8 results
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19ms
·
Sources: EU EUDAMED, US FDA
ROCHE COBAS READY HDL CHOLESTEROL REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SYNCHRON CREATINE KINASE REAGENT
FDA Adverse Event
BECKMAN COULTER INC.·Product code CGS·June 17, 2011
SYNTHES 1.5MM TI BROW LIFT SCREW
FDA 510(k)
FDA Class 2
·Dental
INFRARED EAR THERMOMETER, MODELS TM819, TM820, TM817, TM810A, TM810B, TM818 AND TM818A
FDA 510(k)
FDA Class 2
·General Hospital
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 30, 2014
RENASYSGO
FDA Adverse Event
Injury
·SMITH & NEPHEW·Product code OMP·November 4, 2010
ADVANTA BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·November 29, 2012
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