18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CUSTODIOL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NLITE SYSTEM,MODEL A00-1025
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
MX40 1.4 GHZ SMART HOPPING
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code DSI·March 13, 2013
VIBRANT SOUNDBRIDGE
FDA Adverse Event
Malfunction
·VIBRANT MED-EL HEARING TECHNOLOGY GMBH·Product code MPV·February 25, 2011
ENDOTAK RELIANCE G
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
ZILVER 635 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·May 25, 2011
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