burrs, Trephines & Accessories (Manual) Neurology Class 2 882.4300 2008-02-25
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 1981-04-24
KAN Chisel, Nasal General, Plastic Surgery Class 1 878.4800 2004-11-09
EHZ Evacuator, Oral Cavity Dental Class 1 872.6640 2010-09-21
ELA Instrument, Hand, Calculus Removal Dental Class 1 872.4565 2006-08-03
EMP Marker, Periodontic Dental Class 1 872.4565 1981-04-24
HAE Rongeur, Manual Neurology Class 2 882.4840 2010-03-09
HBF Drills, Burrs, Trephines & Accessories (Compound, Powered) Neurology Class 2 882.4305 2017-09-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2023-02-13
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2000-10-24
EKS File, Pulp Canal, Endodontic Dental Class 1 872.4565 1992-08-26
HXL Mallet General, Plastic Surgery Class 1 878.4800 2003-08-05
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 1981-04-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2010-01-22
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2012-03-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-04-29
EGN Scissors, Surgical Tissue, Dental Dental Class 1 872.4565 1981-04-24
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
ECB Unit, Syringe, Air And/Or Water Dental Class 1 872.4565 1992-08-26
FGM Probe And Director, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2003-09-04
OJG Neurological Tray Neurology Class 1 882.4525 2018-09-10
LXM Manipulator, Plunger-Like Joint Unknown Class U N/A 2008-02-28
EJE Frame, Rubber Dam Dental Class 1 872.6300 2001-12-04
KBL Depressor, Metal Tongue, Surgical Ear, Nose, Throat Class 1 874.4420 2003-08-05
HWK Trephine Orthopedic Class 1 888.4540 2005-03-23
HDK Scissors, Episiotomy Obstetrics/Gynecology Class 1 884.4520 1981-04-24
HXG Tamp Orthopedic Class 1 888.4540 2004-06-04
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
KBC Saw, Nasal Ear, Nose, Throat Class 1 874.4420 1981-04-24
HTE Elevator General, Plastic Surgery Class 1 878.4800 2003-08-05
KAC Tube, Laryngectomy Ear, Nose, Throat Class 1 874.4420 2003-09-04
HNB Spoon, Ophthalmic Ophthalmic Class 1 886.4350 2000-12-14
EHJ Disk, Abrasive Dental Class 1 872.6010 2001-12-04
KAL Retractor, Ent Ear, Nose, Throat Class 1 874.4420 2003-08-05
EAX Mirror, Mouth Dental Class 1 872.4565 1992-08-26
FGY Cannula, Injection General, Plastic Surgery Class 1 878.4200 2015-03-30
KTG Knife, Ent Ear, Nose, Throat Class 1 874.4420 2003-08-05
NWV Laparoscopic Accessories, Gynecologic Obstetrics/Gynecology Class 1 884.1720 2014-01-13
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 2003-08-05
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2003-09-09
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2007-02-22
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 1981-04-24
OFX General Purpose Dental Tray Dental Class 1 872.6640 2020-07-30
GEO File, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1981-04-24
GAD Retractor General, Plastic Surgery Class 1 878.4800 1981-04-24
EMJ Elevator, Surgical, Dental Dental Class 1 872.4565 1981-04-24
EKH Carver, Dental Amalgam, Operative Dental Class 1 872.4565 1981-04-24
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1981-04-24
GDR Saw, Manual And Accessories General, Plastic Surgery Class 1 878.4800 2000-12-14
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2008-03-26
EKM Gutta-Percha Dental Class 1 872.3850 1994-02-17
EIG Retractor, All Types Dental Class 1 872.4565 1981-04-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-09-26
JYF Clamp, Ossicle Holding Ear, Nose, Throat Class 1 874.4420 2014-11-04
MZY Graft, Vascular, Stainless Steel Tunneler Cardiovascular Class 2 870.3450 2013-03-18
GAH Stylet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1981-04-24
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 2017-09-26
HTW Bit, Drill Orthopedic Class 1 888.4540 2005-01-18
HRT Stripper, Surgical Orthopedic Class 1 888.4540 2001-08-06
FBX Sound, Urethral, Metal Or Plastic Gastroenterology, Urology Class 1 876.5520 1981-04-24
HCZ Forceps, Surgical, Gynecological Obstetrics/Gynecology Class 2 884.4530 2014-04-15
EJY Pliers, Operative Dental Class 1 872.4565 1981-04-24
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 2007-05-29
GDL Needle, Suturing, Reusable General, Plastic Surgery Class 1 878.4800 2004-04-12
KAS Knife, Nasal Ear, Nose, Throat Class 1 874.4420 2004-11-09
HRQ Hemostat General, Plastic Surgery Class 1 878.4800 2003-09-09
GDX Scalpel, One-Piece General, Plastic Surgery Class 1 878.4800 1981-04-24
EID Syringe, Restorative And Impression Material Dental Class 1 872.4565 2008-04-09
KBR Needle, Tonsil Suturing Ear, Nose, Throat Class 1 874.4420 2000-10-17
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 1981-04-24
HBD Handpiece (Brace), Drill Neurology Class 1 882.4325 2001-05-31
JYG Curette, Ear Ear, Nose, Throat Class 1 874.4420 2003-09-04
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2001-08-09
JZY Knife, Laryngeal Ear, Nose, Throat Class 1 874.4420 2014-11-04
LGG Instrument, Cast Application/Removal, Manual Orthopedic Class 1 888.5980 2003-09-04
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 1981-04-24
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2011-05-19
HWJ Awl Orthopedic Class 1 888.4540 2000-12-14
FHI Ring, Laparotomy Gastroenterology, Urology Class 1 876.4730 2015-02-04
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-09-26
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2004-06-04
JZD Snare, Ear Ear, Nose, Throat Class 1 874.4420 2008-03-26
JYL Hook, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2009-11-19
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 1981-04-24
KAP Curette, Nasal Ear, Nose, Throat Class 1 874.4420 2003-08-05
HNG Rongeur, Lachrymal Sac Ophthalmic Class 1 886.4350 2008-03-26
EMQ Hoe, Periodontic Dental Class 1 872.4565 2006-08-03
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2013-01-11
GWY Pinwheel Neurology Class 1 882.1750 1981-04-24
EFK Forceps, Articulation Paper Dental Class 1 872.4565 1981-04-24
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1981-04-24
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
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 2017-09-26
GYK Instrument, Shunt System Implantation Neurology Class 1 882.4545 2017-09-26
HTD Forceps General, Plastic Surgery Class 1 878.4800 2003-09-09
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2008-03-26
EJI Syringe, Cartridge Dental Class 2 872.6770 2009-05-27
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 1981-04-24
KBN Gag, Mouth Ear, Nose, Throat Class 1 874.4420 1981-04-24
HAE Rongeur, Manual Neurology Class 2 882.4840 2015-05-07
HXS Twister, Wire Orthopedic Class 1 888.4540 1981-04-24
EXX Probe, Rectal, Non-Powered Gastroenterology, Urology Class 1 876.4730 1981-04-24
KAM Cannula, Sinus General, Plastic Surgery Class 1 878.4800 1981-04-24
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2011-05-24
HBF Drills, Burrs, Trephines & Accessories (Compound, Powered) Neurology Class 2 882.4305 2017-09-26
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
ELR Post, Root Canal Dental Class 1 872.3810 1997-01-14
GDH Gouge, Surgical, General & Plastic Surgery 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
KBZ Snare, Tonsil Ear, Nose, Throat Class 1 874.4420 1981-04-24
KAI Mirror, Ent Ear, Nose, Throat Class 1 874.4420 1981-04-24
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-09-26
JYE Chisel, Middle-Ear Ear, Nose, Throat Class 1 874.4420 2009-11-19
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2004-11-09
KCG Dilator, Tracheal Ear, Nose, Throat Class 1 874.4420 2008-03-25
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2007-02-22
FNS Ring Cutter General Hospital Class 1 880.6200 1981-04-24
GAI Stripper, Vein, Reusable General, Plastic Surgery Class 1 878.4800 2009-11-19
EMI File, Bone, Surgical Dental Class 1 872.4565 1981-04-24
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2021-05-05
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-09-26
EMO Knife, Periodontic Dental Class 1 872.4565 1981-04-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-09-26
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-06-06
JZA Rongeur, Mastoid Ear, Nose, Throat Class 1 874.4420 1981-04-24
HCA Catheter, Ventricular Neurology Class 2 882.4100 2017-09-26
HTX Rongeur Orthopedic Class 1 888.4540 1981-04-24
JYQ Loop, Wire Ear, Nose, Throat Class 1 874.4420 2003-08-05
KAQ Gouge, Nasal, Ent Ear, Nose, Throat Class 1 874.4420 2007-06-27
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2009-11-19
DQR Cannula, Catheter Cardiovascular Class 2 870.1300 2014-02-06
KYW Container, Liquid Medication, Graduated General Hospital Class 1 880.6430 2005-03-02
JYC Cannula, Ear General, Plastic Surgery Class 1 878.4800 1981-04-24
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-09-26
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2000-12-14
KBS Punch, Adenoid Ear, Nose, Throat Class 1 874.4420 1981-02-24
HTS Knife, Orthopedic Orthopedic Class 1 888.4540 1981-04-24
HBF Drills, Burrs, Trephines & Accessories (Compound, Powered) Neurology Class 2 882.4305 2017-09-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-09-27
CCX Support, Patient Position Anesthesiology Class 1 868.6820 2008-08-29
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2001-04-26
HRH Trephine, Manual, Ophthalmic Ophthalmic Class 1 886.4350 2000-12-14
JYZ Rod, Measuring Ear Ear, Nose, Throat Class 1 874.4420 2014-11-04
KAW Punch, Antrum Ear, Nose, Throat Class 1 874.4420 1981-04-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-09-26
JYP Knife, Myringotomy Ear, Nose, Throat Class 1 874.4420 2009-11-19
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 2003-08-05
KBQ Knife, Tonsil Ear, Nose, Throat Class 1 874.4420 1981-04-24
HDC Tenaculum, Uterine Obstetrics/Gynecology Class 2 884.4530 2009-01-20
EKT Curette, Endodontic Dental Class 1 872.4565 2001-12-04
KBM Dissector, Tonsil Ear, Nose, Throat Class 1 874.4420 2009-11-19
HWQ Passer Orthopedic Class 1 888.4540 2007-06-27
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-12
KCC Bistoury, Tracheal Ear, Nose, Throat Class 1 874.4420 1981-04-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-18
EIK Carver, Wax, Dental Dental Class 1 872.4565 1981-04-24
JYO Knife, Ear Ear, Nose, Throat Class 1 874.4420 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 2017-09-26
EMG Forceps, Tooth Extractor, Surgical Dental Class 1 872.4565 1981-04-24
EJI Syringe, Cartridge Dental Class 2 872.6770 2014-12-01
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2019-11-01
HBG Drills, Burrs, Trephines & Accessories (Manual) Neurology Class 2 882.4300 2009-11-19
HBT Applier, Hemostatic Clip General, Plastic Surgery Class 1 878.4800 1981-04-24
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2000-10-24
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2017-09-27
EHM Strip, Polishing Agent Dental Class 1 872.6010 2001-12-04
KQW Goniometer, Nonpowered Orthopedic Class 1 888.1520 2006-10-05
HWT Template Orthopedic Class 1 888.4800 2001-04-26
EJG Forceps, Rubber Dam Clamp Dental Class 1 872.6300 2003-09-04
KCP Syringe, Ent Ear, Nose, Throat Class 1 874.5220 2004-06-04
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2000-12-14
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-09-26
EMS Curette, Periodontic Dental Class 1 872.4565 1981-04-24
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2000-10-24
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2003-08-05
KBX Screw, Tonsil Ear, Nose, Throat Class 1 874.4420 2003-09-04
HCA Catheter, Ventricular Neurology Class 2 882.4100 2017-09-26
FHA Clamp, Penile Gastroenterology, Urology Class 1 876.5160 2009-11-13
GYK Instrument, Shunt System Implantation Neurology Class 1 882.4545 2008-12-12
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2024-03-13
HNC Specula, Ophthalmic Ophthalmic Class 1 886.4350 2003-08-05
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1981-04-24
HBA Neurosurgical Paddie Neurology Class 2 882.4700 2021-01-19
EKI Carrier, Amalgam, Operative Dental Class 1 872.4565 2008-03-26
FFN Clamp, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2013-02-26
EHY Tray, Impression, Preformed Dental Class 1 872.6880 1992-08-26
HWA Impactor Orthopedic Class 1 888.4540 2001-04-26
EIR Scissors, Collar And Crown Dental Class 1 872.4565 1981-04-24
PIY Stainless Steel Instrument, Shunt System Implantation Neurology Class 1 882.4545 2014-12-02
FCW Light Source, Fiberoptic, Routine Gastroenterology, Urology Class 2 876.1500 2007-12-04
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2005-03-24
HXB Probe Orthopedic Class 1 888.4540 2003-09-04
HNM Needle, Ophthalmic Suturing Ophthalmic Class 1 886.4350 2003-09-04
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 1981-04-24
HHF Remover, Intrauterine Device, Contraceptive, Hook-Type Obstetrics/Gynecology Class 1 884.4530 2003-09-04
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 1981-04-24
GDN Knife, Amputation General, Plastic Surgery Class 1 878.4800 1981-04-24
EFH Paper, Articulation Dental Class 1 872.6140 1996-04-02
KTE Trocar, Ent Ear, Nose, Throat Class 1 874.4420 2009-11-19
FZR Contractor, Surgical General, Plastic Surgery Class 1 878.4800 2000-12-14
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2003-09-09
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-18
KAY Punch, Nasal Ear, Nose, Throat Class 1 874.4420 2014-11-04
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
HWO Skid, Bone Orthopedic Class 1 888.4540 1981-04-24
FMA Depressor, Tongue, Non-Surgical General Hospital Class 1 880.6230 1981-04-24
EKK Spreader, Pulp Canal Filling Material, Endodontic Dental Class 1 872.4565 1992-08-26
JYW Press, Vein Ear, Nose, Throat Class 1 874.4420 2004-06-07
FCW Light Source, Fiberoptic, Routine Gastroenterology, Urology Class 2 876.1500 2008-11-26
KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) Ear, Nose, Throat Class 2 874.3620 2015-01-19
KTF Punch, Ent Ear, Nose, Throat Class 1 874.4420 2003-08-05
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1981-04-24
GZX Instrument, Microsurgical Neurology Class 1 882.4525 1998-08-24
KBD Scissors, Nasal Ear, Nose, Throat Class 1 874.4420 1999-05-05
FXG Specula Accessories General, Plastic Surgery Class 1 878.1800 2014-11-04
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2003-07-24
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2003-09-09
GWI Discriminator, Two-Point Neurology Class 1 882.1200 2009-11-19
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
EJZ Knife, Margin Finishing, Operative Dental Class 1 872.4565 2006-08-03
JYD Chisel, Mastoid General, Plastic Surgery Class 1 878.4800 2003-08-04
JYT Pick, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 1999-05-19
KAK Probe, Ent Ear, Nose, Throat Class 1 874.4420 2000-10-17
FHL Scoop Gastroenterology, Urology Class 1 876.4730 2000-12-14
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 1981-04-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2026-03-26
EYR Tourniquet, Gastro-Urology General, Plastic Surgery Class 1 878.5900 2004-06-04
KAZ Rasp, Frontal-Sinus Ear, Nose, Throat Class 1 874.4420 1981-04-24
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 1999-04-27
MMO Tray, Surgical, Ent Ear, Nose, Throat Class 1 874.4420 2015-03-28
HBF Drills, Burrs, Trephines & Accessories (Compound, Powered) Neurology Class 2 882.4305 2020-02-14
EKF Instrument, Contouring, Matrix, Operative Dental Class 1 872.4565 2006-08-03
EZB Stylet For Catheter, Gastro-Urology Gastroenterology, Urology Class 1 876.5130 2015-02-06
KCJ Applicator, Ent Ear, Nose, Throat Class 1 874.5220 1981-04-24
KBB Rongeur, Nasal Ear, Nose, Throat Class 1 874.4420 1981-04-24
JEX Plier, Orthodontic Dental Class 1 872.4565 1981-04-24
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 1981-04-24
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-09-26
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 2017-09-26

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
K950499 American Hydro-Surgical Instruments, Inc. NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS 1995-06-16
K020558 Integra Neurosciences LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE 2002-03-21
K914226 E.I. Dupont DE Nemours & Co., Inc. ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK 1991-11-19
K981246 Integra Neurocare, LLC BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) 1999-05-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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-0019-2023 Hobbs Medical, Inc. 1
Hobbs Scope Introducer Catalog Number: 4650
Z-0031-2014 Aesculap, Inc. 1
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0027-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.

Similar Registrations

Registration Number Establishment Name Location
2031093 LIFE SCIENCE OUTSOURCING, INC. Brea, CA, US
3004608878 INTEGRA LIFESCIENCES CORPORATION CINCINNATI, OH, US
8010456 GUENTER BISSINGER MEDIZINTECHNIK GMBH TENINGEN Baden-Wurttemberg, DE
2244478 LYNX Medical NJ Franklin, NJ, US
9617070 GYRUS MEDICAL LTD. CARDIFF Wales, GB
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014334038. Last updated year: 2026. Please use registration number 3014334038 when referencing this establishment in official correspondence.
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