313 results
·
17ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Recall
×
IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
FDA Recall
Open, Classified
·Philips North America Llc·Product code MHX·June 28, 2024
IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
FDA Recall
Open, Classified
·Philips North America Llc·Product code MHX·June 28, 2024
IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
FDA Recall
Open, Classified
·Philips North America Llc·Product code MHX·June 28, 2024
IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
FDA Recall
Open, Classified
·Philips North America Llc·Product code MHX·June 28, 2024
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
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
VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who have recovered from HBV infection, using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Further assessment of HBV infection (biochemical, serological and/or nucleic acid testing) is required to define the specific disease state. VITROS Anti-HBe test performance has not been established for the monitoring of HBV disease or therapy. Test performance characteristics have not been established in patients under the age of 2, or in populations of immunocompromised or immunosuppressed patients. This test has not been FDA licensed for the screening of blood, plasma and tissue donors.
FDA Recall
Open, Classified
·ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom·Product code LOM·November 1, 2018
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 Recall
Terminated
·Prism Medical Services USA·Product code FSA·May 23, 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 Recall
Terminated
·RF Technologies, Inc.·Product code KMI·May 17, 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 Recall
Terminated
·Stanley Security Solutions, Inc.·Product code KMI·May 4, 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 Recall
Terminated
·Stanley Security Solutions, Inc.·Product code KMI·May 4, 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 Recall
Terminated
·Stanley Security Solutions, Inc.·Product code KMI·May 4, 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 Recall
Terminated
·Stanley Security Solutions, Inc.·Product code KMI·May 4, 2012
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 Recall
Terminated
·Stanley Security Solutions, Inc.·Product code KMI·May 4, 2012
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable
FDA Recall
Open, Classified
·Agilent Technologies Denmark ApS 42 PRODUKTIONSVEJ Glostrup Denmark·Product code NJT·August 11, 2025
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable
FDA Recall
Open, Classified
·Agilent Technologies Denmark ApS 42 PRODUKTIONSVEJ Glostrup Denmark·Product code NJT·August 11, 2025
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable
FDA Recall
Open, Classified
·Agilent Technologies Denmark ApS 42 PRODUKTIONSVEJ Glostrup Denmark·Product code NJT·August 11, 2025
Bassinet Models: BSNT/01; BSNT/02, BSNT/03, BSNT/04 The Nemschoff Perinatal Bassinet products are wheeled carts with a top tray intended for an infant tray with mattress. The bassinets are intended for medical purposes that consist of a bed designated for the use of a pediatric patient.
FDA Recall
Terminated
·Nemschoff Chairs, Inc.·Product code NZG·October 14, 2011