BEUDAMED
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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

    INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.

    FDA Enforcement
    Class III ·Terminated·Carestream Health Inc.·August 13, 2014

    Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.

    FDA Enforcement
    Class III ·Terminated·Carestream Health Inc.·August 13, 2014

    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

    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

    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

    Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·December 21, 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

    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

    Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·October 3, 2012

    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

    The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment.

    FDA Enforcement
    Class III ·Terminated·Ormco/Sybronendo·October 31, 2012

    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