8 results
·
28ms
·
Sources: EU EUDAMED, US FDA
COLD PACK #589
FDA 510(k)
FDA Class 1
·Physical Medicine
ACUMED
FDA UDI
Acumed LLC·10806378051500·Polarus® 3 Depth Gauge
CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 8, 2014
MESH
FDA Adverse Event
Injury
·Product code FTL·October 19, 2012
APEX BALLOON CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·August 16, 2010
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