859 results
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36ms
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Sources: EU EUDAMED, US FDA
SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·August 2, 2019
GUIDANT
FDA Adverse Event
Death
·GUIDANT CORP·Product code LWS·August 26, 2005
RELIANT 600 HD LOW BASE LIFT 9153640382
FDA Adverse Event
Injury
·INVACARE TAYLOR ST.·Product code FSA·February 2, 2018
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·April 25, 2014
AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·LAND AMERICA HEALTH & FITNESS·Product code FNG·August 17, 2011
IMPELLA 5.5
FDA Adverse Event
Injury
·ABIOMED, INC.·Product code OZD·July 27, 2023
PERFECTO2V OXYGEN CONCENTRATOR
FDA Adverse Event
Death
·INVACARE FLORIDA·Product code CAW·May 14, 2024
SARA PLUS
FDA Adverse Event
Other
·MEDIBO N.V.·Product code FSA·October 19, 2007
MAXI TWIN
FDA Adverse Event
Injury
·ARJOHUNTLEIGH POLSKA SP. Z O.O.·Product code FSA·March 18, 2024
SARA 3000
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH POLSKA SP. ZO.O.·Product code FSA·October 17, 2014
PALINDROME
FDA Adverse Event
Injury
·COVIDIEN LLC·Product code MSD·July 24, 2024
AMBULIFT CLASSIC
FDA Adverse Event
Other
·MEDIBO MEDICAL PRODUCTS NV·Product code FSA·August 6, 2012
SARA FLEX
FDA Adverse Event
Injury
·ARJOHUNTLEIGH MAGOG INC.·Product code FSA·November 5, 2024
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 26, 2015
SHWR COMMODE 23 IN TIRES 18 INW 9153640949
FDA Adverse Event
Malfunction
·JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD·Product code ILS·December 22, 2014
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
INVACARE COMMODES
FDA Adverse Event
Injury
·INVACARE CORPORATION·Product code KNN·June 26, 2003
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 Recall
Terminated
·Curbell Medical, Inc.·Product code KMI·August 5, 2014
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices