9 results
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19ms
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Sources: EU EUDAMED, US FDA
CONPHAR CRUTCH PADS
FDA 510(k)
FDA Class 1
·Physical Medicine
MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
ACUMED CLAVICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MONOPOLAR CURVED SCISSORS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 9, 2014
PIAB: 8 FR - 30 CC FOS
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code DSP·October 19, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·August 31, 2007
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
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024