300 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code PEZ·April 9, 2021
Kit: Blood Culture. MAI Kit Part Number: 80315D
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code OFM·April 9, 2021
Kit: Injection REVIEW MAI Kit Part Number: 74736
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code OGJ·April 9, 2021
Kit: Blood Culture MAI Kit Part Number: 80076
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code OFZ·April 9, 2021
Kit: Midline Insertion DA. MAI Kit Part Number: 77981B
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code OFF·April 9, 2021
Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code PEZ·April 9, 2021
Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420
FDA Enforcement
Class I
·Terminated·Medical Action Industries, Inc. 306·May 19, 2021
Kit: Blood Culture. MAI Kit Part Number: 80315D
FDA Enforcement
Class I
·Terminated·Medical Action Industries, Inc. 306·May 19, 2021
Kit: Injection REVIEW MAI Kit Part Number: 74736
FDA Enforcement
Class I
·Terminated·Medical Action Industries, Inc. 306·May 19, 2021
Kit: Blood Culture MAI Kit Part Number: 80076
FDA Enforcement
Class I
·Terminated·Medical Action Industries, Inc. 306·May 19, 2021
Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B
FDA Enforcement
Class I
·Terminated·Medical Action Industries, Inc. 306·May 19, 2021
Kit: Midline Insertion DA. MAI Kit Part Number: 77981B
FDA Enforcement
Class I
·Terminated·Medical Action Industries, Inc. 306·May 19, 2021
Medical Action Industries, Venous Access Tray, using BD Q-Syte Luer Access Split Septum (BD #385100)), Part number: 69498.
FDA Recall
Terminated
·Medical Action Industries Inc·Product code FPA·November 6, 2009
Medical Action Industries, IV Start Bundle Kit, using MPS Acacia with BD Q-Syte (BD #385151), Part number: 69946B.
FDA Recall
Terminated
·Medical Action Industries Inc·Product code FPA·November 6, 2009
Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977.
FDA Recall
Terminated
·Medical Action Industries Inc·Product code FPA·November 6, 2009
Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018
VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum and plasma using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Enforcement
Class III
·Terminated·Ortho-Clinical Diagnostics·September 19, 2018
VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Product Usage:
FDA Enforcement
Class III
·Terminated·Ortho-Clinical Diagnostics·September 19, 2018
Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·February 21, 2018
AVID TruCustom SPINE convenience kits, Item Code: LITT016-04
FDA Recall
Terminated
·Avid Medical, Inc.·Product code LRO·June 22, 2017