ClearanceBrief
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

CodeDeviceRecords
DXTInjector And Syringe, Angiographic10
IZQInjector, Contrast Medium, Automatic3
CXT1
IZOGenerator, High-Voltage, X-Ray, Diagnostic1
JOHTube Tracheostomy And Tube Cuff1
MNTContinuous, Minimal Ventilatory Support, Facility Use Ventilator1
MRNApparatus, Nitric Oxide Delivery1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Dec 11, 2001K003075KNIGHTSTAR 330 VENTILATOR
Mallinckrodt, Inc.
MNT
Nov 8, 2000K003315SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
Mallinckrodt, Inc.
JOH

Latest recalls

DateFirm and productCodeLinked 510(k)
Sep 13, 2022Mallinckrodt, 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
MRNK061901
Jul 26, 2012Mallinckrodt 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
DXTK781334
Feb 29, 2012Mallinckrodt 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
DXTK882329
Feb 29, 2012Mallinckrodt 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
DXTK984088
Feb 29, 2012Mallinckrodt 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
DXTK984088
Feb 29, 2012Mallinckrodt 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
DXTK984088
Feb 29, 2012Mallinckrodt 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
DXTK984088
Feb 29, 2012Mallinckrodt 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
DXTK984088
Jan 20, 2012Mallinckrodt 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
IZQK781334
Jan 19, 2012Mallinckrodt 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
DXTK781334
Jul 21, 2011Mallinckrodt 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
IZQK963071
Jun 25, 2010Mallinckrodt 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
IZOK920742
K943581
Sep 3, 2008Mallinckrodt Inc
Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imaging.
Terminated
DXTK031339
K912944
Aug 15, 2008Mallinckrodt 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
IZQK063503
Oct 13, 2007Mallinckrodt Inc
Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO.
Terminated
DXTK963071
Dec 16, 2006Mallinckrodt Inc
OptiVantage DH Power Injection System.
Terminated
CXTK042744
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