Integra LifeSciences Production Corporation
Mansfield, MA, US
Integra LifeSciences Production Corporation appears in FDA device records in Mansfield, MA. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Integra LifeSciences Production Corporation between 2021 and 2026. The busiest year on record is 2023, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261004 | Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) | JXG | Substantially Equivalent | |
| K243531 | Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology | JXG | Substantially Equivalent | |
| K243552 | Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762) | JXG | Substantially Equivalent | |
| K232890 | CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) | GWM | Substantially Equivalent | |
| K233445 | Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter | JXG | Substantially Equivalent | |
| K233448 | Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set | JXG | Substantially Equivalent | |
| K223330 | Certas Plus Programmable Valves | JXG | Substantially Equivalent | |
| K221840 | Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves | JXG | Substantially Equivalent | |
| K210993 | CereLink ICP Monitor | GWM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014334038 | 3014334038 | Integra LifeSciences Production Corporation | 11 Cabot Blvd., Mansfield, MA 02048 US | 2026 | and 267 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EJRAgent, Polishing, Abrasive, Oral Cavity
- EMXBalloon, Epistaxis
- EQJBur, Ear, Nose And Throat
- EKJBurnisher, Operative
- DQRCannula, Catheter
- EKICarrier, Amalgam, Operative
- EKHCarver, Dental Amalgam, Operative
- EIKCarver, Wax, Dental
- EFNCotton, Roll
- EKTCurette, Endodontic
- EMSCurette, Periodontic
- EHJDisk, Abrasive
- EMJElevator, Surgical, Dental
- EHZEvacuator, Oral Cavity
- EMIFile, Bone, Surgical
- EKSFile, Pulp Canal, Endodontic
- EFKForceps, Articulation Paper
- EFLForceps, Dressing, Dental
- EMHForceps, Rongeur, Surgical
- EJGForceps, Rubber Dam Clamp
- EMGForceps, Tooth Extractor, Surgical
- BWBForceps, Tube Introduction
- EJEFrame, Rubber Dam
- EILGauge, Depth, Instrument, Dental
- EKMGutta-Percha
- EJBHandle, Instrument, Dental
- EMQHoe, Periodontic
- EGZHolder, Film, X-Ray
- EKFInstrument, Contouring, Matrix, Operative
- ELAInstrument, Hand, Calculus Removal
- DWSInstruments, Surgical, Cardiovascular
- EJZKnife, Margin Finishing, Operative
- EMOKnife, Periodontic
- EMFKnife, Surgical
- EMPMarker, Periodontic
- EAXMirror, Mouth
- EOBNasopharyngoscope (Flexible Or Rigid)
- EFHPaper, Articulation
- EEAPlate, Base, Shellac
- EJYPliers, Operative
- EKLPoint, Silver, Endodontic
- ELRPost, Root Canal
- EXXProbe, Rectal, Non-Powered
- ECSPusher, Band, Orthodontic
- EKPReamer, Pulp Canal, Endodontic
- EISRemover, Crown
- EIGRetractor, All Types
- EIRScissors, Collar And Crown
- EGNScissors, Surgical Tissue, Dental
- EQHSource, Carrier, Fiberoptic Light
- EPYSpeculum, Ent
- EKKSpreader, Pulp Canal Filling Material, Endodontic
- EHMStrip, Polishing Agent
- CCXSupport, Patient Position
- EJISyringe, Cartridge
- EIDSyringe, Restorative And Impression Material
- BWNTable And Attachments, Operating-Room
- EHYTray, Impression, Preformed
- ECBUnit, Syringe, Air And/Or Water
- EGDWax, Dental, Intraoral
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain