10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
REFLOTRON CREATININE TEST TABS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Brigade
FDA UDI
Nuvasive, Inc.·00887517963840·Brigade Lateral Trial, 8x38x32mm 12°
ARTS2 SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DIFFUSION TENSOR IMAGING OPTION
FDA 510(k)
FDA Class 2
·Radiology
AUTOSOFT XC,
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 5, 2024
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·August 20, 2025
530G INSULIN PUMP
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 30, 2014
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 26, 2007
*
FDA Adverse Event
Injury
·COVIDIEN·Product code GEI·January 1, 2013
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