152 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.
FDA Enforcement
Class III
·Terminated·Applied Medical Technology Inc·March 1, 2017
CXP Analysis Software, Versions 2.0 & 2.1: Part #722396 CXP Analysis Software Kit V2.1, Single User; Part #722395 CXP Analysis Software Kit V2.1, Single User Upgrade; Part #722397 CXP Analysis Software Kit V2.1, 3 User Pack; Part #722398 CXP Analysis Software Kit V2.1, 5 User Pack; Part #722399 CXP Analysis Software Kit V2. 1, 15 User Pack; Part # 722593 CXP Analysis Software Kit V2.1, 5 Network User Pack Part #722594 CXP Analysis Software Kit V2.1, 10 Network User Pack; Part #722595 CXP Analysis Software Kit V2.1, 15 Network User Pack; Part #629640 CXP Analysis Software Kit V2.0, Single User; Part #629639 CXP Analysis Software Kit V2.0, Single User Upgrade; Part #629641 CXP Analysis Software Kit V2.0, 3 User Pack; Part #629642 CXP Analysis Software Kit V2.0, 5 User Pack; Part #629643 CXP Analysis Software Kit V2.0, 15 User Pack; Part #629644 CXP Analysis Software Kit V2.0, 5 Network User Pack; Part #629645 CXP Analysis Software Kit V2.0, 10 Network User Pack; Part #629646 CXP Analysis Software Kit V2.0, 15 Network User Pack. The Cytomics FC 500 is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·August 29, 2006
Cytomics FC 500 with CXP software, Versions 2.0 & 2.1: Part #722645, Software Kit; CXP version 2.1 New User; Part #723113 Software Kit; CXP version 2.1 Upgrade; Part #629637 Software Kit; CXP version 2.0 New User; Part #629636 Software Kit; CXP version 2.0 Upgrade. The Cytomics FC 500 is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·August 29, 2006
Cytomics FC500 with CXP Software
FDA Recall
Terminated
·Beckman Coulter Inc·Product code JJF·November 23, 2005
Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·July 26, 2006
1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diagnostics
FDA Enforcement
Class I
·Terminated·Beckman Coulter Inc.·November 28, 2018
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1 single user, Automated differential cell counter; Part Number 722396; Beckman Coulter; Miami, FL 33196.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·May 4, 2007
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1, 15 User Pack, Automated differential cell counter; Part Number 722399; Beckman Coulter; Miami, FL 33196.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·May 4, 2007
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1 single user upgrade, Automated differential cell counter; Part Number 722395; Beckman Coulter; Miami, FL 33196.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·May 4, 2007
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1, 3 User Pack, Automated differential cell counter; Part Number 722397; Beckman Coulter; Miami, FL 33196.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·May 4, 2007
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1, 5 User Pack, Automated differential cell counter; Part Number 722398; Beckman Coulter; Miami, FL 33196.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·May 4, 2007
AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.
FDA Enforcement
Class III
·Terminated·Applied Medical Technology Inc·March 1, 2017
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2, 5 User Network, Automated differential cell counter; Part Number 774178; Beckman Coulter; Miami, FL 33196.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·May 4, 2007
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2, 15 User Network, Automated differential cell counter; Part Number 774180; Beckman Coulter; Miami, FL 33196.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·May 4, 2007
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1, 10 network user with Romlock, Automated differential cell counter; Part Number 722594; Beckman Coulter; Miami, FL 33196.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·May 4, 2007
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2, 5 User, Automated differential cell counter; Part Number 774200; Beckman Coulter; Miami, FL 33196.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·May 4, 2007
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2, 10 User Network, Automated differential cell counter; Part Number 774179; Beckman Coulter; Miami, FL 33196.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·May 4, 2007
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1, 5 network user with Romlock, Automated differential cell counter; Part Number 722593; Beckman Coulter; Miami, FL 33196.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·May 4, 2007
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1, 15 network user with Romlock, Automated differential cell counter; Part Number 722595; Beckman Coulter; Miami, FL 33196.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·May 4, 2007
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2 Single User Upgrade, Automated differential cell counter; Part Number 774198; Beckman Coulter; Miami, FL 33196.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·May 4, 2007