9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE
FDA 510(k)
FDA Class 2
·Orthopedic
BD 22 IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY·Product code FOZ·July 15, 2025
MODIFICATION TO NANMA VACUUM PUMP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KSEA SCB-RUI SCO
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD INSYTE AUTOG BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 13, 2025
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code LWS·April 9, 2013
HS III PROXIMAL SEAL SYSTEM 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·February 24, 2011
FLEXTEND 2
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 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