14 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMARTMONITOR 2PS
FDA 510(k)
FDA Class 2
·Anesthesiology
SMARTMONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILLIPS RESPIRONICS - CHMV·Product code FLS·February 21, 2014
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS -CHMV·Product code NPF·August 26, 2014
SMARTMONITOR 2 PROFESSIONAL SERIES
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS - CHMV·Product code FLS·August 23, 2013
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS - CHMV·Product code NPF·May 30, 2013
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS - CHMV·Product code NPF·September 4, 2013
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS - CHMV·Product code NPF·October 11, 2013
TORIC LITE LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
CONTROL PLASMA N
FDA 510(k)
FDA Class 2
·Hematology
SYNCHRON URIC ACID
FDA Adverse Event
BECKMAN COULTER INC.·Product code KNK·June 10, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·April 16, 2013
STANDARD INSERTION HANDLE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code LXH·April 12, 2011
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 19, 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