8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW)
FDA 510(k)
FDA Class 2
·Orthopedic
PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO ENTEC PLASMA WANDS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TALENT THORACIC THORACIC STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·March 27, 2013
CE INFUSOR LV 5, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·March 19, 2011
SHILEY DCT
FDA Adverse Event
Injury
·HENEQUEN·Product code BTO·April 2, 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
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018