ClearanceBrief
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

CodeDeviceRecords
HBGDrills, Burrs, Trephines & Accessories (Manual)13
CAZAnesthesia Conduction Kit4
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)2
FMFSyringe, Piston1
HGBClip, Tubal Occlusion1
JXGShunt, Central Nervous System And Components1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Sep 2, 2016Integra LifeSciences Corp. d.b.a. Integra Pain Management
Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
Terminated
HBGK961113
Aug 24, 2016Integra 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
CAZK943319
Aug 4, 2016Integra LifeSciences Corp. d.b.a. Integra Pain Management
INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.
Terminated
CAZK943319
Oct 30, 2015Integra 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
FMFK960248
Jul 9, 2015Integra 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
BSPK854816
Apr 29, 2015Integra 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
BSPK854816
Dec 20, 2013Integra 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
JXGK042359
Dec 17, 2013Integra 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
CAZK945484
Sep 19, 2013Integra 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
HGBK961113
Jul 5, 2012Integra 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
CAZK945484
Jan 13, 2012Integra 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
HBGK961113
Jan 13, 2012Integra 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
HBGK961113
Jan 13, 2012Integra 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
HBGK961113
Jan 13, 2012Integra 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
HBGK961113
Jan 13, 2012Integra 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
HBGK961113
Jan 13, 2012Integra 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
HBGK961113
Jan 13, 2012Integra 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
HBGK961113
Jan 13, 2012Integra 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
HBGK961113
Jan 13, 2012Integra 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
HBGK961113
Jan 13, 2012Integra 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
HBGK961113
Jan 13, 2012Integra 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
HBGK961113
Jan 13, 2012Integra 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
HBGK961113
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