8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EPIDRUM
FDA 510(k)
FDA Class 2
·General Hospital
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450621448·
AUTOMED 3000 INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
CRYSTAL MONITOR MODEL 16
FDA 510(k)
FDA Class 2
·Neurology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 6, 2013
HIP IMPLANT
FDA Adverse Event
Injury
·SMITH & NEPHEW·Product code JDI·May 16, 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