29 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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Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to administer the collected blood to a patient.
FDA Enforcement
Class I
·Terminated·Combat Medical Systems, LLC·February 24, 2021
Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to administer the collected blood to a patient.
FDA Recall
Terminated
·Combat Medical Systems, LLC·Product code POQ·December 23, 2020
Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Accusorb MRI MAC7003 Part Number: MRI-03 U (Upper) and MRI-03 L (Lower) Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Accusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Accusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Sarns 8000 Cardioplegia Monitor, Catalog Number 16414; also known as PROG COMP BD AMPRO 420 CPG 8K, Catalog Number 816373 The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DWB·August 29, 2011
Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade liquid crystal display (LCD) Medical Monitors with light-emitting diode (LED) backlight technology.
FDA Recall
Terminated
·Sony Medical Systems·Product code FWB·January 13, 2015
Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpose of archiving and teaching.
FDA Recall
Terminated
·Trumpf Medical Systems, Inc.·Product code FWB·December 15, 2017
Battery Module for Sarns Modular Perfusion System 8000 Product Usage: The Sarns Modular Perfusion System 8000 is indicated for up to 6 hours use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DWB·October 21, 2011
Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016