19 results
·
21ms
·
Sources: EU EUDAMED, US FDA
INFINIA LIGHTSPEED
FDA 510(k)
FDA Class 2
·Radiology
SHIELDING NEEDLE HOLDER
FDA 510(k)
FDA Class 2
·General Hospital
ADVANCED LUNG ANALYSIS-1
FDA 510(k)
FDA Class 2
·Radiology
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 9, 2013
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·February 25, 2011
INSIGNIA PLUS
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008
ZILVER 635 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·May 25, 2011
ACL ADVANCE
FDA Adverse Event
INSTRUMENTATION LABORATORY CO.·Product code JPA·July 13, 2005
ZILVER 635 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD.·Product code FGE·April 11, 2011
ZILVER 635 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 5, 2012
ZILVER 635 SELF EXPANDING BILIARY STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·June 13, 2014
ZILVER 635 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·May 30, 2014
ZILVER 635 BILIARY SELF EXPANDING STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·February 13, 2012
ZILVER 635 SELF-EXPANDING BILIARY STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·July 2, 2014
ZILVER 635 SELF-EXPANDING BILIARY STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·July 16, 2014
ZILVER 635 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD.·Product code FGE·April 14, 2011
ZILVER 635 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·February 1, 2012
ZILVER 635 SELF-EXPANDING BILIARY STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·December 12, 2014
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