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Sources: EU EUDAMED, US FDA
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Status: Terminated
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The finger cots are made out of natural rubber. They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry. Cots are packed in clear plastic boxes, with 60 cots in a box They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry
FDA Enforcement
Class II
·Terminated·Afassco Inc·August 15, 2012
MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given temperature range of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The product is designed for single use only, for an application period of no longer than 6 hours.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·March 19, 2014
Atrisorb FreeFlow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier, Sterile
FDA Recall
Terminated
·QLT USA, Inc.·Product code LYC·January 26, 2006
Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulatory or non-ambulatory human patient (includes infants and adults).
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·May 20, 2020
Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·December 21, 2016
Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Power-PRO" are powered ambulance cots are designed to support and transport a maximum weight of 700 lb. (318 kg) in pre-hospital and hospital environments.
FDA Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code FPO·May 5, 2016
Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assist with loading and unloading of a compatible wheeled stretcher (ambulance cot) to and from a transport vehicle and to secure the ambulance cot during transport. The device has a maximum safe working load of 870 lb (395 kg), which includes the weight of the ambulance cot, patient, and equipment attached to the cot (such as oxygen bottles, monitors, and pumps). The intended users of the device are trained professionals, including emergency medical service and medical care center personnel, as well as medical first responders, service technicians and installers.
FDA Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code FPO·March 12, 2018
The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer ambulance cots into and out of the ambulance.
FDA Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code FPO·October 11, 2012
The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer ambulance cots into and out of the ambulance.
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·December 26, 2012
Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled
FDA Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code FPO·November 8, 2016
Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.
FDA Recall
Terminated
·Stryker Medical·Product code FPO·August 17, 2004
Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Power-PRO" are powered ambulance cots are designed to support and transport a maximum weight of 700 lb. (318 kg) in pre-hospital and hospital environments.
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·June 22, 2016
Stryker Power-PRO Powered Ambulance Cot, Model 6500.
FDA Recall
Terminated
·Stryker Medical Div. of Stryker Corporation·Product code FPO·August 29, 2006
Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assist with loading and unloading of a compatible wheeled stretcher (ambulance cot) to and from a transport vehicle and to secure the ambulance cot during transport. The device has a maximum safe working load of 870 lb (395 kg), which includes the weight of the ambulance cot, patient, and equipment attached to the cot (such as oxygen bottles, monitors, and pumps). The intended users of the device are trained professionals, including emergency medical service and medical care center personnel, as well as medical first responders, service technicians and installers.
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·April 25, 2018
Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulatory or non-ambulatory human patient (includes infants and adults).
FDA Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code INK·April 7, 2020
The finger cots are made out of natural rubber. They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry. Cots are packed in clear plastic boxes, with 60 cots in a box They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry
FDA Recall
Terminated
·Afassco Inc·Product code FQM·February 8, 2012
Ferno PROFlexx Model 28Z Chair Cot
FDA Recall
Terminated
·Ferno-Washington Inc·Product code FPO·March 8, 2017
Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000
FDA Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code FPO·November 20, 2018
Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
FDA Recall
Terminated
·Carestream Health Inc.·Product code IWZ·July 2, 2014
INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
FDA Recall
Terminated
·Carestream Health Inc.·Product code IWZ·July 2, 2014