7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
FIBER OPTIC ADAPTER CAT#60-0898
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
MODIFICATION TO MINISPIR, SPIROLAB III
FDA 510(k)
FDA Class 2
·Anesthesiology
NICOLET VASOGUARD
FDA 510(k)
FDA Class 2
·Cardiovascular
SYMBIQ SINGLE CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 21, 2014
KINETRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·October 24, 2012
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·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