8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
QUIDEL HELICOBACTER PYLORI TEST
FDA 510(k)
FDA Class 1
·Microbiology
Triathlon PKR System
FDA 510(k)
FDA Class 2
·Orthopedic
PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FOUNDATION HIP
FDA Adverse Event
Injury
·ENCORE MEDICAL, L.P.·Product code KWA·June 30, 2014
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INT'L., LTD.·Product code KWA·November 17, 2010
URETEX SUPPORT PP TRANSOBTUR KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·November 13, 2012
BD® BLUNT FILL NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·August 1, 2023
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