9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
VIDAR DENTAL FILM DIGITIZER
FDA 510(k)
FDA Class 2
·Radiology
RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
D.SIGN 59
FDA 510(k)
FDA Class 2
·Dental
MEDACTA KNEE IMPLANTS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 28, 2016
BIVONA ADULT TTS TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·September 22, 2015
EP IMPLANT TRAY
FDA Adverse Event
MEDICAL ACTION INDUSTRIES, INC.·Product code FSM·September 11, 2014
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·May 18, 2011
NOVOTWIST 8 MM (30G)
FDA Adverse Event
Injury
·NOVO NORDISK A/S, MS HJOERRING·Product code FMI·August 11, 2016
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