12 results
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11ms
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Sources: EU EUDAMED, US FDA
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
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
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened Micro-Introducer Kit, STF 5F M.I. KIT 45CM SS/SS ECHO S PG, Item Number H787065970415, Catalog No. REF 06597041 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
FDA Enforcement
Class III
·Terminated·Angiodynamics, Inc.·December 28, 2016
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item Number H787065970655, Catalog No.REF 06597065, 2) 4 F Stiffened Micro-Introducer Kit, STF 4F M.I. KIT 45CM NT/T NON-ECHO S PG, Item Number H787065970695, Catalog No.REF 06597069 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
FDA Enforcement
Class III
·Terminated·Angiodynamics, Inc.·December 28, 2016
Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
FDA Enforcement
Class II
·Terminated·MTI Precision Products LLC.·July 23, 2014