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Sources: EU EUDAMED, US FDA
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FDA Recall
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Medline Latex Free Labor Kit & Postpartum CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
FDA Recall
Terminated
·Medline Industries Inc·Product code OHM·August 4, 2008
Medline Latex Free C-Section CDS-LF and C-Section Supplemental CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
FDA Recall
Terminated
·Medline Industries Inc·Product code OHM·August 4, 2008
Medline Latex Free Vaginal Delivery CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
FDA Recall
Terminated
·Medline Industries Inc·Product code OHM·August 4, 2008
Medline Latex Free Labor & Delivery CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
FDA Recall
Terminated
·Medline Industries Inc·Product code OHM·August 4, 2008
Medline Latex Free Mom/Baby Admit Kit - LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
FDA Recall
Terminated
·Medline Industries Inc·Product code OHM·August 4, 2008
Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA TEST KIT Product is an In Vitro Device (IVD) categorized as a Cardiac Marker, manufactured and distributed by BioCheck, Inc., Foster City, CA. Enzyme Immunoassay for the quantitative determination of Human Cardiac Fatty Acid-Binding Protein (H-FABP) concentration in serum, citrate-plasma, EDTA-plasma, and heparin-plasma.
FDA Recall
Terminated
·BioCheck Inc·Product code NUK·July 15, 2010
ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy, Distributed by: DiaSorin Inc., 1951 Northwestern Avenue, P.O. Box 285, Stillwater, MN 55082-0285 In vitro enzyme immunoassay (EIA) intended for use in the qualitative detection of antibodies to hepatitis B surface antigen (anti-HBs) in human serum or plasma.
FDA Recall
Terminated
·Diasorin Inc.·Product code LOM·August 19, 2010
Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a baby.
FDA Recall
Open, Classified
·AMEDA, INC.·Product code HGX·July 10, 2017
McKesson Cardiology Hemo
FDA Recall
Terminated
·Change Healthcare Israel Ltd. 26, Ha-Rokmim Holon Israel·Product code DQK·March 25, 2019
Horizon Cardiology Hemo
FDA Recall
Terminated
·Change Healthcare Israel Ltd. 26, Ha-Rokmim Holon Israel·Product code DQK·March 25, 2019
12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
FDA Recall
Terminated
·Medical Components, Inc dba MedComp·Product code NFK·February 23, 2018
12F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD757, UDI 884908005554 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
FDA Recall
Terminated
·Medical Components, Inc dba MedComp·Product code NFK·February 23, 2018
INFUSE Bone Graft X SMALL KIT REF 7510100
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code NEK·September 27, 2018
INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code NEK·May 28, 2013
CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
FDA Recall
Terminated
·Medical Components, Inc dba MedComp·Product code NFK·February 23, 2018
NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly that has been damaged.
FDA Recall
Terminated
·Arrow International Inc·Product code NFK·July 6, 2020
12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
FDA Recall
Terminated
·Medical Components, Inc dba MedComp·Product code NFK·February 23, 2018
REPAIR KIT, REF ARA101, UDI 884908083637 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
FDA Recall
Terminated
·Medical Components, Inc dba MedComp·Product code NFK·February 23, 2018
REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
FDA Recall
Terminated
·Medical Components, Inc dba MedComp·Product code NFK·February 23, 2018
CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
FDA Recall
Terminated
·Medical Components, Inc dba MedComp·Product code NFK·February 23, 2018