10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
COOLING TEETHERS
FDA 510(k)
FDA Class 2
·Dental
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00
FDA 510(k)
FDA Class 2
·Cardiovascular
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 30, 2014
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·November 7, 2010
MAYFIELD HEAD HOLDER
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code HBL·December 26, 2012
WITTICH NITINOL STONE BASKET
FDA Adverse Event
Malfunction
·COOK INC·Product code LQR·February 20, 2019
WITTICH NITINOL STONE BASKET
FDA Adverse Event
Malfunction
·COOK INC·Product code LQR·February 20, 2019
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·May 22, 2025
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