10 results
·
29ms
·
Sources: EU EUDAMED, US FDA
INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM
FDA 510(k)
FDA Class 2
·Radiology
NEOCIF INSERTION INSTRUMENT
FDA Adverse Event
Malfunction
·BIOMET SPAIN, S.L.·Product code MQP·November 6, 2018
XANTALGIN CRONO
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NEOCIF INSERTION INSTRUMENT
FDA Adverse Event
Malfunction
·BIOMET SPAIN, S.L.·Product code MQP·July 20, 2017
BD PHOENIX AST BROTH, 4.5 ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·March 16, 2021
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·May 6, 2013
PINN MAR +4 NEUT 40IDX60OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·September 16, 2014
NEURON DELIVERY CATHETER 070
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DQY·April 19, 2011
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