10 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16740914550·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674091455060·
ACCUWELL TSH, MODEL KAW-TSH-960
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRUM MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 28, 2014
HUMERUS GSB-III 76
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDC·May 4, 2011
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