493 results
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80ms
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Sources: EU EUDAMED, US FDA
MEDICAL TRANSPORTATION DEVICES LIMITED
FDA registration
MEDICAL TRANSPORTATION DEVICES LIMITED·1 product·🇬🇧 United Kingdom
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·November 28, 2025
Grab n Go Opti series VIPR system Model # PRX-9615 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.
FDA Enforcement
Class II
·Terminated·Western / Scott Fetzer Company·November 13, 2019
Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.
FDA Enforcement
Class II
·Terminated·Western / Scott Fetzer Company·November 13, 2019
Grab n Go Opti series VIPR system Model # PRX-9632 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.
FDA Enforcement
Class II
·Terminated·Western / Scott Fetzer Company·November 13, 2019
Grab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.
FDA Enforcement
Class II
·Terminated·Western / Scott Fetzer Company·November 13, 2019
Grab n Go Opti series VIPR system Model # PRX-9653 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.
FDA Enforcement
Class II
·Terminated·Western / Scott Fetzer Company·November 13, 2019
Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Distractor can be utilized to perform bone transport procedures as an alternative to bone grafts and free flaps.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·July 24, 2013
ILET BIONIC PANCREAS
FDA Adverse Event
Injury
·BETA BIONICS INC.·Product code QFG·January 13, 2026
POWERED WHEELCHAIR
FDA Adverse Event
Injury
·INVACARE TAYLOR STREET·Product code ITI·May 16, 2012
ZOLL
FDA Adverse Event
Death
·ZMI CORPORATION·Product code MKJ·March 15, 1993
BD VACUTAINER® FH 20MG .143 I.U. BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 2, 2019
PORT-A-CUL TRANSPORT SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JSM·June 12, 2013
ILET BIONIC PANCREAS
FDA Adverse Event
Injury
·BETA BIONICS INC.·Product code QFG·January 21, 2026
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·June 21, 2019
PENTA 3MM LEAD, 60 CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·December 1, 2017
PROCLAIM 5 ELITE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 1, 2017
ILET BIONIC PANCREAS
FDA Adverse Event
Injury
·BETA BIONICS, INC.·Product code QFG·May 8, 2026
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·December 19, 2018
UNKNOWN TAYLOR SPATIAL FRAME EXFIX DEV
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDW·May 7, 2020