187 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Guidant Acrobat Vacuum Stabilizer, Model Number OM-9000.
FDA Recall
Terminated
·Guidant Cardiac Surgery·Product code MWS·December 1, 2006
Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code MWS·January 5, 2015
Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code MWS·August 20, 2014
XPOSE 4 Access Device (XP-4000) XPOSE 3 Access Device (XP-3000) positioners. Product Usage: The OM-9100S Acrobat V Vacuum Off-Pump System is intended for use during performance of cardiac surgical procedures through a sternotomy incision. The stabilizer isolates and provides local immobilization of a vessel on the beating heart.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code MWS·November 16, 2011
Guidant Acrobat Vacuum Stabilizer, Model number-OM-9100
FDA Recall
Terminated
·Guidant Cardiac Surgery·Product code MWS·December 1, 2006
Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code MWS·March 2, 2021
Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of cardiac surgical procedures through a sternotomy incision approach.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code MWS·August 13, 2014
ACROBAT Stabilizers- ACROBAT V Vacuum Off-Pump System (OM-91 OOS), ACROBAT SUV Vacuum Off-Pump System (OM-9000S), ACROBAT Mechanical Off-Pump System (OM-6000S) Product Usage: The OM-9100S Acrobat V Vacuum Off-Pump System is intended for use during performance of cardiac surgical procedures through a sternotomy incision. The stabilizer isolates and provides local immobilization of a vessel on the beating heart.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code MWS·November 16, 2011
MOSAIQ Oncology Information System
FDA Recall
Terminated
·Elekta, Inc.·Product code IYE·August 3, 2018
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
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
Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
FDA Enforcement
Class II
·Terminated·Arrow International Inc·March 18, 2015
Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
FDA Recall
Terminated
·Arrow International Inc·Product code DSP·November 8, 2013
Theratron Elite 80 Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron Phoenix Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron 780E Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron 780C Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron Elite 100 Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron 1000E Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron 1000 Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004