7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
RELIEVA SINUS BALLOON DILATION CATHETER
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
MODIFICATION TO SYNTHES (USA) POLYPIN
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
FDA 510(k)
FDA Class 1
·Orthopedic
TOTAL ASR ACET IMP SIZE 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·April 9, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 28, 2011
FINELINE II
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
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