7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
INPLEX CF MOLECULAR TEST
FDA 510(k)
FDA Class 2
·Immunology
NYCOCARD CRP
FDA 510(k)
FDA Class 2
·Immunology
NEWTOM QR-DVT 9000
FDA 510(k)
FDA Class 2
·Radiology
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Injury
·CARFUSION CORP.·Product code FPA·April 3, 2013
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·April 15, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 19, 2008
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