Company ยท US
Mallinckrodt Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2001. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
16recalls (0 in 12 months)
16recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 13, 2022 | Mallinckrodt, LLC. INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of n Open, Classified |
MRN | K061901 |
| Jul 26, 2012 | Mallinckrodt Inc The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that projects upward approximately two inches.
The Handi-Fil Disposa Terminated |
DXT | K781334 |
| Feb 29, 2012 | Mallinckrodt Inc Coiled 60" Low Pressure Extension Tube 400 PSI Max; packaged in Plastic and Tyvec pouch, with 100 pouches per case; Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico.
Sterile, The purpos Terminated |
DXT | K882329 |
| Feb 29, 2012 | Mallinckrodt Inc Mallinckrodt Optistar Elite 60 mL Syringe with Lateral Flow Needle, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 50 pouches per ca Terminated |
DXT | K984088 |
| Feb 29, 2012 | Mallinckrodt Inc Mallinckrodt Optistar Elite 90" Y-Tubing with Single Check Valve, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 100 pouches per cas Terminated |
DXT | K984088 |
| Feb 29, 2012 | Mallinckrodt Inc Mallinckrodt Optistar Elite 60" Y-Tubing with Single Check Valve, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 100 pouches per cas Terminated |
DXT | K984088 |
| Feb 29, 2012 | Mallinckrodt Inc Liebel-Flarsheim Optistar MR 25 mL Syringe w/lateral flow needle, Mallinckrodt, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 100 pouches per case.
Sterile, Terminated |
DXT | K984088 |
| Feb 29, 2012 | Mallinckrodt Inc Liebel-Flarsheim Optistar MR 60 mL Syringe w/lateral flow needle, Mallinckrodt, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 50 pouches per case.
Sterile, Terminated |
DXT | K984088 |
| Jan 20, 2012 | Mallinckrodt Inc Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL Regular Luer Syringe with Handi-Fil (p/n 900101), Made in Mexico, Liebel-Flarsheim Company, Cincinnati, OH
The Li Terminated |
IZQ | K781334 |
| Jan 19, 2012 | Mallinckrodt Inc Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch, Mallinckrodt, Inc., Libel-Flarsheim, Cincinnati, OH Made in Mexico.
The Handi-Fil Disposable Syringe Fill Tube is a sterile Terminated |
DXT | K781334 |
| Jul 21, 2011 | Mallinckrodt Inc Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103), in a sealed molded plastic tray.
The Liebel Flarsheim Illumena 150 mL Linden Luer Syringe with Handi-Fil Straw Terminated |
IZQ | K963071 |
| Jun 25, 2010 | Mallinckrodt Inc Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator & p/n 750733 80W generator). Mallinckrodt, Inc. Cincinnati, OH 45237.
Facilitates digital radiologic and/or fluoroscop Terminated |
IZO | K920742 K943581 |
| Sep 3, 2008 | Mallinckrodt Inc Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imaging. Terminated |
DXT | K031339 K912944 |
| Aug 15, 2008 | Mallinckrodt Inc The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with comput Terminated |
IZQ | K063503 |
| Oct 13, 2007 | Mallinckrodt Inc Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO. Terminated |
DXT | K963071 |
| Dec 16, 2006 | Mallinckrodt Inc OptiVantage DH Power Injection System. Terminated |
CXT | K042744 |