9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ANSWER AT-HOME PREGNANCY TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC·Product code MNT·July 9, 2015
V60 VENTILATOR, MODEL V8000
FDA 510(k)
FDA Class 2
·Anesthesiology
HARDYDISK LOMEFLOXACIN, 10MCG
FDA 510(k)
FDA Class 2
·Microbiology
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC·Product code MNT·August 3, 2015
HS III PROXIMAL SEAL SYSTEM 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·October 19, 2012
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 25, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 17, 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