21 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XODUS MEDICAL ANTI-FOG SOLUTION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS
FDA 510(k)
FDA Class 2
·Dental
CLEARGLIDE PRECISION BIPOLAR DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CLEARGLIDE EVH SMALL
FDA Adverse Event
Malfunction
·SORIN GROUP USA·Product code GEI·October 2, 2009
CLEARGLIDE EVH SMALL
FDA Adverse Event
Malfunction
·SORIN GROUP USA·Product code GEI·October 14, 2009
CLEARGLIDE EVH SMALL
FDA Adverse Event
Malfunction
·SORIN GROUP USA·Product code GEI·October 14, 2009
CLEARGLIDE EVH SMALL
FDA Adverse Event
Malfunction
·SORIN GROUP USA·Product code GEI·October 14, 2009
CLEARGLIDE EVH SMALL
FDA Adverse Event
Malfunction
·SORIN GROUP USA·Product code GEI·October 16, 2009
CLEARGLIDE EVH LONGVIEW W/SCIS
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC.·Product code GEI·November 23, 2009
CLEARGLIDE EVH SMALL
FDA Adverse Event
Malfunction
·SORIN GROUP USA·Product code GEI·October 16, 2009
CLEARGLIDE EVH SMALL W/SCISSOR
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC.·Product code GEI·October 16, 2009
CLEARGLIDE EVH LONGVIEW W/SCIS
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC.·Product code GEI·November 9, 2009
ARCHITECT CA 19-9XR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code NIG·April 17, 2013
AXSYM RUBELLA IGG ANTIBODY
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code LFX·June 19, 2008
ENDOPLEGE CORONARY SINUS CATHETER
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DWF·April 19, 2011
CLEARGLIDE EVH SMALL
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC.·Product code GEI·November 24, 2009
CLEARGLIDE EVH SMALL W/SCISSOR
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC.·Product code GEI·November 3, 2009
CLEARGLIDE EVH SMALL
FDA Adverse Event
Malfunction
·SORIN GROUP USA·Product code GEI·October 16, 2009
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·February 20, 2026
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