8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
THE CRITERION II PACING SYS. MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
REPLICATION MEDICAL VESSEL GUARD
FDA 510(k)
FDA Class 2
·Cardiovascular
SYMBIQ DUAL CHAN INF
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 21, 2014
PROMUS ELEMENT ¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·October 24, 2012
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 17, 2010
Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section, Powered Medical Examination table, Model # 1217. Product Usage: Used to conduct syncope examinations.
FDA Enforcement
Class II
·Terminated·Medical Positioning Inc·August 20, 2014
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