8 results
·
23ms
·
Sources: EU EUDAMED, US FDA
AST REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
KNEEALIGN SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
TOTAL BILIRUBIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·November 11, 2025
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code KWA·June 30, 2014
COATED VICRYL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·January 9, 2013
SAGB QUICK CLOSE
FDA Adverse Event
Injury
·OBTECH MEDICAL SARL_·Product code LTI·November 20, 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