150 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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Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.
FDA Enforcement
Class II
·Terminated·Karl Storz Endoscopy·April 8, 2020
Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.
FDA Recall
Terminated
·Karl Storz Endoscopy·Product code EQN·December 6, 2019
Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intended for stabilization of the thoracic, lumbar, sacral, and/or iliac spine through screw and/or hook and rod fixation.
FDA Recall
Terminated
·Synthes USA HQ, Inc.·Product code HXP·June 22, 2013
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
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