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Integra LifeSciences Corp. d.b.a. Integra Pain Management

20 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND recall (Z-2733-2016)Integra LifeSciences Corp. d.b.a. Integra Pain Management2016-09-02
Integra Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and compone recall (Z-0193-2016)Integra LifeSciences Corp. d.b.a. Integra Pain Management2015-10-30
Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic recall (Z-2056-2015)Integra LifeSciences Corp. d.b.a. Integra Pain Management2015-07-09
Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable recall (Z-1544-2015)Integra LifeSciences Corp. d.b.a. Integra Pain Management2015-04-29
Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (C recall (Z-0551-2014)Integra LifeSciences Corp. d.b.a. Integra Pain Management2013-12-20
Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Onl recall (Z-0533-2014)Integra LifeSciences Corp. d.b.a. Integra Pain Management2013-12-17
Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The k recall (Z-2260-2013)Integra LifeSciences Corp. d.b.a. Integra Pain Management2013-09-19
Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119 recall (Z-1943-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-07-05
1104HC Integra NeuroSciences Ventricular Bold Monitoring Kit W/ Cranial Access, Drain incl recall (Z-0748-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
Cranial Access Kit Ref INSHITH Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non- recall (Z-0749-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
Cranial Access Kit Ref INSHITHNR Integra NeuroSciences Plainsboro, NJ 08536 Sterile and no recall (Z-0750-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
Cranial Access Kit Ref HITHSP04 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non recall (Z-0751-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
Cranial Access Kit Ref HITHSP06 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non recall (Z-0752-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
Cranial Access Kit Ref SP0153 Integra NeuroSciences Plainsboro, NJ 08536 Contents Sterile recall (Z-0753-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
1104LC Combo Kit including 1 Camino ICP Monitoring Catheter, 1 Cranial Kit w/Cam Chuck. In recall (Z-0754-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
31147 Combo Kit W/110-4BT & 30361 including 1 Cranial Kit w/Cam Chuck 1 intracranial press recall (Z-0755-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
31144 Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 Micro Ventricular Bolt ICP, 1 CSF D recall (Z-0756-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
1104HMC Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 Micro Ventricular Bolt ICP Monito recall (Z-0757-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
1104BC Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 OLM Intracranial Pressure Monitori recall (Z-0758-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
Cranial Access Kit Ref HITHSP06 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non recall (Z-0759-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13

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Every clearance here is in the API, with alerts when new ones post.