10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PHILIPS VIEWFORUM 2003
FDA 510(k)
FDA Class 2
·Radiology
DISPOSABLE VITRECTOMY LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TAMPONS, OPEN END FLUSHABLE APPLICATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code LFL·March 29, 2013
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 28, 2011
ASCENSIA CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·April 18, 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
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018