886 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Bacteroides Bile Esculin Agar (BBE) is recommended as a primary isolation medium for the selection and presumptive identification of the B. fragilis group.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·July 31, 2013
AXIOM Artis dBA, Model Number 7555357
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019
AXIOM Artis dBA, Model Number 7555357
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019
Axiom Artis dBA, Axiom Artis Modular Angiography X-Ray System, Model number 7555357.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IZI·September 2, 2008
Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
FDA Enforcement
Class II
·Terminated·Nakanishi Inc.·October 31, 2018
BC Hammock Mesh Sling (Junior), product number, 537005. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
FDA Enforcement
Class II
·Terminated·Prism Medical Services USA·June 26, 2013
Tabs Professional Monitor, without wall bracket, Model 25023. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
FDA Enforcement
Class II
·Terminated·Stanley Security Solutions, Inc.·October 10, 2012
Tabs Professional Voice + Monitor, includes one wall bracket, Model 25222. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
FDA Enforcement
Class II
·Terminated·Stanley Security Solutions, Inc.·October 10, 2012
Tabs Professional Monitor, includes one wall bracket, Model 25022. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
FDA Enforcement
Class II
·Terminated·Stanley Security Solutions, Inc.·October 10, 2012
Tabs Professional Voice + Monitor, with wire bracket, Model 25223. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
FDA Enforcement
Class II
·Terminated·Stanley Security Solutions, Inc.·October 10, 2012
BC Hammock Mesh Sling (Large), product number, 537030. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
FDA Enforcement
Class II
·Terminated·Prism Medical Services USA·June 26, 2013
BC Hammock Mesh Sling (Small), product number, 537010. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
FDA Enforcement
Class II
·Terminated·Prism Medical Services USA·June 26, 2013
Tabs Professional Monitor, without pull cord or wall bracket, Model 25025. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
FDA Enforcement
Class II
·Terminated·Stanley Security Solutions, Inc.·October 10, 2012
BC Hammock Mesh Sling (Medium), product number, 537005. Product Usage: Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
FDA Enforcement
Class II
·Terminated·Prism Medical Services USA·June 26, 2013
BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Bacteroides Bile Esculin Agar (BBE) is recommended as a primary isolation medium for the selection and presumptive identification of the B. fragilis group.
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code JSI·June 6, 2013
Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.
FDA Enforcement
Class II
·Terminated·RF Technologies, Inc.·July 3, 2013
CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMON/USUAL NAME: Bed Patient Monitor; CLASSIFICATION NAME: Bed Patient Monitor --- Monitor is connected to a sensor pad that monitors the patient if they attempt to arise from a bed, chair, floor mat, or toilet seat. The monitor will sound an alarm.
FDA Enforcement
Class II
·Terminated·Curbell Medical, Inc.·September 3, 2014
BC Hammock Mesh Sling (Small), product number, 537010. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
FDA Recall
Terminated
·Prism Medical Services USA·Product code FSA·May 23, 2013
BC Hammock Mesh Sling (Junior), product number, 537005. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
FDA Recall
Terminated
·Prism Medical Services USA·Product code FSA·May 23, 2013
BC Hammock Mesh Sling (Large), product number, 537030. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
FDA Recall
Terminated
·Prism Medical Services USA·Product code FSA·May 23, 2013