7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE
FDA 510(k)
FDA Class 2
·Orthopedic
INTER-OP DURASUL ACETABULAR INSERTS (4MM)
FDA 510(k)
FDA Class 2
·Orthopedic
PREFERNCE IMRT TREATMENT PLANNING MODULE
FDA 510(k)
FDA Class 2
·Radiology
UNKNOWN
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·April 23, 2013
PYXIS ANESTHESIA SYSTEM (PAS)
FDA Adverse Event
Malfunction
·CAREFUSION·Product code BRY·April 21, 2011
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 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