7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTEGRATED REGISTRATION
FDA 510(k)
FDA Class 2
·Radiology
ENDOSCOPIC PLICATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MICROJET CRONO
FDA 510(k)
FDA Class 2
·General Hospital
COULTER® LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 5, 2013
LIFESTYLES ULTRA SENSITIVE
FDA Adverse Event
Injury
·SURETEX LTD·Product code HIS·September 4, 2014
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DXJ·April 14, 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