26 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler
FDA Recall
Terminated
·Cepheid·Product code NSR·July 22, 2005
8F ZUMA 2 SR 4.0 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR40SH
FDA Recall
Terminated
·Medtronic, Inc.·Product code DQY·April 5, 2006
8F ZUMA 2 SR 3.5 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR35SH
FDA Recall
Terminated
·Medtronic, Inc.·Product code DQY·April 5, 2006
8F ZUMA 2 SR 5.0 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR50SH
FDA Recall
Terminated
·Medtronic, Inc.·Product code DQY·April 5, 2006
8F ZUMA 2 SR 4.0 100CM CATHETER Z28SR40 Z2 8F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR40
FDA Recall
Terminated
·Medtronic, Inc.·Product code DQY·April 5, 2006
8F ZUMA 2 SR 3.0 100CM CATHETER Z28SR30 Z2 8F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR30
FDA Recall
Terminated
·Medtronic, Inc.·Product code DQY·April 5, 2006
8F ZUMA 2 SR 5.0 100CM CATHETER Z28SR50 Z2 8F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR50
FDA Recall
Terminated
·Medtronic, Inc.·Product code DQY·April 5, 2006
8F ZUMA 2 SR 3.5 100CM CATHETER Z28SR35 Z2 8F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR35
FDA Recall
Terminated
·Medtronic, Inc.·Product code DQY·April 5, 2006
SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters. Model# FG3105 Patient Scales. Product Usage: The FG3105 Scale is designed for Joerns Healthcare for use in portable patient weighing systems. The scale is designed to be connected between the patient hoist mechanism and patient sling apparatus. The scale is not intended to be used for patient transport.
FDA Recall
Terminated
·Sr Instruments Inc·Product code FRW·December 13, 2012
SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters. Model# FG3105 Patient Scales. Product Usage: The FG3105 Scale is designed for Joerns Healthcare for use in portable patient weighing systems. The scale is designed to be connected between the patient hoist mechanism and patient sling apparatus. The scale is not intended to be used for patient transport.
FDA Enforcement
Class II
·Terminated·Sr Instruments Inc·April 24, 2013
Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, Model number 85863,shipped in cases of 20
FDA Recall
Terminated
·Nellcor Puritan Bennett·Product code BSR·July 12, 2006
Vital Signs Intubation Pack, Part Number: INTPKF, Sterile, Vital Signs Colorado Inc, Englewood, CO 80112. Contains one lighted stylet per pack.
FDA Recall
Terminated
·Vital Signs Colorado Inc.·Product code BSR·August 11, 2008
Rsch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.
FDA Recall
Terminated
·Teleflex Medical·Product code BSR·August 24, 2015
Light Wand Intro Pack, Part Number: 3960, Sterile, Vital Signs Colorado, Inc., Englewood, CO. Contains 5 lighted stylets per pack.
FDA Recall
Terminated
·Vital Signs Colorado Inc.·Product code BSR·August 11, 2008
DeRoyal (R) Umbilicup, REF 72-8000NS, Rx Only, Manufactured by DeRoyal, Powell, TN 37849 Product Usage: Collection of cord blood
FDA Recall
Terminated
·DeRoyal Industries Inc·Product code KSR·January 20, 2012
Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip, 6FR, Catalog numbers: 502501, Teleflex Medical Sdn Bhd, P.O. Box, Industrial Estate, 24600 Kamunting, Perak, Malaysia. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
FDA Recall
Terminated
·Teleflex Medical·Product code BSR·December 2, 2011
Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
FDA Recall
Terminated
·Vital Signs Colorado Inc.·Product code BSR·March 13, 2015
Light Wand Orotracheal Lighted Stylet, Part number: 3910. Sterile, Vital Signs Colorado Inc., Englewood, CO. , packaged 20 per case.
FDA Recall
Terminated
·Vital Signs Colorado Inc.·Product code BSR·August 11, 2008
Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is used in surgical or medical emergency facilities. Primarily used on infants and pediatric patients.
FDA Recall
Terminated
·Cardinal Health·Product code BSR·December 23, 2014
Portex Tracheal Tube Guide 15 Fr, non-sterile Catalog Number: 153013
FDA Recall
Terminated
·Smiths Medical ASD, Inc·Product code BSR·January 26, 2004