7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
IMMUNODOT THYROID AUTOIMMUNITY PANEL
FDA 510(k)
FDA Class 2
·Immunology
ENVIVE MINIFORMS
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
OXIMAX 100
FDA 510(k)
FDA Class 2
·Cardiovascular
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·June 30, 2014
SUREFIT DISPERSIVE ELECTRODE
FDA Adverse Event
Injury
·CONMED ELECTROSURGERY·Product code GEI·November 20, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 9, 2013
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