18 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL
FDA 510(k)
FDA Class 2
·Hematology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450090473·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450270929·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450220061·
CNS-9300 SERIES CENTRAL STATION
FDA 510(k)
FDA Class 2
·Cardiovascular
BALLERT CRANIAL MOLDING HELMET
FDA 510(k)
FDA Class 2
·Neurology
VASOVIEW 6 ACCESSORY PACK
FDA Adverse Event
Malfunction
·MAQUET CV·Product code GCJ·January 10, 2019
VASOVIEW 6 ACCESSORY PACK
FDA Adverse Event
Malfunction
·MAQUET CV·Product code GCJ·January 10, 2019
VASOVIEW 6 ACCESSORY PACK
FDA Adverse Event
Malfunction
·MAQUET CV·Product code GCJ·January 10, 2019
BD INSYTE AUTOG BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 18, 2025
BD INSYTE AUTOG BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 18, 2025
BD INSYTE AUTOG BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 18, 2025
I-STAT TROPONIN (CTNI) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code MMI·February 14, 2012
PANORAMA CENTRAL STATION
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC·Product code MHX·April 30, 2013
SIGMA CRVD XLK INS 4 10MM
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code JWH·September 16, 2014
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·May 17, 2011
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018