8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
CREATINE PHOSPHOKINASE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Swish™ Ball Abutment
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307115670·
PORTABLE BREAST COMPRESSION DEVICE
FDA 510(k)
FDA Class 1
·Radiology
EVGUIDE TIP LOCATION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 30, 2014
VULCAN GENERATORS
FDA Adverse Event
Malfunction
·SMITH & NEPHEW OKLAHOMA CITY MANUFACTURING SITE·Product code GEI·January 9, 2013
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-REDWOOD CITY·Product code MGB·November 20, 2010
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