12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
HARDKYDISK NEOMYCIN, 30 MCG
FDA 510(k)
FDA Class 2
·Microbiology
HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
INSYTE-N AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 31, 2025
MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·April 10, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·April 4, 2011
ILLUMENA-SYR-W/HF-150ML (LINDEN LUER)
FDA Adverse Event
Malfunction
·COVIDIEN·Product code DXT·May 16, 2008
INSYTE-N AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 21, 2025
INSYTE-N AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 21, 2025
STERRAD 100NX STERILIZER 1-DR
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·January 6, 2021
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
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018