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Mallinckrodt Inc

15 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inc recall (Z-2081-2012)Mallinckrodt Inc2012-07-26
Liebel-Flarsheim Optistar MR 60 mL Syringe w/lateral flow needle, Mallinckrodt, Cincinnati recall (Z-1118-2012)Mallinckrodt Inc2012-02-29
Liebel-Flarsheim Optistar MR 25 mL Syringe w/lateral flow needle, Mallinckrodt, Cincinnati recall (Z-1119-2012)Mallinckrodt Inc2012-02-29
Mallinckrodt Optistar Elite 60" Y-Tubing with Single Check Valve, Liebel-Flarsheim Company recall (Z-1120-2012)Mallinckrodt Inc2012-02-29
Mallinckrodt Optistar Elite 90" Y-Tubing with Single Check Valve, Liebel-Flarsheim Company recall (Z-1121-2012)Mallinckrodt Inc2012-02-29
Mallinckrodt Optistar Elite 60 mL Syringe with Lateral Flow Needle, Liebel-Flarsheim Compa recall (Z-1122-2012)Mallinckrodt Inc2012-02-29
Coiled 60" Low Pressure Extension Tube 400 PSI Max; packaged in Plastic and Tyvec pouch, w recall (Z-1123-2012)Mallinckrodt Inc2012-02-29
Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL Regu recall (Z-0830-2012)Mallinckrodt Inc2012-01-20
Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch, Mallinckrodt, In recall (Z-0815-2012)Mallinckrodt Inc2012-01-19
Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103), in recall (Z-2859-2011)Mallinckrodt Inc2011-07-21
Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator & p/n 7507 recall (Z-1904-2010)Mallinckrodt Inc2010-06-25
Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media deliver recall (Z-1828-2008)Mallinckrodt Inc2008-09-03
The OptiVantage DH Injection System is a contrast delivery system and is designed to injec recall (Z-1694-2008)Mallinckrodt Inc2008-08-15
Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO. recall (Z-0056-2008)Mallinckrodt Inc2007-10-13
OptiVantage DH Power Injection System. recall (Z-0288-2007)Mallinckrodt Inc2006-12-16

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