7 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIS QUATRO SENSOR
FDA 510(k)
FDA Class 2
·Neurology
MEDRAD STELLANT CT INJECTOR SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
THERMAGE THERMACOOL II SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 4, 2013
DUAL COOLER/HEATER
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DWC·May 3, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 5, 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