569 results
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22ms
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Sources: EU EUDAMED, US FDA
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The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. The product consists of a vertical column (with counterbalanced vertical carriage, counterweight and pulley system), horizontal floor car and a floor mounted track to ride on.
FDA Recall
Terminated
·Summit Industries Inc.·Product code IYB·October 28, 2014
VersaRad Generator
FDA Recall
Terminated
·Fischer Imaging Corporation·Product code IYB·September 30, 2004
Tube Stand for the Dynarad Phantom Mobile X-Ray System; Del Medical Systems, 11550 West King Street, Franklin Park, IL 60131
FDA Recall
Terminated
·Del Medical Systems Group·Product code IYB·March 10, 2005
3D TOP Ceiling Stand. X-Ray System model number 8773673
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYB·November 30, 2005
Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630.
FDA Recall
Terminated
·General Electric Med Systems·Product code IYB·December 8, 2003
3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a vertical axle. The ceiling stand can be used within a stationary diagnostic X-ray system as well.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYB·June 29, 2018
3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a vertical axle. The ceiling stand can be used within a stationary diagnostic X-ray system as well.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYB·June 29, 2018
3D-I/III Ceiling Stand. Diagnostic x-ray tube mount
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYB·April 28, 2006
DCTM Digital Ceiling Tube Mount, model DCTM; a fully counter-balanced radiographic x-ray tube suspension system designed to facilitate a wide range of procedures; Manufactured by Del Medical Imaging Corporation, Franklin Park, IL 60131 U.S.A.
FDA Recall
Terminated
·Del Medical Systems Group·Product code IYB·February 13, 2004
Ceiling Tube Mount Ceiling Tube Mount (CTM)/Digital Ceiling Tube Mount (DCTM) with 5 inch or 10 inch Column Extensions; a radiographic x-ray tube suspension system designed to facilitate a wide range of procedures; Del Medical Systems Group, 11550 West King Street, Franklin Park, IL 60131-1330. The device is used for X-Ray tube positioning.
FDA Recall
Terminated
·Del Medical Systems Group·Product code IYB·January 12, 2009
VersaRad/Traumex General Radiographic System.
FDA Recall
Terminated
·Fischer Imaging Corporation·Product code IYB·April 23, 2004
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms
FDA Enforcement
Class II
·Terminated·Brainlab AG·January 20, 2016
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms
FDA Enforcement
Class II
·Terminated·Brainlab AG·January 20, 2016
FiberOptix IAB Ultra 8 Fr, 40cc Model: IAB-05840-LWS
FDA Recall
Terminated
·Arrow International, Inc., Division of Teleflex Medical Inc.·Product code DSP·October 11, 2010
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
FDA Recall
Terminated
·Arrow International Inc·Product code DSP·November 27, 2012
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
FDA Recall
Terminated
·Arrow International Inc·Product code DSP·November 27, 2012
8 FR 40CC Rediguard IAB, IAB-S840C, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.
FDA Recall
Terminated
·Arrow International, Inc.·Product code DSP·February 2, 2009
7 FR 30CC Rediguard IAB, IAB-S730C, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.
FDA Recall
Terminated
·Arrow International, Inc.·Product code DSP·February 2, 2009
FiberOptix IAB Sheath, Ultra 8 Fr, 30cc. Model: IAB-05830-LWS
FDA Recall
Terminated
·Arrow International, Inc., Division of Teleflex Medical Inc.·Product code DSP·October 11, 2010
8 Fr 30cc FIBEROPTIX IAB, IAB-05830-LWS, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.
FDA Recall
Terminated
·Arrow International, Inc.·Product code DSP·February 2, 2009