8 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Cardiovascular
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
FDA 510(k)
FDA Class 2
·Anesthesiology
EDWARDS TRANSCATHETER INTRODUCER SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·December 11, 2019
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS·Product code JAA·April 26, 2013
MUSTANG?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·September 16, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 4, 2011
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