7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15
FDA 510(k)
FDA Class 2
·Cardiovascular
LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE
FDA 510(k)
FDA Class 2
·Radiology
QCU ANALYTICAL SOFTWARE PACKAGE
FDA 510(k)
FDA Class 2
·Radiology
HELICAL BLADE INSERTER
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code LXH·May 3, 2013
STAPLE, IMPLANTABLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 16, 2014
SWIFT-LOCK ANCHOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 28, 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