Company
Integra LifeSciences Corp. d.b.a. Integra Pain Management
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
22recalls (0 in 12 months)
22recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2016 | Integra LifeSciences Corp. d.b.a. Integra Pain Management Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND Terminated |
HBG | K961113 |
| Aug 24, 2016 | Integra LifeSciences Corp. d.b.a. Integra Pain Management PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379.
Intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administra Terminated |
CAZ | K943319 |
| Aug 4, 2016 | Integra LifeSciences Corp. d.b.a. Integra Pain Management INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile. Terminated |
CAZ | K943319 |
| Oct 30, 2015 | Integra LifeSciences Corp. d.b.a. Integra Pain Management Integra Bone Marrow Biopsy Trays Catalogue No. 3404253
Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable p Terminated |
FMF | K960248 |
| Jul 9, 2015 | Integra LifeSciences Corp. d.b.a. Integra Pain Management Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra Long Epidural Steroid Injection Needle (Catalogue #PITRW2050) Terminated |
BSP | K854816 |
| Apr 29, 2015 | Integra LifeSciences Corp. d.b.a. Integra Pain Management Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalogue No. PITRW1850.
Used to administer steroid medication in t Terminated |
BSP | K854816 |
| Dec 20, 2013 | Integra LifeSciences Corp. d.b.a. Integra Pain Management Integra Cranial Access Kit, Model Number HITHSP10, Rx Only.
Integra Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is Terminated |
JXG | K042359 |
| Dec 17, 2013 | Integra LifeSciences Corp. d.b.a. Integra Pain Management Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only
Product Usage:
The Integra kits which contain a BD LOR syringe are intended to provide licensed medical p Terminated |
CAZ | K945484 |
| Sep 19, 2013 | Integra LifeSciences Corp. d.b.a. Integra Pain Management Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN
The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended Terminated |
HGB | K961113 |
| Jul 5, 2012 | Integra LifeSciences Corp. d.b.a. Integra Pain Management Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administratio Terminated |
CAZ | K945484 |
| Jan 13, 2012 | Integra LifeSciences Corp. d.b.a. Integra Pain Management Cranial Access Kit Ref HITHSP06 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile, Terminated |
HBG | K961113 |
| Jan 13, 2012 | Integra LifeSciences Corp. d.b.a. Integra Pain Management 1104BC Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 OLM Intracranial Pressure Monitoring Kit, contains sterile and non-sterile product. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 S Terminated |
HBG | K961113 |
| Jan 13, 2012 | Integra LifeSciences Corp. d.b.a. Integra Pain Management 1104HMC Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 Micro Ventricular Bolt ICP Monitoring Kit, 1 CSF Drainage System, contains sterile and non-sterile product. Integra NeuroSciences, Integra Life Terminated |
HBG | K961113 |
| Jan 13, 2012 | Integra LifeSciences Corp. d.b.a. Integra Pain Management 31144 Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 Micro Ventricular Bolt ICP, 1 CSF Drainage System, contains sterile and non-sterile product. Integra NeuroSciences, Integra LifeSciences 3498 Wes Terminated |
HBG | K961113 |
| Jan 13, 2012 | Integra LifeSciences Corp. d.b.a. Integra Pain Management 31147 Combo Kit W/110-4BT & 30361 including 1 Cranial Kit w/Cam Chuck 1 intracranial pressure & temperature monitoring kit, contains sterile and non-sterile product. Integra NeuroSciences, Integra Lif Terminated |
HBG | K961113 |
| Jan 13, 2012 | Integra LifeSciences Corp. d.b.a. Integra Pain Management 1104LC Combo Kit including 1 Camino ICP Monitoring Catheter, 1 Cranial Kit w/Cam Chuck. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 South, West Valley City, Utah 84119.
Product Usage: Terminated |
HBG | K961113 |
| Jan 13, 2012 | Integra LifeSciences Corp. d.b.a. Integra Pain Management Cranial Access Kit Ref SP0153 Integra NeuroSciences Plainsboro, NJ 08536 Contents Sterile and non-sterile, Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO, Contents 5 units.
Product Usage: Terminated |
HBG | K961113 |
| Jan 13, 2012 | Integra LifeSciences Corp. d.b.a. Integra Pain Management Cranial Access Kit Ref HITHSP06 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile, Terminated |
HBG | K961113 |
| Jan 13, 2012 | Integra LifeSciences Corp. d.b.a. Integra Pain Management Cranial Access Kit Ref HITHSP04 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile, Terminated |
HBG | K961113 |
| Jan 13, 2012 | Integra LifeSciences Corp. d.b.a. Integra Pain Management Cranial Access Kit Ref INSHITHNR Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile Terminated |
HBG | K961113 |
| Jan 13, 2012 | Integra LifeSciences Corp. d.b.a. Integra Pain Management Cranial Access Kit Ref INSHITH Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile, Terminated |
HBG | K961113 |
| Jan 13, 2012 | Integra LifeSciences Corp. d.b.a. Integra Pain Management 1104HC Integra NeuroSciences Ventricular Bold Monitoring Kit W/ Cranial Access, Drain including (1) Cranial Kit W/Cam. Chuck, (1) Ventricular Bolt ICP Monitoring Kit, (1) CSF Drainage System. Contain Terminated |
HBG | K961113 |