20 results
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71ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ResQGARD FM Kit
FDA UDI
ADVANCED CIRCULATORY SYSTEMS INC·M5921207070000·The ResQGARD ITD 7 is indicated for the tempora...
ResQCPR System
FDA UDI
ADVANCED CIRCULATORY SYSTEMS INC·M5921208250001·The ResQCPR system contains two ResQPODs and on...
CirQPOD Intrathoracic Pressure Regulator
FDA UDI
ADVANCED CIRCULATORY SYSTEMS INC·M5921224150000·The CirQPOD Intrathoracic Pressure Regulator (I...
ResQPOD ITD 10
FDA UDI
ADVANCED CIRCULATORY SYSTEMS INC·M5921202420000·The ResQPOD ITD 10 is indicated for the tempora...
RESQPOD CE
FDA Adverse Event
Injury
·ADVANCED CIRCULATORY SYSTEMS, INC.·Product code BWF·November 29, 2007
RESQPOD
FDA Adverse Event
Malfunction
·ADVANCED CIRCULATORY SYSTEMS, INC·Product code BWF·July 14, 2011
RESQPOD
FDA Adverse Event
Malfunction
·ADVANCED CIRCULATORY SYSTEMS, INC.·Product code BWF·August 24, 2011
RESQPOD
FDA Adverse Event
Malfunction
·ACSI ADVANCED CIRCULATORY SYSTEMS, INC·Product code BWF·September 29, 2011
CRQ424, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS, A Consort Medical Company, Noblesville, IN 46060, www.kingsystems.com, 317-776-6823. Advanced Circulatory Systems, Inc., Eden Prairie, MN, www.advancedcirculatory.com, 877-7377763. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·January 14, 2011
CRQ423, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS, A Consort Medical Company, Noblesville, IN 46060, www.kingsystems.com, 317-776-6823. Advanced Circulatory Systems, Inc., Eden Prairie, MN, www.advancedcirculatory.com, 877-7377763. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·January 14, 2011
CRQ425, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS, A Consort Medical Company, Noblesville, IN 46060, www.kingsystems.com, 317-776-6823. Advanced Circulatory Systems, Inc., Eden Prairie, MN, www.advancedcirculatory.com, 877-7377763. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·January 14, 2011
THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·December 2, 2025
THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·December 2, 2025
IMPELLA
FDA Adverse Event
Death
·ABIOMED, INC. - 1220648·Product code OZD·March 12, 2026
IMPELLA
FDA Adverse Event
Death
·ABIOMED, INC. - 1220648·Product code OZD·April 2, 2026
GUIDE WIRE 0.018"PTFE COATED
FDA Adverse Event
Malfunction
·ABIOMED, INC. - 1220648·Product code OZD·March 3, 2026
IMPELLA
FDA Adverse Event
Malfunction
·ABIOMED, INC. - 1220648·Product code OZD·February 26, 2026
PURGE CASSETTE GEN 2, STERILE, NON QSK
FDA Adverse Event
Injury
·ABIOMED, INC. - 1220648·Product code OZD·March 9, 2026
IMPELLA CP
FDA Adverse Event
Death
·ABIOMED, INC.·Product code OZD·August 24, 2024
RP FLEX W SMART ASSIST SET, US
FDA Adverse Event
Malfunction
·ABIOMED, INC. - 1220648·Product code PYX·March 5, 2026