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Companies / Integra LifeSciences Corp. d.b.a. Integra Pain Management
Integra LifeSciences Corp. d.b.a. Integra Pain Management
FDA Regulatory Profile
Summary
- Total Recalls
- 10
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2733-2016 | Class II | Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND | August 24, 2016 |
| Z-2868-2016 | Class II | PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical profe | August 24, 2016 |
| Z-2684-2016 | Class II | INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile. | August 4, 2016 |
| Z-0193-2016 | Class II | Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used | September 22, 2015 |
| Z-2056-2015 | Class II | Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Meta | May 1, 2015 |
| Z-1544-2015 | Class II | Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Met | March 30, 2015 |
| Z-0551-2014 | Class II | Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) all | November 26, 2013 |
| Z-0533-2014 | Class II | Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Pro | October 28, 2013 |
| Z-2260-2013 | Class II | Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits all | September 4, 2013 |
| Z-1943-2012 | Class III | Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit | June 7, 2012 |