7 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INFX-8000V, INFINIX-CFI AND INFINIX VFI
FDA 510(k)
FDA Class 2
·Radiology
LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE
FDA 510(k)
FDA Class 2
·Radiology
QCU ANALYTICAL SOFTWARE PACKAGE
FDA 510(k)
FDA Class 2
·Radiology
STRYKER REELX STT
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code MBI·April 29, 2013
DURASTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·April 13, 2011
MESH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·July 24, 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