11 results
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25ms
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Sources: EU EUDAMED, US FDA
HOWMEDICA KNEE BRUSH
FDA 510(k)
FDA Class 1
·Orthopedic
Unimed
FDA UDI
Unimed Medical Supplies, Inc.·06945664810814·Reusable SpO2 Sensor/GE OxyTip+/Y-type Multi-si...
REGAIN DESKTOP
FDA 510(k)
FDA Class 2
·Neurology
ASAHI CORSAIR MICROCATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
STERRAD 100NX STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·May 9, 2014
NOVAMAX LINK GLUCOSE MONITOR
FDA Adverse Event
Malfunction
·NOVA BIOMEDICAL CORP·Product code NBW·October 19, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 31, 2007
SYRINGE 5ML EMERALD BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·April 30, 2019
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