8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
AMES SERA-PAK ALBUMIN REAGENT KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LANX SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
U2 HIP STEM, TI POROUS COATED
FDA 510(k)
FDA Class 2
·Orthopedic
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 9, 2014
ARCHITECT CA 19-9XR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code NIG·October 24, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 10, 2007
10 F DIREX STEERABLE SHEATH
FDA Adverse Event
Malfunction
·OSCOR INC.·Product code DYB·March 15, 2017
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