93 results
·
12ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging
FDA Recall
Terminated
·Ziehm Imaging Inc·Product code JAA·April 15, 2016
Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging
FDA Enforcement
Class II
·Terminated·Ziehm Imaging Inc·August 31, 2016
RAD SOURCE RS 3000 Blood Irradiator Three Bag Option
FDA Recall
Terminated
·Rad-Source Technologies, Inc.
20283 State Rd. 7
Suite 107
Boca Raton FL 33498·Product code MOT·June 1, 2002
Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.
FDA Recall
Terminated
·BEST THERATRONICS LTD.·Product code MOT·May 6, 2016
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
Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code KPS·April 11, 2012
E.CAM emission computed tomography system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code KPS·April 11, 2012
Maquet Getinge-BO-T 6600 TUBING PACK Material:701052324
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BO-T 52360 Cardioplegia Pack Material: 709000127
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BO-T 44201 MAYO PULMONARY PACK Material: 701064834
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BO-T 41302 PRIMING LINES BUMC Material:701066291
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BO-T 41301 BUMC ECC PACK Material: 701065209
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge- BO-T 41301 BUMC ECC PACK Material: -701065209R01
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BO-T 51502 Ochsner ECC Adult Pack Material: 709000385
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack Material: 709000006
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BO-T 2303 Small Adult Cardiac Surgery Material:709000004
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BO-T 46201 Small Pediatric Cardiac Surge Material: 709000133
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BO-T 46200 3/16" x 1/4" Neonate Pack Material: 701065620
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge- BO-T 2303 3/8" x 3/8" Adult Pack Material: 709000004R01
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
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