11 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
FDA 510(k)
FDA Class 2
·Hematology
DC-UIBC-CO2-CAL, MODEL SE-153
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ELECSYS HCG AND BETA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INNOVA 4100
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS·Product code MQB·April 4, 2011
LINEAR 3-4
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 23, 2025
INNOVA 4100
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS·Product code MQB·May 6, 2011
PROMUS ELEMENT¿ PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 23, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 29, 2011
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
CT EXPRES
FDA Adverse Event
Injury
·BRACCO INJENEERING S.A.·Product code IZQ·September 27, 2023
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