28 results
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71ms
·
Sources: EU EUDAMED, US FDA
UNKNOWN ELASTOMERIC LFR
FDA Adverse Event
Malfunction
·AVANOS MEDICAL - IRVINE·Product code MEB·March 9, 2020
VISIONAIRE 5
FDA Adverse Event
Death
·CAIRE INC.·Product code CAW·March 30, 2022
PORTABLE
FDA Adverse Event
Malfunction
·CAIRE, INC·Product code BYJ·July 22, 2008
HEPARIN LOCK FLUSH SOLUTION USP
FDA Adverse Event
Injury
·Product code NZW·January 2, 2008
CLEARDETECT COVID-19
FDA Adverse Event
Malfunction
·MAXIM BIOMEDICAL, INC.·Product code QKP·August 22, 2022
ENTRALITE INFINITY ENTERAL FEEDING PUMP
FDA Adverse Event
Injury
·ZEVEX INC·Product code LZH·November 5, 2008
IHEALTH
FDA Adverse Event
Malfunction
·ANDON MEDICAL CO.,LTD·Product code QKP·July 8, 2022
630G INSULIN PUMP MMT-1715KL 630G
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 9, 2023
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit MMOL EMEA. Abbott Item Number 71036-01, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009
Freestyle Navigator Continuous Glucose Monitor System, ABB Transmitter Navigator. Abbott Item Number: PRT 03831-001, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009
Freestyle Navigator Continuous Glucose Monitor System, System Kit, Business 1, (Orange). Abbott Item Number: PRT 03415-001, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB Warranty Kit Xmitter Nav, Abbott Item Number 70791-01, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, SYSTEM KIT PACKAGING ORANGE, Abbott Item Number 70684-02, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit MMOL (EMEA) SV. Abbott Item Number 70966-04, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, Replacement Kit, Transmitter, Abbott Item Number 70791-02, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009
Freestyle Navigator Continuous Glucose Monitor System, Clinical System Kit, Packaging. Abbott Item Number: PRT 03415-010, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009
Freestyle Navigator Continuous Glucose Monitor System, Clinical Transmitter, Abbott Item Number: PRT 03831-091, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System, Business 1, MMOL. Abbott Item Number 70966-02, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009
Freestyle Navigator Continuous Glucose Monitor System, Assy, Transmitter Poly Contac, Abbott Item Number: PRT 03831-002, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, Reorder/Warranty Kit EMEA, Abbott Item Number 70791-20, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009