9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
VECTORVISION UNI-KNEE
FDA 510(k)
FDA Class 2
·Neurology
IMPROVED TRY-IN GEL
FDA 510(k)
FDA Class 2
·Dental
PF 5050 PRESSURE UNIT, MODEL PF 5050
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDFUSION® 3500 SYRINGE PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·November 28, 2017
BD INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 8, 2013
PENUMBRA SYSTEM REPERFUSION CATHETER 032
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code NRY·March 30, 2011
ENDOTAK RELIANCE SG
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
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