10 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AED MONOPOLAR LAP ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Harvard MTA XR Flow Fast OptiCaps
FDA UDI
Harvard Dental International GmbH·EHAR70815031·Endodontic repair cement, flowable, extra fast
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0315030·Probe, 1.5 inch Ball, Steffee, Curved, Impaction
AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
UNINHIBITED
FDA 510(k)
FDA Class 2
·Dental
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·April 29, 2013
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 19, 2011
ASIAN IMHS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.·Product code JDS·July 23, 2008
Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750.
FDA Recall
Terminated
·Ossur North America Inc·Product code ISY·March 17, 2003
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