12 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ROCHE ACETAMINOPHEN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DISNEY
FDA UDI
FGX INTERNATIONAL INC.·00193033512401·
DISNEY
FDA UDI
FGX INTERNATIONAL INC.·00193033512418·
DISNEY
FDA UDI
FGX INTERNATIONAL INC.·00193033512395·
DISNEY
FDA UDI
FGX INTERNATIONAL INC.·00193033512388·
LFIT V40 FEMORAL HEAD COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
THERMOFX MESH
FDA 510(k)
FDA Class 2
·Dental
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·March 20, 2013
AXIEM PORTABLE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·February 5, 2011
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWA·March 13, 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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022