42 results
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55ms
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Sources: EU EUDAMED, US FDA
AMSCO
FDA Adverse Event
Malfunction
·STERIS·Product code FQO·August 15, 2012
ENTERPRISE 9000
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH POLSKA SP. Z O.O.·Product code FNL·October 26, 2012
Micro-Tech Informer Plus Silver Monitor, Model 81830. The firm name on the label is Stanley Security Solutions, Inc., Lincoln, NE. Product Usage: The system is a bed exit system designed to indicate, by alarm or signal, when someone attempts to leave the bed. The system consists of a control unit that is mounted on the bed and a pressure sensitive bed sensor pad that is placed across the width of the bed under the mattress or just beneath the sheets and overlays. The control unit is powered by means of a plug-in type power supply and an alarm cord is used to interface the control unit with the nurse call system.
FDA Recall
Terminated
·Stanley Security Solutions, Inc.·Product code KMI·December 13, 2011
INTROCAN SAFETY
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FOZ·February 24, 2012
MAXI MOVE
FDA Adverse Event
Injury
·ARJO HOSPITAL EQUIPMENT AB·Product code FSA·April 23, 2012
ENTERPRISE 5000
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH POLSKA SP. ZO.O.·Product code FNL·August 23, 2012
ENTERPRISE 8000
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH POLSKA SP. ZO.O.·Product code FNL·August 28, 2012
FREESTYLE COMFORT
FDA Adverse Event
Malfunction
·CAIRE INC.·Product code CAW·September 1, 2022
BARI-BREEZE
FDA Adverse Event
Other
·ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB·Product code FNM·December 27, 2012
DAVINCI XI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·December 17, 2021
SUREFORM
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code GDW·June 10, 2023
MARISA
FDA Adverse Event
Malfunction
·ARJO HOSPITAL EQUIPMENT AB·Product code FSA·November 19, 2010
MARISA
FDA Adverse Event
Malfunction
·ARJO HOSPITAL EQUIPMENT AB·Product code FSA·December 29, 2010
ALP 501
FDA Adverse Event
Injury
·CURRIE MEDICAL SPECIALTIES·Product code JOW·July 25, 2012
JACKSON TABLE
FDA Adverse Event
Malfunction
·MIZUHO ORTHOPEDIC SYSTEMS, INC.·Product code FQO·December 22, 2009
FLOWTRON/UNIVERSAL PUMPS
FDA Adverse Event
Malfunction
·GETINGE (SUZHOU) CO. LTD.·Product code JOW·July 17, 2012
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·May 15, 2022
MED-TECH INC.
Manufacturer
🇯🇵 Japan
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices