8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
GERARD MEDICAL, INC. TRIM-PORT
FDA 510(k)
FDA Class 2
·General Hospital
SOLO MICROPUMP INSULIN DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
VIVO 200 DPS VIVOSCAN
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 4, 2024
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 30, 2014
HUMERAL PLATE, DISTAL LATERAL NUMELOCK II FOR RIG
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS SELZACH·Product code KTT·November 10, 2010
HEARTMATE II LVAS
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·January 4, 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