11 results
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18ms
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Sources: EU EUDAMED, US FDA
14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496021759·SOLIDEA LEG, SIZE S, NERO, MICRO-MASSAGING LEG ...
SEE H10
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KXA·November 1, 2011
RADIUS NEXT GENERATION GUIDEWIRE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ
FDA 510(k)
FDA Class 2
·Orthopedic
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 26, 2013
PROSTHETIC LIMB
FDA Adverse Event
Injury
·Product code ISS·March 12, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC·Product code JAA·March 19, 2008
ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code MIH·March 9, 2023
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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014