10 results
·
33ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
EZ-MIO, EZ-IO DISTAL TIBIA
FDA 510(k)
FDA Class 2
·General Hospital
HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCUSONIC A-SCAN MODEL, 24-4000
FDA 510(k)
FDA Class 2
·Radiology
AMI
FDA Adverse Event
Other
·AIRWAY MANAGEMENT INC.·Product code LRK·July 10, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 17, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 16, 2011
WALLSTENT ENTERAL ENDOPROSTHESIS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC IRELAND, LTD.·Product code MQR·June 19, 2008
AXON ECLIPSE CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·October 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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015